ANDA Litigation Settlements Summer 2021 | Hatch-Waxman

Reported settlements in federal district court cases

Second 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
Amgen Inc. v. Aurobindo Pharma Ltd., 18-11219 (D.N.J.)	Otezla® (apremilast tablets)	6,962,940 7,208,516 7,427,638 7,659,302 7,893,101 8,455,536 8,802,717 9,018,243 9,724,330 9,872,854 10,092,541	The patents-in-suit are valid and enforceable. The patents-in-suit would be infringed by the Aurobindo ANDA product. Until expiration of the patents-in-suit, Aurobindo 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.
Pfizer Inc. v. Micro Labs, Ltd., 21-0361 (D. Del.)	Xeljanz® (tofacitinib tablets)	RE41,783 6,965,027	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 parties waive any right of appeal. Each party shall bear its own costs and fees.
Eagle Pharms., Inc. v. Shilpa Medicare Ltd., 20-20270 (D.N.J.)	Pemfexy® (pemetrexed for injection)	9,604,990	All claims, counterclaims, and demands are dismissed without prejudice. Each party will bear its own attorneys’ fees and costs. The basis for this consent order is the referenced Confidential Stipulation and Proposed Order of Dismissal Without Prejudice. The court orders the reference Confidential Stipulation and Proposed Order of Dismissal Without Prejudice to be sealed.
Boehringer Ingelheim Pharms. Inc. v. Alembic Pharms. Ltd., 18-1762, 19-1885 (D. Del.)	Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® (empagliflozin / metformin tablets)	9,949,998 10,258,637	The ’998 and ’637 patents are valid, enforceable, and infringed by the Alembic ANDA product. Alembic is enjoined from infringing the patents-in-suit through their expiration. Complaints, claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
Cydex Pharms., Inc. v. Lupin Ltd., 19-2043 (D. Del.)	Evomela® (Captisol®-enabled melphalan HCl for injection)	9,200,088 9,493,582	Lupin’s ANDA product infringes the patents-in-suit. All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees. Lupin is enjoined from infringing the patents-in-suit until such date as permitted by the parties’ settlement agreement. Nothing prohibits Lupin from maintaining a PIV certification with respect to the patents-in-suit. Nothing restricts FDA from approving Lupin’s ANDA product. Neither the consent judgment nor its entry may be asserted by Plaintiffs against Lupin, and shall have no preclusive effect in any proceeding with respect to any product other than Lupin’s ANDA product. The parties waive any right to appeal.
Actelion Pharms. Ltd. v. MSN Pharms. Inc., 20-3859 (D.N.J.)	Uptravi® (selexipag tablets)	8,791,122 9,284,280	All claims, counterclaims, and defenses between Plaintiffs and Alembic are dismissed without prejudice, and each party shall bear its own costs and attorney fees.
ViiV Healthcare Co. v. Cipla Ltd., 17-1741 (D. Del.)	Tivicay® (dolutegravir tablets)	9,242,986	Except as specifically authorized pursuant to the settlement agreement, Cipla is enjoined from infringing the patent-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Pfizer Inc. v. Cipla USA Inc., 20-1393 (D. Del.)	Ibrance® (palbociclib capsules)	10,723,730	All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. Pursuant to the parties’ settlement agreement, Cipla is enjoined from infringing the patent-in-suit. This stipulation shall not act as an adjudication on the merits.
ACADIA Pharms. Inc. v. Hetero Labs Ltd., 20-1022 (D. Del.)	Nuplazid® (pimavanserin tartrate capsules)	7,601,740 10,449,185 10,646,480	All claims and counterclaims are dismissed without prejudice.
Pharmacyclics LLC v. Cipla Ltd., 18-0247 (D. Del.)	Imbruvica® (ibrutinib tablets)	9,296,753 9,725,455 9,540,382 9,713,617 8,754,090 9,125,889	No party admits liability. Each party shall bear its own costs, attorneys’ fees, and expenses. Claims and counterclaims are dismissed without prejudice.
Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-0611 (D. Del.)	Trulance® (plecanatide tablets)	7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637	Plaintiffs voluntarily dismiss action without prejudice.
Pharmacyclics LLC v. Sandoz Inc., 18-0275 (D. Del.)	Imbruvica® (ibrutinib tablets)	9,296,753 9,725,455 9,795,604 9,713,617	No party admits liability. Each party shall bear its own costs, attorneys’ fees, and expenses. Claims and counterclaims are dismissed without prejudice.
Pfizer Inc. v. Alembic Pharms., Inc., 20-1392 (D. Del.)	Ibrance® (palbociclib capsules)	10,723,730	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. Alembic will not infringe the ’730 patent except as provided for in that agreement. The order shall not act as an adjudication on the merits.
Amgen Inc. v. Torrent Pharms. Ltd., 18-11156 (D.N.J.)	Otezla® (apremilast tablets)	7,427,638 7,893,101 9,872,854 10,092,541	Torrent admits, solely with respect to the Torrent ANDA Product, the patents-in-suit are valid and enforceable. Torrent admits that the patents-in-suit would be infringed by making, using, offering to sell, selling, or importing the Torrent ANDA Product. Until expiration of the patents-in-suit, Torrent is enjoined from infringing the patents-in-suit, except as specifically authorized by Amgen in writing. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Amgen Inc. v. Alkem Labs. Ltd., 18-11265 (D.N.J.)	Otezla® (apremilast tablets)	6,962,940 7,427,638 7,659,302 8,455,536 9,724,330 10,092,541	Alkem admits that the patents-in-suit are valid and enforceable. Alkem admits that the patents-in-suit would be infringed by making, using, offering to sell, selling, or importing the Alkem ANDA Product. Until expiration of the patents-in-suit, Alkem is enjoined from infringing the patents-in-suit, except as and to the extent specifically authorized by Amgen in writing. Nothing shall prevent FDA from granting final approval to Alkem’s ANDA No. 211761. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Boehringer Ingelheim Pharms. Inc. v. Prinston Pharm. Inc., 18-1787, 19-1499 (D. Del.)	Glyxambi® (empagliflozin / linagliptin tablets)	8,551,957 9,949,998 10,258,637	The patents-in-suit are valid, enforceable, and infringed by the Prinston ANDA product. Unless specifically authorized or otherwise modified between the parties, Prinston is enjoned from infringing the patents-in-suit through and until their expiration. The complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Boehringer Ingelheim Pharms. Inc. v. Aizant Drug Research Solutions Prv. Ltd., 18-1783, 19-1492 (D. Del.)	Jardiance® (empagliflozin tablets)	8,551,957 9,949,998 10,258,637	The patents-in-suit are valid, enforceable, and infringed by the Aizant ANDA product. Unless specifically authorized or otherwise modified between the parties, Aizant is enjoned from infringing the patents-in-suit through and until their expiration. The complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Aclaris Therapeutics, Inc. v. Taro Pharms., Inc., 19-1910 (D. Del.)	Rhofade® (oxymetazoline HCl cream)	7,812,049 8,420,688 8,815,929 9,974,773 10,335,391	All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Parties waive any right to appeal.
Amgen Inc. v. MSN Labs. Private Ltd., 18-11213 (D.N.J.)	Otezla® (apremilast tablets)	6,962,940 7,427,638 7,659,302 8,455,536 9,724,330 10,092,541	MSN admits, solely with respect to the MSN ANDA and MSN ANDA product, that the patents-in-suit are valid and enforceable. Alkem admits, solely with respect to the MSN AND and MSN ANDA product, that the patents-in-suit would be infringed by making, using, offering to sell, selling, or importing the MSN ANDA Product. Until expiration of the patents-in-suit, MSN is enjoined from infringing the patents-in-suit, except as and to the extent specifically authorized by Amgen in writing. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
CyDex Pharms., Inc. v. Alembic Global Holding SA, 19-0956 (D. Del.)	Evomela® (melphalan HCl for injection)	8,410,077 9,200,088 9,493,582	Alembic has infringed the patents-in-suit pursuant to 35 U.S.C. § 271(e)(2)(A) by filing ANDA No. 212810 before their expiration. All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees. Alembic is enjoined from infringing the patents-in-suit until such date permitted by the parties’ settlement agreement. Nothing prohibits Alembic from maintaining a Paragraph IV Certification with respect to the patents-in-suit. Nothing restricts FDA from approving Alembic’s ANDA. This dismissal may not be asserted by CyDex against Alembic and shall have no preclusive effect other than to Alembic’s ANDA product. The parties waive any right to appeal.
Merz Pharms., LLC v. Aurobindo Pharma Ltd., 20-1760 (D. Del.)	Cuvposa® (glycopyrrolate oral solution)	7,638,552 7,816,396	All claims and counterclaims are dismissed without prejudice. Each Party will bear its own costs and attorneys’ fees.
Amgen Inc. v. Alembic Pharms. Ltd., 21-0061 (D. Del.)	Corlanor® (ivabradine tablets)	7,361,649 7,361,650 7,867,996 7,879,842	The patents-in-suit are valid and enforceable. The patents-in-suit would be infringed by making, selling, offering to sell, or importing the Alembic ANDA product. Until expiration of the patents-in-suit, Alembic 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.
Galderma Labs., L.P. v. Zydus Pharms. (USA) Inc., 20-14857 (D.N.J.)	Epiduo® Forte (adapalene / benzoyl peroxide gel)	8,936,800 9,814,690 8,785,420 8,703,820 9,387,187 8,445,543	The parties claims and counterclaims are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Astellas US LLC v. Sandoz Inc., 18-1676 (D. Del.)	Lexiscan® (regadenoson for injection)	8,106,183 9,085,601 RE47,301	All claims, defenses, and counterclaims are dismissed without prejudice. The parties will bear their own costs, disbursements, and attorney fees. The parties expressly waive any right to appeal.
Amgen Inc. v. Dr. Reddy’s Labs., Inc., 18-11269 (D.N.J.)	Otezla® (apremilast tablets)	7,427,638 7,893,101 8,455,536 10,092,541	DRL admits that the patents-in-suit are valid and enforceable. DRL admits that at least one claim of each of the patents-in-suit would be infringed by the DRL ANDA product. Until expiration of the patents-in-suit, DRL is enjoined from infringing the patents-in-suit, except as specifically authorized by Amgen in writing. All claims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Celgene Corp. v. Sun Pharma Global FZE, 18-11630, 19-10099, 21-1734 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,465,800 7,855,217 7,968,569 7,977,357 8,193,219 8,431,598 8,530,498 8,648,095 9,101,621 9,101,622	Sun is enjoined from infringing the patents-in-suit until their expiration, unless specifically authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands in these actions are dismissed without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Sun from maintaining a “Paragraph IV Certification” with respect to the patents-in-suit, any other patent listed in FDA’s Orange Book in connection with Revlimid, or any other patent listed in the Orange Book in connection with a product other than Revlimid. Nothing prohibits Sun from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving the Sun ANDA.
Genentech, Inc. v. Amneal Pharms. LLC, 19-0190, 19-0195 (D. Del.)	Esbriet® (pirfenidone tablets/capsules)	7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679	The complaints against Amneal are are dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees.
Silvergate Pharms., Inc. v. Amneal Pharms. LLC, 19-0678, 20-1255 (D. Del.)	Epaned® (enalapril maleate oral solution)	9,669,008 9,808,442 10,039,745 10,154,987 10,772,868	N/A
Pfizer Inc. v. Mylan Pharms. Inc., 19-0752 (D. Del.)	Ibrance® (palbociclib capsules)	6,936,612 RE47,739 7,456,168	All claims and affirmative defenses are dismissed with prejudice. Nothing shall prevent (a) Mylan from engaging in activities covered by 21 U.S.C. § 271(e)(1) or from manufacturing Mylan’s ANDA Product outside the United States, (b) Plaintiffs from asserting patents issued outside the United States against Mylan’s activities outside the United States, or (c) Mylan and Plaintiffs from later agreeing in writing to modify the terms of the the dismissal order. Each party shall bear its own costs, attorney fees, and expenses.