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Federal district court cases that are filed pursuant to the Hatch-Waxman Act
GENERICally Speaking

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).
Taiho Pharm. Co., Ltd. v. MSN Labs. Private Ltd., 23-0008 (D. Del.) Jan. 3, 2023 Hon. Colm F. Connolly Lonsurf® (tipiracil HCl / trifluridine tablets) 10,960,004
GW Research Ltd. v. Teva Pharms., Inc., 23-0018 (D.N.J.) Jan. 3, 2023 Hon. Susan D. Wigenton Epidiolex® (cannabidiol) 9,949,937
9,956,183
9,956,184
9,956,185
9,956,186
10,092,525
10,111,840
10,137,095
10,603,288
10,709,671
10,709,673
10,709,674
10,849,860
10,918,608
10,966,939
11,065,209
11,096,905
11,154,516
11,160,795
11,207,292
11,311,498
11,357,741
11,400,055
11,406,623
11,446,258
Chiesi USA Inc. v. Eugia Pharma Specialties Ltd., 23-0022 (D.N.J.) Jan. 4, 2023 Hon. Karen M. Williams Kengreal® (cangrelor injection) 8,680,052
9,295,687
9,427,448
9,439,921
9,700,575
9,925,265
10,039,780
IBSA Institut Biochimique SA v. Accord Healthcare, Inc., 23-0054 (D.N.J.) Jan. 5, 2023 Hon. Julien Xavier Neals Tirosint®-SOL (levothyroxine sodium oral solution) 10,537,538
11,096,913
Cosette Pharms., Inc. v. Azurity Pharms., Inc., 23-0018 (D. Del.) Jan. 6, 2023 Hon. Mitchell S. Goldberg Firvanq® Kit (vancomycin HCl oral solution) 10,493,028
10,688,046
10,959,946
10,959,947
10,959,948
10,959,949
Azurity Pharms., Inc. v. Alkem Labs Ltd., 23-0079 (D.N.J.) Jan. 6, 2023 Hon. Karen M. Williams Eprontia® (topiramate oral solution) 11,433,046
Merck Sharp & Dohme LLC v. Lupin Ltd., 23-0094 (D.N.J.) Jan. 9, 2023 Hon. Claire C. Cecchi Isentress HD® (raltegravir tablets) 7,754,731
9,649,311
10,772,888
Astellas Pharma Inc. v. Qilu Pharma, Inc., 23-0022 (D. Del.) Jan. 10, 2023 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 10,842,780
Actelion Pharms. Ltd. v. Sun Pharm. Indus. Ltd., 23-0116 (D.N.J.) Jan. 10, 2023 Hon. Stanley R. Chesler Opsumit® (macitentan tablets) 7,094,781
10,946,015
Fennec Pharms. Inc. v. Cipla Ltd., 23-0123 (D.N.J.) Jan. 10, 2023 Hon. Madeline Cox Arleo Pedmark® (sodium thiosulfate injection) 11,291,728
11,510,984
10,596,190
Novartis Pharms. Corp. v. HEC Pharm Co., Ltd., 23-0026 (D. Del.) Jan. 11, 2023 Hon. Gregory B. Williams Gilenya® (fingolimod capsules) 10,543,179
Astellas Pharma Inc. v. Qilu Pharma, Inc., 23-0125 (E.D. Pa.) Jan. 11, 2023 Hon. Kelley Brisbon Hodge Myrbetriq® (mirabegron extended-release tablets) 10,842,780
Amgen Inc. v. MSN Labs. Private Ltd., 23-0031 (D. Del.) Jan. 12, 2023 Hon. Mayellen Noreika Parsabiv® (etelcalcetide injection) 11,162,500
Bausch Health Ireland Ltd. v. Aurobindo Pharma Ltd., 23-0170 (D.N.J.) Jan. 12, 2023 Hon. Stanley R. Chesler Trulance® (plecanatide tablets) 7,041,786
9,610,321
9,616,097
9,919,024
9,925,231
10,011,637
11,142,549
11,319,346
Merck KGaA v. Aurobindo Pharma USA, Inc., 23-0039 (D. Del.) Jan. 13, 2023 Hon. Gregory B. Williams Mavenclad® (cladribine tablets) 7,713,947
8,377,903
10,849,919
Boehringer Ingelheim Pharms. Inc. v. Hetero USA Inc., 23-0048 (D. Del.) Jan. 13, 2023 Hon. Colm F. Connolly Tradjenta® (linagliptin tablets) 9,486,526
10,034,877
GW Research Ltd. v. Invagen Pharms., Inc., 23-0256 (E.D.N.Y.) Jan. 13, 2023 Hon. Diane Gujarati Epidiolex® (cannabidiol) 9,949,937
9,956,183
9,956,184
9,956,185
9,956,186
10,092,525
10,111,840
10,137,095
10,603,288
10,709,671
10,709,673
10,709,674
10,849,860
10,966,939
11,096,905
11,154,516
11,207,292
11,311,498
11,357,741
11,446,258
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Graviti Pharms. Private Ltd., 23-0068 (D. Del.) Jan. 20, 2023 Hon. Colm F. Connolly Desyrel® (trazodone HCl tablets) 8,133,893
Jazz Pharms. Ireland Ltd. v. Lupin Ltd., 23-0329 (D.N.J.) Jan. 20, 2023 Hon. Stanley R. Chesler Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) 11,426,373
11,554,102
Novo Nordisk Inc. v. Viatris Inc., 23-0101 (D. Del.) Jan. 27, 2023 Hon. Colm F. Connolly Wegovy® (semaglutide injection) 8,129,343
8,536,122
9,764,003
10,888,605
11,318,191
Novo Nordisk Inc. v. Viatris Inc., 23-0013 (N.D.W.V.) Jan. 27, 2023 Hon. Thomas S. Kleeh Wegovy® (semaglutide injection) 8,129,343
8,536,122
9,764,003
10,888,605
11,318,191
AbbVie Inc. v. Teva Pharms., Inc., 23-0133 (D. Del.) Feb. 3, 2023 Hon. Richard G. Andrews Oriahnn® (elagolix sodium / estradiol / norethindrone acetate oral capsules) 10,881,659 11,045,470
Sandoz Inc. v. Acerta Pharma B.V., IPR2023-00478 (PTAB) Feb. 3, 2023 N/A Calquence® (acalabrutinib capsules) Calquence® (acalabrutinib maleate tablets) 10,272,083
Exela Pharma Sciences, LLC v. Nivagen Pharms., Inc., 23-0137 (D. Del.) Feb. 6, 2023 Hon. Maryellen Noreika Elcys® (cysteine HCl injection) 10,583,155
11,510,941
Abraxis Bioscience, LLC v. Hainan Shuangcheng Pharms. Co., Ltd., 23-0750 (D.N.J.) Feb. 8, 2023 Hon. Karen M. Williams Abraxane® (paclitaxel injection) 7,758,891
7,820,788
7,923,536
8,034,375
8,138,229
8,268,348
8,314,156
9,101,543
9,393,318
9,511,046
9,597,409
Actelion Pharms. US, Inc. v. Lupin Ltd., 23-0150 (D. Del.) Feb. 9, 2023 Hon. Gregory B. Williams Uptravi® (selexipag for injection) 8,791,122
9,284,280
Bausch & Lomb Inc. v. Lupin Ltd., 23-0790 (D.N.J.) Feb. 10, 2023 Hon. Julien Xavier Neals Lotemax® SM (loteprednol etabonate ophthalmic gel) 10,596,107
AstraZeneca Pharms. LP v. Natco Pharma Ltd., 23-0796 (D.N.J.) Feb. 10, 2023 Hon. Zahid N. Quraishi Lynparza® (olaparib tablets) 7,449,464
8,475,842
8,859,562
Hopewell Pharma Ventures, Inc. v. Ares Trading SA, IPR2023-00482 (PTAB) Feb. 10, 2023 N/A Mavenclad® (cladribine tablets) 10,849,919
Apotex Inc. v. Celgene Corp., IPR2023-00512 (PTAB) Feb. 10, 2023 N/A Onureg® (azacitidine tablets) 8,846,628
Shionogi & Co., Ltd. v. Norwich Pharms., Inc., 23-0161 (D. Del.) Feb. 13, 2023 Hon. Maryellen Noreika Xofluza® (baloxavir marboxil tablets) 8,927,710
8,987,441
9,815,835
10,392,406
10,633,397
10,759,814
11,261,198
11,306,106
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-0926 (D.N.J.) Feb. 16, 2023 Hon. Karen M. Williams Yupelri® (revefenacin inhalation solution) 8,541,451
9,765,028
10,550,081
11,008,289
11,484,531
Novo Nordisk Inc. v. Orbicular Pharm. Technologies Pvt. Ltd., 23-0179 (D. Del.) Feb. 17, 2023 Hon. Colm F. Connolly Victoza® (liraglutide recombinant solution injection) 8,114,833
9,265,893
Theravance Biopharma R&D IP, LLC v. Lupin Inc., 23-0187 (D. Del.) Feb. 17, 2023 Hon. Gregory B. Williams Yupelri® (revefenacin inhalation solution) 8,541,451
9,765,028
10,550,081
11,008,289
11,484,531
Theravance Biopharma R&D IP, LLC v. Accord Healthcare, Inc., 23-0157 (M.D.N.C.) Feb. 17, 2023 Hon. William L. Osteen, Jr. Yupelri® (revefenacin inhalation solution) 8,541,451
9,765,028
10,550,081
11,008,289
11,484,531
Astellas Pharma Inc. v. Humanwell Puracap Pharms. (Wuhan) Co., Ltd., 23-1020 (D.N.J.) Feb. 21, 2023 Hon. John Michael Vazquez Xtandi® (enzalutamide capsules) 7,709,517
8,183,274
Alcon Inc. v. Alembic Pharms. Ltd., 23-0194 (D. Del.) Feb. 22, 2023 Hon. Gregory B. Williams Pataday® (olopatadine HCl ophthalmic solution) 8,791,154
9,533,053
Upsher-Smith Labs., LLC v. Xiamen LP Pharm. Co., Ltd., 23-0199 (D. Del.) Feb. 23, 2023 Hon. Gregory B. Williams Qudexy® XR (topiramate extended-release capsules) 8,889,190
9,101,545
9,555,005
10,363,224
Par Pharm., Inc. v. Cipla Ltd., 23-1150 (D.N.J.) Feb. 28, 2023 Hon. Madeline Cox Arleo Vasostrict® (vasopressin injection) 9,919,026
9,925,233
9,962,422
9,968,649
9,974,827
9,981,006
10,010,575
9,925,234
Catalyst Pharms., Inc. v. Teva Pharms., Inc., 23-1190 (D.N.J.) Mar. 1, 2023 Hon. Madeline Cox Arleo Firdapse® (amifampridine tablets) 10,626,088
10,793,893
11,060,128
11,268,128
11,274,331
11,274,332
Catalyst Pharms., Inc. v. Annora Pharma Private Ltd., 23-1194 (D.N.J.) Mar. 1, 2023 Hon. Madeline Cox Arleo Firdapse® (amifampridine tablets) 10,626,088
10,793,893
11,060,128
11,268,128
11,274,331
11,274,332
Catalyst Pharms., Inc. v. Lupin Ltd., 23-1197 (D.N.J.) Mar. 1, 2023 Hon. Madeline Cox Arleo Firdapse® (amifampridine tablets) 10,626,088
10,793,893
11,060,128
11,268,128
11,274,331
11,274,332
Catalyst Pharms., Inc. v. Lupin Ltd., 23-0229 (D. Del.) Mar. 2, 2023 Hon. Maryellen Noreika Firdapse® (amifampridine tablets) 10,626,088
10,793,893
11,060,128
11,268,128
11,274,331
11,274,332
Hikma Pharms. USA Inc. v. Annora Pharma Private Ltd., 23-0231 (D. Del.) Mar. 2, 2023 Hon. Richard G. Andrews Mitigare® (colchicine capsules) 8,927,607
9,399,036
9,555,029
9,675,613
9,789,108
Astellas Pharma Inc. v. Sandoz, Inc., 23-1214 (D.N.J.) Mar. 2, 2023 Hon. Esther Salas Xospata® (gilteritinib tablets) 10,786,500
Nexus Pharms., Inc. v. Somerset Pharma, LLC, 23-1248 (D.N.J.) Mar. 3, 2023 Hon. Zahid N. Quraishi Emerphed® (ephedrine sulfate injection) 11,478,436
11,426,369
UCB, Inc. v. Annora Pharma Private Ltd., 23-0243 (D. Del.) Mar. 6, 2023 Hon. Colm F. Connolly Briviact® (brivaracetam oral solution) 6,911,461
Adverio Pharma GmbH v. Alembic Pharms. Ltd., 23-1285 (D.N.J.) Mar. 7, 2023 Hon. Susan D. Wigenton Adempas® (riociguat tablets) 7,173,037
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 23-0266 (D. Del.) Mar. 10, 2023 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 8,039,627
8,357,697
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 23-1369 (D.N.J.) Mar. 10, 2023 Hon. Claire C. Cecchi Ingrezza® (valbenazine capsules) 8,039,627
8,357,697
Allergan, Inc. v. Mankind Pharma Ltd., 23-0272 (D. Del.) Mar. 13, 2023 Hon. Richard G. Andrews Lumigan® (bimatoprost ophthalmic solution) 7,851,504
Exelixis, Inc. v. Cipla Ltd., 23-0287 (D. Del.) Mar. 16, 2023 Hon. Richard G. Andrews Cabometyx® (cabozantinib tablets) 8,877,776
11,091,439
11,091,440
11,098,015
11,298,349
Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00722 (PTAB) Mar. 16, 2023 N/A Ozempic® (semaglutide injection) Rybelsus® (semaglutide tablets) Wegovy® (semaglutide injection) 8,536,122
Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724 (PTAB) Mar. 16, 2023 N/A Ozempic® (semaglutide injection) 10,335,462
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Sun Pharm. Indus., Inc., 23-0295 (D. Del.) Mar. 17, 2023 Hon. Richard G. Andrews Desyrel® (trazodone HCl tablets) 8,133,893
Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc., 23-1505 (D.N.J.) Mar. 17, 2023 Hon. Renee Marie Bumb Korlym® (mifepristone tablets) 10,842,800 10,842,801
Alcon Inc. v. Gland Pharma Ltd., 23-0303 (D. Del.) Mar. 20, 2023 Hon. Gregory B. Williams Pataday® Once-Daily Relief 0.7% (olopatadine HCl ophthalmic solution) 8,791,154
9,533,053
Jazz Pharms. Ireland Ltd. v. Teva Pharms., Inc., 23-1617 (D.N.J.) Mar. 21, 2023 Hon. Stanley R. Chesler Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) 8,591,922
8,772,306
8,901,173
9,050,302
9,132,107
9,486,426
10,195,168
10,213,400
10,675,258
10,864,181
11,253,494
11,426,373
11,554,102
Bayer Intellectual Property GmbH v. Apotex Inc., 23-0327 (D. Del.) Mar. 24, 2023 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 9,539,218
Keryx Biopharmaceuticals, Inc. v. Zydus Worldwide DMCC, 23-0331 (D. Del.) Mar. 24, 2023 Hon. Gregory B. Williams Auryxia® (ferric citrate tablets) 7,767,851
8,093,423
8,299,298
8,338,642
8,609,896
8,754,257
8,754,258
8,846,976
8,901,349
9,050,316
9,387,191
9,328,133
9,757,416
10,300,039
Bayer Intellectual Property GmbH v. Biocon Pharma Ltd., 23-0334 (D. Del.) Mar. 24, 2023 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
Bayer Intellectual Property GmbH v. Sciegen Pharms., Inc., 23-0335 (D. Del.) Mar. 24, 2023 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
Aragon Pharms., Inc. v. Zydus Worldwide DMCC, 23-1685 (D.N.J.) Mar. 24, 2023 Hon. Evelyn Padin Erleada® (apalutamide tablets) 8,445,507
8,802,689
9,388,159
9,987,261
RE49,353
Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 23-1695 (D.N.J.) Mar. 24, 2023 Hon. Susan D. Wigenton Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) 10,780,064
10,925,842
10,940,124
10,966,942
Par Pharm., Inc. v. Baxter Healthcare Corp., 23-0358 (D. Del.) Mar. 29, 2023 Hon. Gregory B. Williams Vasostrict® (vasopressin injection) 9,993,520
11,135,265
11,207,372
AbbVie Inc. v. Teva Pharm., Inc., 23-0362 (D. Del.) Mar. 30, 2023 Hon. Richard G. Andrews Oriahnn® (elagolix sodium / estradiol / norethindrone acetate oral capsules copackaged with elagolix sodium oral capsules) 11,542,239
Azurity Pharms., Inc. v. Accord Healthcare, Inc., 23-0373 (D. Del.) Mar. 31, 2023 Hon. Colm F. Connolly Thyquidity® (levothyroxine sodium oral solution) 9,050,307

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