ANDA Litigation Settlements of Q3 - Fall 2023 | Hatch-Waxman

Reported settlements in federal district court cases

Third Quarter

This ANDA Litigation Settlements chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act.

Case Name	Drug	Patent No(s).	Publicly Available Terms
Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-0383 (D. Del.)	Uptravi® (selexipag tablets)	7,205,302	The patent-in-suit is valid and enforceable. Unless otherwise authorized by Plaintiffs, Alembic is enjoined from infringing the patents-in-suit through and until after the later of (a) October 31, 2026, or (b) the last day of any period of pediatric exclusivity that is or may become associated with the ’302 patent. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Fresenius Kabi USA, LLC v. Steriscience PTE Ltd., 22-1810 (D.N.J.)	Levothyroxine sodium powder for injection	9,006,289 9,168,238 9,168,239	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Astellas Pharma Inc. v. Humanwell Puracap Pharms. (Wuhan) Co., Ltd., 23-1020 (D.N.J.)	Xtandi® (enzalutamide capsules)	7,709,517 8,183,274	Each of plaintiffs’ claims against Defendants with respect to the patents-in-suit is dismissed with prejudice. The parties shall each bear their own costs.
Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 19-2021, 21-1330 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	8,101,659 8,796,331 8,877,938 9,388,134 11,096,918	Consent Judgement and Order of Injunction between Plaintiff and Defendants Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. sealed.
Servier Pharms. LLC v. Alembic Pharms. Ltd., 22-1420 (D. Del.)	Tibsovo® (ivosidenib tablets)	9,968,595 10,449,184 10,799,490 10,980,788	Case stayed. Order sealed.
Anacor Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 21-1349 (D. Del.)	Eucrisa® (crisaborole ointment)	8,039,451 8,168,614 8,501,712 9,682,092	All claims and counterclaim are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. DRL will not infringe the patents-in-suit, except as provided for in the parties’ settlement and license agreement.
Abraxis Bioscience, LLC v. Mylan Pharms. Inc., 23-0033 (N.D.W.V.)	Abraxane® (paclitaxel protein-bound particles for injectable suspension)	7,820,788	Until expiration of the ’788 patent, Mylan is enjoined from infringing the ’788 patent. All claims, counterclaims, affirmative defenses, and demands are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Mylan from maintaining a “Paragraph IV Certification” with respect to the ’788 patent. Nothing restricts FDA approving Mylan’s ANDA.
Novartis Pharms. Corp. v. Ingenus Pharms., LLC, 22-1045 (D. Del.)	Xiidra® (lifitegrast ophthalmic solution)	8,084,047 8,168,655 8,367,701 8,592,450 8,927,574 9,085,553 9,353,088 9,447,077 9,890,141 11,058,677	All claims and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Takeda Pharms. U.S.A., Inc. v. Sun Pharm. Indus. Ltd., 22-0911 (D. Del.)	Mydayis® (mixed salts of a single-entity amphetamine product extended-release capsules)	8,846,100 9,173,857	The patents-in-suit are valid and enforceable solely with respect to the Sun ANDA product. All affirmative defenses, claims, and counterclaims, which have been or could have been raised with respect to the validity or enforceability are dismissed with prejudice. Sun admits that in the absence of a license, its ANDA product infringes infringe each of the patents-in-suit. Except as authorized by Plaintiffs, Sun is enjoined during the term of the patents-in-suit from infringing the patents-in-suit or from challenging the validity or enforceability of the patents-in-suit. Any Protective Order entered by the Court shall remain in full force notwithstanding the conclusion of this action. The parties waive all right to appeal. Each party shall bear its own costs, expenses, and attorneys’ fees. Nothing shall prohibit (i) Sun from maintaining or filing Paragraph IV certifications and (ii) FDA from reviewing or approving Sun’s ANDA.
Bayer Intellectual Property GmbH v. Biocon Pharma Ltd., 23-0334 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218 10,828,310	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Aragon Pharms., Inc. v. Sandoz Inc., 22-0678 (D. Del.)	Erleada® (apalutamide tablets)	8,445,507 8,802,689 9,388,159 9,481,663 9,987,261	Plaintiffs dismiss the action without prejudice.
Merck Sharp & Dohme LLC v. Biocon Pharma Ltd., 23-0683 (D. Del.)	Januvia® (sitagliptin phosphate tablets)	7,326,708	Unless otherwise authorized pursuant to the settlement agreement, Biocon is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Newron Pharms. S.p.A. v. Aurobindo Pharma Ltd., 21-0843 (D. Del.)	Xadago® (safinamide tablets)	8,076,515 8,278,485 8,283,380	The parties have entered into a confidential settlement agreement resolving this action. All affirmative defenses, claims, and counterclaims, which have been or could have been raised by Plaintiffs against Prinston, or by Prinston against Plaintiffs, are dismissed without prejudice. The Parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees.
Supernus Pharms., Inc. v. Riconpharma LLC, 21-12133 (D.N.J.)	Oxtellar XR® (oxcarbazepine extended-release tablets)	7,722,898 7,910,131 8,617,600 8,821,930 9,119,791 9,351,975 9,370,525 9,855,278 10,220,042	All claims, counter-claims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Anacor Pharms., Inc. v. Macleods Pharms. Ltd., 21-1350 (D. Del.)	Eucrisa® (crisaborole ointment)	8,039,451 8,168,614 8,501,712 9,682,092	All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. The parties have entered into a settlement and license agreement, and Macleods will not infringe the patents-in-suit with its ANDA product, except as provided by the settlement agreement.
Gilead Sciences, Inc. v. Natco Pharma Ltd., 22-0852, 22-1259 (D. Del.)	Zydelig® (idelalisib tablets)	RE44,599 RE44,638 8,865,730 9,469,643 9,492,449 10,730,879	All affirmative defenses, claims, and counterclaims are dismissed without prejudice. Except as provided by the parties’ agreement, Natco is enjoined from infringing the patents-in-suit. The parties waive all right to appeal. Each party shall bear its own costs and attorneys’ fees.
Pfizer Inc. v. Sun Pharm. Indus. Ltd., 23-0718 (D. Del.)	Xeljanz® XR (tofacitinib citrate extended-release tablets)	RE41,783	Plaintiffs dismiss all claims without prejudice.
Pfizer Inc. v. Annora Pharma Private Ltd., 23-0634 (D. Del.)	Xeljanz® (tofacitinib oral solution)	RE41,783	Plaintiffs dismiss all claims without prejudice.
Apotex Inc. v. Boehringer Ingelheim Pharms., Inc., 23-0704 (D. Del.)	Tradjenta® (linagliptin tablets)	8,673,927 8,846,695 8,883,805	The Court grants final judgment that the claims of the ’927 patent are invalid for obviousness and obviousness-type double patenting. Final judgment of invalidity of the ’927 patent is therefore entered in favor of Apotex. The Court grants final judgment that the claims of the ‘695 patent are not enforceable since all claims have been disclaimed by the patentee. Final judgment of unenforceability of the ‘695 patent is therefore entered in favor of Apotex. The Court grants final judgment that Apotex’s ANDA and product do not infringe any claim of the ‘805 patent. Final judgment of non-infringement of the ‘805 patent is therefore entered in favor of Apotex. This final judgment shall not have any preclusive effect in any cause of action, litigation, or proceeding with respect to any other product other than the Apotex ANDA product. Each party shall bear its own fees and costs.
Takeda Pharms. America, Inc. v. Teva Pharms., Inc., 22-7454 (D.N.J.)	Iclusig® (ponatinib HCl tablets)	9,493,470 11,192,895 11,192,897 11,384,086	Until expiration of the patents-in-suit, Teva is enjoined from infringing the patents-in-suit, except as specifically authorized by Takeda. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Teva from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Teva’s ANDA.
Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-847, 23-0848, 23-849 (D. Del.)	Jardiance® (empagliflozin tablets)	9,949,998 10,258,637 11,090,323	The patents-in-suit are valid and enforceable with respect to the Ajanta ANDA products. Making and selling Ajanta’s ANDA products would infringe the patents-in-suit. Unless authorized by BI, Ajanta is enjoined from infringing the patents-in-suit until their expiration. Neither this judgment nor the entry of this consent judgment may be asserted by BI against Ajanta, and there shall be no preclusive effect in any proceeding with respect to any product other than the Ajanta ANDA products with respect to the patents-in-suit. The parties shall bear their own fees and costs. The complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Alkermes, Inc. v. Teva Pharm. Indus. Ltd., 20-12470 (D.N.J.)	Vivitrol® (extended-release naltrexone for injection)	7,919,499	Terms not public.
Galderma Labs., L.P. v. Dr. Reddy’s Labs., Ltd., 23-0711 (D. Del.)	Oracea® (doxycycline capsules	7,749,532 8,206,740	All claims, counterclaims, and affnmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Boehringer Ingelheim Pharms. Inc. v. Cipla Ltd., 18-1789, 19-1494 (D. Del.)	Jardiance® (empagliflozin tablets) Synjardy XR® (empagliflozin / metformin HCl extended-release tablets)	9,949,998 10,258,637	The patents-in-suit are valid and enforceable. Unless specifically authorized, Cipla is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit. The parties shall bear their own costs and fees, including attorneys’ fees. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice.
Bristol-Myers Squibb Co. v. Xspray Pharma AB, 22-0964 (D.N.J.)	Sprycel® (dasatinib tablets)	7,491,725 8,680,103	All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Evofem Biosciences, Inc. v. Padagis Israel Pharms. Ltd., 23-3003 (D.N.J.)	Phexxi® (lactic acid / citric acid / potassium bitartrate vaginal gel)	10,568,855 11,337,989 11,439,610	Padagis has amended its PIV certifications to the patents-in-suit to PIII certifications. All claims, counterclaims, and defenses are voluntarily dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Azurity Pharms., Inc. v. Alkem Labs Ltd., 23-0079 (D.N.J.)	Eprontia® (topiramate oral solution)	11,433,046	All claims and counterclaims are dismissed without prejudice. The parties shall bear their own fees and costs.
Astellas Pharma Inc. v. Qilu Pharma, Inc., 23-0022 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	10,842,780	All claims asserted against Qilu are dismissed without prejudice, and all defenses to such claims and counterclaims are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Otsuka Pharm. Co., Ltd. v. Apotex Inc., 23-0710 (D. Del.)	Jynarque® (tolvaptan tablets)	8,501,730 8,273,735	With respect to Apotex’s ANDA and ANDA products, the patents-in-suit are valid and enforceable. Apotex stipulates that the patents-in-suit would be infringed by its ANDA products. Apotex, except as licensed by Plaintiff, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Each party will bear its own attorneys’ fees and costs.
Par Pharm., Inc. v. Cipla Ltd., 23-1150 (D.N.J.)	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	All claims, counterclaims, causes of action, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Actelion Pharms. Ltd. v. Apotex Inc., 23-0734 (D. Del.)	Opsumit® (macitentan tablets)	7,094,781	Apotex admits the ’781 patent is valid and enforceable and that its claims would be infringed by the ANDA product. Unless otherwise authorized by plaintiff, Apotex is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-1902 (D.N.J.)	Opsumit® (macitentan tablets)	7,094,781	Alembic admits the ’781 patent is valid and enforceable and that its claims would be infringed by the ANDA product. Unless otherwise authorized by plaintiff, Alembic is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.