ANDA Litigation Settlements

Reported settlements in federal district court cases

First 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
Merck Sharp & Dohme Corp. v. MSN Pharms. Inc., 21-1172 (D. Del.) Januvia® (sitagliptin phosphate tablets) 7,326,708 Unless authorized by the settlement agreement, MSN is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands in this action are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Bristol-Myers Squibb Co. v. Eugia Pharma Specialties, Ltd., 21-20409 (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. Dr. Reddy’s Labs., Inc., 20-1530 (D. Del.) Ibrance® (palbociclib capsules) 10,723,730 All claims and counterclaims are dismissed with prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. Per the parties’ settlement agreement, DRL will not make or sell it’s ANDA product in the US. Stipulation and order will not act as an adjudication on the merits.
Celgene Corp. v. Hikma Pharms. USA, Inc., 21-10398, 21-20459 (D.N.J.) Revlimid® (lenalidomide capsules) 7,189,740
7,465,800
7,855,217
7,968,569
7,977,357
8,193,219
8,404,717
8,431,598
8,530,498
8,648,095
9,056,120
9,101,621
9,101,622
Until expiration of the patents-in-suit, Hikma is enjoined from infringing the patents-in-suit, unless otherwise specifically authorized by Celgene, and is further enjoined from assisting with any third parties in connection with any infringement of the patents-in-suit by any such third parties. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Hikma from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Hikma’s ANDA.
Vanda Pharms. Inc. v. MSN Pharms. Inc., 18-0690, 20-0235, 20-0318 (D. Del.) Hetlioz® (tasimelteon capsules) RE46,604
9,060,995
9,539,234
9,549,913
9,730,910
9,855,241
10,149,829
10,071,977
10,376,487
10,449,176
10,610,510
10,610,511
10,829,465
10,611,744
Vanda owns the patents-in-suit and has standing to sue. The asserted patents are valid and enforceable. MSN infringed the patents-in-suit. MSN is enjoined from infirnging the asserted patents. All claims are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fes.
Actelion Pharms. Ltd. v. MSN Pharms. Inc., 20-3859 (D.N.J.) Uptravi® (selexipag tablets) 7,205,302 Unless otherwise authorized by Plaintiffs, Zydus is enjoined from infringing the ’302 patent. The complaint, remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Taro Pharms. U.S.A., Inc. v. Lupin Ltd., 21-20320 (D.N.J.) Topicort® (desoximetasone topical spray) 8,277,780
8,715,624
Taro voluntarily dismisses case against Lupin.
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. CrossMedica S.A., 21-0455 (D. Del.) Desyrel® (trazodone HCl tablets) 8,133,893 The parties agree that the all claims, counterclaims, and affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Astellas US LLC v. Dr. Reddy’s Labs., Ltd., 19-1160 (D. Del.) Lexiscan® (regadenoson for injection) 8,106,183
RE47,301
8,524,883
All claims and countercalims, defenses, motions, and petitions are dismissed without prejudice pursuant to a settlement and license agreement. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Astellas US LLC v. Sun Pharma Global FZE, 18-1677 (D. Del.) Lexiscan® (regadenoson for injection) 8,106,183
9,085,601
All claims and countercalims, defenses, motions, and petitions are dismissed without prejudice pursuant to a settlement and license agreement. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) Odefsey® (emtricitabine / rilpivirine / tenofovir alafenamide tablets) 8,754,065
9,296,769
All affirmative defenses, claims and counterclaims, which have been or could have been raised by Gilead and/or Sunshine Lake are dismissed without prejudice. Except as provided in the parties settlement agreement, Sunshine Lake is enjoined from infringing the patents-in-suit, until permitted under the parties’ agreement. The parties waive all right to appeal. Each party shall bear its own costs and attorneys’ fees.
Astellas US LLC v. International Medication Systems, Ltd., 20-0273 (D. Del.) Lexiscan® (regadenoson for injection) 8,106,183
9,085,601
All claims and countercalims, defenses, motions, and petitions are dismissed without prejudice pursuant to a settlement and license agreement. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Astellas US LLC v. Apotex Inc., 18-1675 (D. Del.) Lexiscan® (regadenoson for injection) 8,106,183
9,085,601
All claims and countercalims, defenses, motions, and petitions are dismissed without prejudice pursuant to a a binding term sheet. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Allergan Sales, LLC v. Sandoz, Inc., 17-10129 (D.N.J.) Combigan® (brimonidine tartrate / timolol maleate ophthalmic solution) 9,770,453 Each party shall bear its own attorneys’ fees, expenses, and costs. The parties agree that all other claims, defenses, and counterclaims asserted against each other should be dismissed, without prejudice.
Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc., 19-1987, 20-1287 (D. Del.) Rexulti® (brexpiprazole tablets) 8,349,840
8,618,109
9,839,637
10,307,419
RE48059
The patents-in-suit are valid and enforceable. The patents-in-suit would be infringed by Accord’s ANDA product. Except as licensed by Plaintiffs, Accord is enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Each party will bear its own attorneys’ fees and costs.
Leo Pharma A/S v. Glenmark Pharms. Ltd., 20-1359 (D. Del.) Enstilar® (calcipotriene / betamethasone dipropionate foam) 10,617,698
10,660,908
10,682,364
10,688,108
10,716,799
N/A
UCB, Inc. v. Sunshine Lake Pharma Co., Ltd., 20-1343 (D. Del.) Briviact® (brivaracetam tablets) 6,911,461 Unless otherwise authorized pursuant to the settlement agreement, Sunshine is enjoined from infringing the ’461 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs,  disbursements, or attorneys’ fees to any party.
Baudax Bio, Inc. v. Axsome Therapeutics, Inc., 21-1585 (D. Del.) Anjeso® (meloxicam injection) 8,512,727
10,471,067
All claims asserted by Baudax are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees.
Amgen Inc. v. Annora Pharma Private Ltd., 20-0122 (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 submission of Annora’s ANDA was an act of infringement of at least one of the patents-in-suit. Until expiration of the patents-in-suit, Annora is enjoined from infringing the patents-in-suit, except as specifically 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.
Novartis Pharms. Corp. v. Lupin Inc., 21-1105 (D. Del.) Rydapt® (midostaurin capsules) 8,575,146 N/A
Allergan USA, Inc. v. Aurobindo Pharma Ltd., 19-1727, 21-1062 (D. Del.) Viberzi® (eluxadoline tablets) 8,691,860
9,115,091
9,364,489
9,675,587
9,789,125
10,188,632
11,007,179
11,090,291
11,160,792
The filing of Aurobindo’s ANDA was a technical act of infringement of each of the patents-in-suit.  All other claims and defenses asserted by the parties against each other are dismissed, without prejudice. Aurobindo is enjoined from infringing the patents-in-suit, absent a license agreement or other authorization by plaintiffs. Plaintiffs and Aurobindo expressly waive any right to appeal. This stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between Aurobindo and any of the plaintiffs regarding the patents-in-suit, and a product other than Aurobindo’s ANDA product.
Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd., 21-1006 (D. Del.) Januvia® (sitagliptin phosphate tablets) 7,326,708 Unless specifically authorized under the settlement agreement, Annora 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.
Relypsa, Inc. v. Alkem Labs. Ltd., 20-0106 (D. Del.) Veltassa® (patiromer sorbitex calcium powder for oral suspension) 8,147,873
8,337,824
9,492,476
9,925,212
11,123,363
Unless authorized bythe settlement agreement, Ascent 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. Nothing prohibits Ascent from maintaining a Paragraph IV Certification with respect to the patents-in-suit or any other patent listed in the Orange Book for Veltassa for purposes of receiving final approval of its ANDA product. The 30-month stay is terminated. Nothing restricts FDA from approving Ascent’s ANDA product.
Mitsubishi Tanabe Pharma Corp. v. Macleods Pharms., Ltd., 21-0697 (D.N.J.) Invokamet® XR (canagliflozin / metformin extended-release tablets) 7,943,582
8,513,202
All claims, defenses, and counterclaims between the parties are dismissed without prejudice. The parties shall bear their own attorneys’ fees and costs.
Bayer Healthcare LLC v. Yabao Pharm. Co., Ltd. Beijing, 21-1549 (D. Del.) Nexavar® (sorafenib tosylate tablets) 8,877,933
9,737,488
Plaintiffs’ action against Yabao, including all claims and defenses asserted by Plaintiffs against Yabao and all claims and defenses asserted by Yabao against Plaintiffs, are hereby dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
UCB, Inc. v. Annora Pharma Private Ltd., 20-0987 (D. Del.) Briviact® (brivaracetam tablets) 6,911,461 Unless authorized by the settlement agreement, Zydus is enjoined from infringing the ’461 patent. All claims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Amgen Inc. v. Torrent Pharma Inc., 20-0065 (D. Del.) Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Torrent admits that the patents-in-suit are valid and enforceable with respect to its ANDA product. Torrent admits that the patents-in-suit would be infringed by its 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 are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Bial – Portela & Ca., S.A. v. Jubilant Life Sciences Ltd., 18-0336, 20-0783, 21-0189 (D. Del.) Aptiom® (eslicarbazepine acetate tablets) 8,372,431
9,206,135
9,566,244
9,643,929
9,750,747
9,763,954
10,675,287
10,702,536
10,695,354
10,912,781
Jubilant admits that the patents-in-suit are patentable, valid, and enforceable. Jubilant admits that its ANDA product infringes the patents-in-suit. Except as provided in the settlement, Jubilant shall not challenge infringement, patentability, validity, or enforceability of the patents-in-suit. Except as provided in the settlement, Jubilant is enjoined from infringing the patents-in-suit until their expiration. The case is dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Patheon Softgels Inc. v. Strides Pharma Inc., 21-13521 (D.N.J.) Naproxen sodium capsules 9,693,978
9,693,979
10,022,344
10,028,925
Claims, counterclaims, and affirmative defenses are dismissed with prejudice. Each party will bear its own costs, expenses, and attorneys’ fees.
Medicure Int’l, Inc. v. Aurobindo Pharma Ltd., 21-17534 (D.N.J.) Aggrastat® (tirofiban HCl injection) 6,770,660 The claims asserted by all parties in this action are dismissed. Aurobindo shall not amend its Paragraph III Certification for the ’660 patent back to a Paragraph IV Certification without providing Medicure with the required patent certification notice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Bausch & Lomb, Inc. v. Harrow Health, Inc., 21-19252 (D.N.J.) Lumify® (brimonidine tartrate ophthalmic solution) 8,765,758
9,259,425
Plaintiffs dismiss all claims without prejudice and without costs, disbursements, or attorney fees.
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
Plaintiffs’ claims against Optimus Pharma are dismissed without prejudice. Each party shall bear its own costs, expenses, and taxes in connection with this action.
Novo Nordisk Inc. v. Sandoz Inc., 20-0747 (D. Del.) Victoza® (liraglutide recombinant solution injection) 6,268,343
7,762,994
8,114,833
8,579,869
8,846,618
9,265,893
Novo Nordisk and Sandoz have agreed to a negotiated settlement. All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits Sandoz from maintaining a Paragraph IV certification to the patents-in-suit for purposes of receiving final approval of the Sandoz ANDA. Nothing prevents FDA from granting final approval of the Sandoz ANDA. Each party will bear its own attorneys’ fees and costs.
ViiV Healthcare Co. v. Lupin Ltd., 20-0293 (D. Del.) Juluca® (dolutegravir sodium / rilpivirine HCl tablets) 9,242,986
10,426,780
No party contests subject matter or personal jurisdiction. Except as specifically authorized, Lupin 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. Nothing prohibits Lupin from maintaining any Paragraph IV certification with respect to the patents-in-suit. Nothing shall have preclusive effect on Lupin in any other pending or future action or proceeding involving a product other than the Lupin ANDA product. Nothing prohibits Lupin from challenging the validity, enforceability, or infringement of the patents-in-suit or any other patent in any other action or proceeding involving a product other than the Lupin ANDA product. The 30-month stay is terminated.
Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc., 22-0295 (D. Del.) Ozempic® (semaglutide injection) 7,762,994
8,114,833
8,129,343
8,536,122
8,579,869
8,684,969
8,920,383
9,108,002
9,132,239
9,457,154
9,616,180
9,687,611
9,775,953
9,861,757
10,220,155
10,335,462
10,357,616
10,376,652
11,097,063
RE46,363
Novo Nordisk voluntarily dismisses, without prejudice, all claims.

Oren D. Langer

Partner

Managing Partner, New York Office

Related Publications

First Quarter
New ANDA Cases
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
ANDA Approvals
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
Generic Launches
GENERICally Speaking Hatch Waxman Bulletin
March 22, 2022
Genentech, Inc. v. Sandoz, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Fed. Cir. 2022
GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top