ANDA Litigation Settlements

Reported settlements in federal district court cases

Fourth 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
Bausch & Lomb, Inc. v. Lupin Ltd., 23-2452 (D.N.J.) Lumify® (brimonidine tartrate ophthalmic solution) 11,596,600 All claims, defenses, and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Jazz Pharms. Ireland Ltd. v. Alkem Labs. Ltd., 23-3182 (D.N.J.) Xyrem® (sodium oxybate oral solution) 8,772,306
9,050,302
9,486,426
10,213,400
10,864,181
11,253,494
Jazz dismisses the matter without prejudice and without costs.
Neurocrine Biosciences, Inc. v. Sandoz Int’l GmbH, 22-1124 (D. Del.) Ingrezza® (valbenazine tosylate capsules) 8,039,627
8,357,697
11,311,532
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Exela Pharma Sciences, LLC v. Dr. Reddy’s Labs S.A., 20-0365 (D. Del.) Elcys® (cysteine HCl for injection) 10,478,453
10,583,155
Consistent with the October 2023 Settlement and License Agreement entered between the Parties, the Final Judgment in this case should be amended to remove paragraph 4. All claims, counterclaims, and defenses are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees.
Sanofi-Aventis U.S. LLC v. Sandoz Inc., 20-0804, 20-0646, 20-0761, 20-0803 (D. Del.) Jevtana® Kit (cabazitaxel injection) 10,583,110 Federal Circuit appeal is dismissed. Each side shall bear their own costs.
AbbVie Inc. v. Teva Pharms., Inc., 23-0374 (D. Del.) Orilissa® (elagolix sodium tablets) 11,542,239 The filing of Teva’s ANDA was an act of infringement of the ’239 patent. All other claims, counterclaims, and defenses are dismissed without prejudice. Teva is enjoined from infringing the ’239 patent during the life of the ’239 patent, absent a license agreement or other authorization by AbbVie. The parties waive any right to appeal. This stipulation and order are without prejudice to any claim, defense, or counterclaim in any possible future action between Teva and any of the Plaintiffs regarding the ’239 patent and a product other than the Teva ANDA product.
Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 21-1707 (D. Del.) Epaned® (enalapril oral solution) 10,786,482
10,918,621
11,040,023
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. Each party shall bear its own costs and attorneys’ fees. This stipulation shall not act as an adjudication on the merits.
Boehringer Ingelheim Pharms. Inc. v. Hetero USA Inc., 23-0048 (D. Del.) Tradjenta® (linagliptin tablets) 9,486,526
10,034,877
Unless specifically authorized, Hetero is enjoined from infringing the patents-in-suit until their expiration. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Astellas Pharma Inc. v. Sun Pharm. Indus., Inc., 22-7357 (D.N.J.) Xtandi® (enzalutamide tablets) 7,709,517 Claims, defenses, and counterclaims are dismissed without prejudice. Parties shall bear their own costs.
Merck Sharp & Dohme LLC v. Hetero USA Inc., 23-2364 (D.N.J.) Isentress® (raltegravir tablets) 7,169,780
8,771,733
7,754,731
8,852,632
The Hetero Product infringes the patents-in-suit. Unless specifically authorized, Hetero 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.
Amgen Inc. v. Aurobindo Pharma Ltd., 22-0037, 22-0227 (D. Del.) Parsabiv® (etelcalcetide injection) 9,820,938
10,344,765
11,162,500
The patents-in-suit are valid and enforceable. The patents-in-suit would be infringed by Aurobindo ANDA product. Until expiration of the patents-in-suit, Aurobindo 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. All other claims, counterclaims, affirmative defenses, and demands between Amgen and any other party remain pending.
Celgene Corp. v. Accord Healthcare, Inc., 23-21189 (D.N.J.) Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
8,741,929
Until expiration of the patents-in-suit, Accord is enjoined from infringing the patents-in-duit to the extent otherwise 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 Accord from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits Accord from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Accord’s ANDA product.
Celgene Corp. v. Deva Holding A.S., 23-2992 (D.N.J.) Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
8,741,929
Until expiration of the patents-in-suit, Deva is enjoined from infringing the patents-in-suit, unless otherwise 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 Deva from maintaining any “Paragraph IV Certification” with respect to the patents-in-duit. Nothing prohibits Deva from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Deva’s ANDA.
AbbVie Inc. v. Alkem Labs. Ltd., 22-1423 (D. Del.) Orilissa® (elagolix sodium tablets) 7,056,927
7,419,983
10,537,572
10,682,351
11,344,551
11,542,239
The filing of MSN’s ANDA infringed each of the patents-in-suit. All other claims, counterclaims, and defenses are dismissed without prejudice. MSN is enjoined from infringing the patents-in-suit during the life of the patents-in-suit, absent a license agreement or other authorization by Plaintiffs. Plaintiffs and MSN waive any right to appeal. This dismissal order is without prejudice to any claim, defense, or counterclaim in any possible future action between MSN and any of the Plaintiffs regarding any of the patents-in-suit and a product other than MSN’s ANDA product. Nothing shall prohibit MSN from maintaining its “Paragraph IV Certifications” to the patents-in-suit.
Galderma Labs., L.P. v. Alembic Pharms. Ltd., 22-1312 (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.
Bausch Health Ireland Ltd. v. Aurobindo Pharma Ltd., 23-0170 (D.N.J.) Trulance® (plecanatide tablets) 7,041,786
9,610,321
9,616,097
9,919,024
9,925,231
10,011,637
11,142,549
11,319,346
The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Plaintiffs acknowledge that Aurobindo may maintain their Paragraph IV certifiation to the patents-in-suit. The parties agree that the 30-month stay with respect to Aurobindo’s ANDA is terminated.
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-0926, 23-6667 (D.N.J.) Yupelri® (revefenacin inhalation solution) 8,541,451
9,765,028
10,550,081
11,008,289
11,484,531
11,691,948
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Teva, except as expressly licensed by Plaintiffs, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Nothing shall prevent FDA from granting final approval to Teva’s ANDA. Each party shall bear its own attorneys’ fees and costs.
Zogenix, Inc. v. Lupin Ltd., 21-1424 (D. Del.) Fintepla® (fenfluramine oral solution) 10,947,183
11,406,606
Unless otherwise authorized, Lupin is enjoined from infringing the patents-in-suit. All claims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
UCB, Inc. v. Annora Pharma Private Ltd., 23-0243 (D. Del.) Briviact® (brivaracetam oral solution) 6,911,461 Unless otherwise authorized, Annora is enjoined from infringing the patent-in-suit. All claims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Indivior Inc. v. Alvogen Pine Brook LLC, 17-7106, 18-5285 (D.N.J.) Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) 9,931,305
9,687,454
Action dismissed with prejudice, with each party to bear its own costs and fees. Clerk to release $36 million bond to plaintiff.
Supernus Pharms., Inc. v. Lupin Ltd., 21-1293 (D. Del.) Trokendi XR® (topiramate extended-release capsules) 8,298,576
8,298,580
8,663,683
8,877,248
8,889,191
8,992,989
9,549,940
9,555,004
9,622,983
10,314,790
All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 21-1553, 22-0439, 23-0266 (D. Del.) Ingrezza® (valbenazine capsules) 8,039,627
8,357,697
10,065,952
10,844,058
10,851,103
10,851,104
10,857,137
10,857,148
10,874,648
10,906,902
10,906,903
10,912,771
10,919,892
10,940,141
10,952,997
10,993,941
11,026,931
11,026,939
11,040,029
11,311,532
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Neurocrine Biosciences, Inc. v. Lupin Ltd., 22-0639, 22-1061 (D. Del.) Ingrezza® (valbenazine tosylate capsules) 8,039,627
8,357,697
10,065,952
10,844,058
10,851,103
10,851,104
10,857,137
10,857,148
10,874,648
10,906,902
10,906,903
10,912,771
10,919,892
10,940,141
10,952,997
10,993,941
11,026,931
11,026,939
11,040,029
11,311,532
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Amgen Inc. v. MSN Labs. Private Ltd., 21-0712, 23-0031 (D. Del.) Parsabiv® (etelcalcetide for injection) 8,377,880
8,999,932
9,278,995
9,701,712
9,820,938
10,344,765
11,162,500
Stipulation sealed.
Amgen Inc. v. USV Private Ltd., 22-0387 (D. Del.) Parsabiv® (etelcalcetide injection) 9,820,938
10,344,765
11,162,500
Stipulation sealed.
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 and RK Pharma have entered into a confidential settlement agreement resolving this action. All affirmative defenses, claims, and counterclaims  are dismissed without prejudice. The Parties waive all right to appeal. Each Party is to bear its own costs and attorneys’ 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 and Zenara Pharma have entered into a confidential settlement agreement resolving this action. All affirmative defenses, claims, and counterclaims  are dismissed without prejudice. The Parties waive all right to appeal. Each Party is to bear its own costs and attorneys’ 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 and MSN Labs have entered into a confidential settlement agreement resolving this action. All affirmative defenses, claims, and counterclaims  are dismissed without prejudice. The Parties waive all right to appeal. Each Party is to bear its own costs and attorneys’ fees.
Actelion Pharms. Ltd. v. MSN Labs. Private Ltd., 23-3371 (D.N.J.) Opsumit® (macitentan tablets) 7,094,781 MSN admits that the ’781 patent is valid and enfoceable, and that it would be infringed by MSN’s ANDA product. MSN is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmatve defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall prohibit MSN from maintaining paragraph IV certifications in MSN’s ANDA. Each party agrees that the 30-month stay with respect to MSN’s ANDA is terminated.
Micro Labs Ltd. v. Hikma Pharms. USA Inc., 23-1138 (D. Del.) Mitigare® (colchicine capsules) 8,927,607
9,399,036
9,555,029
9,675,613
Plaintiffs voluntarily dismiss this action without prejudice.
GW Research Ltd. v. Teva Pharms., Inc., 23-3914 (D.N.J.) Epidiolex® (cannabidiol oral solution) 11,633,369 Plaintiff and Teva stipulate that all claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties.
CMP Development, LLC v. Hetero USA, Inc., 23-0747 (D. Del.) CaroSpir® (spironolactone oral suspension) 9,757,394
10,493,083
10,624,906
10,660,907
10,888,570
11,389,461
11,395,828
11,491,166
Plaintiff dismisses all claims with prejudice.
Actelion Pharms. US Inc. v. Alembic Pharms. Ltd., 22-1450 (D. Del.) Uptravi® (selexipag tablets) 8,791,122
9,284,280
Alembic is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit, including any patent term extensions and/or patent term adjustments and during the period of any associated exclusivity. The parties waive all right to appeal. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Celgene Corp. v. Accord Healthcare Inc., 21-1795, 23-0424 (D. Del.) Onureg® (azacitidine tablets) 8,846,628
11,571,436
Until expiration of the patents-in-suit, Accord is enjoined from infringing the patents-in-suit, unless otherwise specifically authorized by Plaintiffs. All claims, counterclaims, affirmative defenses, motions, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Accord from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit or any other patent. Nothing restricts FDA from approving Accord’s ANDA. Nothing prohibits Accord from engaging in any activity permitted under 35 U.S.C. § 271(e)(1).
Vertex Pharms. Inc. v. Lupin Ltd., 21-1019, 23-0581 (D. Del.) Kalydeco® (ivacaftor tablets) 10,646,481
11,564,916
The parties have entered into a settlement and license agreement with respect to Vertex’s claims. Lupin will not make, have made, use, offer for sale, or sell the Lupin Product in the US except as provided for in the parties’ settlement and license agreement. All claims, counterclaims, and defenses are dismissed without prejudice and without costs or attorneys’ fees to any party.
Vertex Pharms. Inc. v. Aurobindo Pharma Ltd., 22-0728, 23-0582 (D. Del.) Kalydeco® (ivacaftor tablets) 10,646,481
11,564,916
The parties have entered into a settlement and license agreement with respect to Vertex’s claims. Aurobindo will not make, have made, use, offer for sale, or sell the Aurobindo Product in the US except as provided for in the parties’ settlement and license agreement. All claims, counterclaims, and defenses are dismissed without prejudice and without costs or attorneys’ fees to any party.
Zogenix, Inc. v. Apotex Inc., 21-1252, 21-1533, 22-1232 (D. Del.) Fintepla® (fenfluramine HCl oral solution) 10,351,510
10,947,183
Unless otherwise authorized by the settlement agreement or the Safe Harbor, Apotex is enjoined from infringing the patents-in-suit. All claims, affirmative defenses, and demands of the parties are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to Apotex’s ANDA.
Novartis Pharms. Corp. v. Lotus Pharm. Co., Ltd., 21-1107 (D. Del.) Rydapt® (midostaurin capsules) 7,973,031
8,575,146
The ANDA product infringes all claims of the patents-in-suit. By virtue of Novartis’s license to Teva, there is no longer a cause of action for infringement of the patents-in-suit. Final approval of Teva’s ANDA may be granted on the date that the Consent Judgment is entered. All other claims and counterclaims are dismissed with prejudice. Teva is enjoined from infringing the patents-in-suit prior to the generic entry date as set forth in the settlement agreement. Each party shall bear its own costs and attorney fees. Each party expressly waives any right to appeal.
Orphalan SA v. Novitium Pharma LLC, 23-1079 (D. Del.) Cuvrior® (triethylenetetramine tetrachloride tablets) 10,988,436
11,072,577
Plaintiff voluntary dismisses the action without prejudice.
Novartis Pharms. Corp. v. Lupin Inc., 21-1105 (D. Del.) Rydapt® (midostaurin capsules) 8,575,146 Lupin’s ANDA product infringes the asserted claims of the patent-in-suit. The parties have entered into a settlement agreement and there no longer exists a cause of action for infringement of the patent-in-suit, and all claims and counterclaims are dismissd with prejudice. Final approval of Lupin’s ANDA may be granted. Lupin is enjoined from infringing the patent-in-suit as set forth in the settlement agreement. Nothing prohibits Lupin from filing a Paragraph IV certification. Nothing restricts FDA from approving Lupin’s ANDA. The consent judgment shall have no preclusive effect in any proceeding with respect to any product other than Lupin’s ANDA. Each party shall bear its own costs and attorney fees. The parties waive any right to appeal.
Aragon Pharms., Inc. v. Lupin Ltd., 22-2825 (D.N.J.) Erleada® (apalutamide tablets) 9,481,663 Lupin does not infringe the patent-in-suit based on the ANDAs disclosed to plaintiffs on Apr. 21, 2022. Judgment of non-infringement with prejudice is entered in favor of Lupin. Lupin dismisses its counterclaims. Stipulaed judgment does not affect Plaintiffs’ ability to reassert the ’663 patent against Lupin if the ANDA is changed. Each party will bear its own attorneys’ fees and costs.
Hikma Pharms. USA Inc. v. Padagis Israel Pharms. Ltd., 23-0654 (D. Del.) Kloxxado® (naloxone HCl nasal spray) 10,722,510
10,973,814
11,135,155
11,617,713
11,628,139
The complaint is dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees.
Actelion Pharms. Ltd. v. Sun Pharm. Indus. Ltd., 23-0116 (D.N.J.) Opsumit® (macitentan tablets) 7,094,781 Sun admits that the ’781 patent is valid and enforceable, and that the claims would be infringed by the Sun ANDA product. Unless otherwise authorized, Sun 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. Nothing shall prohibit Sun from maintaining Paragraph IV certifications in its ANDA and nothing shall prohibit FDA from approving Sun’s ANDA. The parties acknowledge that the 30-month stay with respect to Sun’s ANDA is terminated. 
Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 21-1106 (D. Del.) Rydapt® (midostaurin capsules) 7,973,031 Judgment is entered that DRL’s accused ANDA product infringes the ’031 patent. By virtue of the license granted by Novartis to DRL as part of the Settlement Agreement, judgment is entered that there no longer exists a cause of action for infringement. This consent judgment constitutes a “consent decree” such that Final Approval of DRL’s ANDA may be granted on the date that this consent judgment is entered. All other claims and counterclaims are dismissed without prejudice. Other than as set forth in the settlement agreement, DRL, is enjoined infringing the ’031 patent prior to the Generic Entry Date. Nothing prohibits DRL from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Each Party shall bear its own costs and attorney fees. Each party waives any right to appeal.
Arbor Pharms., LLC v. Alkem Labs. Ltd., 22-0143 (D.N.J.) Nymalize® (nimodipine oral solution) 10,342,787
10,576,070
All claims and counterclaims are dismissed without prejudice. Azurity and Alkem shall bear their own fees and costs.
Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0717 (D. Del.) Xeljanz® XR (tofacitinib citrate extended-release tablets) RE41,783 All claims and counterclaims are dismissed without prejudice. Any protective orders shall remain in full effect notwithstanding the dismissal. Parties waive any right of appeal. Each party shall bear its own costs and fees.
Horizon Therapeutics USA Inc. v. Dr. Reddy’s Labs., Ltd., 23-0623 (D. Del.) Rayos® (prednisone delayed-release tablets) 9,504,699 The action is dismissed with prejudice, including all claims, counterclaims, defenses, and demands, with each party to bear its own costs and attorneys’ fees.
Fresenius Kabi USA, LLC v. Amneal Pharms. LLC, 23-4343 (D.N.J.) Diprivan® (propofol injection) 8,476,010 Action dismissed without prejudice.
Fresenius Kabi USA, LLC v. Meitheal Pharms., Inc., 23-1050 (D. Del.) Diprivan® (propofol injection) 8,476,010 Action dismissed without prejudice.
GW Research Ltd. v. Teva Pharms., Inc., 23-0018, 23-3914 (D.N.J.) Epidiolex® (cannabidiol oral solution) 11,633,369 Plaintiff and Alkem stipulate that all claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties.
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0896 (D. Del.) Saxenda® (liraglutide recombinant solution injection) 8,920,383
9,265,893
9,775,953
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits Sun from maintaining a Paragraph IV certification in the Sun ANDA or prevents FDA from granting final approval of the Sun ANDA. Each party shall bear its own costs and attorneys’ fees.
Novo Nordisk Inc. v. Meitheal Pharms., Inc., 23-1195 (D. Del.) Victoza® (liraglutide recombinant solution injection) 8,114,833
9,265,893
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits Meitheal from maintaining a Paragraph IV certification in its ANDA or prevents FDA from granting final approval of the Meitheal ANDA. Each party shall bear its own costs and attorneys’ fees.
Novo Nordisk Inc. v. Biocon Pharma Ltd., 22-0936 (D. Del.) Victoza® (liraglutide recombinant solution injection) 7,762,994
8,114,833
9,265,893
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits Biocon from maintaining a Paragraph IV certification in its ANDA or prevents FDA from granting final approval of the Biocon ANDA. Each party shall bear its own costs and attorneys’ fees.
AbbVie Inc. v. Lupin Ltd., 23-0750 (D. Del.) Orilissa® (elagolix sodium tablets) 11,542,239 The filing of Lupin’s ANDA was an act of infringement of each of the patents-in-suit. All other claims, counterclaims, and defenses are dismissed, without prejudice, and without costs, disbursements, or attorneys’ fees. Lupin is enjoined from infringing the patents-in-suit until their expiration, absent a license agreement or other authorization by Plaintiffs. Nothing prohibits Lupin from maintaining a Paragraph IV Certification with respect to the patents-in-suit. The parties waive any right to appeal. The stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between Lupin and any of the Plaintiffs regarding any of the patents-in-suit other than the products described in Lupin’s ANDA.
Endo Par Innovation Co. v. Deva Holding A.S., 23-21684 (D.N.J.) Adrenalin® (epinephrine injection) 9,119,876
9,295,657
Plaintiffs voluntarily dismiss action without prejudice.
Amring Pharms. Inc. v. Rubicon Research Private Ltd., 23-3494 (D.N.J.) Lysteda® (tranexamic acid tablets) 7,947,739
8,022,106
8,273,795
8,487,005
8,791,160
8,809,394
8,957,113
9,060,939
All claims are dismissed without prejudice and with each side bearing its own costs and attorneys’ fees.
Astellas Pharma Inc. v. Lupin Ltd., 23-0819 (D. Del.) Myrbetriq® (mirabegron extended-release tablets) 11,707,451 All claims, counterclaims, defenses, and demands in the case by and between Astellas and Sandoz are dismissed with prejudice. Each party will bear its own attorneys’ fees and costs.
AbbVie Inc. v. Teva Pharms., Inc., 23-1268 (D. Del.) Oriahnn® (elagolix sodium / estradiol / norethindrone acetate capsules) 11,690,845 The filing of Teva’s ANDA was an act of infringement of the ’845 patent. All other claims, counterclaims, and defenses are dismissed without prejudice. Teva is enjoined from infringing the ’845 patent during the life of the ’845 patent, absent a license agreement or other authorization by AbbVie. The parties expressly waive any right to appeal. The stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between Teva and AbbVie regarding the ’845 patent and a product other than Teva’s ANDA product.

Related Publications

September 18, 2024
Astellas Pharma, Inc. v. Sandoz Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 9, 2024
Purdue Pharma L.P v. Accord Healthcare Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 4, 2024
Exeltis USA, Inc. v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
August 28, 2024
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.
GENERICally Speaking Hatch Waxman Bulletin
August 13, 2024
Allergan USA, Inc. v. MSN Labs. Private Ltd.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top