ANDA Litigation Settlements

Reported settlements in federal district court cases

Third Quarter

GENERICally Speaking

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
Celgene Corp. v. Alembic Pharms. Ltd., 21-20099 (D.N.J.) Revlimid® (lenalidomide capsules) 7,465,800 Until expiration of the patent-in-suit, Alembic is enjoined from infringing the patent-in-suit with respect to the ANDA product, unless specifically authorized by Celgene.
All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Nothing prohibits Alembic from maintaining any Paragraph IV Certification with respect to the patent-in-suit or any other patent.
Nothing restricts FDA from approving Alembic’s ANDA product.
Symed Labs Ltd. v. Amneal Pharms. LLC, 18-13628 (D.N.J.) Zyvox® (linezolid) 7,429,661
7,351,824
The patents-in-suit are valid and enforceable. The products made and to be sold according to Amneal’s ANDA infringe claims 1, 2, and 3 of the ’824 patent and claims 64, 65, and 66 of the ’661  patent. Except in accordance with the parties’ settlement agreement, Amneal is enjoined until the last to expire of the patents-in-suit from infringing the patents-in-suit.
Each party will bear its own attorneys’ fees and costs. All claims, counterclaims, and affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Chiesi USA Inc. v. Gland Pharma Ltd., 19-18565, 19-21204 (D.N.J.) Kengreal® (cangrelor for injection) 6,130,208
8,680,052
9,427,448
9,439,921
9,925,265
10,039,780
Unless specifically authorized under the settlement agreement, Gland 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.
Bayer Pharma AG v. Micro Labs Ltd., 22-0165 (D. Del.) Xarelto® (rivaroxaban tablets) 10,828,310 All claim and defenses are dismissed with prejudice.
All parties shall bear their own costs, disbursements, and attorneys’ fees.
Mitsubishi Tanabe Pharma Corp. v. Dr. Reddy’s Labs., Inc., 19-18764 (D.N.J.) Invokamet® (canagliflozin / metformin HCl tablets) 7,943,788 All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Otsuka Pharm. Co., Ltd. v. Macleods Pharms. Ltd., 19-2065, 21-0316 (D. Del.) Rexulti® (brexpiprazole tablets) RE 48,059
10,307,419
With respect to Macleods’ ANDA only, the patents-in-suit are valid and enforceable. The patents-in-suit would be infringed by Macleods’ ANDA.
Macleods, except as expressly licensed by Plaintiffs, 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.
Otsuka Pharm. Co., Ltd. v. Ajanta Pharma Ltd., 19-1939, 20-1335 (D. Del.) Rexulti® (brexpiprazole tablets) 8,349,840
8,618,109
9,839,637
10,307,419
RE 48,059
All claims, countercalims, affirmative defenses and demands between Plaintiffs and Ajanta are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Ajanta, except as expressly licensed by Plaintiffs, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit.
Nothing prevents FDA from granting final approval to Ajanta’s ANDA.
Cipla Ltd. v. Boehringer Ingelheim Pharms. Inc., 22-0300 (D. Del.) Ofev® (nintedanib capsules) 9,907,756
10,105,323
The Court finds that Cipla’s ANDA does not infringe any claim of the ’756 patent and ’323 patent. The Court grants judgment that Cipla’s manufacture, use, offer for sale, sale, marketing and/or importation of the Cipla ANDA Products does not and will not infringe any claim of the ’756 patent or ’323 patent. 
Cipla may rely on this Final Judgment of non-infringement of the ’756 patent and ’323 patent with respect to its ANDA to the extent permitted by law.
Neither this Judgment and Order nor the entry of this Judgment and Order may be asserted by Cipla or any other entity against Boehringer or any of its affiliates, and shall have no preclusive effect in any cause of action, litigation or proceeding with respect to any product other than the Cipla ANDA.
All remaining claims, counterclaims, or affirmative defenses in this action are dismissed without costs, disbursements, or attorney fees to any party.
Eisai Co., Ltd. v. Hetero USA Inc., 22-1795 (D.N.J.) Banzel® (rufinamide oral suspension) 6,740,669 The ’669 patent is enforceable and valid. Hetero has technically infringed the ’669 patent pursuant to § 271(e)(2) by filing its ANDA. Except as permitted by the settlement agreement, Hetero is enjoined from infringing the ’669 patent, until the license to the ’669 patent becomes effective as set forth in the settlement agreement. All claims and counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties each expressly waive any right to appeal.
Merck Sharp & Dohme Corp. v. Mankind Pharma Ltd., 22-0444 (D. Del.) Januvia® (sitagliptin phosphate tablets) 7,326,708 Unless authorized by the settlement agreement, Mankind 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. Sintetica S.A., 22-0217 (D. Del.) Naropin® (ropivacaine HCl injection) 8,118,802 Fresenius Kabi dismisses the action without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Allergan, Inc. v. Aurobindo Pharma Ltd., 21-1808 (D. Del.) Alphagan® (brimonidine tartrate ophthalmic solution) 8,858,961 The filing of Aurobindo’s ANDA was a technical act of infringement of the ’961 patent. All other claims and defenses are dismissed without prejudice.
Aurobindo is enjoined from infringing the ’961 patent during the life of the ’961 patent, absent a license agreement or other authorization by Allergan, unless all of the claims of the ’961 patent are found invalid or unenforceable by a court decision from which no appeal has been or can be taken.
The parties waive any right to appeal.
The dismissal order is without prejudice to any claim, defense, or counterclaim in any possible future action between Aurobindo and Allergan regarding the ’961 patent and a product other than the ANDA product.
Bausch Health Companies Inc. v. Gland Pharma Ltd., 22-0939 (D.N.J.) Relistor® (methylnaltrexone bromide injection) 8,247,425
8,420,663
8,552,025
8,822,490
9,180,125
9,492,445
9,669,096
10,376,584
In the event that the patents-in-suit are not held invalid or unenforceable, absent a license or other authorization from Plaintiffs, the patents-in-suit would be infringed by Gland’s ANDA product. Gland, except as expressly licensed by Plaintiffs, is enjoined until expiration of the patents-in-suit, from infringing the patents-in-suit.
Gland shall be entitled to contest the infringement, validity, and/or enforceability of the patents-in-suit in any future litigation pertaining to a product that is not the ANDA product.
Each party will bear its own attorneys’ fees and costs. Gland is entitled to maintain its Paragraph IV certification to the patents-in-suit.
The 30-month stay with respect to the approval of the Gland ANDAs is terminated.
Otsuka Pharm. Co., Ltd. v. Lupin Ltd., 19-1988, 20-1296 (D. Del.) Rexulti® (brexipiprazole tablets) 8,349,840
8,618,109
9,839,637
10,307,419
RE48,059
The patents-in-suit are valid and enforceable solely with respect to Lupin’s ANDA products. The asserted claims would be infringed by Lupin’s ANDA products.
Lupin, except as expressly licensed by Plaintiffs, is enjoined until expiration of the patents-in-suit from infringing the patents-in-suit with regard to the Lupin ANDA products.
Each party will bear its own attorneys’ fees and costs.
Merck Sharp & Dohme B.V. v. Zydus Pharms. (USA) Inc., 20-3068 (D.N.J.) Bridion® (sugammadex for injection) RE 44,733 Zydus is enjoined from infringing the patent-in-suit without express written authorization of Merck.
All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys' fees to any party.
Bayer Healthcare LLC v. Amneal Pharms. LLC, 21-1770 (D. Del.) Astepro® (azelastine HCl nasal spray) 8,071,073
8,518,919
9,919,050
All claims and defenses are dismissed without prejudice.
The parties shall bear their own costs, disbursements and attorneys’ fees.
Hoffmann-La Roche, Inc. v. Fresenius Kabi USA, LLC, 20-0394 (D. Del.) Alcensa® (alectinib HCl capsules) 9,126,931
9,440,922
9,365,514
10,350,214
All claims and counterclaims are dismissed without prejudice.
Each party shall bear its own costs and attorneys’ fees.
Aragon Pharms., Inc. v. Lupin Ltd., 22-0637 (D. Del.) Erleada® (apalutamide tablets) 9,481,663 Plaintiffs dismissed the action without prejudice.
Belcher Pharms., LLC v. Hospira, Inc., 19-1854 (D. Del.) Abboject® (epinephrine for injection) 10,004,700
10,039,728
Dismissed without prejudice for lack of standing.
Bristol-Myers Squibb Co. v. Accord Healthcare Inc., 22-3743 (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.
Otsuka Pharm. Co., Ltd. v. Amneal Pharms. LLC, 19-1952, 20-1297 (D. Del.) Rexulti® (brexipiprazole tablets) 7,888,362
8,349,840
8,618,109
9,839,637
10,307,419
RE 48,059
All claims and defenses asserted by the parties are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Otsuka Pharm. Co., Ltd. v. Zydus Pharms. (USA) Inc., 19-2024, 20-1763 (D. Del.) Rexulti® (brexipiprazole tablets) 8,349,840
8,618,109
9,839,637
10,307,419
RE48,059
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Zydus, except as expressly lcensed or authorized by Plaintiffs, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit with regard to its ANDA product.
Nothing herein prevents FDA from granting final approval to Zydus’s ANDA product.
Intercept Pharms., Inc. v. Dr. Reddy’s Labs., Inc., 21-0035 (D. Del.) Ocaliva® (obeticholic acid tablets) RE 48,286
9,238,673
10,047,117
10,052,337
10,174,073
10,751,349
10,758,549
Except as authorized pursuant to the settlement agreement, DRL 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.
Horizon Medicines LLC v. Aleor Dermaceuticals Ltd., 22-0944 (D. Del.) Pennsaid® 2% (diclofenac sodium topical solution) 9,066,913 Plaintiffs voluntary dismiss the action without prejudice.
Duchesnay Inc. v. Alkem Labs. Ltd., 22-0917 (D. Del.) Bonjesta® (doxylamine succinate / pyridoxine HCl extended-release tablets) 9,089,489
9,375,404
9,526,703
9,937,132
All claims and counterclaims are dismissed without prejudice.
Each party shall bear its own costs, attorneys’ fees, and expenses.
Pfizer Inc. v. MSN Labs. Private Ltd., 22-0746 (D. Del.) Xeljanz® (tofacitinib oral solution) RE 41,783 Plaintiffs dismiss all claims without prejudice.
Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 22-0591 (D. Del) Rexulti® (brexpiprazole tablets) 8,618,109
9,839,637
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 19-2080, 21-0580 (D. Del.) Rexulti® (brexpiprazole tablets) 7,888,362
8,349,840
8,618,109
9,839,637
10,307,419
RE 48,059
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Otsuka Pharm. Co., Ltd. v. Aurobindo Pharma Ltd., 19-1965, 20-1581 (D. Del.) Rexulti® (brexpiprazole tablets) 7,888,362
8,349,840
8,618,109
9,839,637
10,307,419
RE 48,059
All claims and defenses are dismissed without prejudice.
All parties shall bear their own costs, disbursements, and attorneys’ fees.
Otsuka Pharm. Co., Ltd. v. Prinston Pharm. Inc., 19-1956, 20-1502 (D. Del.) Rexulti® (brexpiprazole tablets) 7,888,362
8,349,840
8,618,109
9,839,637
10,307,419
RE 48,059
Otsuka’s patents-in-suit are valid and enforceable. The patents-in-suit would be infringed by Prinston’s ANDA.
Prinston shall be permitted to maintain its paragraph IV certification to the patents-in-suit.
Each party shall bear its own attorneys’ fees and costs. Other terms redacted.
UCB, Inc. v. Annora Pharma Private Ltd., 20-0987 (D. Del.) Briviact® (brivaracetam tablets) 6,911,461 Unless authorized under the settlement agreement, Lupin is enjoined from infringing the patent-in-suit.
All claims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) 8,754,065
9,296,769
All affirmative defenses, claims, and counterclaims which have been or could have been brought by Gilead and Apotex are dismissed without prejudice.
Except as provided by the parties’ agreement, Apotex is enjoined from infringing the patents-in-suit until permitted under the settlement agreement.
The parties waive all right to appeal. Parties are permitted to notify FDA in writing of the relevant terms of the agreement.
Each party to bear its own costs and attorneys’ fees.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) 7,390,791
8,754,065
9,296,769
All affirmative defenses, claims, and counterclaims which have been or could have been brought by Gilead and Lupin are dismissed without prejudice.
Except as provided by the parties’ agreement, Lupin is enjoined from infringing the patents-in-suit until permitted under the settlement agreement.
The parties waive all right to appeal. Each party to bear its own costs and attorneys’ fees.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) 8,754,065
9,296,769
All affirmative defenses, claims, and counterclaims which have been or could have been brought by Gilead and Macleods are dismissed without prejudice.
Except as provided by the parties’ agreement, Macleods is enjoined from infringing the patents-in-suit until permitted under the settlement agreement.
The parties waive all right to appeal. Parties are permitted to notify FDA in writing of the relevant terms of the agreement.
Each party to bear its own costs and attorneys’ fees.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) 7,390,791
8,754,065
9,296,769
All affirmative defenses, claims, and counterclaims which have been or could have been brought by Gilead and Cipla are dismissed without prejudice.
Except as provided by the parties’ agreement, Cipla is enjoined from infringing the patents-in-suit until permitted under the settlement agreement.
The parties waive all right to appeal.
Each party to bear its own costs and attorneys’ fees.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) 7,390,791
8,754,065
9,296,769
All affirmative defenses, claims, and counterclaims which have been or could have been brought by Gilead and Hetero are dismissed without prejudice.
Except as provided by the parties’ agreement, Cipla is enjoined from infringing the patents-in-suit until permitted under the settlement agreement.
The parties waive all right to appeal.
Parties are permitted to notify FDA in writing of the relevant terms of the agreement.
Each party to bear its own costs and attorneys’ fees.
Vanda Pharms. Inc. v. West-ward Pharms. Int’l Ltd., 15-1919 (D. Del.) Fanapt® (iloperidone tablets) 9,138,432 Vanda owns and has standing to sue for infringement of the ’432 patent. The ’432 patent is valid and enforceable, subject to the restrictions contained in the license agreement.
Hickma acknowledges technically infringing the ’432 patent. Hikma is permanently enjoined from infringing the ’432 patent, subject to the parties’ license agreement.
All claims and counterclaims are dismissed without prejudice.
Each party shall bear its own costs and attorneys’ fees.
Bristol-Myers Squibb Co. v. Biocon Pharma Ltd., 22-3505 (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.
Pfizer Inc. v. Natco Pharma, Inc., 21-1466 (D. Del.) Ibrance® (palbociclib tablets) 11,065,250 Plaintiff’s claims are dismissed without prejudice. Each party shall bear its own costs, expenses, and attorneys’ fees. Stipulation of dismissal is not an adjudication on the merits.
Pfizer Inc. v. Synthon Pharms., Inc., 21-0045 (D. Del.) Ibrance® (palbociclib tablets) 11,065,250 Plaintiff’s claims are dismissed without prejudice. Each party shall bear its own costs, expenses, and attorneys’ fees. Stipulation of dismissal is not an adjudication on the merits.
Otsuka Pharm. Co., Ltd. v. Optimus Pharma Pvt. Ltd., 19-2008, 20-1332 (D. Del.) Rexulti® (brexpiprazole tablets) 7,888,362
8,349,840
8,618,109
9,839,637
10,307,419
RE 48,059
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
Optimus, except as expressly licensed, is enjoined until expiration of the patents-in-suit from infringing the patents-in-suit.
Nothing prevents FDA from granting final approval to Optimus’s ANDA.
UCB, Inc. v. Annora Pharma Private Ltd., 20-0987 (D. Del.) Briviact® (brivaracetam tablets) 6,911,461 Unless authorized under the settlement agreement, Aurobindo is enjoined from infringing the patent-in-suit.
All claims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Astellas US LLC v. GE Healthcare Inc., 22-0523 (D. Del.) Lexiscan® (regadenoson intravenous solution) 8,106,183
RE 47,301
8,524,883
All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice.
Each party shall bear its own costs and attorneys’ fees.
The parties waive any right to appeal.
Novartis Pharms. Corp. v. Biocon Pharma Ltd., 22-0726 (D. Del.) Entresto® (sacubitril / valsartan tablets) 11,058,667 Consent Judgment Filed Under Seal
Somaxon Pharms., Inc. v. Actavis Elizabeth LLC, 10-1100 (D. Del.) Silenor® (doxepin HCl tablets) 6,211,229 Each of Mylan’s claims against Currax is dismissed with prejudice.
The parties are each to bear their own costs.
Pfizer Inc. v. Sun Pharms. Indus., Ltd., 22-0161 (D. Del.) Ibrance® (palbociclib tablets) 11,065,250 Plaintiff’s claims are dismissed without prejudice.
Each party shall bear its own costs, expenses, and attorneys’ fees.
Stipulation of dismissal is not an adjudication on the merits.
Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., 22-0083 (D. Del.) Entresto® (sacubitril / valsartan tablets) 11,058,667 Sealed Order

Oren D. Langer

Partner

Managing Partner, New York Office

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