Reported settlements in federal district court cases
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. |
