ANDA Litigation Settlements

Reported settlements in federal district court cases

First Quarter

This 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
Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 20-1630 (D. Del.)	Vascepa® (icosapent ethyl capsules)	9,700,537 8,642,077 10,568,861	All claims and counterclaims, defenses, motions, and petitions asserted between Amarin, Mochida, and Health Net are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees. This has no impact on any claims between Plaintiffs Amarin and Mochida, and Defendants Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC, as to which the Court already issued a Final Judgment.
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 case. All affirmative defenses, claims, and counterclaims, which have been or could have been raised by the parties are dismissed without prejudice. The parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees.
Nexus Pharms., Inc. v. Nephron SC, Inc., 22-0137 (D.S.C.)	Emerphed® (ephedrine sulfate for injection)	11,090,278	The parties stipulate to the voluntary dismissal without prejudice of all claims that have been asserted by each party in this action. Each party shall bear its own costs and attorneys’ fees.
Anacor Pharms., Inc. v. Alkem Labs. Ltd., 21-1348 (D. Del.)	Eucrisa® (crisaborole ointment)	8,039,451 8,168,614 8,501,712 9,682,092	All claims, counterclaims, and defenses between the parties are voluntarily dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees with respect to any claim, counterclaim, or defense relating to the patents-in-suit.
Novo Nordisk Inc. v. Hikma Pharms. USA Inc., 21-1783 (D. Del.)	Victoza® (liraglutide recombinant solution injection)	8,579,869 7,762,994 8,114,833 9,265,893	The parties dismiss all claims, counterclaims, and defenses without prejudice. Each party will bear its own attorneys’ fees and costs.
Intercept Pharms., Inc. v. Optimus Pharma Pvt. Ltd., 20-1215 (D. Del.)	Ocaliva® (obeticholic acid tablets)	7,138,390 9,238,673 10,047,117 10,052,337 10,174,073	The patents-in-suit are valid and enforceable. The ANDA products infringe the patents-in-suit. Except as authorized under the settlement agreement, Optimus 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.
Intercept Pharms., Inc. v. Amneal Pharms. LLC, 20-1154 (D. Del.)	Ocaliva® (obeticholic acid tablets)	9,238,673 10,047,117 10,052,337 10,174,073	Except as authorized under the settlement agreement, Amneal is enjoined from infringing the patents-in-suit. Nothing herein shall prevent Amneal from engaging in conduct that is covered by 35 U.S.C. § 271(e)(1). All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Eisai R&D Management Co., Ltd. v. Long Grove Pharms., LLC, 22-1211 (D. Del.)	Halaven® (eribulin mesylate injection)	RE46,965	Plaintiffs dismiss case without prejudice and without costs.
Novartis Pharms. Corp. v. Micro Labs Ltd., 21-0969 (D. Del.)	Xiidra® (lifitegrast ophthalmic solution)	7,314,938 7,745,460 7,790,743 7,928,122 9,216,174 10,124,000 8,084,047 8,592,450 8,168,655 8,367,701 9,447,077 8,927,574 9,353,088 9,890,141 9,085,553	All claims and defenses asserted by the parties are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Amgen Inc. v. Apotex Inc., 22-3827 (D.N.J.)	Otezla® (apremilast tablets)	7,427,638 9,872,854 10,092,541	Apotex admits, with respect to the Apotex ANDA product, that the patents-in-suit are valid and enforceable. Apotex admits that the patents-in-suit would be infringed by the Apotex ANDA product. Until expiration of the patents-in-suit, Apotex is enjoined from infringing the patents-in-suit, except as authorized by Amgen in writing. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall prevent FDA from granting final approval to the Apotex ANDA.
Pfizer Inc. v. Sun Pharm. Indus. Ltd., 22-1501 (D. Del.)	Xeljanz® XR (tofacitinib citrate extended-release tablets)	RE41,783	All claims asserted relating to the generic tofacitinib citrate extended-release tablet that are the subject of Sun’s ANDA as amended, are dismissed without prejudice.
Array Biopharma Inc. v. Eugia Pharma Specialities Ltd., 22-1236 (D. Del.)	Braftovi® (encorafenib capsules)	9,474,754	Plaintiff’s claims are hereby dismissed without prejudice. Each party shall bear its own costs, expenses, and fees. In the event Eugia converts its Section viii certification with respect to the ’754 patent back to a Paragraph IV certification, Eugia will send a new paragraph IV certification to Plaintiff, and if Plaintiff timely brings suit, Eugia will not contest the imposition of a thirty-month stay of final approval by the FDA of Eugia’s ANDA.
Eli Lilly and Co. v. Dr. Reddy’s Labs., Ltd., 22-1354 (D. Del.)	Forteo® (teriparatide injection)	7,517,334	The DRL ANDA product does not infringe the ’334 patent. There is no reason for delay and this judgment is final in favor of DRL and against Lilly. DRL shall promptly notify Lilly of any modification, amendment, or supplement to the DRL ANDA that changes the structure or operation of the DRL ANDA product as it relates to the ’334 patent. Nothing prohibits Lilly from asserting an action for infringement of the ’334 patent against DRL in the event DRL makes changes to the structure or operation of the pen device component of its ANDA product. Nothing prohibits DRL from submitting, modifying or maintaining a Paragraph IV certification with respect to the ’334 patent. The parties shall bear their own costs and attorneys’ fees.
Evoke Pharma, Inc. v. Teva Pharms., Inc., 22-2019 (D.N.J.)	Gimoti® (metoclopramide nasal spray)	8,334,281 11,020,361	All claims, defenses, and counterclaims are dismissed without prejudice, and each party shall bear its own attorneys’ fees and costs.
AstraZeneca AB v. USV Private Ltd., 22-0899 (D. Del.)	Brilinta® (ticagrelor tablets)	10,300,065	Unless specifically authorized by the settlement agreement, Defendants, are enjoined from infringing the ’065 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Janssen Products, L.P. v. Evenus Pharms. Labs. Inc., 20-9369 (D.N.J.)	Yondelis® (trabectedin for injection)	8,895,557 7,420,051	Sun and Natco admit that the claims of the patents-in-suit are valid and enforceable, and that they would be infringed by Defendants’ ANDA product. Sun and Natco are enjoined from infringing the patents-in-suit until their expiration, other than as authorized by Plaintiffs. All affirmative defenses, claims, and counterclaims are dismissed without prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive any right to appeal.
Astellas Pharma Inc. v. Sawai Pharm. Co., Ltd., 22-0818 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	6,346,532 7,342,117 7,982,049 8,835,474 RE44,872 10,842,780	Astellas and Sawaii agree that all claims and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc., 22-1227 (D. Del.)	Velphoro® (sucroferric oxyhydroxide chewable tablets)	11,446,252	All claims, counterclaims, and affirmative defenses are dismissed without prejudice and, except as specifically provided by agreement, without costs, disbursements, or attorneys’ fees to any party.
Takeda Pharms. America, Inc. v. Apotex, Inc., 21-12998 (D.N.J.)	Iclusig® (ponatinib HCl tablets)	8,114,874 9,029,533 9,493,470 11,192,895 11,192,897 11,384,086	Until expiration of the patents-in-duit, Apotex is enjoined from infringing the patents-in-suit, except as 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 Apotex from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Apotex’s ANDA product.
Boehringer Ingelheim Pharms. Inc. v. Mankind Pharma Ltd., 18-1689, 19-1498, 21-1766 (D. Del.)	Jardiance® (empagliflozin tablets)	8,551,957 9,949,998 10,258,637 11,090,323	The patents-in-suit are valid, enforceable, and infringed by the Mankind ANDA products. Unless authorized by BI, Mankind is enjoined from infringing the patents-in-suit until their expiration. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Apotex Inc. v. Eli Lilly & Co., 22-2342 (S.D. Ind.)	Forteo® (teriparatide injection)	7,517,334	The Apotex ANDA product does not infringe the ’334 patent. There is no just reason for delay and this judgment is final in favor of Apotex and against Lilly pursuant to F.R.C.P. 54(b). Nothing prohibits Apotex from submitting or maintaining a Paragraph IV Certification with respect to the ’334 patent. Nothing prohibits Lilly from asserting an action for infringement of the ’334 patent against Apotex in the event Apotex makes changes to the structure or operation of the pen device component of the Apotex ANDA product. Parties shall bear their own costs and attorneys’ fees.
Merck Sharp & Dohme LLC v. Prinston Pharm. Inc., 22-1071 (D. Del.)	Januvia® (sitagliptin phosphate tablets)	7,326,708	Unless authorized under the settlement agreement, Prinston 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.
Fresenius Kabi USA, LLC v. Accord Healthcare Inc., 22-6341 (D.N.J.)	levothyroxine sodium for injection	9,006,289 9,168,238 9,168,239	All claims, counterclaims, and affirmative defenses of Fresenius and Accord are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Intercept Pharms., Inc. v. Lupin Ltd., 20-1155 (D. Del.)	Ocaliva® (obeticholic acid tablets)	9,238,673 10,047,117 10,052,337 10,174,073	Except as authorized under the settlement agreement, Lupin is enjoined from infringing the patents-in-suit. Nothing prevents FDA from granting final approval to Lupin’s ANDA. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Intercept Pharms., Inc. v. Apotex Inc., 20-1105 (D. Del.)	Ocaliva® (obeticholic acid tablets)	7,138,390 9,238,673 10,047,117 10,052,337 10,174,073	Except as authorized under the settlement agreement, Apotex 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.
Intercept Pharms., Inc. v. MSN Labs. Private Ltd., 20-1214 (D. Del.)	Ocaliva® (obeticholic acid tablets)	7,138,390 9,238,673 10,047,117 10,052,337 10,174,073	Except as authorized under the settlement agreement, MSN 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.
Chiesi USA Inc. v. Eugia Pharma Specialties Ltd., 23-0022 (D.N.J.)	Kengreal® (cangrelor injection)	8,680,052 9,295,687 9,427,448 9,439,921 9,700,575 9,925,265 10,039,780	Until expiration of the patents-in-suit, Eugia is enjoined from infringing the patents-in-suit, except as specifically authorized by Chiesi. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Eugia from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Eugia’s ANDA product.
Azurity Pharms., Inc. v. Amneal Pharms. LLC, 21-8717 (D.N.J.)	Katerzia® (amlodipine oral suspension)	10,695,329 10,799,453 10,894,039 10,952,998	All claims and counterclaims are dismissed without prejudice. Azurity and Amneal shall bear their own fees and costs.
ViiV Healthcare Co. v. Lupin Ltd., 21-1561 (D. Del.)	Tivicay PD™ (dolutegravir tablets)	9,242,986	Except as specifically authorized, Lupin is enjoined from infringing the ’986 patent. All claims and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Lupin from maintaining any “Paragraph IV Certification” with respect to the ‘986 patent or any other patent. Nothing shall have preclusive or other res judicata effect on Lupin in any other pending or future action or proceeding involving a product other than the Lupin ANDA product, and nothing prohibits Lupin from challenging the validity, enforceability or infringement of the ‘986 patent or any other patent in any other action involving a product other than the Lupin ANDA Product. The 30-month stay is terminated and no longer in effect.
Salix Pharms., Inc. v. Zydus Pharms. (USA), Inc., 22-5589 (D.N.J.)	Colazal® (balsalazide disodium capsules)	7,452,872 7,625,884 8,497,256	All claims, defenses, and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys' fees, and expenses.
ViiV Healthcare Co. v. Cipla Ltd., 20-0977 (D. Del.)	Juluca® (dolutegravir sodium / rilpivirine HCl tablets)	9,242,986 10,426,780	Except as authorized pursuant to the settlement agreement, Cipla 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.
AstraZeneca AB v. Mylan Pharms. Inc., 22-0035 (N.D.W.V.)	Symbicort® (budesonide / formoterol fumarate dehydrate inhalation aerosol)	11,311,558	In light of Mylan’s stipulation of infringement and validity, Final Judgment shall be entered in favor of AstraZeneca, finding that Mylan infringed the ‘558 patent. Final Judgment shall be entered in favor of AstraZeneca on all counterclaims seeking declarations of non-infringement and invalidity of the ‘558 patent. Mylan is enjoined until July 29, 2023, from infringing the ’558 patent, except as agreed to by the parties in their settlement agreement. Nothing prevents FDA from maintaining the final approval issued to Mylan’s ANDA. Each party shall bear its own costs and fees.
Novartis Pharms. Corp. v. Aurobindo Pharma Ltd., 20-1426 (D. Del.)	Xiidra® (lifitegrast ophthalmic solution)	7,314,938 7,745,460 7,790,743 7,928,122 9,216,174 10,124,000 8,084,047 8,592,450 8,168,655 8,367,701 9,447,077 8,927,574 9,353,088 9,890,141 9,085,553	Novartis’ action against Aurobindo, including all claims and defenses asserted by Novartis and all counterclaims and defenses asserted by Aurobindo against Novartis, are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Gilead Sciences, Inc. v. Lupin Ltd., 21-1615 (D. Del.)	Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide)	8,754,065 9,296,769	All affirmative defenses, claims, and counterclaims are dismissed without prejudice. Except as provided by the parties’ agreement, Lupin is enjoined from infringing the patents-in-suit, until permitted under the parties’ agreement. The parties waive all right to appeal. Each party to bear its own costs and attorneys’ fees. Nothing in this Consent Judgment and Dismissal impacts Gilead v. Lupin, 21-1621 (D. Del.).
Galderma Labs., L.P. v. Prinston Pharm., Inc., 22-1166 (D. Del.)	Oracea® (doxycycline capsules)	7,749,532 8,206,740	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Novartis Pharms. Corp. v. Fresenius Kabi USA, LLC, 21-0870 (D. Del.)	Kisqali® (ribociclib tablets) Kisqali® Femara® Co-pack (ribociclib / letrozole tablets)	8,324,225 8,415,355 8,685,980 8,962,630 9,193,732 9,416,136 9,868,739 10,799,506	The case is dismissed with respect solely to Fresenius, without prejudice. Fresenius shall be entitled to contest the infringement, validity, and/or enforceability of the patents-in-suit pertaining to any product that is not the Fresenius ANDA products. Each party will bear its own attorneys’ fees and costs.
Azurity Pharms., Inc. v. Glenmark Pharms. Ltd., 22-1604 (D. Del.)	Edarbi® (azilsartan medoxomil tablets)	9,066,936	All claims, counterclaims, and defenses are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
Horizon Therapeutics, LLC v. Taro Pharm. Indus. Ltd., 22-4663 (D.N.J.)	Ravicti® (glycerol phenylbutyrate oral liquid)	8,642,012 9,254,278 9,326,966 9,561,197 9,962,359 9,999,608 10,045,958 10,045,959 10,183,002 10,183,003 10,183,004 10,183,005 10,183,006 10,668,040	All claims, counterclaims, and defenses are dismissed without prejudice.
Neurocrine Biosciences, Inc. v. Teva Pharms., Inc., 22-0965 (D. Del.)	Ingrezza® (valbenazine capsules)	11,311,532	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Teva, except as expressly licensed by Neurocrine, will be enjoined until expiration of the patent-in-suit from infringing the patents-in-suit. Nothing shall prevent FDA from granting Teva’s ANDA. Each party will bear its own attorneys’ fees and costs.
Merck Sharp & Dohme Corp. v. Mylan Pharms. Inc., 19-0101 (N.D.W.V.)	Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCl / sitagliptin phosphate tablets)	7,326,708 8,414,921	The Amended Final Judgment (ECF No. 197) is vacated. Final Judgment shall be entered in favor of Merck and against Mylan. Mylan is enjoined, unless permitted by the Settlement Agreement, from infringing the patents-in-suit until the expiration of the patents-in-suit. The 30-month stay is terminated. Nothing prevents FDA from granting final approval to Mylan’s ANDAs.