New ANDA Cases - Third Quarter 2025

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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).
Supernus Pharms., Inc. v. Appco Pharma LLC, 24-0807 (D. Del.) July 1, 2025 Hon. Jennifer L. Hall Qelbree® (viloxazine extended-release capsules) 9,358,204
9,603,85
9,662,338
11,324,753
11,458,143
12,121,523
Supernus Pharms., Inc. v. Aurobindo Pharma Ltd., 24-0808 (D. Del.) July 1, 2025 Hon. Jennifer L. Hall Qelbree® (viloxazine extended-release capsules) 9,358,204
9,603,853
9,662,338
11,324,753
11,458,143
12,121,523
Takeda Pharms. U.S.A., Inc. v. Lupin, Ltd., 25-12574 (D.N.J.) July 1, 2025 Hon. Robert Kirsch Eohilia® (budesonide oral suspension) 11,260,064
11,564,934
Ferring Pharms. Inc. v. Alkem Labs. Ltd., 25-0810 (D. Del.) July 2, 2025 Hon. Colm F. Connolly Clenpiq® (sodium picosulfate / magnesium oxide / anhydrous citric acid oral solution) 9,827,231
10,624,879
11,191,753
Azurity Pharms., Inc. v. Saba Ilac Sanayi ve Ticaret AS, 25-0814 (D. Del.) July 2, 2025 Hon. Maryellen Noreika Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) 9,066,936
9,169,238
9,387,249
Neurelis, Inc. v. Padagis LLC, 25-0821 (D. Del.) July 2, 2025 Hon. Maryellen Noreika Valtoco® (diazepam nasal spray) 11,241,414
11,793,786
12,268,664
Orion Corp. v. Alembic Pharms Ltd., 25-0825 (D. Del.) July 3, 2025 Hon. Jennifer L. Hall Nubeqa® (darolutamide tablets) 10.010.530
10.383.853
10.835.515
11.168.058
Mitsubishi Tanabe Pharma Corp. v. Lupin Ltd., 25-0828 (D. Del.) July 3, 2025 Hon. Jennifer L. Hall Radivaca Ors® (edaravone oral suspension) 12,285,409
Heron Therapeutics, Inc. v. Qilu Pharm. Co., Ltd., 25-0829 (D. Del.) July 3, 2025 Hon. William C. Bryson 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
12,115,254
12,115,255
12,290,520
Ascendis Pharma A/S v. Biomarin Pharm. Inc., 25-5696 (N.D. Cal.) July 7, 2025 Hon. P. Casey Pitts Voxzogo® (vosoritide powder for injection) RE48,267
Janssen Pharms., Inc. v. Sun Pharm. Indus. Ltd., 25-13061 (D.N.J.) July 9, 2025 Hon. Claire C. Cecchi Invega Sustenna® (palperidone palmitate extended-release injectable suspension) 9,439,906
Janssen Pharms., Inc. v. Sun Pharm. Indus. Ltd., 25-0857 (D. Del.) July 10, 2025 Hon. William C. Bryson Invega Sustenna® (palperidone palmitate extended-release injectable suspension) 9,439,906
Hope Medical Enterprises, Inc. v. Accord Healthcare, Inc., 25-0860 (D. Del.) July 10, 2025 Hon. John F. Murphy Sodium Thiosulfate Injection 12,304,813
Endo Operations Ltd. v. Baxter Healthcare Corp., 25-0861 (D. Del.) July 10, 2025 Hon. Jennifer L. Hall Adrenalin® (epinephrine in 0.9% sodium chloride injection) 11,071,719
11,207,280
12,133,837
10,653,646
11,083,698
Boehringer Ingelheim Pharms. Inc. v. USV Private Ltd., 25-0862 (D. Del.) July 10, 2025 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 8,551,957
11,090,323
12,115,179
Braintree Labs., Inc. v. Lupin Ltd., 25-13133 (D.N.J.) July 10, 2025 Hon. Edward S. Kiel Suflave® (polyethylene glycol /sodium sulfate / potassium chloride / magnesium sulfate / sodium chloride solution) 12,239,659
12,290,529
Novartis Pharms. Corp. v. Taro Pharms. USA, Inc., 25-13193 (D.N.J.) July 11, 2025 Hon. Georgette Castner Promacta® (eltrombopag olamine tablets) 8,052,993
8,052,994
8,062,665
8,071,129
8,828,430
Supernus Pharms., Inc. v. Creekwood Pharms., LLC, 25-13201 (D. Del.) July 11, 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
Supernus Pharms., Inc. v. MSN Pharms. Inc., 25-13204 (D. Del.) July 11, 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
Supernus Pharms., Inc. v. Zenara Pharma Private Ltd., 25-13207 (D. Del.) July 11, 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
Incyte Corp. v. Sun Pharm. Indus., Inc., 25-13225 (D.N.J.) July 11, 2025 Hon. Christine P. O’Hearn Jakafi® (ruxolitinib tablets) 8,722,693
8,822,481
8,829,013
10,016,429
Incyte Corp. v. Granules India Ltd., 25-13227 (D.N.J.) July 11, 2025 Hon. Christine P. O’Hearn Jakafi® (ruxolitinib tablets) 7,598,257
8,415,362
8,722,693
8,822,481
8,829,013
Supernus Pharms., Inc. v. MSN Pharms. Inc., 25-0879 (D. Del.) July 15, 2025 Hon. Jennifer L. Hall 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. Creekwood Pharms., LLC, 25-0880 (D. Del.) July 15, 2025 Hon. Jennifer L. Hall Qelbree® (viloxazine extended-release capsules) 9,358,204
9,603,853
9,662,338
11,324,753
11,458,143
12,121,523
Braintree Labs., Inc. v. Hetero USA, Inc., 25-13632 (D.N.J.) July 22, 2025 Hon. Christine P. O’Hearn Sutab® (sodium sulfate / magnesium sulfate / potassium chloride osmotic laxative tablet) 10,143,656
11,033,498
11,382,864
11,638,697
Ipsen Biopharmaceuticals, Inc. v. Conjupro Biotherapeutics, Inc., 25-13647 (D.N.J.) July 22, 2025 Hon. Renee Marie Bumb Onivyde® (irinotecan liposome injection) 12,364,691
Celgene Corp. v. Deva Holding A.S., 25-13687 (D.N.J.) July 23, 2025 Hon. Esther Salas Pomalyst® (pomalidomide capsules) 8,828,427
9,993,467
10,555,939
Hikma Pharms. USA Inc. v. InfoRLife SA, 25-13688 (D.N.J.) July 23, 2025 Hon. Robert Kirsch Immphentiv® (phenylephrine HCl injection) 11,471,400
12,257,342
BioDelivery Sciences Int’l, Inc. v. Alvogen PB Research & Development LLC, 25-0926 (D. Del.) July 24, 2025 Hon. Colm F. Connolly Belbuca® (buprenorphine buccal film) 8,147,866
9,901,539
Novartis Pharms. Corp. v. Teva Pharms., Inc., 25-0928 (D. Del.) July 24, 2025 Hon. Gregory B. Williams Mekinist® (trametinib dimethyl sulfoxide tablets) 8,580,304
9,155,706
9,271,941
9,399,021
Mitsubishi Tanabe Pharma Corp. v. Cipla USA, Inc., 25-0929 (D. Del.) July 24, 2025 Hon. Jennifer L. Hall Radivaca Ors® (edaravone oral suspension) 12,285,409
Azurity Pharms., Inc. v. MSN Pharms. Inc., 25-13775 (D.N.J.) July 25, 2025 Hon. Sisan D. Wigenton Fleqsuvy® (baclofen oral suspension) 11,324,696
11,446,246
Astellas Pharma Inc. v. Lupin Ltd., 25-13779 (D.N.J.) July 25, 2025 Hon. Michael A. Shipp Xtandi® (enzalutamide tablets) 11,839,689
12,161,628
Gilead Sciences, Inc. v. Aspiro Pharma Ltd., 25-13936 (D.N.J.) July 30, 2025 Hon. Stanley R. Chesler Veklury® (remdesivir injection) 10,675,296
11,266,681
11,975,017
11,491,169
11,903,953
11,975,012
Sumitomo Pharma Switzerland GmbH v. Sandoz Inc., 25-0970 (D. Del.) Aug. 1, 2025 Hon. Maryellen Noreika Orgovyx® (relugolix tablets) 11,795,178
12,325,714
12,097,198
12,144,809
12,336,990
BPI Labs, LLC v. Eli Lilly and Co., IPR2025-01346 (PTAB) Aug. 4, 2025 N/A Mounjaro® (tirzepatide injection) Zepbound® (tirzepatide injection) 9,474,780
Array BioPharma Inc. v. Alembic Pharms. Ltd., 25-1016 (D. Del.) Aug. 13, 2025 Hon. Colm F. Connolly Vitrakvi® (larotrectinib sulfate capsules) 9,782,414
10,172,861
10,285,993
10,799,505
10,813,936
Bow River LLC v. Alembic Pharms. Ltd., 25-1016 (D. Del.) Aug. 13, 2025 Hon. Colm F. Connolly Vitrakvi® (larotrectinib sulfate capsules) 11,337,967
11,974,998
Jazz Pharms. Ireland Ltd. v. Granules India Ltd., 25-14606 (D.N.J.) Aug. 13, 2025 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
11,986,446
American Regent, Inc. v. Hikma Pharms. USA Inc., 25-14671 (D.N.J.) Aug. 15, 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
Alkermes, Inc. v. Teva Pharms., Inc., 25-14685 (D.N.J.) Aug. 15, 2025 Hon. Karen M. Williams Lybalvi® (olanzapine / samidorphan tablets) 11,707,466
11,951,111
Axsome Malta Ltd. v. Alkem Labs. Ltd., 25-14694 (D.N.J.) Aug. 15, 2025 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 12,102,609
12,194,016
12,263,145
12,318,362
Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 25-1043 (D. Del.) Aug. 19, 2025 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Vifor (Int’l) AG v. Orbicular Pharm. Techs. Pvt. Ltd., 25-1051 (D. Del.) Aug. 21, 2025 Hon. William C. Bryson Injectafer® (ferric carboxymaltose injection) 7,612,109
7,754,702
8,895,612
11,364,260
11,433,091
11,478,502
Nexus Pharms., LLC v. Saba Ilac Sanayi ve Ticaret A.S., 25-14927 (D.N.J.) Aug. 26, 2025 Hon. Claire C. Cecchi Emerphed® (ephedrine sulfate injection) 11,090,278
11,241,400
11,478,436
11,426,369
Alkermes, Inc. v. Apotex Corp., 25-14977 (D.N.J.) Aug. 27, 2025 Hon. Karen M. Williams Lybalvi® (olanzapine / samidorphan tablets) 11,707,466
11,951,111
12,390,474
Alkermes, Inc. v. Apotex Corp., 25-1086 (D. Del.) Aug. 28, 2025 Hon. Colm F. Connolly Lybalvi® (olanzapine / samidorphan tablets) 11,707,466
11,951,111
12,390,474
Actelion Pharms. Ltd. v. Seasons Biotechnology (Taizhou) Co. Ltd., 25-15027 (D.N.J.) Aug. 28, 2025 Hon. Stanley R. Chesler Opsumit® (macitentan tablets) 7,094,781
10,946,015
PH Health Ltd. v. Fresenius Kabi USA, LLC, 25-1096 (D. Del.) Aug. 29, 2025 Hon. Jennifer L. Hall Ephedrine Sulfate Injection 10,869,845
Baxter Healthcare Corp. v. PH Health Ltd., 25-15120 (D.N.J.) Aug. 29, 2025 Hon. Madeline Cox Arleo Nexterone® (amiodarone HCl premixed injection) 7,635,773
ARS Pharms. Operations, Inc. v. Lupin Inc., 25-15123 (D.N.J.) Aug. 29, 2025 Hon. Julien Xavier Neals neffy® (epinephrine nasal spray) 10,576,156
10,682,414
11,173,209
11,191,838
11,717,571
11,744,895
11,918,655
12,324,838
Bausch & Lomb Inc. v. Saba Ilac Sanayi ve Ticaret A.S., 25-15127 (D.N.J.) Aug. 29, 2025 Hon. Stanley R. Chesler Vyzulta® (latanoprostene bunod ophthalmic solution) 8,058,467
Actelion Pharms. US, Inc. v. VGYAAN Pharms. LLC, 25-15227 (D.N.J.) Sept. 3, 2025 Hon. Renee Marie Bumb Uptravi® (selexipag tablets) 7,205,302
Onyx Therapeutics, Inc. v. Amneal Pharms. of NY, LLC, 25-1107 (D. Del.) Sept. 4, 2025 Hon. Gregory B. Williams Kyprolis® (carfilzomib injection) 7,737,112
Jazz Pharms. Ireland Ltd. v. InvaGen Pharms., Inc., 25-15276 (D.N.J.) Sept. 4, 2025 Hon. Robert Kirsch Zepzelca® (lurbinectedin injection) 12,324,806
Alkermes, Inc. v. MSN Pharms., Inc., 25-15324 (D.N.J.) Sept. 5, 2025 Hon. Karen M. Williams Lybalvi® (olanzapine / samidorphan tablets) 11,707,466
11,951,111
8,778,960
12,390,474
Supernus Pharms., Inc. v. Macleods Pharms. Ltd., 25-15399 (D.N.J.) Sept. 9, 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
Astellas Pharma Inc. v. Hetero USA, Inc., 25-15434 (D.N.J.) Sept. 10, 2025 Hon. Michael A. Shipp Xtandi® (enzalutamide tablets) 11,839,689
12,161,628
Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 25-1139 (D. Del.) Sept. 12, 2025 Hon. Colm F. Connolly Katerzia® (amlodipine benzoate oral suspension) 10,799,453
11,471,409
11,484,498
11,701,326
11,918,685
12,053,461
12,336,984
Apotex Inc. v. Ipsen Biopharm Ltd., IPR2025-01531 (P.T.A.B.) Sept. 12, 2025 N/A Onivyde® (irinotecan HCl for injection) 11,344,552
Supernus Pharms., Inc. v. Macleods Pharms. Ltd., 25-1146 (D. Del.) Sept. 15, 2025 Hon. Jennifer L. Hall Qelbree® (viloxazine extended-release capsules) 9,358,204
9,603,853
9,662,338
11,324,753
11,458,143
12,121,523
Teva Pharms. Int’l GmbH v. Almaject, Inc., 25-1168 (D. Del.) Sept. 18, 2025 Hon. Jennifer L. Hall Bendeka® (bendamustine HCl injection) 8,609,707
9,265,831
9,572,796
9,572,797
9,034,908
9,144,568
9,572,887
9,597,397
9,597,398
9,597,399
9,000,021
9,579,384
10,010,533
10,052,385
11,844,783
11,872,214
12,138,248
12,350,257
12,343,333
GlaxoSmithKline LLC v. Sun Pharm. Indus. Ltd., 25-1170 (D. Del.) Sept. 18, 2025 Hon. Colm F. Connolly Zejula® (niraparib tablets) 8,071,623
11,091,459
11,673,877
Kudos Pharms. Ltd. v. Sun Pharm. Indus. Ltd., 25-15825 (D.N.J.) Sept. 19, 2015 Hon. Robert Kirsch Zejula® (niraparib tablets) 8,859,562
Glaxo Group Ltd. v. Transpire Bio Inc., 25-61939 (S.D. Fla.) Sept. 25, 2025 Hon. Melissa Damian Breo Ellipta (fluticasone furoate / vilanterol trifenatate inhaler) 11,116,721
8,534,281
8,746,242
8,161,968
Axsome Therapeutics, Inc. v. Apotex Inc., 25-16038 (D.N.J.) Sept. 26, 2025 Hon. Michael E. Farbiarz Symbravo® (meloxicam / rizatriptan tablets) 9,821,075
10,029,010
10,058,614
10,137,131
10,195,278
10,265,324
10,363,31
10,369,224
10,426,839
10,463,736
10,471,014
10,471,069
10,512,692
10,512,693
10,517,950
10,532,101
10,537,642
10,561,664
10,583,144
10,653,777
10,688,102
10,688,185
10,695,429
10,695,430
10,702,535
10,702,602
10,722,583
10,729,696
10,729,697
10,729,773
Orion Corp. v. MSN Pharms. Inc., 25-1201 (D. Del.) Sept. 26, 2025 Hon. Jennifer L. Hall Nubeqa® (darolutamide tablets) 10,010,530
10,383,853
10,835,515
11,168,058
Pfizer Inc. v. Prinston Pharm. Inc., 25-1202 (D. Del.) Sept. 26, 2025 Hon. Colm F. Connolly Xeljanz® (tofacitinib tablets) RE41,783
Boehringer Ingelheim Pharms. Inc. v. Ipca Labs. Ltd., 25-1207 (D. Del.) Sept. 29, 2025 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 11,090,323
11,833,166

 

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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