| Astellas Pharma Inc. v. Hikma Pharms. USA Inc., 25-0578 (D.N.J.) |
Xtandi®
(enzalutamide tablets) |
11,839,689
12,161,628 |
The parties’ claims and counterclaim are dismissed with prejudice. Parties shall bear their own costs. |
| Pacira Pharms., Inc. v. Fresenius Kabi USA, LLC, 24-12416 (N.D. Ill.) |
Exparel®
(bupivacaine liposome injectable suspension) |
12,156,940 |
Pacira, Fresenius Kabi, and Jiangsu Hengrui agree that all claims, counterclaims, and affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| eVenus Pharm. Labs., Inc. v. Pacira Pharms., Inc., 24-11014 (D.N.J.) |
Exparel®
(bupivacaine liposome injectable suspension) |
12,156,940 |
Pacira, eVenus, Jiangsu Hengrui, and Fresenius Kabi agree that all claims, counterclaims, and affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 21-19829, 22-0718, (D.N.J.) |
Exparel®
(bupivacaine liposome injectable suspension) |
11,033,495
11,179,336 |
Proceeding dismissed at Federal Circuit. |
| Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 23-2367 (D.N.J.) |
Exparel®
(bupivacaine liposome injectable suspension) |
11,033,495 |
Pacira, eVenus, Jiangsu Hengrui, and Fresenius Kabi agree that all claims, counterclaims, and affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 24-6294 (D.N.J.) |
Exparel®
(bupivacaine liposome injectable suspension) |
11,819,574
11,819,575 |
Pacira, eVenus, Jiangsu Hengrui, and Fresenius Kabi agree that all claims, counterclaims, and affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Alkermes Pharma Ireland Ltd. v. Nanjing Delova Biotech Co., Ltd., 23-9763 (D.N.J.) |
Anjeso®
(meloxicam injection) |
9,974,746
10,709,713
10,881,663
11,458,145 |
Aall claims, counterclaims, and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| AbbVie Inc. v. Hetero USA, Inc., 23-1332, 24-1254 (D. Del.) |
Rinvoq®
(upadacitinib tablets) |
RE47,221
8,962,629
9,951,080
10,981,923
11,186,584
11,661,425
11,680,069
11,718,627
11,198,697
9,963,459
10,519,164
10,981,924
10,597,400
11,535,624
11,773,105
11,780,847
11,787,815
11,795,175
9,879,018
12,077,545
12,103,933
12,110,297
12,110,298 |
The filing of Sandoz’s ANDA was an act of infringement under 35 U.S.C. § 271(e)(2)(A). All other claims, counterclaims, and defenses are dismissed, without prejudice. Absent a license, Sandoz is enjoined from infringing the patents-in-suit during the life of the patents-in-suit, including any extensions and pediatric exclusivities thereof. The parties waive any right to appeal. The dismissal order is without prejudice to any claim, defense, or counterclaim in any future actions between Sandoz and Plaintiff regarding the patents-in-suit and a product other than Sandoz’s ANDA product. Nothing prohibits Sandoz from maintaining Paragraph IV certifications to the patents-in-suit for the purpose of receiving or maintaining final FDA approval of the Sandoz ANDA. |
| American Regent, Inc. v. Xiromed, LLC, 24-7811, 24-11130 (D.N.J.) |
Selenious Acid |
11,998,565
12,150,957 |
Unless specifically authorized by ARI or by 35 U.S.C. § 271(e)(1), Xiromed is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Each party shall bear its own costs, expenses, and attorneys’ fees. Nothing shall preclude FDA from granting final approval to Xiromed’s ANDA or shall preclude Xiromed from filing, modifying, or maintaining with the FDA any Paragraph IV certification for the Xiromed ANDA product. |
| Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc., 19-2216 (D. Del.) |
Colcrys®
(colchicine tablets) |
7,906,519
7,935,731
8,093,297
8,093,298
7,964,648 |
Takeda’s breach of License Agreement and patent infringement claims for damages and injunctive relief, Mylan’s defenses to Takeda’s claims and breach of License Agreement counterclaims for damages, and Takeda’s defenses to Mylan’s counterclaims are dismissed with prejudice. Each party shall bear its own attorneys’ fees and costs. |
| Hetero Labs Ltd. v. AbbVie Inc., 25-0431 (D. Del.) |
Orilissa®
(elagolix sodium tablets) |
12,102,637 |
Complaint voluntarily dismissed without prejudice. |
| Nexus Pharms., Inc. v. Endo USA, Inc., 22-5683 (D.N.J.) |
Emerphed®
(ephedrine sulfate for injection) |
11,426,369 |
In view of the Settlement and License Agreement, the parties forego any further litigation involving their respective assertions raised or that may have been raised in this matter. All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses in connection with this suit. |
| Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., 24-4404 (D.N.J.) |
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 |
All claims, defenses, and counterclaims are dismissed, without prejudice. Each party shall bear its own costs. |
| Novartis Pharms. Corp. v. Natco Pharma Ltd., 24-1367 (D. Del.) |
Kisqali®
(ribociclib tablets) |
9,868,739 |
Novartis dismissed all claims with prejudice. Each party will bear its own attorneys’ fees and costs. |
| Metacel Pharms. LLC v. Rubicon Research Private Ltd., 25-1382 (D.N.J.) |
Ozobax®
(baclofen oral solution) |
10,610,502 |
All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs. |
| Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 24-8809 (D.N.J.) |
Firvanq®
(vancomycin HCl oral solution) |
10,493,028
10,688,046
10,959,946
10,959,947
10,959,948
10,959,949
11,638,692 |
All of Azurity’s infringement claims are dismissed with prejudice, and all other counterclaims, defenses, motions, and petitions are dismissed without prejudice as moot. This dismissal is without prejudice to to Azurity’s ability to re-assert any of the patents-in-suit against Annora in the event that any change is made to the formulation of the Annora ANDA Product. In the event that Azurity pursues such relief, Annora shall retain the right to respond with any and all defenses and counterclaims. Any protective orders entered by the Court shall remain in full force and effect notwithstanding the dismissal of this action. The parties shall bear their own costs and attorneys’ fees. |
| Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 23-23273 (D.N.J.) |
Firvanq®
(vancomycin HCl oral solution) |
10,493,028
10,688,046
10,959,946
10,959,947
10,959,948
10,959,949
11,638,692 |
All claims and counterclaims are dismissed without prejudice. Any protective orders entered by the Court shall remain in full force and effect notwithstanding the dismissal of this action. The 30-month stay of FDA approval for Aurobindo’s ANDA is hereby extinguished. The parties shall bear their own fees and costs. |
| ZS Pharma, Inc. v. Macleods Pharms. Ltd., 22-1055, 22-1100, 23-1190 (D. Del.) |
Lokelma®
(sodium zirconium cyclosilicate oral suspension) |
8,802,152
8,808,750
8,877,255
9,592,253
9,844,567
9,861,658
9,913,860
10,300,087
10,335,432
10,398,730
10,413,569
10,695,365
11,406,662
11,738,044 |
Unless specifically authorized pursuant to the settlement agreement, Macleods is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Heron Therapeutics, Inc. v. Mylan Pharms. Inc., 24-0043 (D. Del.) |
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 |
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The stipulation and order of dismissal shall finally resolve this action between the parties. |
| Esperion Therapeutics, Inc. v. Micro Labs USA, Inc., 24-5921 (D.N.J.) |
Nexletol®
(bempedoic acid tablets) |
11,760,714
11,613,511 |
All claims and counterclaims are dismissed without prejudice, with each party to bear its own costs, fees, and expenses. All other claims against all other defendants remain pending. |
| Merck Sharp & Dohme LLC v. Sun Pharm. Indus. Ltd., 25-1424 (D.N.J.) |
Dificid®
(fidaxomicin tablets) |
7,906,489
7,378,508
7,863,249
8,859,510 |
Unless specifically authorized by Merck, Sun is enjoined from infringing the patents-in-suit. All claims and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Pfizer Inc. v. Annora Pharma Private Ltd., 25-0424 (D. Del.) |
Xeljanz®
(tofacitinib tablets) |
RE41,783 |
Pfizer dismisses all claims without prejudice. At the time of dismissal, Annora had not served an answer or moved for summary judgment. |
| American Regent, Inc. v. Accord Healthcare, Inc., 24-9600 (D.N.J.) |
Tralement®
(trace elements injection) Multrys®
(trace elements injection) |
11,786,548
11,975,022
11,998,565
12,150,956 |
Unless authorized by ARI pursuant to the settlement agreement, Accord is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to Accord’s ANDA or shall preclude Accord from filing, modifying, or maintaining any Paragraph IV Certification for the Accord ANDA product. |
| Takeda Pharms. U.S.A., Inc. v. Dr. Reddy’s Labs., Ltd., 20-0845 (D. Del.) |
Colcrys®
(colchicine tablets) |
7,906,519
7,935,731
7,964,648
8,093,297
8,093,298 |
This action is dismissed with prejudice under Fed. R. Civ. P. 41(a)(1)(A)(ii) and 41(c). Each party shall bear its own attorneys’ fees and costs. |
| Esperion Therapeutics, Inc. v. Hetero USA Inc., 24-6389 (D.N.J.) |
Nexletol®
(bempedoic acid tablets) |
7,335,799
11,760,714
11,613,511 |
All claims and counterclaims between the Plaintiff and Hetero Defendants are dismissed without prejudice, with each party to bear its own costs, fees, and expenses incurred in relation to this action. All other claims asserted by Plaintiff against all other defendants and counterclaims asserted by all other defendants against Plaintiff in the consolidated actions remain pending. |
| American Regent, Inc. v. Xiromed, LLC, 25-0723 (D.N.J.) |
Tralement®
(trace elements injection of zinc,
copper, manganese, selenium) |
11,786,548
11,975,022
11,998,565
12,150,956
12,150,957 |
Unless otherwise authorized by ARI or by 35 U.S.C. § 271(e)(1), Xiromed is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Each party shall bear its own costs, expenses, and attorneys’ fees in connection with the claims dismissed by the Consent Judgment. Nothing shall preclude FDA from granting final approval to Xiromed’s ANDA or shall preclude Xiromed from filing, modifying, or maintaining with the FDA any Paragraph IV Certification for the Xiromed Product(s). |
| Array Biopharma Inc. v. Alembic Pharms. Ltd., 22-1277 (D. Del.) |
Mektovi®
(binimetinib tablets) |
9,314,464
9,850,229
10,005,761
9,562,016
9,598,376
9,980,944 |
All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses incurred in connection with the claims and counterclaims dismissed by this Order. Alembic will not infringe the patents-in-suit, except as provided for in the parties’ Settlement and License Agreement. Nothing prohibits Alembic from maintainin its existing Paragraph IV Certification to the patents-in-suit or prohibits FDA from granting final approval to Alembic’s ANDA. |
| Harmony Biosciences Management, Inc. v. Lupin Ltd., 25-0102 (D. Del.) |
Wakix®
(pitolisant HCl tablets) |
8,486,947
8,207,197 |
Unless specifically authorized pursuant to the Settlement Agreement, Lupin is enjoined from infringing the patents-in-suit. All claims, counterclaims, and affirmative defenses asserted, or could have been asserted, are dismissed with prejudice. Harmony and Lupin shall not seek an award of costs, disbursements, or attorneys’ fees in this Action. |
| AstraZeneca AB v. Sciegen Pharms., Inc., 24-0923 (D. Del.) |
Farxiga®
(dapagliflozin tablets) |
8,685,934
7,851,502
8,221,786
8,361,972
8,716,251
7,919,598
8,501,698 |
All claims are dismissed without prejudice. |
| American Regent, Inc. v. Zydus Pharms. (USA) Inc., 24-7812, 24-11133 (D.N.J.) |
Selenious Acid |
11,998,565
12,150,957 |
Unless specifically authorized by ARI or by 35 U.S.C. § 271(e)(1), Zydus is enjoined from infringing the patent-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to Zydus’s ANDA or shall preclude Zydus from filing, modifying, or maintaining with the FDA any Paragraph IV Certification for the Zydus product. |
| Endo USA, Inc. v. Baxter Healthcare Corp., 25-2365 (N.D. Ill.) |
Adrenalin®
(epinephrine in 0.9% sodium chloride injection) |
11,071,719
11,207,280
12,133,837 |
All claims and defenses are dismissed without prejudice and each party shall bear its own costs, expenses, and attorneys’ fees. All pending deadlines and hearings are vacated. |
| Novartis Pharms. Corp. v. Nanjing Noratech Pharm. Co., Ltd., 23-0401 (D. Del.) |
Entresto®
(sacubitril / valsartan tablets) |
8,101,659
11,058,667 |
Claims 1-4 of the ’659 patent, claim 1 of the ’918 patent, and claims 7 and 15 of the ’667 patent are valid and enforceable. The manufacture and sale of Noratech’s ANDA product infringes the asserted claims under 35 U.S.C. § 271(e)(2), § 271(a), and §§ 271(b) and (c). By virtue of the license granted by Novartis to Noratech as part of the settlement agreement, judgment is entered that there no longer exists a cause of action for infringement of the patents-in-suit. Pursuant to the terms of the settlement agreement, all other Novartis claims as to Noratech only are dismissed without prejudice and all of Noratech’s defenses, demands, and counterclaims are dismissed with prejudice. Noratech is enjoined from infringing the patents-in-suit. The parties shall bear their own costs and attorney fees. The parties waive any right to appeal. |
| Pfizer Inc. v. Sandoz Inc., 24-1244 (D. Del.) |
Inlyta®
(axitinib tablets) |
8,791,140 |
Pfizer’s action against Sandoz is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Salix Pharms, Inc. v. Carnegie Pharms. LLC, 24-10356 (D.N.J.) |
Xifaxan®
(rifaximin tablets) |
11,564,912
11,779,571
8,193,196 |
All claims, counterclaims, or affirmative defenses, are dismissed without prejudice and without costs, disbursements, or attorney fees. Plaintiffs acknowledge that Defendant is entitled to maintain its Paragraph IV certifications to U.S. Patent Nos. 8,193,196, 8,309,569, 10,456,384, 10,765,667, 11,564,912, and 11,779,571 pursuant to 21 C.F.R. § 314.94(a)(12)(v). Each Party acknowledges and agrees that the 30-month stay with respect to the approval of the Carnegie ANDA is hereby terminated. |
| Pfizer Inc. v. Alkem Labs. Ltd., 25-0565 (D. Del.) |
Xeljanz® XR
(tofacitinib citrate extended-release tablets) |
RE41,783 |
All claims dismissed without prejudice. At the time of dismissal, Alkem had not served an answer or filed a motion for summary judgment in this matter. |
| Bausch & Lomb Inc. v. Dr. Reddy’s Labs. Ltd., 23-3463 (D.N.J.) |
Vyzulta®
(latanoprostene bunod ophthalmic solution) |
7,273,946
7,629,345
7,910,767
8,058,467 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
