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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).
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 24-0150 (D.N.J.) Jan. 9, 2024 Hon. Karen M. Williams Yupelri® (revefenacin inhalation solution) 11,858,898
Heron Therapeutics, Inc. v. Mylan Pharms. Inc., 24-0043 (D. Del.) Jan. 11, 2024 Hon. William C. Bryson Aponvie® (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
Axsome Malta Ltd. v. Hetero USA Inc., 24-0196 (D.N.J.) Jan. 11, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,771,666
11,771,667
11,779,554
11,793,776
Galderma Labs., L.P. v. Teva Pharms., Inc., 24-0197 (D.N.J.) Jan. 11, 2024 Hon. Michael A. Shipp Aklief® (trifarotene cream) 9,084,778
9,498,465
Novo Nordisk Inc. v. Mylan Pharms. Inc., 24-0050 (D. Del.) Jan. 12, 2024 Hon. Colm F. Connolly Wegovy® (semaglutide injection) 11,752,198
Upsher-Smith Labs., LLC v. AMTA Labs Ltd., 24-0058 (D. Del.) Jan. 17, 2024 Hon. Gregory B. Williams Qudexy® XR (topiramate extended-release capsules) 10,363,224
Eagle Pharms., Inc. v. Apotex Inc., 24-0064 (D. Del.) Jan. 17, 2024 Hon. Jennifer L. Hall Belrapzo® (bendamustine HCl injection) 11,844,783
11,872,214
Eagle Pharms., Inc. v. Slayback Pharma LLC, 24-0065 (D. Del.) Jan. 17, 2024 Hon. Jennifer L. Hall Belrapzo® (bendamustine HCl injection) 11,844,783
11,872,214
Eagle Pharms., Inc. v. Baxter Healthcare Corp., 24-0066 (D. Del.) Jan. 17, 2024 Hon. Jennifer L. Hall Belrapzo® (bendamustine HCl injection) 11,844,783
11,872,214
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-0309 (D.N.J.) Jan. 18, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,771,666
11,771,667
11,779,554
11,793,776
Novo Nordisk Inc. v. Rio Biopharms., Inc., 24-0330 (D.N.J.) Jan. 19, 2024 Hon. Renee Marie Bumb Victoza® (liraglutide recombinant solution injection) 8,114,833
9,265,893
Galderma Labs., L.P. v. Taro Pharms. Inc., 24-0333 (D.N.J.) Jan. 19, 2024 Hon. Michael A. Shipp Aklief® (trifarotene cream) 9,084,778
9,498,465
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Granules India Ltd., 24-0081 (D. Del.) Jan. 22, 2024 Hon. Richard G. Andrews Desyrel® (trazodone HCl tablets) 8,133,893
Heron Therapeutics, Inc. v. Slayback Pharma LLC, 24-0423 (D.N.J.) Jan. 24, 2024 Hon. Jamel K. Semper Cinvanti® (aprepitant injectable emulsion) 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
Dr. Reddy’s Labs. S.A. v. Eye Therapies, LLC, IPR2024-00467 (PTAB) Jan. 24, 2024 N/A Lumify® (brimonidine tartrate solution) 11,833,245
Advanced Accelerator Applications USA, Inc. v. Lantheus Medical Imaging, Inc., 24-0095 (D. Del.) Jan. 25, 2024 Hon. Maryellen Noreika Lutathera® (lutetium Lu 177 dotatate injection) 10,596,276
Celgene Corp. v. Amneal Pharms. of NY, LLC, 24-0500 (D.N.J.) Jan. 26, 2024 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
Bayer Pharma AG v. Lupin Ltd., 24-0138 (D. Del.) Feb. 2, 2024 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Eagle Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 24-0637 (D.N.J.) Feb. 2, 2024 Hon. Jamel K. Semper Belrapzo® (bendamustine HCl injection) 11,844,783
11,872,214
AstraZeneca Pharms. LP v. Sandoz Inc., 24-0641 (D.N.J.) Feb. 2, 2024 Hon. Robert Kirsch Lynparza® (olaparib tablets) 7,449,464
8,475,842
8,859,562
11,633,396
AbbVie Inc. v. Hetero Labs Ltd., 24-0151 (D. Del.) Feb. 5, 2024 Hon. Jennifer L. Hall Orilissa® (elagolix sodium tablets) 11,690,845
11,690,854
AbbVie Inc. v. Prinston Pharm. Inc., 24-0152 (D. Del.) Feb. 5, 2024 Hon. Jennifer L. Hall Orilissa® (elagolix sodium tablets) 11,690,845
11,690,854
AbbVie Inc. v. Sun Pharm. Indus. Ltd., 24-0153 (D. Del.) Feb. 5, 2024 Hon. Jennifer L. Hall Orilissa® (elagolix sodium tablets) 11,690,845
11,690,854
AbbVie Inc. v. Zenara Pharma Private Ltd., 24-0154 (D. Del.) Feb. 5, 2024 Hon. Jennifer L. Hall Orilissa® (elagolix sodium tablets) 11,690,845
11,690,854
Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc., 24-0688 (D.N.J.) Feb. 5, 2024 Hon. Renee Marie Bumb Saxenda® (liraglutide injection solution) 8,114,833
8,684,969
8,920,383
9,108,002
9,132,239
9,457,154
9,616,180
9,687,611
9,775,953
9,861,757
10,220,155
10,357,616
10,376,652
11,097,063
11,311,679
11,446,443
RE46,363
Nexus Pharms., LLC v. Exela Pharma Sciences, LLC, PGR2024-00016 (PTAB) Feb. 8, 2024 N/A Elcys® (cysteine HCl injection solution) 11,642,370
UCB, Inc. v. Prinston Pharm. Inc., 24-0167 (D. Del.) Feb. 8, 2024 Hon. Colm F. Connolly Briviact® (brivaracetam tablets) 6,911,461
Axsome Malta Ltd. v. Sandoz Inc., 24-0860 (D.N.J.) Feb. 14, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,771,666
11,771,667
11,779,554
11,793,776
11,839,598
11,839,599
11,850,226
11,850,227
11,850,228
Eagle Pharms., Inc. v. Accord Healthcare Inc., 24-0095 (E.D.N.C.) Feb. 16, 2024 Hon. James C. Dever, III Belrapzo® (bendamustine HCl injection) 11,844,783
11,872,214
Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-0909 (D.N.J.) Feb. 16, 2024 Hon. Stanley R. Chesler QVAR RediHaler® (beclomethasone dipropionate inhalation aerosol) 8,132,712
8,931,476
10,022,509
10,022,510
10,086,156
10,561,808
10,695,512
10,792,447
11,395,888
11,395,889
11,559,637
11,583,643
Dr. Reddy’s Labs. S.A. v. Eye Therapies, LLC, IPR2024-00563 (PTAB) Feb. 21, 2024 N/A Lumify® (brimonidine tartrate ophthalmic solution) 11,596,600
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-1022 (D.N.J.) Feb. 22, 2024 Hon. Brian R. Martinotti Tralement® (trace elements injection 4*, USP) 11,786,548
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-1030 (D.N.J.) Feb. 22, 2024 Hon. Brian R. Martinotti Multrys® (trace elements injection 4*, USP) 11,786,548
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-0248 (D Del.) Feb. 23, 2024 Hon. Maryellen Noreika Tralement® (trace elements injection 4*, USP) 11,786,548
American Regent, Inc. v. Somerset Therapeutics, LLC, 24-0249 (D. Del.) Feb. 2324-, 2024 Hon. Maryellen Noreika Multrys® (trace elements injection 4*, USP) 11,786,548
American Regent, Inc. v. RK Pharma, Inc., 24-1169 (D.N.J.) Feb. 28, 2024 Hon. Brian R. Martinotti Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) 11,786,548
American Regent, Inc. v. RK Pharma, Inc., 24-0268 (D. Del.) Feb. 29, 2024 Hon. Maryellen Noreika Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) 11,786,548
Apotex Inc. v. Novo Nordisk A/S, IPR2024-00631 (PTAB) Mar. 1, 2024 N/A Ozempic® (semaglutide injection) 10,335,462
Pfizer Inc. v. MSN Labs. Private Ltd., 24-0315 (D. Del.) Mar. 8, 2024 Hon. Jennifer L. Hall Oxbryta® (voxelotor tablets) 9,447,071
10,493,035
10,722,502
11,020,382
11,452,720
Pfizer Inc. v. Zydus Lifesciences Ltd., 24-0316 (D. Del.) Mar. 8, 2024 Hon. Jennifer L. Hall Oxbryta® (voxelotor tablets) 9,447,071
10,493,035
10,722,502
11,020,382
11,452,720
Beigene USA, Inc. v. MSN Pharms. Inc., 24-1971 (D.N.J.) Mar. 8, 2024 Hon. Zahid N. Quraishi Brukinsa® (zanubrutinib capsules) 10,927,117
11,591,340
11,786,531
11,851,437
Beigene USA, Inc. v. Sandoz Inc., 24-1972 (D.N.J.) Mar. 8, 2024 Hon. Zahid N. Quraishi Brukinsa® (zanubrutinib capsules) 10,927,117
11,591,340
American Regent, Inc. v. Apotex, Inc., 24-2268 (D.N.J.) Mar. 11, 2024 Hon. Brian R. Martinotti Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) 11,786,548
America Regent, Inc. v. Apotex, Inc., 24-0327 (D. Del.) Mar. 13, 2024 Hon. Maryellen Noreika Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) 11,786,548
Bayer Intellectual Property GmbH v. Prinston Pharm., Inc., 24-0336 (D. Del.) Mar. 14, 2024 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
Merck Sharp & Dohme B.V. v. Hikma Pharms. USA Inc., 24-3206 (D.N.J.) Mar. 15, 2024 Hon. Claire C. Cecchi Bridion® (sugammadex injection) RE44,733
Actelion Pharms. Ltd. v. Torrent Pharms. Ltd., 24-3990 (D.N.J.) Mar. 19, 2024 Hon. Georgette Castner Opsumit® (macitentan tablets) 7,094,781
10,946,015
Axsome Malta Ltd. v. Hetero USA Inc., 24-3999 (D.N.J.) Mar. 19, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,839,598
11,839,599
11,850,226
11,850,227
11,850,228
11,857,528
11,865,098
11,872,203
11,872,204
Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 24-4002 (D.N.J.) Mar. 19, 2024 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,839,598
11,850,226
11,850,227
11,850,228
11,857,528
11,865,098
11,872,203
11,872,204
Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharms. Ltd., 24-4231 (D.N.J.) Mar. 26, 2024 Hon. Edward S. Kiel Zoryve® (roflumilast cream) 9,884,050
9,907,788
10,940,142
11,129,818
11,793,796
11,819,496
Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharms. Ltd., 24-0391 (D. Del.) Mar. 27, 2024 Hon. Colm F. Connolly Zoryve® (roflumilast cream) 9,884,050
9,907,788
10,940,142
11,129,818
11,793,796
11,819,496
Intra-Cellular Therapies, Inc. v. Aurobindo Pharma Ltd., 24-4264 (D.N.J.) Mar. 27, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 9,956,227
10,695,345
10,960,009
11,026,951
11,690,842
11,753,419
11,806,348
RE48,839
Azurity Pharms., Inc. v. Hetero Labs Ltd., 24-0396 (D. Del.) Mar. 28, 2024 Hon. Maryellen Noreika Edarbi® (azilsartan medoxomil tablets) 9,066,936
Bayer Healthcare LLC v. Aurobindo Pharma Ltd., 24-0399 (D. Del.) Mar. 28, 2024 Hon. William C. Bryson Children’s Astepro® Allergy OTC (azelastine HCl nasal spray) 8,071,073
8,518,919
9,919,050
Intra-Cellular Therapies, Inc. v. Alkem Labs. Ltd., 24-4312 (D.N.J.) Mar. 28, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 9,956,227
10,695,345
10,960,009
11,026,951
11,052,084
11,690,842
11,753,419
11,806,348
RE48,839
Intra-Cellular Therapies, Inc. v. Dr. Reddy’s Labs Inc., 24-4314 (D.N.J.) Mar. 28, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 8,648,077
9,168,258
9,199,995
9,616,061
9,956,227
10,117,867
10,464,938
10,695,345
10,960,009
11,026,951
11,052,084
11,690,842
11,753,419
11,806,348
RE48,825
RE48,839
Intra-Cellular Therapies, Inc. v. Hetero USA, Inc., 24-4317 (D.N.J.) Mar. 28, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 8,648,077
9,956,227
10,695,345
10,960,009
11,026,951
11,052,084
11,690,842
11,753,419
11,806,348
RE48,839
Intra-Cellular Therapies, Inc. v. MSN Labs. Private Ltd., 24-4325 (D.N.J.) Mar. 28, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 9,956,227
10,695,345
10,960,009
11,026,951
11,052,084
11,690,842
11,753,419
11,806,348
RE48,839
Intra-Cellular Therapies, Inc. v. Sandoz Inc., 24-4327 (D.N.J.) Mar. 28, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 8,648,077
9,168,258
9,199,995
9,616,061
9,956,227
10,117,867
10,464,938
10,695,345
10,960,009
11,026,951
11,052,084
11,690,842
11,753,419
11,806,348
RE48,825
RE48,839
Intra-Cellular Therapies, Inc. v. Zydus Pharms. (USA) Inc., 24-4330 (D.N.J.) Mar. 28, 2024 Hon. Michael A. Shipp Caplyta® (lumateperone capsules) 10,695,345
11,052,084
11,690,842
11,753,419
11,806,348
Incyte Corp. v. Apotex Inc., 24-4366 (D.N.J.) Mar. 28, 2024 Hon. Christine P. O’Hearn Jakafi® (ruxolitinib tablets) 7,598,257
8,415,362
8,722,693
8,822,481
8,829,013
AbbVie Inc. v. Alembic Pharms. Ltd., 24-0405 (D. Del.) Mar. 29, 2024 Hon. Colm F. Connolly Lastacaft® (alcaftadine ophthalmic solution) 8,664,215
10,617,695
AbbVie Inc. v. Aurobindo Pharma U.S.A., Inc., 24-4403 (D.N.J.) Mar. 29, 2024 Hon. Zahid N. Quraishi Ubrelvy® (Ubrogepant tablets) 10,117,836
11,717,515
11,857,542
11,925,709
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., 24-4404 (D.N.J.) Mar. 29, 2024 Hon. Stanley R. Chesler ProAir® HFA (albuterol sulfate inhalation aerosol) 8,132,712
9,463,289
9,808,587
10,022,509
10,022,510
10,086,156
10,561,808
10,695,512
11,395,889

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