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Federal district court cases that are filed pursuant to the Hatch-Waxman Act and Post Grant Proceedings at the PTAB involving Orange Book-listed patents

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.

Case Name Date Filed Judge Drug Patent No(s).
American Regent, Inc. v. Hikma Pharms. USA Inc., 25-2224 (D.N.J.) Apr. 1, 2025 Hon. Brian R. Martinotti Tralement®
(trace elements zinc sulfate / cupric sulfate /
manganese sulfate / selenious acid injection)
11,786,548
11,975,022
11,998,565
12,150,956
12,150,957
Merck Sharp & Dohme B.V. v. Xiromed Pharma España, S.L., 25-2254 (D.N.J.) Apr. 2, 2025 Hon. Claire C. Cecchi Nexplanon®
(etonogestrel implant)
8,722,037
9,757,552
Urovant Sciences GmbH v. Annora Pharma Private Ltd., 25-0419 (D. Del.) Apr. 3, 2025 Hon. Gregory B. Williams Gemtesa®
(vibegron tablets)
12,102,638
Urovant Sciences GmbH v. MSN Labs. Private Ltd., 25-0420 (D. Del.) Apr. 3, 2025 Hon. Gregory B. Williams Gemtesa®
(vibegron tablets)
12,102,638
AbbVie Inc. v. Aurobindo Pharma USA, Inc., 25-0422 (D. Del.) Apr. 4, 2025 Hon. Maryellen Noreika Rinvoq®
(upadacitinib extended-release tablets)
RE47,221
Melinta Therapeutics, LLC v. Gland Pharma Ltd., 25-3676 (N.D. Ill.) Apr. 4, 2025 Hon. Jeremy C. Daniel Minocin®
(minocycline injection)
9,278,105
9,084,802
11,944,634
12,161,656
Salix Pharms., Inc. v. SABA Ilac Sanayi ve Ticaret A.S., 25-2307 (D.N.J.) Apr. 4, 2025 Hon. John F. Murphy Xifaxan®
(rifaximin tablets)
11,564,912
11,779,571
8,193,196
7,928,115
Exelixis, Inc. v. Sun Pharm. Indus. Ltd., 25-0423 (D. Del.) Apr. 4, 2025 Hon. Richard G. Andrews Cabometyx®
(cabozantinib tablets)
12,128,039
Pfizer Inc. v. Annora Pharma Private Ltd., 25-0424 (D. Del.) Apr. 4, 2025 Hon. Colm F. Connolly Xeljanz®
(tofacitinib tablets)
RE41,783
Hetero Labs Ltd. v. AbbVie Inc., 25-0431 (D. Del.) Apr. 7, 2025 Hon. Jennifer L. Hall Orilissa®
(elagolix sodium tablets)
12,102,637
Aurinia Pharms. Inc. v. Hikma Pharms. USA Inc., 25-2580 (D.N.J.) Apr. 10, 2025 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Ascendis Pharma A/S v. BioMarin Pharm. Inc., 25-3302 (N.D. Cal.) Apr. 11, 2025 Hon. Joseph C. Spero Voxzogo®
(vosoritide injection)
RE48,267
Merck Sharp & Dohme LLC v. Aurobindo Pharma Ltd., 25-0449 (D. Del.) Apr. 11, 2025 Hon. Richard G. Andrews Janumet XR®
(metformin HCl / sitagliptin phosphate extended-release tablets)
7,326,708
Aurinia Pharms. Inc. v. Lotus Pharm. Co., Ltd., 25-2613 (D.N.J.) Apr. 11, 2025 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
American Regent, Inc. v. Amneal Pharms. of NY, LLC, 25-2642 (D.N.J.) Apr. 11, 2025 Hon. Brian R. Martinotti Tralement®
(trace elements zinc sulfate / cupric sulfate /
manganese sulfate / selenious acid injection)
11,786,548
11,975,022
11,998,565
12,150,956
12,150,957
Vertex Pharms. Inc. v. Lupin Ltd., 25-0450 (D. Del.) Apr. 11, 2025 Hon Richard G. Andrews Kalydeco®
(ivacaftor granules)
8,883,206
10,272,046
10,646,481
11,147,770
11,564,916
11,752,106
12,214,083
Exelixis, Inc. v. Biocon Pharma Ltd., 25-0452 (D. Del.) Apr. 11, 2025 Hon Richard G. Andrews Cabometyx®
(cabozantinib(S)-malate tablets)
8,877,776
11,091,439
11,091,440
11,098,015
12,128,039
Veloxis Pharms., Inc. v. Glenmark Pharms. Inc., 25-0458 (D. Del.) Apr. 14, 2025 Hon. Maryellen Noreika Envarsus XR®
(tacrolimus extended-release tablets)
8,685,998
9,549,918
10,166,190
10,864,199
11,110,081
11,123,331
11,419,823
12,083,103
Jazz Pharms., Inc. v. Almaject, Inc., 25-2785 (D.N.J.) Apr. 16, 2025 Hon. Stanley R. Chesler Defitelio®
(defibrotide sodium injection)
11,085,043
11,236,328
11,746,348
Aurinia Pharms. Inc. v. Galenicum Health S.L.U., 25-2807 (D.N.J.) Apr. 17, 2025 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Aragon Pharms., Inc. v. Lupin Ltd., 25-2860 (D.N.J.) Apr. 18, 2025 Hon. Stanley R. Chesler Erleada®
(apalutamide tablets)
11,963,952
Fresenius Kabi USA, LLC v. Endo Operations Ltd., 25-2861 (D.N.J.) Apr. 18, 2025 Hon. Susan D. Wigenton levothyroxine sodium injection 9,782,376
10,398,669
11,135,190
Exelixis, Inc. v. Azurity Pharms., Inc., 25-0478 (D. Del.) Apr. 18, 2025 Hon. Richard G. Andrews Cabometyx®
(cabozantinib (S)-malate tablets)
8,877,776
11,091,439
11,091,440
11,098,015
11,298,349
12,128,039
Adverio Pharma GmbH v. Changzhou Pharm. Factory, 25-0479 (D. Del.) Apr. 18, 2025 Hon. Gregory B. Williams Verquvo®
(vericiguat tablets)
8,420,656
8,921,377
9,604,948
9,993,476
10,736,896
11,439,642
Aurinia Pharms. Inc. v. Zydus Pharms. (USA) Inc., 25-2893 (D.N.J.) Apr. 21, 2025 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Tris Pharma, Inc. v. Granules Pharms., Inc., 25-0498 (D. Del.) Apr. 24, 2025 Hon. Jennifer L. Hall Dyanavel® XR
(amphetamine extended-release tablets)
11,590,081
Onyx Therapeutics, Inc. v. Somerset Therapeutics, LLC, 25-0500 (D. Del.) Apr. 24, 2025 Hon. Gregory B. Williams Kyprolis®
(carfilzomib injection)
7,737,112
Pharmacosmos A/S v. Teva Pharms., Inc., 25-3218 (D.N.J.) Apr. 24, 2025 Hon. Julien Xavier Neals Cosela®
(trilaciclib injection)
11,529,352
12,168,666
Aurinia Pharms. Inc. v. Teva Pharms., Inc., 25-3267 (D.N.J.) Apr. 25, 2025 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Mitsubishi Tanabe Pharma Corp. v. Shanghai Auzone Biological Technology Co., Ltd., 25-3326 (D.N.J.) Apr. 25, 2025 Hon. Claire C. Cecchi Radicava ORS®
(edaravone oral suspension)
10,987,341
11,241,416
11,478,450
11,826,352
11,957,660
Vifor (Int’l) AG v. MSN Labs. Private Ltd., 25-3286 (D.N.J.) Apr. 25, 2025 Hon. Georgette Castner Injectafer®
(ferric carboxymaltose injection)
7,612,109
7,754,702
8,895,612
11,364,260
11,433,091
11,478,502
Impax Labs., LLC v. Qilu Pharm. (Hainan) Co., Ltd., 25-3292 (D.N.J.) Apr. 25, 2025 Hon. Brian R. Martinotti Rytary®
(carbidopa / levodopa extended-release capsules)
8,557,283
9,089,608
9,463,246
9,533,046
9,901,640
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 25-3354 (D.N.J.) Apr. 25, 2025 Hon. Karen M. Williams Ingrezza® Sprinkle
(valbenazine capsules)
8,039,627
8,357,697
10,065,952
10,844,058
10,851,103
10,851,104
10,857,137
10,857,148
10,874,648
10,906,902
10,906,903
10,912,771
10,919,892
10,940,141
10,952,997
10,993,941
11,026,931
11,026,939
11,040,029
11,311,532
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 25-0509 (D. Del.) Apr. 25, 2025 Hon. Maryellen Noreika Ingrezza® Sprinkle
(valbenazine capsules)
8,039,627
8,357,697
10,065,952
10,844,058
10,851,103
10,851,104
10,857,137
10,857,148
10,874,648
10,906,902
10,906,903
10,912,771
10,919,892
10,940,141
10,952,997
10,993,941
11,026,931
11,026,939
11,040,029
11,311,532
Bausch & Lomb Inc. v. Somerset Therapeutics, LLC, 25-3395 (D.N.J.) Apr. 28, 2025 Hon. Robert Kirsch Lumify®
(brimonidine tartrate ophthalmic solution)
8,293,742
9,259,425
11,596,600
11,833,245
Boehringer Ingelheim Pharms. Inc. v. Biocon Ltd., 25-0523 (D. Del.) Apr. 30, 2025 Hon. Colm F. Connolly Tradjenta®
(linagliptin tablets)
8,853,156
9,486,526
10,034,877
11,911,388
Aurinia Pharms. Inc. v. DifGen Pharms. LLC, 25-3533 (D.N.J.) Apr. 30, 2025 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Aurinia Pharms. Inc. v. DifGen Pharms. LLC, 25-0530 (D. Del.) 1-May-25 Hon. Jennifer L. Hall Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Aurinia Pharms. Inc. v. Dr. Reddy’s Labs., Inc., 25-3693 (D.N.J.) 1-May-25 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 25-3721 (D.N.J.) 1-May-25 Hon. Madeline Cox Arleo Sunosi®
(solriamfetol tablets)
12,194,016
Azurity Pharms., Inc. v. Helsinn Healthcare S.A., IPR2025-00945 (PTAB) 1-May-25 N/A Akynzeo®
(netupitant / palonosetron HCl capsules)
8,623,826
Azurity Pharms., Inc. v. Helsinn Healthcare S.A., IPR2025-00946 (PTAB) 1-May-25 N/A Akynzeo®
(netupitant / palonosetron HCl capsules)
9,186,357
Azurity Pharms., Inc. v. Helsinn Healthcare S.A., IPR2025-00947 (PTAB) 1-May-25 N/A Akynzeo®
(netupitant / palonosetron HCl capsules)
9,186,357
Azurity Pharms., Inc. v. Helsinn Healthcare S.A., IPR2025-00948 (PTAB) 1-May-25 N/A Akynzeo®
(netupitant / palonosetron HCl capsules)
9,943,515
Azurity Pharms., Inc. v. Helsinn Healthcare S.A., IPR2025-00949 (PTAB) 1-May-25 N/A Akynzeo®
(netupitant / palonosetron HCl capsules)
10,828,297
Vifor (Int’l) AG v. Orbicular Pharm. Technologies Pvt. Ltd., 25-0540 (D. Del.) 2-May-25 Hon. Colm F. Connolly Injectafer®
(ferric carboxymaltose injection)
7,612,109
7,754,702
8,895,612
11,433,091
11,478,502
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 25-3790 (D.N.J.) 2-May-25 Hon. Karen M. Williams Yupelri®
(revefenacin oral inhalation solution)
12,285,417
Aveo Pharms., Inc. v. Somerset Therapeutics, LLC, 25-0560 (D. Del.) 7-May-25 Hon. Maryellen Noreika Fotivda®
(tivozanib HCl capsules)
11,504,365
Azurity Pharms., Inc. v. Alkem Labs. Ltd., 25-0563 (D. Del.) 7-May-25 Hon. Gregory B. Williams Zonisade®
(zonisamide oral suspension)
11,478,456
11,529,333
Pfizer Inc. v. Alkem Labs. Ltd., 25-0565 (D. Del.) 7-May-25 Hon. Colm F. Connolly Xeljanz® XR
(tofacitinib citrate extended-release tablets)
RE41,783
Pharmacosmos A/S v. Hetero Labs Ltd., 25-3945 (D.N.J.) 7-May-25 Hon. Julien Xavier Neals Cosela®
(trilaciclib for injection)
11,529,352
12,168,666
Pharmacosmos A/S v. Dr. Reddy’s Labs., Inc., 25-3967 (D.N.J.) 7-May-25 Hon. Julien Xavier Neals Cosela®
(trilaciclib for injection)
8,598,186
8,598,197
9,957,276
10,189,849
10,189,850
10,927,120
11,040,042
9,487,530
10,085,992
10,966,984
11,717,523
11,529,352
12,168,666
Aurinia Pharms. Inc. v. Sandoz Inc., 25-3986 (D.N.J.) 8-May-25 Hon. Jamel K. Semper Lupkynis®
(voclosporin capsules)
10,286,036
11,622,991
Incyte Corp. v. Apotex Inc., 25-4044 (D.N.J.) 8-May-25 Hon. Christine P. O’Hearn Jakafi®
(ruxolitinib tablets)
7,598,257
8,415,362
8,722,693
8,822,481
8,829,013
Novartis Pharms. Corp. v. Lupin Ltd., 25-0578 (D. Del.) 9-May-25 Hon. John F. Murphy Mayzent®
(siponimod tablets)
8,492,441
11,944,602
United Therapeutics Corp. v. Liquidia Techs., Inc., 25-0368 (M.D.N.C.) 9-May-25 Hon. Thomas D. Schroeder Yutrepia®
(treprostinil inhalation powder)
11,357,782
Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Ltd., 25-4282 (D.N.J.) 15-May-25 Hon. Renee Marie Bumb Mayzent®
(siponimod tablets)
8,492,441
11,944,602
American Regent, Inc. v. BPI Labs, LLC, 25-4439 (D.N.J.) 16-May-25 Hon. Brian R. Martinotti Selenious Acid 11,998,565
12,150,957
Pfizer Inc. v. Somerset Therapeutics LLC, 25-0617 (D. Del.) 16-May-25 Hon. Colm F. Connolly Xeljanz®
(tofacitinib tablets)
RE41,783
AbbVie Inc. v. Hetero Labs Ltd., 25-0625 (D. Del.) 19-May-25 Hon. Jennifer L. Hall Orilissa®
(elagolix sodium tablets)
12,102,637
Pfizer Inc. v. Macleods Pharms. Ltd., 25-0632 (D. Del.) 21-May-25 Hon. Colm F. Connolly Xeljanz®
(tofacitinib tablets)
RE41,783
Bayer Pharma AG v. Aurobindo Pharma Ltd., 25-0631 (D. Del.) 21-May-25 Hon. Richard G. Andrews Xarelto®
(rivaroxaban tablets)
10,828,310
Aveo Pharms., Inc. v. Hetero USA Inc., 25-0639 (D. Del.) 23-May-25 Hon. Maryellen Noreika Fotivda®
(tivozanib HCl capsules)
11,504,365
Novartis Pharms. Corp. v. Zenara Pharma Private Ltd., 25-0644 (D. Del.) 23-May-25 Hon. Gregory B. Williams Promacta®
(eltrombopag olamine tablets)
8,828,430
Incyte Corp. v. Padagis Israel Pharms. Ltd., 25-5380 (D.N.J.) 23-May-25 Hon. Madeline Cox Arleo Opzelura®
(ruxolitinib cream)
12,226,419
Otsuka America Pharm., Inc. v. Hetero Labs Ltd., 25-0647 (D. Del.) 27-May-25 Hon. Gregory B. Williams Nuedexta®
(dextromethorphan hydrobromide / quinidine sulfate capsules)
7,659,282
Fennec Pharms. Inc. v. Cipla Ltd., 25-5709 (D.N.J.) 27-May-25 Hon. Jamel K. Semper Pedmark®
(sodium thiosulfate injection)
12,311,026
Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 25-0663 (D. Del.) 29-May-25 Hon. Colm F. Connolly Jardiance®
(empagliflozin tablets)
9,949,998
10,258,637
11,090,323
11,833,166
Celgene Corp. v. USV Private Ltd., 25-6320 (D.N.J) 30-May-25 Hon. Esther Salas Pomalyst®
(pomalidomide capsules)
8,828,427
9,993,467
10,555,939
Incyte Corp. v. Taro Pharms. Inc., 25-7243 (D.N.J.) 4-Jun-25 Hon. Madeline Cox Arleo Opzelura®
(ruxolitinib cream)
12,226,419
Bayer Pharma AG v. Apotex Inc., 25-0694 (D. Del.) 5-Jun-25 Hon. Richard G. Andrews Xarelto®
(rivaroxaban tablets)
10,828,310
American Regent, Inc. v. BPI Labs, LLC, 25-1470 (M.D. Fla.) 6-Jun-25 Hon. William F. Jung Selenious Acid 11,998,565
12,150,957
Bayer Pharma AG v. Macleods Pharms. Ltd., 25-0719 (D. Del.) 9-Jun-25 Hon. Richard G. Andrews Xarelto®
(rivaroxaban tablets)
10,828,310
Salix Pharms., Inc. v. Alkem Labs. Ltd., 25-9344 (D.N.J.) 10-Jun-25 Hon. John F. Murphy Xifaxan®
(rifaximin tablets)
11,779,571
11,564,912
8,193,196
United Therapeutics Corp. v. Actelion Pharms., Ltd., IPR2025-01139 (PTAB) 10-Jun-25 N/A Opsumit®
(macitentan tablets)
Opsynvi®
(macitentan / tadalafil tablets)
8,268,847
Aveo Pharms., Inc. v. Glenmark Pharms. Ltd., 25-0735 (D. Del.) 13-Jun-25 Hon. Maryellen Noreika Fotivda®
(tivozanib HCl capsules)
11,504,365
7,166,722
Braintree Labs., Inc. v. Appco Pharma LLC, 25-10876 (D.N.J.) 13-Jun-25 Hon. Christine P. O’Hearn Sutab®
(sodium sulfate / magnesium sulfate /
potassium chloride osmotic laxative tablets)
10,143,656
11,033,498
11,382,864
11,638,697
Pfizer Inc. v. Orient Pharma Co., Ltd., 25-0743 (D. Del.) 16-Jun-25 Hon. Gregory B. Williams Xeljanz® XR
(tofacitinib citrate extended-release tablets)
9,937,181
10,639,309
11,253,523
Bayer Pharma AG v. Alembic Pharms. Ltd., 25-0753 (D. Del.) 18-Jun-25 Hon. Richard G. Andrews Xarelto®
(rivaroxaban tablets)
10,828,310
Bayer Pharma AG v. Hetero Labs Ltd., 25-0754 (D. Del.) 18-Jun-25 Hon. Richard G. Andrews Xarelto®
(rivaroxaban tablets)
10,828,310
Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V., 25-11924 (D.N.J.) 18-Jun-25 Hon. Stanley R. Chesler Erleada®
(apalutamidetablets)
8,445,507
8,802,689
9,388,159
9,987,261
9,481,663
9,884,054
RE49,353
10,849,888
10,702,508
11,963,952
American Regent, Inc. v. Endo Operations Ltd., 25-11945 (D.N.J.) 18-Jun-25 Hon. Brian R. Martinotti Tralement®
(trace elements zinc sulfate / cupric sulfate /
manganese sulfate / selenious acid injection)
11,786,548
11,975,022
11,998,565
12,150,956
12,150,957
Indivior Inc. v. Lupin Inc., 25-0757 (D. Del.) 20-Jun-25 Hon. Jennifer L. Hall Opvee®
(nalmefene Nasal spray)
11,458,091
12,290,596
Amneal Pharms. LLC v. Sandoz Inc., 25-11981 (D.N.J.) 20-Jun-25 Hon. Georgette Castner Crexont®
(carbidopa / levodopa extended-release capsules)
12,201,596
12,263,148
12,263,149
12,274,793
Pfizer Inc. v. Apotex Inc., 25-0765 (D. Del.) 20-Jun-25 Hon. Colm F. Connolly Ibrance®
(palbociclib tablets)
RE47,739
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 25-0767 (D. Del.) 20-Jun-25 Hon. Colm F. Connolly Wegovy®
(semaglutide injection)
12,214,017
Pfizer Inc. v. Apotex Inc., 25-0775 (D. Del.) 23-Jun-25 Hon. Colm F. Connolly Xeljanz® XR
(tofacitinib extended-release tablets)
RE41,783
Braintree Labs., Inc. v. Alkem Labs. Ltd., 25-12118 (D.N.J.) 25-Jun-25 Hon. Christine P. O’Hearn Sutab®
(sodium sulfate / magnesium sulfate /
potassium chloride osmotic laxative tablets)
10,143,656
11,033,498
11,382,864
11,638,697
American Regent, Inc. v. Amneal Pharms. of NY, LLC, 25-12169 (D.N.J.) 26-Jun-25 Hon. Brian R. Martinotti Multrys®
(trace elements injection)
11,786,548
11,975,022
11,998,565
12,150,956
Supernus Pharms., Inc. v. Appco Pharma LLC, 25-12183 (D.N.J.) 26-Jun-25 Hon. Michael E. Farbiarz Qelbree®
(viloxazine extended-release capsules)
9,358,204
9,603,853
9,662,338
11,324,753
11,458,143
12,121,523
Supernus Pharms., Inc. v. Apotex Inc., 25-12184 (D.N.J.) 26-Jun-25 Hon. Michael E. Farbiarz Qelbree®
(viloxazine extended-release capsules)
9,358,204
9,603,853
9,662,338
11,324,753
11,458,143
12,121,523
Supernus Pharms., Inc. v. Aurobindo Pharma Ltd., 25-12186 (D.N.J.) 26-Jun-25 Hon. Michael E. Farbiarz Qelbree®
(viloxazine extended-release capsules)
9,358,204
9,603,853
9,662,338
11,324,753
11,458,143
12,121,523
Supernus Pharms., Inc. v. Zydus Lifesciences Global FZE, 25-12188 (D.N.J.) 26-Jun-25 Hon. Michael E. Farbiarz Qelbree®
(viloxazine extended-release capsules)
9,358,204
9,603,853
9,662,338
Novartis Pharms. Corp. v. Eugia Pharma Specialities Ltd., 25-800 (D. Del.) 27-Jun-25 Hon. Gregory B. Williams Tasigna®
(nilotinib HCl capsules)
8,163,904
8,293,756
8,389,537
8,415,363
8,501,760
9,061,029
Eli Lilly & Co. v. Qilu Pharm. Co., Ltd., 25-12347 (D.N.J.) 30-Jun-25 Hon. Evelyn Padin Reyvow®
(lasmiditan tablets)
12,257,246

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