Robins Kaplan LLP

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).
HQ Specialty Pharma Corp. v. Sagent Pharms (Inc.), 25-1227 (D. Del.) Oct. 3, 2025 Hon. Maryellen Noreika calcium gluconate in sodium chloride injection 10,130,646
Neurelis, Inc. v. Padagis LLC, 25-1228 (D. Del.) Oct. 3, 2025 Hon. Maryellen Noreika Valtoco® (diazepam nasal spray) 12,324,852
12,337,061
Impax Labs., LLC v. Sciegen Pharms., Inc., 25-1233 (D. Del.) Oct. 6, 2025 Hon. Gregory B. Williams Rytary® (carbidopa / levodopa extended-release capsules) 8,557,283
9,089,608
9,463,246
9,533,046
9,901,640
HQ Specialty Pharma Corp. v. Cipla Ltd., 25-1236 (D. Del.) Oct. 7, 2025 Hon. Maryellen Noreika calcium gluconate in sodium chloride injection 10,130,646
Bayer Healthcare Pharms. Inc. v. Aurobindo Pharma Ltd., 25-1246 (D. Del.) Oct. 9, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Bayer Healthcare Pharms. Inc. v. Teva Pharms., Inc., 25-1247 (D. Del.) Oct. 9, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
American Regent, Inc. v. Cipla USA, Inc., 25-16422 (D.N.J.) Oct. 9, 2025 Hon. Brian R. Martinotti Multrys® (trace elements zinc / copper / manganese / selenium injection) 11,786,548
11,975,022
11,998,565
12,150,956
12,150,957
Mylan Institutional LLC v. Alora Pharms., LLC, 25-5870 (N.D. Ga.) Oct. 13, 2025 Hon. Tiffany R. Johnson isosulfan blue injection 7,662,992
8,969,616
9,353,050
10,464,888
10,508,080
10,590,071
10,626,086
10,752,580
Bayer Healthcare Pharms. Inc. v. Zydus Lifesciences Ltd., 25-1260 (D. Del.) Oct. 15, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Bayer Healthcare Pharms. Inc. v. Apotex Inc., 25-1262 (D. Del.) Oct. 15, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Janssen Pharmaceutica NV v. Natco Pharma Ltd., 25-16648 (D.N.J.) Oct. 15, 2025 Hon. Julien Xavier Neals Balversa® (erdafitinib tablets) 12,037,644
10,478,494
Mitsubishi Tanabe Pharma Corp. v. Sandoz Inc., 25-16664 (D.N.J.) Oct. 15, 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
12,194,025
12,285,409
12,310,946
Mitsubishi Tanabe Pharma Corp. v. Shanghai Auzone Biological Technology Co., Ltd., 25-16665 (D.N.J.) Oct. 15, 2025 Hon. Claire C. Cecchi Radicava ORS® (edaravone oral suspension) 12,194,025
12,285,409
12,310,946
Mitsubishi Tanabe Pharma Corp. v. Cipla USA, Inc., 25-16677 (D.N.J.) Oct. 16, 2025 Hon. Claire C. Cecchi Radicava ORS® (edaravone oral suspension) 12,194,025
12,310,946
Mitsubishi Tanabe Pharma Corp. v. Apotex Inc., 25-16679 (D.N.J.) Oct. 16, 2025 Hon. Claire C. Cecchi Radicava ORS® (edaravone oral suspension) 12,194,025
12,285,409
12,310,946
Mitsubishi Tanabe Pharma Corp. v. Lupin Ltd., 25-16680 (D.N.J.) Oct. 16, 2025 Hon. Claire C. Cecchi Radicava ORS® (edaravone oral suspension) 12,194,025
12,310,946
Braintree Labs., Inc. v. Strides Pharma Inc., 25-16717 (D.N.J.) Oct. 17, 2025 Hon. Edward Kiel Suflave® (polyethylene glycol / sodium sulfate / potassium chloride / magnesium sulfate / sodium chloride solution) 12,290,529
Bayer Healthcare Pharms. Inc. v. Macleods Pharms. Ltd., 25-1280 (D. Del.) Oct. 20, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Bayer Healthcare Pharms. Inc. v. MSN Pharms. Inc., 25-1281 (D. Del.) Oct. 20, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Bayer Healthcare Pharms. Inc. v. SABA Ilac Sanayi ve Ticaret A.S., 25-1282 (D. Del.) Oct. 20, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Bayer Healthcare Pharms. Inc. v. ScieGen Pharms., Inc., 25-1283 (D. Del.) Oct. 20, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Bayer Healthcare Pharms. Inc. v. Dr. Reddy’s Labs., Ltd., 25-1299 (D. Del.) Oct. 23, 2025 Hon. Jennifer L. Hall Kerendia® (finerenone tablets) RE49,826
Celgene Corp. v. Sandoz Inc., 25-16878 (D.N.J.) Oct. 23, 2025 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 8,828,427
9,993,467
10,555,939
Pfizer Inc. v. Apotex Inc., 25-1306 (D. Del.) Oct. 24, 2025 Hon. Gregory B. Williams Vyndamax® (tafamidis capsules) 9,770,441
Bayer Healthcare Pharms. Inc. v. Dr. Reddy’s Labs., Ltd., 25-16901 (D.N.J.) Oct. 24, 2025 Hon. Renee Marie Bumb Kerendia® (finerenone tablets) RE49,826
Novartis Pharms. Corp. v. Apotex Inc., 25-1330 (D. Del.) Oct. 30, 2025 Hon. Gregory B. Williams Mekinist® (trametinib dimethyl sulfoxide tablets) 8,580,304
9,155,706
9,271,941
9,399,021
ViiV Healthcare Co. v. Aurobindo Pharma Ltd., 25-1331 (D. Del.) Oct. 30, 2025 Hon. Gregory B. Williams Tivicay® (dolutegravir sodium tablets) 9,242,986
AbbVie Inc. v. Deva Holding A.S., 25-1332 (D. Del.) Oct. 30, 2025 Hon. Maryellen Noreika Vraylar® (cariprazine capsules) 7,737,142
7,943,621
RE47,350
RE49,110
RE49,302
Genentech, Inc. v. Natco Pharma Ltd., 25-17100 (D.N.J.) Oct. 31, 2025 Hon. Brian R. Martinotti Evrysdi® (risdiplam oral solution) 12,350,273
Grünenthal GmbH v. MSN Labs. Private Ltd., 25-1343 (D. Del.) Nov. 3, 2025 Hon. Colm F. Connolly Nucynta® ER (tapentadol extended-release tablets) 8,536,130
11,344,512
Exeltis USA, Inc. v. Glenmark Pharms. Ltd., 25-17250 (D.N.J.) Nov. 6, 2025 Hon. Esther Salas Slynd® (drospirenone tablets) 9,603,860
10,179,140
10,603,281
10,849,857
10,987,364
11,123,299
11,291,632
11,291,633
11,351,122
11,413,249
11,439,598
11,452,695
11,478,487
11,491,113
11,504,334
11,951,213
12,090,231
12,280,151
Axsome Malta Ltd. v. Alkem Labs. Ltd., 25-17395 (D.N.J.) Nov. 12, 2025 Hon. Stanley R. Chesler Sunosi® (solriamfetol tablets) 12,384,743
12,390,419
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Gland Pharma Ltd., 25-1382 (D. Del.) Nov. 13, 2025 Hon. Colm F. Connolly Korsuva® (difelikefalin acetate injection) 7,402,564
7,713,937
7,727,963
8,217,007
8,236,766
8,486,894
8,536,131
9,334,305
9,359,399
10,017,536
10,138,270
10,793,596
Kyowa Kirin Co., Ltd. v. Sun Pharm. Indus. Ltd., 25-17403 (D.N.J.) Nov. 13, 2025 Hon. Renee Marie Bumb Nourianz® (istradefylline tablets) 7,727,993
Astellas Pharma Inc. v. Renata Ltd., 25-1383 (D. Del.) Nov. 14, 2025 Hon. Maryellen Noreika Myrbetriq® (mirabegron extended-release tablets) 10,842,780,
11,707,451
12,059,409
12,097,189
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 25-17592 (D.N.J.) Nov. 14, 2025 Hon. Stanley R. Chesler Sunosi® (solriamfetol tablets) 12,263,145
12,318,362
12,390,419
Salix Pharms., Inc. v. Ajanta Pharma Ltd., 25-17780 (D.N.J.) Nov. 20, 2025 Hon. John F. Murphy Xifaxan® (rifaximin tablets) 11,779,571
11,564,912
8,193,196
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Cipla Ltd, 25-1420 (D. Del.) Nov. 21, 2025 Hon. Colm F. Connolly Korsuva® (difelikefalin acetate injection) 7,402,564
Incyte Corp. v. Dr. Reddy’s Labs., Inc., 25-17832 (D.N.J.) Nov. 21, 2025 Hon. Christine P. O’Hearn Jakafi® (ruxolitinib tablets) 7,598,257
8,415,362
8,722,693
8,822,481
8,829,013
Incyte Corp. v. Eugia Pharma Specialities Ltd., 25-17833 (D.N.J.) Nov. 21, 2025 Hon. Christine P. O’Hearn Jakafi® (ruxolitinib tablets) 7,598,257
8,415,362
8,722,693
8,822,481
8,829,013
9,079,912
Oyster Point Pharma, Inc. v. Lupin Ltd., 25-17843 (D.N.J.) Nov. 21, 2025 Hon. Michael E. Farbiarz Tyrvaya® (varenicline solution) 9,504,644
9,504,645
9,532,944
9,597,284
10,456,396
11,224,598
11,903,941
11,903,943
11,911,380
Vifor (Int’l) AG v. Xiromed Pharma Espana, S.L., 25-17822 (D.N.J.) Nov. 21, 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
Bayer Intellectual Property GmbH v. Mankind Pharma Ltd., 25-1429 (D. Del.) Nov. 24, 2025 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 9,539,218
Ascendis Pharma A/S v. Biomarin Pharm. Inc., PGR2026-00013 (PTAB) Nov. 24, 2025 N/A Voxzogo® (vosoritide injection) 12,233,106
Vifor Fresenius Medical Care Renal Pharma Ltd. v. MSN Labs. Private Ltd., 25-1440 (D. Del.) Nov. 26, 2025 Hon. Colm F. Connolly Korsuva® (difelikefalin acetate injection) 7,402,564
Neurelis, Inc. v. Lupin Inc., 25-1443 (D. Del.) Nov. 26, 2025 Hon. Maryellen Noreika Valtoco® (diazepam nasal spray) 12,324,852
12,337,061
Pacira Pharms., Inc. v. The Whiteoak Group, Inc., 25-1445 (D. Del.) Nov. 26, 2025 Hon. Jennifer L. Hall Exparel® (bupivacaine Liposome injectable suspension) 11,033,495
11,819,574
12,144,890
12,151,024
12,156,940
12,251,468
12,296,047
12,318,483
12,370,142
Acrotech Biopharma Inc. v. Gland Pharma Ltd., 25-17982 (D.N.J.) Nov. 26, 2025 Hon. Zahid N. Quraishi Evomela® (melphalan hydrochloride injection) 10,864,183
10,940,128
11,020,363
Mitsubishi Tanabe Pharma Corp. v. Zydus Pharms. (USA) Inc., 25-18032 (D.N.J.) Nov. 29, 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
12,194,025
12,285,409
12,310,946
Pacira Pharms., Inc. v. Qilu Pharm. (Hainan) Co., Ltd., 25-6742 (E.D. Pa.) Dec. 1, 2025 Hon. Nitza I. Quinones Alejandro Exparel® (bupivacaine Liposome injectable suspension) 11,033,495
11,819,574
12,144,890
12,151,024
12,156,940
12,251,468
12,296,047
12,318,483
12,370,142
Bausch & Lomb Inc. v. Granules India Ltd., 25-18325 (D.N.J.) Dec. 9, 2025 Hon. Robert Kirsch Lumify® (brimonidine tartrate ophthalmic solution) 8,293,742
9,259,425
11,596,600
11,833,245
Actelion Pharms. US, Inc. v. Apotex Inc., 25-1488 (D. Del.) Dec. 10, 2025 Hon. Gregory B. Williams Uptravi® (selexipag tablets) 8,791,122
9,284,280
Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 25-1493 (D. Del.) Dec. 11, 2025 Hon. Maryellen Noreika Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) 9,066,936
9,169,238
9,387,249
Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 25-1507 (D. Del.) Dec. 15, 2025 Hon. Maryellen Noreika Edarbi® (azilsartan kamedoxomil tablets) 9,066,936
Supernus Pharms., Inc. v. Macleods Pharms. Ltd., 25-18683 (D.N.J.) Dec. 16, 2025 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
ViiV Healthcare Co. v. Zydus Pharms. (USA) Inc., 25-1520 (D. Del.) Dec. 17, 2025 Hon. Gregory B. Williams Juluca® (dolutegravir sodium / rilpivirine HCl tablets) 9,242,986
10,426,780
Hope Medical Enterprises, Inc. v. Somerset Therapeutics, LLC, 25-1523 (D. Del.) Dec. 17, 2025 Hon. John F. Murphy Sodium Thiosulfate Injection 8,496,973
9,345,724
11,753,301
12,304,813
Pfizer Inc. v. Apotex Ins., 25-1532 (D. Del.) Dec. 18, 2025 Hon. Gregory B. Williams Vyndamax® (tafamidis capsules) 9,770,441
PH Health Ltd. v. Somerset Therapeutics, LLC, 25-1533 (D. Del.) Dec. 18, 2025 Hon. Jennifer L. Hall Vasostrict® (vasopressin injection) 9,919,026
9,925,233
9,925,234
9,962,422
9,968,649
9,974,827
9,981,006
10,010,575
12,186,362
Mirum Pharms., Inc. v. Annora Pharma Private Ltd., 25-1537 (D. Del.) Dec. 19, 2025 Hon. Jennifer L. Hall Livmarli® (maralixibat chloride oral solution) 10,512,657
11,229,661
12,350,267
11,229,647
11,376,251
11,497,745
11,918,578
11,260,053
Mirum Pharms., Inc. v. Sandoz Inc., 25-1538 (D. Del.) Dec. 19, 2025 Hon. Jennifer L. Hall Livmarli® (maralixibat chloride oral solution) 11,229,647
11,376,251
11,497,745
11,918,578
11,260,053
Mirum Pharms., Inc. v. Zenara Pharma Private Ltd., 25-1539 (D. Del.) Dec. 19, 2025 Hon. Jennifer L. Hall Livmarli® (maralixibat chloride oral solution) 10,512,657
11,229,661
12,350,267
11,229,647
11,376,251
11,497,745
11,918,578
11,260,053
Mirum Pharms., Inc. v. Zydus Lifesciences Global FZE, 25-1541 (D. Del.) Dec. 19, 2025 Hon. Jennifer L. Hall Livmarli® (maralixibat chloride oral solution) 10,512,657
11,229,661
12,350,267
11,229,647
11,376,251
11,497,745
11,918,578
11,260,053
Allergan, Inc. v. Alembic Pharms. Ltd., 25-6986 (E.D.N.Y.) Dec. 19, 2025 Hon. Ann M. Donnelly Lumigan® (bimatoprost ophthalmic solution) 7,851,504
AbbVie Inc. v. Apotex Inc., 25-18972 (D.N.J.) Dec. 23, 2025 Hon. Zahid N. Quraishi Qulipta® (atogepant tablets) 12,090,148
12,350,259
12,383,545
12,465,598
Heron Therapeutics, Inc. v. Baxter Healthcare Corp., 25-1555 (D. Del.) Dec. 23, 2025 Hon. William C. Bryson Cinvanti® (aprepitant injection) 9,561,229
9,808,465
9,974,742
9,974,793
9,974,794
10,500,208
10,624,850
10,953,018
11,173,118
11,744,800
12,115,254
12,115,255
12,290,520
Bristol-Myers Squibb Co. v. Azurity Pharms., Inc., 25-1558 (D. Del.) Dec. 23, 2025 Hon. Gregory B. Williams Eliquis® (apixaban tablets) 6,967,208
9,326,945
Genentech, Inc. v. Sun Pharm. Indus. Ltd., 25-19019 (D.N.J.) Dec. 29, 2025 Hon. Evelyn Padin Alecensa® (alectinib capsules) 9,126,931
9,365,514
10,350,214
11,433,076
9,714,229
10,344,014
10,774,067
AbbVie Inc. v. Macleods Pharms. Ltd., 25-19038 (D.N.J.) Dec. 29, 2025 Hon. Zahid N. Quraishi Qulipta® (atogepant tablets) 12,090,148
12,350,259
12,383,545
12,465,598
AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., 25-19039 (D.N.J.) Dec. 29, 2025 Hon. Zahid N. Quraishi Qulipta® (atogepant tablets) 12,090,148
12,350,259
12,383,545
12,465,598

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