Hatch-Waxman Lawsuits: How Often Indian Generic Makers Are Sued, FY2018–FY2025
Original analysis of 2,229 records from the Federal Judicial Center, FY2018–FY2025 (federal fiscal years, Oct. 1–Sept. 30). Published October 23, 2026.
We matched the first-listed defendant in every federal ANDA patent case (nature of suit 835) filed from fiscal 2018 through fiscal 2025 to its corporate group and the group's home country.
What the federal court records show
In fiscal 2025, 170 of the 301 Hatch-Waxman patent suits filed in U.S. district courts (56.5%) named a company belonging to an India-based drug group as the first defendant. Indian groups accounted for more than half of these cases in 7 of the eight fiscal years since the courts began coding ANDA cases separately. Our case totals for the fiscal years we checked match the federal judiciary's published counts to within one case.
- 56%FY2025 ANDA suits with an India-based first defendant
- 301ANDA patent suits filed in fiscal 2025
- 24Indian drug groups named first in FY2025 suits
A majority in fiscal 2025
170 of 301 ANDA patent suits (56.5%) named an entity of an India-based group as first defendant, up 5.1 percentage points from 51.4% in fiscal 2024.
Above half in most years
Across fiscal 2018 to 2025, 1,239 of 2,229 cases (55.6%) had an India-based first defendant. The highest share in the series was 63.7% in fiscal 2021.
Indian groups lead the ranking
Hetero (21 cases), Sun Pharma (17) and MSN (16) were the drug groups most often named as first defendant in fiscal 2025, counting subsidiaries and affiliates with their group; 8 of the ten most frequently named groups are headquartered in India.
U.S. firms a distant second
Groups based in the United States were first defendant in 46 fiscal 2025 cases (15.3%), and Chinese groups in 5.6%.
Two courts handle nearly all cases
96.0% of fiscal 2025 ANDA suits were filed in the District of New Jersey or the District of Delaware.
Quote this finding
In fiscal 2025, 170 of the 301 Hatch-Waxman patent suits filed in U.S. district courts (56.5%) named a company belonging to an India-based drug group as the first defendant. Source: Settlement Insight, Hatch-Waxman suits: Indian generics
What Share of Hatch-Waxman Lawsuits Target Indian Generic Makers
Federal courts have coded patent suits over Abbreviated New Drug Applications as a separate nature of suit since June 2017. We counted each fiscal year's cases and checked whether the first-named defendant belongs to a drug group headquartered in India.
The India-based share was 47.2% in fiscal 2018, reached 63.7% in fiscal 2021 and stood at 56.5% in fiscal 2025.
A brand-name drug company or patent holder usually files these suits after a generic company tells it that its abbreviated application challenges a listed patent. FDA explains that if the patent holder sues within 45 days, approval of the generic is generally postponed for 30 months. The generic applicant is therefore normally the defendant, and the first defendant listed on the docket is the company we classify.
We count a case as India-based when the first defendant is a company of a group whose ultimate parent is headquartered in India, whether the Indian parent itself or a U.S. or other foreign subsidiary, for example a U.S. sales arm of Lupin or Aurobindo. Across all eight years, 1,239 of 2,229 cases (55.6%) met that test. The share fell from fiscal 2021 to fiscal 2024 and rose again in fiscal 2025, when the number of cases also rose to 301 from 282.
Share of ANDA patent suits with an India-based first defendant
- FY201847.2%159 of 337 cases
- FY201955.1%168 of 305 cases
- FY202061.0%172 of 282 cases
- FY202163.7%142 of 223 cases
- FY202257.8%148 of 256 cases
- FY202355.6%135 of 243 cases
- FY202451.4%145 of 282 cases
- FY202556.5%170 of 301 cases
Federal fiscal years run from October 1 to September 30; FY2025 ended September 30, 2025.
Which Generic Drugmakers Are Sued Most in ANDA Litigation
We grouped every first-defendant name under its corporate parent, so that an Indian parent and its U.S. subsidiary count as one group.
In fiscal 2025, Hetero led with 21 cases, followed by Sun Pharma with 17 and MSN with 16. The most frequently named groups outside India were Apotex of Canada and Sandoz of Switzerland, with 12 cases each.
73 different drug groups appeared as first defendant in fiscal 2025, 24 of them headquartered in India. The five most frequently named Indian groups together accounted for 84 cases, or 27.9% of all fiscal 2025 ANDA suits.
Group totals depend on how subsidiaries are assigned. Sun Pharma's 17 cases include 5 naming Taro Pharmaceuticals, which we count under its parent; Hetero's total includes its affiliates Annora Pharma and Aspiro Pharma. The ranking counts lawsuits, not products or patents, and does not account for how many abbreviated applications each company files. A company that files many applications or challenges heavily patented drugs can be sued more often.
First-defendant drug groups in ANDA patent suits
| Group | Based in | FY2025 |
|---|---|---|
| Hetero | India | 21 |
| Sun Pharma | India | 17 |
| MSN | India | 16 |
| Aurobindo | India | 15 |
| Zydus | India | 15 |
| Cipla | India | 14 |
| Lupin | India | 13 |
| Apotex | Canada | 12 |
| Sandoz | Switzerland | 12 |
| Alkem | India | 10 |
| Hikma | United Kingdom | 8 |
| Teva | Israel | 6 |
| Dr. Reddy's | India | 6 |
| Qilu | China | 6 |
| Somerset Therapeutics | United States | 6 |
All drug groups
| Group | Based in | FY2025 |
|---|---|---|
| Granules | India | 6 |
| Intas | India | 5 |
| Alembic | India | 5 |
| Natco | India | 5 |
| Alvogen | United States | 5 |
| Amneal | United States | 4 |
| Macleods | India | 4 |
| Fosun Pharma | China | 4 |
| Saba | Turkey | 4 |
| Curium | France | 4 |
| Viatris | United States | 3 |
| Fresenius Kabi | Germany | 3 |
| Biocon | India | 3 |
| Insud Pharma | Spain | 3 |
| Orbicular | India | 3 |
| USV | India | 3 |
| Appco | United States | 3 |
| Creekwood | United States | 3 |
| Padagis | United States | 2 |
| Biophore | India | 2 |
| Glenmark | India | 2 |
| Endo | United States | 2 |
| Deva | Turkey | 2 |
| Meitheal | United States | 2 |
| Azurity | United States | 2 |
| Humanwell | China | 2 |
| Ever Pharma | Austria | 2 |
| BPI Labs | United States | 2 |
| Difgen | United States | 2 |
| Galenicum | Spain | 2 |
| Huahai | China | 1 |
| Ascent Pharmaceuticals | United States | 1 |
| Laurus Labs | India | 1 |
| Aizant | India | 1 |
| Baxter | United States | 1 |
| Towa | Japan | 1 |
| ANI Pharmaceuticals | United States | 1 |
| RK Pharma | United States | 1 |
| Rubicon Research | India | 1 |
| Umedica | India | 1 |
| Changzhou Pharmaceutical | China | 1 |
| Boehringer Ingelheim | Germany | 1 |
| CSPC | China | 1 |
| Lotus | Taiwan | 1 |
| Carnegie | United States | 1 |
| AbbVie | United States | 1 |
| Auzone | China | 1 |
| Inforlife | Switzerland | 1 |
| Ipca | India | 1 |
| Lannett | United States | 1 |
| MedChemExpress | United States | 1 |
| Nichi-Iko | Japan | 1 |
| Orient Pharma | Taiwan | 1 |
| PH Health | United Kingdom | 1 |
| Pacira | United States | 1 |
| Seasons Biotechnology | China | 1 |
| Takeda | Japan | 1 |
| Vgyaan | United States | 1 |
| Torrent | India | 0 |
| Perrigo | Ireland | 0 |
| Ajanta Pharma | India | 0 |
| Slayback | United States | 0 |
| Micro Labs | India | 0 |
| Synthon | Netherlands | 0 |
| Unichem | India | 0 |
| Shilpa Medicare | India | 0 |
| Bionpharma | United States | 0 |
| Mankind Pharma | India | 0 |
| Strides | India | 0 |
| Pfizer | United States | 0 |
| ScieGen | United States | 0 |
| Custopharm | United States | 0 |
| Evenus | United States | 0 |
| HEC | China | 0 |
| Nexus | United States | 0 |
| Novartis | Switzerland | 0 |
| Anobri | United States | 0 |
| Crystal Pharmaceutical | China | 0 |
| Eli Lilly | United States | 0 |
| BendaRx | United States | 0 |
| Handa | Taiwan | 0 |
| Inventia Healthcare | India | 0 |
| Jubilant | India | 0 |
| KVK-Tech | United States | 0 |
| Long Grove | United States | 0 |
| Emcure | India | 0 |
| Encube Ethicals | India | 0 |
| Hansoh | China | 0 |
| Mallinckrodt | United States | 0 |
| Optimus Pharma | India | 0 |
| Pharmascience | Canada | 0 |
| Rio Biopharmaceuticals | United States | 0 |
| Wockhardt | India | 0 |
| AET | Austria | 0 |
| Acrux | Australia | 0 |
| Amphastar | United States | 0 |
| Apicore | United States | 0 |
| AstraZeneca | United Kingdom | 0 |
| Auson | United States | 0 |
| Aveva | United States | 0 |
| Banner Life Sciences | United States | 0 |
| BioQ | United States | 0 |
| Bioprojet | France | 0 |
| Dexcel | Israel | 0 |
| Eagle | United States | 0 |
| GSK | United Kingdom | 0 |
| HBT Labs | United States | 0 |
| Hengrui | China | 0 |
| Indoco | India | 0 |
| Liquidia | United States | 0 |
| Luye | China | 0 |
| Nanjing Noratech | China | 0 |
| Riconpharma | United States | 0 |
| Saptalis | United States | 0 |
| Sigmapharm | United States | 0 |
| Sinotherapeutics | China | 0 |
| Steriscience | Singapore | 0 |
| Suven | India | 0 |
| Xspray | Sweden | 0 |
| ACME Laboratories | Bangladesh | 0 |
| Adamis | United States | 0 |
| Airgas | United States | 0 |
| Airis Pharma | India | 0 |
| Akorn | United States | 0 |
| Altan Pharma | Spain | 0 |
| Amta Labs | Not verified | 0 |
| Anchen | United States | 0 |
| Bayer | Germany | 0 |
| CMP Pharma | United States | 0 |
| Caplin Point | India | 0 |
| Celerity | United States | 0 |
| Centaur Pharmaceuticals | India | 0 |
| Cosette | United States | 0 |
| Cronus Pharma | United States | 0 |
| Crossmedika | Switzerland | 0 |
| Daiichi Sankyo | Japan | 0 |
| Dechra | United Kingdom | 0 |
| Elite | United States | 0 |
| Epic Pharma | United States | 0 |
| Eton | United States | 0 |
| Eurohealth | Luxembourg | 0 |
| First Time US Generics | United States | 0 |
| Fisiopharma | Italy | 0 |
| GE HealthCare | United States | 0 |
| Gerbera | United States | 0 |
| Graviti Pharmaceuticals | India | 0 |
| Haimen Pharma | China | 0 |
| Hainan Shuangcheng | China | 0 |
| Hisun | China | 0 |
| Hopewell | United States | 0 |
| Indivior | United Kingdom | 0 |
| Ingenus | United States | 0 |
| Jazz | Ireland | 0 |
| Kashiv | United States | 0 |
| King-Friend | China | 0 |
| Lantheus | United States | 0 |
| Merck | United States | 0 |
| Nanjing Delova | China | 0 |
| Nanocopoeia | United States | 0 |
| Navinta | United States | 0 |
| Nephron | United States | 0 |
| Nevakar | United States | 0 |
| Nivagen | United States | 0 |
| Novugen | Malaysia | 0 |
| Oncogen | Malaysia | 0 |
| Patrin | United States | 0 |
| Piramal | India | 0 |
| Purdue | United States | 0 |
| Radius | United States | 0 |
| Renata | Bangladesh | 0 |
| Sawai | Japan | 0 |
| ScinoPharm | Taiwan | 0 |
| Shanghai Pharmaceuticals | China | 0 |
| Sino Biopharmaceutical | China | 0 |
| Sintetica | Switzerland | 0 |
| Solaris | United States | 0 |
| Sumitomo Pharma | Japan | 0 |
| TWi | Taiwan | 0 |
| Tolmar | United States | 0 |
| Upsher-Smith | United States | 0 |
| VistaPharm | United States | 0 |
| Viwit | China | 0 |
| Windlas | India | 0 |
| Xellia | Denmark | 0 |
| Xiamen LP | China | 0 |
| Yabao | China | 0 |
How We Assigned Each Defendant to a Country
The court database records the first defendant's name as typed on the docket, cut off at 30 characters. We list every recorded name with the group and country we assigned.
Every one of the 2,229 cases is assigned; 19 cases name an individual or a company outside the drug industry and count as not India-based.
Names were matched by their leading characters, so spelling variants such as "LUPIN LTD." and "LUPIN LIMITED, ET AL" fall into the same group. A few cases coded as ANDA suits name defendants outside the pharmaceutical industry, apparently coding errors on the civil cover sheet; we keep them in the total so that it matches the judiciary's published count, which lowers the India share slightly. Excluding the 2 such cases in fiscal 2025, the share would be 56.9%.
Recorded first-defendant names in FY2025 suits and assigned group
- SANDOZ INC.11Sandoz · Switzerland
- ZYDUS PHARMACEUTICALS (, ET AL11Zydus · India
- SUN PHARMACEUTICAL INDU, ET AL10Sun Pharma · India
- LUPIN LIMITED, ET AL9Lupin · India
- CIPLA LIMITED, ET AL8Cipla · India
- MSN LABORATORIES PRIVAT, ET AL8MSN · India
- ALKEM LABORATORIES LTD.7Alkem · India
- HIKMA PHARMACEUTICALS USA INC.7Hikma · United Kingdom
- DR. REDDY'S LABORATORIE, ET AL6Dr. Reddy's · India
- ALEMBIC PHARMACEUTICALS, ET AL5Alembic · India
All recorded names
- APOTEX INC.5Apotex · Canada
- APOTEX INC., ET AL5Apotex · Canada
- AUROBINDO PHARMA LTD., ET AL5Aurobindo · India
- HETERO USA, INC., ET AL5Hetero · India
- QILU PHARMACEUTICAL CO., ET AL5Qilu · China
- AMNEAL PHARMACEUTICALS , ET AL4Amneal · United States
- AUROBINDO PHARMA LIMITE, ET AL4Aurobindo · India
- AUROBINDO PHARMA USA, I, ET AL4Aurobindo · India
- CIPLA USA, INC., ET AL4Cipla · India
- CURIUM US LLC, ET AL4Curium · France
- GLAND PHARMA LIMITED4Fosun Pharma · China
- HETERO LABS LIMITED, ET AL4Hetero · India
- HETERO USA INC., ET AL4Hetero · India
- MSN PHARMACEUTICALS INC, ET AL4MSN · India
- NATCO PHARMA LIMITED, ET AL4Natco · India
- SOMERSET THERAPEUTICS, , ET AL4Somerset Therapeutics · United States
- TEVA PHARMACEUTICALS, I, ET AL4Teva · Israel
- ALKEM LABORATORIES LIMITED3Alkem · India
- APPCO PHARMA LLC, ET AL3Appco · United States
- ANNORA PHARMA PRIVATE L, ET AL3Hetero · India
- MACLEODS PHARMACEUTICAL, ET AL3Macleods · India
- ORBICULAR PHARMACEUTICAL TECHN3Orbicular · India
- SABA ILAC SANAYI VE TICARET A.3Saba · Turkey
- USV PRIVATE LIMITED3USV · India
- APOTEX CORP., ET AL2Apotex · Canada
- EUGIA PHARMA SPECIALITI, ET AL2Aurobindo · India
- AZURITY PHARMACEUTICALS, ET AL2Azurity · United States
- BPI LABS, LLC2BPI Labs · United States
- ZENARA PHARMA PRIVATE L, ET AL2Biophore · India
- DIFGEN PHARMACEUTICALS LLC2Difgen · United States
- EVER VALINJECT GMBH, ET AL2Ever Pharma · Austria
- GALENICUM HEALTH S.L.U.2Galenicum · Spain
- GRANULES INDIA LIMITED2Granules · India
- ANNORA PHARMA PRIVATE LIMITED2Hetero · India
- HUMANWELL PHARMACEUTICA, ET AL2Humanwell · China
- ACCORD HEALTHCARE, INC.2Intas · India
- INTAS PHARMACEUTICALS L, ET AL2Intas · India
- LUPIN INC., ET AL2Lupin · India
- MSN PHARMACEUTICALS INC.2MSN · India
- MEITHEAL PHARMACEUTICAL, ET AL2Meitheal · United States
- Non-pharmaceutical or individual defendant2Non-pharmaceutical or individual defendant ·
- SUN PHARMACEUTICAL INDUSTRIES2Sun Pharma · India
- TARO PHARMACEUTICALS IN, ET AL2Sun Pharma · India
- MYLAN PHARMACEUTICALS INC.2Viatris · United States
- ZYDUS LIFESCIENCES GLOB, ET AL2Zydus · India
- NOVITIUM PHARMA LLC1ANI Pharmaceuticals · United States
- ABBVIE INC., ET AL1AbbVie · United States
- AIZANT DRUG RESEARCH SOLUTIONS1Aizant · India
- ALMAJECT INC., ET AL1Alvogen · United States
- ALMAJECT, INC., ET AL1Alvogen · United States
- ALVOGEN PB RESEARCH & D, ET AL1Alvogen · United States
- ALVOGEN, INC., ET AL1Alvogen · United States
- NORWICH PHARMACEUTICALS, ET AL1Alvogen · United States
- ASCENT PHARMACEUTICALS, INC.1Ascent Pharmaceuticals · United States
- SHANGHAI AUZONE BIOLOGI, ET AL1Auzone · China
- BAXTER HEALTHCARE CORPORATION1Baxter · United States
- BIOCON LIMITED, ET AL1Biocon · India
- BIOCON PHARMA LIMITED, ET AL1Biocon · India
- BIOCON PHARMA LTD, ET AL1Biocon · India
- BOEHRINGER INGELHEIM PH, ET AL1Boehringer Ingelheim · Germany
- CONJUPRO BIOTHERAPEUTIC, ET AL1CSPC · China
- CARNEGIE PHARMACEUTICAL, ET AL1Carnegie · United States
- CHANGZHOU PHARMACEUTICA, ET AL1Changzhou Pharmaceutical · China
- CIPLA LIMITED1Cipla · India
- INVAGEN PHARMACEUTICALS, ET AL1Cipla · India
- CREEKWOOD PHARMACEUTICALS LLC1Creekwood · United States
- CREEKWOOD PHARMACEUTICALS, LL1Creekwood · United States
- CREEKWOOD PHARMACEUTICALS, LLC1Creekwood · United States
- DEVA HOLDING A.S.1Deva · Turkey
- DEVA HOLDING A/S1Deva · Turkey
- ENDO OPERATIONS LIMITED1Endo · United States
- ENDO OPERATIONS LIMITED, ET AL1Endo · United States
- FRESENIUS KABI USA LLC, ET AL1Fresenius Kabi · Germany
- FRESENIUS KABI USA, LLC1Fresenius Kabi · Germany
- FRESENIUS KABI USA, LLC, ET AL1Fresenius Kabi · Germany
- GLENMARK PHARMACEUTICAL, ET AL1Glenmark · India
- GLENMARK PHARMACEUTICALS INC.,1Glenmark · India
- GRANULES INDIA LIMITED, ET AL1Granules · India
- GRANULES INDIA LTD.1Granules · India
- GRANULES PHARMACEUTICALS INC.1Granules · India
- GRANULES PHARMACEUTICALS, INC.1Granules · India
- ASPIRO PHARMA LTD.1Hetero · India
- ASPIRO PHARMA LTD., ET AL1Hetero · India
- HETERO LABS LIMITED UNI, ET AL1Hetero · India
- HIKMA PHARMACEUTICALS P, ET AL1Hikma · United Kingdom
- PRINSTON PHARMACEUTICAL INC.1Huahai · China
- INFORLIFE SA, ET AL1Inforlife · Switzerland
- XIROMED PHARMA ESPAA, S, ET AL1Insud Pharma · Spain
- XIROMED, LLC , ET AL1Insud Pharma · Spain
- XIROMED, LLC, ET AL1Insud Pharma · Spain
- ACCORD HEALTHCARE INC.1Intas · India
- IPCA LABORATORIES LTD.1Ipca · India
- LANNETT COMPANY, INC.1Lannett · United States
- LAURUS LABS, LTD., ET AL1Laurus Labs · India
- LOTUS PHARMACEUTICAL CO., LTD.1Lotus · Taiwan
- LUPIN LTD., ET AL1Lupin · India
- LUPIN, LTD., ET AL1Lupin · India
- MSN LABORATORIES PRIVATE LTD.1MSN · India
- MSN PHARMACEUTICALS, IN, ET AL1MSN · India
- MACLEODS PHARMACEUTICALS LTD.1Macleods · India
- MEDCHEMEXPRESS LLC1MedChemExpress · United States
- NATCO PHARMA LIMITED1Natco · India
- SAGENT PHARMACEUTICALS1Nichi-Iko · Japan
- ORIENT PHARMA CO., LTD.1Orient Pharma · Taiwan
- PH HEALTH LTD., ET AL1PH Health · United Kingdom
- PACIRA PHARMACEUTICALS, ET AL1Pacira · United States
- PADAGIS ISRAEL PHARMACEUTICALS1Padagis · United States
- PADAGIS LLC, ET AL1Padagis · United States
- QILU PHARMACEUTICAL (HA, ET AL1Qilu · China
- RK PHARMA, INC.1RK Pharma · United States
- RUBICON RESEARCH PRIVATE LIMIT1Rubicon Research · India
- SABA ILAC SANAYI VE TICARET AS1Saba · Turkey
- SANDOZ INC., ET AL1Sandoz · Switzerland
- SEASONS BIOTECHNOLOGY (, ET AL1Seasons Biotechnology · China
- SOMERSET THERAPEUTICS LLC1Somerset Therapeutics · United States
- SOMERSET THERAPEUTICS, LLC1Somerset Therapeutics · United States
- TARO PHARMACEUTICALS INC.1Sun Pharma · India
- TARO PHARMACEUTICALS US, ET AL1Sun Pharma · India
- TARO PHARMACEUTICALS, INC.1Sun Pharma · India
- SHIRE-NPS PHARMACEUTICA, ET AL1Takeda · Japan
- TEVA PHARMACEUTICALS U, ET AL1Teva · Israel
- TEVA PHARMACEUTICALS, INC.1Teva · Israel
- BRECKENRIDGE PHARMACEUTICAL, I1Towa · Japan
- UMEDICA LABORATORIES PVT. LTD.1Umedica · India
- VGYAAN PHARMACEUTICALS , ET AL1Vgyaan · United States
- MYLAN PHARMACEUTICALS, INC.1Viatris · United States
- ZYDUS LIFESCIENCES LIMI, ET AL1Zydus · India
- ZYDUS PHARMACEUTICALS (USA) IN1Zydus · India
- THE ACME LABORATORIES LTD.0ACME Laboratories · Bangladesh
- AET PHARMA US, INC., ET AL0AET · Austria
- ANI PHARMACEUTICALS, INC.0ANI Pharmaceuticals · United States
- NOVITIUM PHARMA, LLC0ANI Pharmaceuticals · United States
- ACRUX DDS PTY LTD.0Acrux · Australia
- ACRUX DDS PTY. LTD.0Acrux · Australia
- ADAMIS PHARMACEUTICALS CORP.0Adamis · United States
- AIRGAS THERAPEUTICS LLC, ET AL0Airgas · United States
- AIRIS PHARMA PRIVATE LIMITED0Airis Pharma · India
- AIZANT DRUG RESEARCH SO, ET AL0Aizant · India
- AJANTA PHARMA LIMITED0Ajanta Pharma · India
- AJANTA PHARMA LIMITED, ET AL0Ajanta Pharma · India
- AJANTA PHARMA LTD.0Ajanta Pharma · India
- AJANTA PHARMA LTD., ET AL0Ajanta Pharma · India
- AKORN, INC., ET AL0Akorn · United States
- ALEMBIC GLOBAL HOLDING , ET AL0Alembic · India
- ALEMBIC PHARMACEUTICALS LIMITE0Alembic · India
- ALEOR DERMACEUTICALS LTD.0Alembic · India
- ALKEM LABORATORIES LIMI, ET AL0Alkem · India
- ALKEM LABORATORIES LTD., ET AL0Alkem · India
- ALTAN PHARMA LTD.0Altan Pharma · Spain
- ALVOGEN PINE BROOK LLC0Alvogen · United States
- ALVOGEN PINE BROOK LLC, ET AL0Alvogen · United States
- ALVOGEN PINE BROOK, LLC, ET AL0Alvogen · United States
- ALVOGEN, INC.0Alvogen · United States
- AMNEAL EU, LIMITED, ET AL0Amneal · United States
- AMNEAL PHARMACEUTICALS LLC0Amneal · United States
- AMNEAL PHARMACEUTICALS LLC.0Amneal · United States
- AMNEAL PHARMACEUTICALS, ET AL0Amneal · United States
- AMNEAL PHARMACEUTICALS, LLC0Amneal · United States
- IMPAX LABORATORIES LLC0Amneal · United States
- IMPAX LABORATORIES, INC.0Amneal · United States
- AMPHASTAR PHARMACEUTICA, ET AL0Amphastar · United States
- INTERNATIONAL MEDICATION SYSTE0Amphastar · United States
- AMTA LABS LIMITED0Amta Labs · Not verified
- ANCHEN PHARMACEUTICALS, ET AL0Anchen · United States
- ANOBRI PHARMACEUTICALS , ET AL0Anobri · United States
- APICORE US LLC0Apicore · United States
- APICORE US LLC , ET AL0Apicore · United States
- APOTEX, INC.0Apotex · Canada
- APOTEX, INC.,0Apotex · Canada
- APOTEX, INC., ET AL0Apotex · Canada
- APPCO PHARMA LTD., ET AL0Appco · United States
- ASCENT PHARMACEUTICALS , ET AL0Ascent Pharmaceuticals · United States
- ASCENT PHARMACEUTICALS INC.0Ascent Pharmaceuticals · United States
- ASCENT PHARMACEUTICALS, ET AL0Ascent Pharmaceuticals · United States
- ASTRAZENECA AB, ET AL0AstraZeneca · United Kingdom
- AUROBINDO PHARMA LIMITED0Aurobindo · India
- AUROBINDO PHARMA LTD. , ET AL0Aurobindo · India
- AUROBINDO PHARMA U.S.A., ET AL0Aurobindo · India
- AUROBINDO PHARMA USA IN, ET AL0Aurobindo · India
- AUROBINDO PHARMA USA INC.0Aurobindo · India
- AUROBINDO PHARMA USA, INC.0Aurobindo · India
- AUROBINDO PHARMA, LTD., ET AL0Aurobindo · India
- AUROBINDO PHARMACEUTICA, ET AL0Aurobindo · India
- AUROLIFE PHARMA LLC0Aurobindo · India
- EUGIA PHARMA SPECIALTIE, ET AL0Aurobindo · India
- EUGIA PHARMA SPECIALTIES, LTD.0Aurobindo · India
- AUSON PHARMACEUTICALS I, ET AL0Auson · United States
- AUSON PHARMACEUTICALS, , ET AL0Auson · United States
- AVEVA DRUG DELIVERY SYS, ET AL0Aveva · United States
- AZURITY PHARMACEUTICALS, INC.0Azurity · United States
- BANNER LIFE SCIENCES LLC0Banner Life Sciences · United States
- BAXTER HEALTHCARE CORPO, ET AL0Baxter · United States
- BAYER INTELLECTUAL PROP, ET AL0Bayer · Germany
- BENDARX CORP.0BendaRx · United States
- BENDARX USA0BendaRx · United States
- BENDARX USA CORP0BendaRx · United States
- BIOQ PHARMA INC.0BioQ · United States
- BIOQ PHARMA INCORPORATED0BioQ · United States
- BIOCON PHARMA LIMITED0Biocon · India
- BIOCON PHARMA LTD., ET AL0Biocon · India
- BIONPHARMA INC.0Bionpharma · United States
- BIONPHARMA INC., ET AL0Bionpharma · United States
- BIONPHARMA, INC.0Bionpharma · United States
- BIOPHORE PHARMA INC., ET AL0Biophore · India
- ZENARA PHARMA PRIVATE LIMITED0Biophore · India
- BIOPROJET SOCIETE CIVILE DE RE0Bioprojet · France
- BOEHRINGER LNGELHEIM PH, ET AL0Boehringer Ingelheim · Germany
- CMP DEVELOPMENT LLC0CMP Pharma · United States
- CAPLIN STERILES LTD., ET AL0Caplin Point · India
- CARNEGIE PHARMACEUTICALS, LLC0Carnegie · United States
- CELERITY PHARMACEUTICAL, ET AL0Celerity · United States
- CENTAUR PHARMACEUTICALS PRIVAT0Centaur Pharmaceuticals · India
- CHANGZHOU PHARMACEUTICAL FACTO0Changzhou Pharmaceutical · China
- CIPLA LTD.0Cipla · India
- CIPLA LTD., ET AL0Cipla · India
- CIPLA USA, INC. , ET AL0Cipla · India
- CIPLA, LTD., ET AL0Cipla · India
- INVAGEN PHARMACEUTICALS INC.0Cipla · India
- INVAGEN PHARMACEUTICALS, INC.0Cipla · India
- COSETTE PHARMACEUTICALS, INC.0Cosette · United States
- CRONUS PHARMA LLC, ET AL0Cronus Pharma · United States
- CROSSMEDIKA S.A.0Crossmedika · Switzerland
- CRYSTAL PHARMACEUTICAL (SUZHOU0Crystal Pharmaceutical · China
- CRYSTAL PHARMACEUTICAL , ET AL0Crystal Pharmaceutical · China
- CUSTOPHARM, INC.0Custopharm · United States
- AMERICAN REGENT, INC., ET AL0Daiichi Sankyo · Japan
- DECHRA VETERINARY PRODUCTS, LL0Dechra · United Kingdom
- DEXCEL PHARMA TECHNOLOG, ET AL0Dexcel · Israel
- DEXCEL PHARMA TECHNOLOGIES LTD0Dexcel · Israel
- DR. REDDY'S LABORATORIES, INC.0Dr. Reddy's · India
- DR. REDDYS LABORATORIES, ET AL0Dr. Reddy's · India
- DR.REDDY'S LABORATORIES, ET AL0Dr. Reddy's · India
- EAGLE PHARMACEUTICALS, INC.0Eagle · United States
- ELI LILLY & COMPANY0Eli Lilly · United States
- ELI LILLY AND COMPANY0Eli Lilly · United States
- ELI LILLY AND COMPANY, ET AL0Eli Lilly · United States
- ELITE LABORATORIES, INC, ET AL0Elite · United States
- EMCURE PHARMACEUTICALS , ET AL0Emcure · India
- EMCURE PHARMACEUTICALS LTD.0Emcure · India
- ENCUBE ETHICALS PRIVATE, LTD.0Encube Ethicals · India
- ENCUBE ETHICALS PVT. LTD.0Encube Ethicals · India
- PAR PHARMACEUTICAL COMP, ET AL0Endo · United States
- PAR PHARMACEUTICAL INC, ET AL0Endo · United States
- PAR PHARMACEUTICAL, INC, ET AL0Endo · United States
- PAR PHARMACEUTICAL, INC.0Endo · United States
- PAR PHARMACEUTICALS, IN, ET AL0Endo · United States
- EPIC PHARMA, LLC0Epic Pharma · United States
- ETON PHARMACEUTICALS, I, ET AL0Eton · United States
- EUROHEALTH INTERNATIONAL SARL0Eurohealth · Luxembourg
- EVENUS PHARMACEUTICALS , ET AL0Evenus · United States
- FIRST TIME US GENERICS, LLC0First Time US Generics · United States
- FISIOPHARMA S.R.L.0Fisiopharma · Italy
- GLAND PHARMA LIMITED, ET AL0Fosun Pharma · China
- GLAND PHARMA LTD0Fosun Pharma · China
- GLAND PHARMA LTD.0Fosun Pharma · China
- FK FRESENIUS KABI USA, LLC0Fresenius Kabi · Germany
- GE HEALTHCARE INC.0GE HealthCare · United States
- GLAXOSMITHKLINE CONSUM, ET AL0GSK · United Kingdom
- GLAXOSMITHKLINE LLC, ET AL0GSK · United Kingdom
- GERBERA THERAPEUTICS IN, ET AL0Gerbera · United States
- GLENMARK PHARMACEUTICALS LIMIT0Glenmark · India
- GLENMARK PHARMACEUTICALS LTD.0Glenmark · India
- GRANULES PHARMACEUTICAL, ET AL0Granules · India
- GRAVITI PHARMACEUTICALS PRIVAT0Graviti Pharmaceuticals · India
- HBT LABS, INC.0HBT Labs · United States
- HEC PHARM CO., LTD., ET AL0HEC · China
- SUNSHINE LAKE PHARMA CO, ET AL0HEC · China
- HAIMEN PHARMA INC., ET AL0Haimen Pharma · China
- HAINAN SHUANGCHENG PHARMACEUTI0Hainan Shuangcheng · China
- HANDA NEUROSCIENCE, LLC, ET AL0Handa · Taiwan
- HANDA ONCOLOGY, LLC0Handa · Taiwan
- JIANGSU HANSOH PHARMACEUTICAL0Hansoh · China
- JIANGSU HENGRUI MEDICINE CO.,0Hengrui · China
- JIANGSU HENGRUI PHARMACEUTICAL0Hengrui · China
- ANNORA PHARMA PRIVATE LTD.0Hetero · India
- ASPIRO PHARMA LIMITED0Hetero · India
- HETERO LABS LTD., ET AL0Hetero · India
- HIKMA PHARMACEUTICALS I, ET AL0Hikma · United Kingdom
- HIKMA PHARMACEUTICALS U, ET AL0Hikma · United Kingdom
- HIKMA PHARMACEUTICALS USA, INC0Hikma · United Kingdom
- WEST-WARD PHARMACEUTICA, ET AL0Hikma · United Kingdom
- HISUN PHARMACEUTICAL (H, ET AL0Hisun · China
- HOPEWELL PHARMA VENTURE, ET AL0Hopewell · United States
- PRINSTON PHARMACEUTICAL, ET AL0Huahai · China
- PRINSTON PHARMACEUTICAL, INC.0Huahai · China
- HUMANWELL PURACAP PHARM, ET AL0Humanwell · China
- PURACAP PHARMACEUTICAL LLC0Humanwell · China
- INDIVIOR INC., ET AL0Indivior · United Kingdom
- INDOCO REMEDIES LIMITED, ET AL0Indoco · India
- INDOCO REMEDIES LTD.0Indoco · India
- INGENUS PHARMACEUTICALS, LLC0Ingenus · United States
- CHEMO RESEARCH S.L., ET AL0Insud Pharma · Spain
- CHEMO RESEARCH, S.L., ET AL0Insud Pharma · Spain
- XIROMED PHARMA ESPANA, , ET AL0Insud Pharma · Spain
- ACCORD HEALTHCARE INC., ET AL0Intas · India
- ACCORD HEALTHCARE INC., USA0Intas · India
- ACCORD HEALTHCARE, INC., ET AL0Intas · India
- INVENTIA HEALTHCARE LIMITED0Inventia Healthcare · India
- INVENTIA HEALTHCARE LTD, ET AL0Inventia Healthcare · India
- JAZZ PHARMACEUTICALS, INC.0Jazz · Ireland
- JUBILANT DRAXIMAGE INC.0Jubilant · India
- JUBILANT LIFE SCIENCES , ET AL0Jubilant · India
- JUBILANT PHARMOVA LIMIT, ET AL0Jubilant · India
- KVK-TECH, INC.0KVK-Tech · United States
- KASHIV PHARMA, LLC0Kashiv · United States
- HONG KONG KING-FRIEND INDUSTRI0King-Friend · China
- LANTHEUS MEDICAL IMAGIN, ET AL0Lantheus · United States
- LAURUS LABS LIMITED, ET AL0Laurus Labs · India
- LAURUS LABS LTD., ET AL0Laurus Labs · India
- LIQUIDIA TECHNOLOGIES, INC.0Liquidia · United States
- LONG GROVE PHARMACEUTICALS, LL0Long Grove · United States
- LOTUS PHARMACEUTICAL CO, ET AL0Lotus · Taiwan
- LUPIN ATLANTIS HOLDINGS, ET AL0Lupin · India
- LUPIN INC.0Lupin · India
- LUPIN LIMITED0Lupin · India
- LUPIN LTD.0Lupin · India
- LUYE PHARMA GROUP LTD., ET AL0Luye · China
- MSN PHARMACEUTICALS, I, ET AL0MSN · India
- MACLEODS PHARMACEUTICA, ET AL0Macleods · India
- MALLINCKRODT PLC, ET AL0Mallinckrodt · United States
- SPECGX LLC0Mallinckrodt · United States
- MANKIND PHARMA LIMITED0Mankind Pharma · India
- MANKIND PHARMA LIMITED, ET AL0Mankind Pharma · India
- MANKIND PHARMA LTD.0Mankind Pharma · India
- MANKIND PHARMA LTD., ET AL0Mankind Pharma · India
- MEITHEAL PHARMACEUTICALS, IN0Meitheal · United States
- MEITHEAL PHARMACEUTICALS, INC.0Meitheal · United States
- MERCK SHARP & DOHME CORP.0Merck · United States
- MICRO LABS LIMITED, ET AL0Micro Labs · India
- MICRO LABS LTD., ET AL0Micro Labs · India
- MICRO LABS USA, INC. , ET AL0Micro Labs · India
- MICRO LABS, LTD., ET AL0Micro Labs · India
- NANJING DELOVA BIOTECH CO., LT0Nanjing Delova · China
- NANJING NORATECH PHARMA, ET AL0Nanjing Noratech · China
- NANJING NORATECH PHARMACEUTICA0Nanjing Noratech · China
- NANOCOPOEIA, LLC0Nanocopoeia · United States
- NATCO PHARMA LTD.0Natco · India
- NATCO PHARMA LTD., ET AL0Natco · India
- NATCO PHARMA, INC., ET AL0Natco · India
- NAVINTA LLC, ET AL0Navinta · United States
- NEPHRON SC, INC.0Nephron · United States
- NEVAKAR INJECTABLES, IN, ET AL0Nevakar · United States
- NEXUS PHARMACEUTICALS, , ET AL0Nexus · United States
- NEXUS PHARMACEUTICALS, INC.0Nexus · United States
- NIVAGEN PHARMACEUTICALS, ET AL0Nivagen · United States
- NOVARTIS AG, ET AL0Novartis · Switzerland
- NOVARTIS PHARMACEUTICAL, ET AL0Novartis · Switzerland
- NOVARTIS PHARMACEUTICALS CORPO0Novartis · Switzerland
- NOVUGEN ONCOLOGY SDN. B, ET AL0Novugen · Malaysia
- ONCOGEN PHARMA (MALAYSIA) SDN.0Oncogen · Malaysia
- OPTIMUS PHARMA PVT. LTD, ET AL0Optimus Pharma · India
- OPTIMUS PHARMA PVT. LTD.0Optimus Pharma · India
- ORBICULAR PHARMACEUTICA, ET AL0Orbicular · India
- PADAGIS ISRAEL PHARMACE, ET AL0Padagis · United States
- PATRIN PHARMA, INC.0Patrin · United States
- PERRIGO COMPANY, ET AL0Perrigo · Ireland
- PERRIGO ISRAEL PHARMACE, ET AL0Perrigo · Ireland
- PERRIGO PHARMA INTERNAT, ET AL0Perrigo · Ireland
- PERRIGO UK FINCO LIMITE, ET AL0Perrigo · Ireland
- PERRIGO UK FINCO LIMITED PARTN0Perrigo · Ireland
- HOSPIRA, INC.0Pfizer · United States
- PFIZER INC, ET AL0Pfizer · United States
- PFIZER INC., ET AL0Pfizer · United States
- PFIZER, INC., ET AL0Pfizer · United States
- PHARMASCIENCE INC.0Pharmascience · Canada
- PHARMASCIENCE INC., ET AL0Pharmascience · Canada
- PIRAMAL HEALTHCARE UK LIMITED0Piramal · India
- RHODES PHARMACEUTICALS L.P.0Purdue · United States
- QILU PHARMA INC.0Qilu · China
- QILU PHARMA, INC., ET AL0Qilu · China
- QILU PHARMACEUTICAL CO. LTD.0Qilu · China
- QILU PHARMACEUTICAL CO., LTD.0Qilu · China
- RK PHARMA INC. , ET AL0RK Pharma · United States
- RK PHARMA, INC., ET AL0RK Pharma · United States
- RADIUS HEALTH, INC.0Radius · United States
- RENATA LIMITED, ET AL0Renata · Bangladesh
- RICONPHARMA LLC, ET AL0Riconpharma · United States
- RIO BIOPHARMACEUTICALS, ET AL0Rio Biopharmaceuticals · United States
- RIO BIOPHARMACEUTICALS, INC.0Rio Biopharmaceuticals · United States
- RUBICON RESEARCH PRIVATE LTD.0Rubicon Research · India
- SABA ILAC SANAYI VE TIC, ET AL0Saba · Turkey
- SANDOZ, INC.0Sandoz · Switzerland
- SANDOZ, INC., ET AL0Sandoz · Switzerland
- SAPTALIS PHARMACEUTICALS, LLC0Saptalis · United States
- SAWAI PHARMACEUTICAL CO, ET AL0Sawai · Japan
- SCIEGEN PHARMACEUTICALS, ET AL0ScieGen · United States
- SCIEGEN PHARMACEUTICALS, INC.0ScieGen · United States
- SCINOPHARM TAIWAN LTD.0ScinoPharm · Taiwan
- SPH SHANGHAI ZHONGXI PHARMACEU0Shanghai Pharmaceuticals · China
- SHILPA MEDICARE LIMITED0Shilpa Medicare · India
- SHILPA MEDICARE LIMITED, ET AL0Shilpa Medicare · India
- SHILPA MEDICARE LTD.0Shilpa Medicare · India
- SHIPLA MEDICARE LIMITED0Shilpa Medicare · India
- SIGMAPHARM LABORATORIES, LLC0Sigmapharm · United States
- CHIA TAI TIANQING PHARM, ET AL0Sino Biopharmaceutical · China
- SINOTHERAPEUTICS INC.0Sinotherapeutics · China
- SINTETICA S.A.0Sintetica · Switzerland
- SLAYBACK PHARMA LIMITED LIABIL0Slayback · United States
- SLAYBACK PHARMA LLC0Slayback · United States
- SLAYBACK PHARMA LLC, ET AL0Slayback · United States
- SLAYBACK PHARMA, LLC, ET AL0Slayback · United States
- SOLARIS PHARMA CORP.0Solaris · United States
- SOMERSET PHARMA, LLC, ET AL0Somerset Therapeutics · United States
- STERISCIENCE PTE LIMITED0Steriscience · Singapore
- STERISCIENCE PTE. LTD0Steriscience · Singapore
- STRIDES PHARMA GLOBAL P, ET AL0Strides · India
- STRIDES PHARMA INC., ET AL0Strides · India
- STRIDES PHARMA, INC., ET AL0Strides · India
- SUMITOMO DAINIPPON PHAR, ET AL0Sumitomo Pharma · Japan
- OHM LABORATORIES INC.0Sun Pharma · India
- SUN PHARMA ADVANCED RES, ET AL0Sun Pharma · India
- SUN PHARMA GLOBAL FZE0Sun Pharma · India
- SUN PHARMA GLOBAL FZE, ET AL0Sun Pharma · India
- SUN PHARMACEUTICAL IN, ET AL0Sun Pharma · India
- SUN PHARMACEUTICAL INDUSTRIE0Sun Pharma · India
- SUN PHARMACEUTICAL INDUSTRIES,0Sun Pharma · India
- SUN PHARMACEUTICALS IND, ET AL0Sun Pharma · India
- SUN PHARMACEUTICALS INDUSTRIES0Sun Pharma · India
- TARO PHARMACEUTICAL IND, ET AL0Sun Pharma · India
- TARO PHARMACEUTICALS U., ET AL0Sun Pharma · India
- TARO PHARMACEUTICALS U.S.A., I0Sun Pharma · India
- SUVEN LIFE SCIENCES, LTD0Suven · India
- SYNTHON BV, ET AL0Synthon · Netherlands
- SYNTHON PHARMACEUTICALS, ET AL0Synthon · Netherlands
- SYNTHON PHARMECEUTICALS, ET AL0Synthon · Netherlands
- TWI PHARMACEUTICALS, IN, ET AL0TWi · Taiwan
- ACTAVIS ELIZABETH LLC, ET AL0Teva · Israel
- ACTAVIS LABORATORIES FL, ET AL0Teva · Israel
- ACTAVIS LABORATORIES FL, INC.0Teva · Israel
- ACTAVIS LABORATORIES UT0Teva · Israel
- ACTAVIS LABORATORIES UT, INC.0Teva · Israel
- ACTAVIS LLC, ET AL0Teva · Israel
- BARR LABORATORIES, INC.0Teva · Israel
- TEVA PHARMACEUTICAL IN, ET AL0Teva · Israel
- TEVA PHARMACEUTICAL IND, ET AL0Teva · Israel
- TEVA PHARMACEUTICAL USA, INC.0Teva · Israel
- TEVA PHARMACEUTICALS , ET AL0Teva · Israel
- TEVA PHARMACEUTICALS DE, ET AL0Teva · Israel
- TEVA PHARMACEUTICALS DEVELOPME0Teva · Israel
- TEVA PHARMACEUTICALS IN, ET AL0Teva · Israel
- TEVA PHARMACEUTICALS US, ET AL0Teva · Israel
- TEVA PHARMACEUTICALS USA INC.0Teva · Israel
- TEVA PHARMACEUTICALS USA, INC0Teva · Israel
- TEVA PHARMACEUTICALS USA, INC.0Teva · Israel
- WATSON LABORATORIES, IN, ET AL0Teva · Israel
- TOLMAR, INC., ET AL0Tolmar · United States
- TORRENT PHARMA INC., ET AL0Torrent · India
- TORRENT PHARMACEUTICALS LTD.0Torrent · India
- TORRENT PHARMACEUTICALS, ET AL0Torrent · India
- BRECKENRIDGE PHARMACEUT, ET AL0Towa · Japan
- USV PRIVATE LTD., ET AL0USV · India
- UMEDICA LABORATORIES PVT., LTD0Umedica · India
- UNICHEM INC., ET AL0Unichem · India
- UNICHEM LABORATORIES LI, ET AL0Unichem · India
- UNICHEM LABORATORIES LTD.0Unichem · India
- UNICHEM LABORATORIES, LIMITED0Unichem · India
- UNICHEM LABORATORIES, LTD.0Unichem · India
- UPSHER-SMITH LABORATORIES, LLC0Upsher-Smith · United States
- MYLAN API US LLC, ET AL0Viatris · United States
- MYLAN INSTITUTIONAL LLC0Viatris · United States
- MYLAN LABORATORIES LIMI, ET AL0Viatris · United States
- MYLAN LABORATORIES LIMITED0Viatris · United States
- MYLAN LABORATORIES LTD, ET AL0Viatris · United States
- MYLAN LABORATORIES LTD.0Viatris · United States
- MYLAN LABORATORIES LTD., ET AL0Viatris · United States
- MYLAN N.V., ET AL0Viatris · United States
- MYLAN PHARMACEUTICALS I, ET AL0Viatris · United States
- MYLAN TECHNOLOGIES INC.0Viatris · United States
- MYLAN TECHNOLOGIES INC., ET AL0Viatris · United States
- VIATRIS INC., ET AL0Viatris · United States
- VISTAPHARM, INC.0VistaPharm · United States
- VIWIT PHARMACEUTICAL CO., LTD.0Viwit · China
- WINDLAS HEALTHCARE, PVT. LTD.0Windlas · India
- WOCKHARDT BIO AG, ET AL0Wockhardt · India
- WOCKHARDT USA LLC, ET AL0Wockhardt · India
- XELLIA PHARMACEUTICALS , ET AL0Xellia · Denmark
- XIAMEN LP PHARMACEUTICAL CO.,0Xiamen LP · China
- XSPRAY PHARMA AB0Xspray · Sweden
- YABAO PHARMACEUTICAL CO, ET AL0Yabao · China
- ZYDUS LIFESCIENCES LTD., ET AL0Zydus · India
- ZYDUS PHARMACEUTICALS (USA), I0Zydus · India
- ZYDUS PHARMACEUTICALS U, ET AL0Zydus · India
- ZYDUS WORLDWIDE DMCC, ET AL0Zydus · India
Download the Data and Cite This Study
Every table as a CSV file and in one Excel workbook, a short PDF summary and every chart as an image, free to reuse with attribution (CC BY 4.0).
- ANDA patent suits by first-defendant corporate group, FY2018-FY2025Number of NOS 835 cases in which each generic drug group's entity was the first-listed defendant, with the headquarters country of the group's ultimate parent. · 201 rows · CSV, 10 KB
- Hatch-Waxman (ANDA) patent suits by fiscal year and India-based first defendantFederal district court cases commenced under nature of suit 835 per fiscal year, split by whether the first-listed defendant belongs to a drug group headquartered in India. · 8 rows · CSV, 1 KB
- How each recorded first-defendant name was assigned to a corporate groupEvery first-defendant name as recorded (truncated) in the FJC Integrated Database for NOS 835 cases filed FY2018-FY2025, with our group and country assignment; individuals and non-drug firms pooled. · 493 rows · CSV, 27 KB
- All tables in one Excel workbookOne sheet per table plus an About sheet with sources, method and citation · Excel (.xlsx), 38 KB
- Summary to print or forward (3 pages)Short answer, key figures, main chart, findings, method and citation · PDF, 195 KB
Charts for your story
Share of ANDA patent suits with an India-based first defendant
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First-defendant drug groups in ANDA patent suits
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Recorded first-defendant names in FY2025 suits and assigned group
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How to cite
Goldberg, L. (2026). Hatch-Waxman (ANDA) patent suits in U.S. district courts — first defendants by drug group and home country (FY2018–FY2025) [Data set]. Settlement Insight. https://settlementinsight.com/research/hatch-waxman-lawsuits-indian-generic-makers
BibTeX
@dataset{goldberg_2026_hatch_waxman_lawsuits_indian_generic_makers,
author = {Goldberg, Leonard},
title = {Hatch-Waxman (ANDA) patent suits in U.S. district courts --- first defendants by drug group and home country (FY2018--FY2025)},
year = {2026},
publisher = {Settlement Insight},
url = {https://settlementinsight.com/research/hatch-waxman-lawsuits-indian-generic-makers}
}How We Measured
Data come from the Integrated Database of the Federal Judicial Center, which compiles case filings that the U.S. district courts report to the Administrative Office of the U.S. Courts. We used the civil file as held in our database on October 10, 2026, and downloaded the judiciary's Table C-2 for comparison on October 23, 2026.
Checked against published figures
- NOS 835 (Patent--ANDA) civil cases commenced in U.S. district courts, 12 months ending Sept. 30, 2025: published 301, our count 301 (exact match).Table C-2. U.S. District Courts - Civil Cases Commenced, by Basis of Jurisdiction and Nature of Suit (September 30, 2025)
- NOS 835 civil cases commenced, 12 months ending Sept. 30, 2024 (prior-year column of the same table): published 282, our count 282 (exact match).Table C-2. U.S. District Courts - Civil Cases Commenced, by Basis of Jurisdiction and Nature of Suit (September 30, 2025)
- NOS 835 civil cases commenced, 12 months ending Sept. 30, 2021: published 222, our count 223 (0.45% apart).Table C-2. U.S. District Courts - Civil Cases Commenced, by Basis of Jurisdiction and Nature of Suit (September 30, 2021)
- NOS 835 civil cases commenced, 12 months ending Sept. 30, 2018: published 337, our count 337 (exact match).Table C-2. U.S. District Courts - Civil Cases Commenced, by Basis of Jurisdiction and Nature of Suit (September 30, 2018)
Full method and limits of the data
We counted civil cases with nature of suit code 835 (Patent - Abbreviated New Drug Application) filed from October 1, 2017, through September 30, 2025, fiscal 2018 to fiscal 2025. The code took effect on June 1, 2017, so fiscal 2017 is incomplete and left out. A case that was closed, reopened and closed again appears twice in the database; we kept one record per district, docket number and filing date, which removed 12 duplicate records.
Each case's first-listed defendant was assigned to a corporate group and to the country where the group's ultimate parent is headquartered. A case counts as India-based when that country is India (Ultimate parent headquartered in India). U.S.-registered firms whose ownership we could not verify were counted under the United States. The full name-to-group table is in the CSV.
Our case totals match Table C-2 of the federal judiciary: 301 cases in fiscal 2025, 282 in fiscal 2024 and 337 in fiscal 2018, exactly as published, and 223 in fiscal 2021, within 0.45% of the published figure.
What this data cannot tell you
- The database keeps only the first-listed defendant. Many ANDA suits name several generic companies, and cases where an Indian company is a co-defendant but not listed first are not counted as India-based, so the figures understate how many suits involve an Indian company at all.
- A case is not the same as a patent dispute. Patent holders often sue the same generic applicant over the same drug in both New Jersey and Delaware, or file separate suits against each applicant, so case counts are higher than the number of drugs or applications in dispute. Like the judiciary's own count of cases commenced, the totals also include cases that were reopened, remanded or transferred in from another district, so a single lawsuit can be counted more than once.
- Country assignment is ours and reflects corporate ownership as we understand it. Some India-headquartered firms have foreign shareholders, some U.S.-registered firms have Indian owners or affiliates that we did not count, and Indian subsidiaries of non-Indian groups, such as Mylan Laboratories Limited of Viatris, count as not India-based. For the same reason Gland Pharma of Hyderabad, in which China's Fosun Pharma has held a controlling stake throughout the period, counts under China.
- ANDA suits filed before June 1, 2017, and any ANDA cases that courts recorded under the general patent code 830 are not included. The counts say nothing about who won: they reflect lawsuits filed, not infringement found.
Frequently Asked Questions
What is Hatch-Waxman litigation?
It is patent litigation between brand-name drug companies and generic applicants under the Drug Price Competition and Patent Term Restoration Act of 1984. When a generic company's abbreviated application challenges a listed patent, the patent holder can sue, and federal courts record such cases under nature of suit 835. There were 301 such cases in fiscal 2025.
How many ANDA lawsuits are filed each year?
Federal district courts recorded 301 ANDA patent cases in fiscal 2025 and 282 in fiscal 2024. Over fiscal 2018 to 2025 the total was 2,229 cases.
What share of Hatch-Waxman lawsuits are against Indian generic companies?
In fiscal 2025, 56.5% of ANDA patent suits (170 of 301) named a company of an India-based drug group as first defendant. Over fiscal 2018 to 2025 the share was 55.6%.
Which generic drug companies are sued most in ANDA litigation?
In fiscal 2025 the most frequent first defendants were Hetero with 21 cases, Sun Pharma with 17 and MSN with 16, all headquartered in India. Counts include subsidiaries and affiliates of each group, such as Taro Pharmaceuticals under Sun Pharma and Annora Pharma and Aspiro Pharma under Hetero.
Where are Hatch-Waxman cases filed?
Almost all are filed in New Jersey and Delaware: 289 of 301 fiscal 2025 ANDA cases (96.0%) were filed in one of those two districts.
Does a lawsuit mean the generic company infringed a patent?
No. Filing a suit after a patent challenge is the standard step under the Hatch-Waxman framework, and it postpones FDA approval for up to 30 months. These figures count suits filed, not their outcomes.
Sources
- Integrated Database (IDB), civil cases — Federal Judicial Center
- Table C-2. U.S. District Courts - Civil Cases Commenced, by Basis of Jurisdiction and Nature of Suit (September 30, 2025) — Administrative Office of the U.S. Courts
- Table C-2. U.S. District Courts - Civil Cases Commenced, by Basis of Jurisdiction and Nature of Suit (September 30, 2021) — Administrative Office of the U.S. Courts
- Table C-2. U.S. District Courts - Civil Cases Commenced, by Basis of Jurisdiction and Nature of Suit (September 30, 2018) — Administrative Office of the U.S. Courts
- New Nature of Suit Code 835 for ANDA Cases — U.S. District Court for the District of Delaware
- New Nature of Suit Code for ANDA Cases — U.S. District Court for the Western District of Pennsylvania
- Patent Certifications and Suitability Petitions — U.S. Food and Drug Administration
- China's Fosun Pharma to Unload 6% of India's Gland Pharma for USD210 Million — Yicai Global
Independent analysis. Settlement Insight is not a law firm and not affiliated with any agency named here. Analysis by Leonard Goldberg, Editor. How we work: methodology, our data.
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