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., 23-2664 (D.N.J.) | Lotemax® SM (loteprednol etabonate ophthalmic gel) |
11,534,395 | All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. |
| Boehringer Ingelheim Pharms. Inc. v. USV Private Ltd., 25-0862 (D. Del.) | Jardiance® (empagliflozin tablets) |
8,551,957 11,090,323 12,115,179 |
The patents-in-suit are valid and enforceable with respect to the USV ANDA product. USV’s use and sale of its ANDA product would infringe one or more claims of the patents-in-suit absent authorization by BI. Unless authorized by BI, USV is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit. If BI becomes entitled to any other regulatory exclusivities, BI may apply to the Court for modification of the consent judgment to incorporate such specified exclusivity. The parties shall bear their own fees and costs, including attorneys’ fees. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed with prejudice and without costs, disbursements, or attomeys’ fees to any party. |
| Janssen Pharms., Inc. v. Hikma Pharms. USA Inc., 23-2942 (D.N.J.) | Spravato® (esketamine nasal spray) |
10,869,844 11,173,134 11,311,500 11,446,260 |
For purposes of this litigation, Hikma admits that the claims of the patents-in-suit are valid and enforceable, and that they would be infringed by Hikma’s ANDA product. Unless otherwise authorized by Janssen, Hikma 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 shall preclude FDA from granting final approval to Hikma’s ANDA. |
| Bayer Intellectual Property GmbH v. Prinston Pharm., Inc., 24-0336 (D. Del.) | Xarelto® (rivaroxaban tablets) |
9,539,218 10,828,310 |
All claims and defenses asserted by Bayer and Janssen against Prinston are dismissed with prejudice. All claims and defenses asserted by Prinston against Bayer and Janssen are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Bayer Intellectual Property GmbH v. Teva Pharms. USA, Inc., 21-1001, 23-0551 (D. Del.) | Xarelto® (rivaroxaban tablets) |
9,539,218 10,828,310 |
Bayer and Janssen’s claims and defenses against Teva are dismissed with prejudice. Teva’s claims and defenses against Bayer and Janssen are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Astellas Pharma Inc. v. Creekwood Pharms. LLC, 25-0045 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) |
10,842,780 11,707,451 12,059,409 12,097,189 |
Pursuant to the parties’ settlement and license agreement, the parties seek dismissal of all claims without prejudice. The parties will submit their settlement agreement to he FTC and DOJ as soon as practicable. Each party will bear its own costs and attorneys’ fees. |
| Bausch & Lomb Inc. v. Somerset Therapeutics, LLC, 25-3395 (D.N.J.) | Lumify® (brimonidine tartrate ophthalmic solution) |
8,293,742 9,259,425 11,596,600 11,833,245 |
All claims, defenses, and counterclaims between the Parties are dismissed without prejudice. Each party shall bear its own costs, attorneys' fees, and expenses incurred in connection with the claims and counterclaims dismissed by this Order. |
| Salix Pharms., Inc. v. Ajanta Pharma Ltd., 25-17780 (D.N.J.) | Xifaxan® (rifaximin tablets) |
11,779,571 11,564,912 8,193,196 |
All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Ajanta is entitled to maintain its Paragraph IV certification to the patents-in-suit. The 30-month stay with respect to the approval of the Ajanta ANDA is hereby terminated. |
| Bayer Intellectual Property GmbH v. Mankind Pharma Ltd., 25-1429 (D. Del.) | Xarelto® (rivaroxaban tablets) |
9,539,218 | All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Veloxis Pharms., Inc. v. Alkem Labs. Ltd., 24-0784 (D. Del.) | Envarsus XR® (tacrolimus extended-release tablets) |
8,685,998 9,549,918 10,166,190 10,864,199 11,110,081 11,123,331 11,419,823 12,083,103 |
Until expiration of the patents-in-suit, Alkem is enjoined from infringing the patents-in-suit, unless otherwise specifically authorized by Veloxis. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Alkem from maintaining a “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving the Alkem ANDA at any time. |
| Pfizer Inc. v. Teva Pharms., Inc., 24-0627 (D. Del.) | Nurtec ODT® (rimegepant sulfate tablets) |
11,083,724 | Teva is no longer seeking FDA approval of the Teva ANDA prior to the expiration of the ’724 patent. Pfizer’s claims and Teva’s counterclaims are dismissed without prejudice. Pfizer agrees that it will not re-assert the ’724 patent against Teva with respect to the Teva ANDA product so long as Teva maintains its paragraph III certification with respect to the ’724 patent. Each party bears its own fees and expenses. |
| Pierre Fabre Medicament SAS v. Rubicon Research Private Ltd., 24-0811 (D. Del.) | Hemangeol® (propranolol HCl oral solution) |
8,338,489 8,987,262 |
Rubicon’s ANDA product infringes the patents-in-suit. The claims of the patents-in-suit are valid and enforceable with respect to Rubicon’s ANDA product. Unless otherwise authorized under the settlement agreement, Rubicon 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. |
| Harmony Biosciences, LLC v. Lupin Ltd., 23-1286, 23-1340 (D. Del.) | Wakix® (pitolisant HCl tablets) |
8,486,947 8,207,197 8,354,430 |
Unless otherwise authorized by the settlement agreement, Novitium is enjoined from infringing the patents-in-suit. Nothing prohibits Novitium from maintaining and/or filing a “Paragraph IV” certification with respect to the patents-in-suit. All claims, counterclaims, and affirmative defenses that the parties asserted or could have asserted are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Harmony Biosciences, LLC v. Hikma Pharms. USA Inc., 23-1286, 23-1340 (D. Del.) | Wakix® (pitolisant HCl tablets) |
8,486,947 8,207,197 |
Unless otherwise authorized by the settlement agreement, Hikma is enjoined from infringing the patents-in-suit. All claims, counterclaims, and affirmative defenses that the parties asserted or could have asserted are dismissed with prejudice. Harmony and Hikma shall not seek an award of costs, disbursements, or attorneys’ fees. |
| Harmony Biosciences, LLC v. MSN Pharms. Inc., 23-1286, 23-1420 (D. Del.) | Wakix® (pitolisant HCl tablets) |
8,486,947 8,207,197 8,354,430 |
Unless otherwise authorized by the settlement agreement, MSN is enjoined from infringing the patents-in-suit. Nothing prohibits MSN from maintaining and/or filing a “Paragraph IV” certification with respect to the patents-in-suit. All claims, counterclaims, and affirmative defenses that the parties asserted or could have asserted are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Astellas Pharma Inc. v. Haimen Pharma Inc., 24-9403 (D.N.J.) | Xtandi® (enzalutamide tablets) |
7,709,517 11,839,689 |
Claims and counterclaims are dismissed with prejudice. Parties shall bear their own costs. |
| Astellas Pharma Inc. v. Renata Ltd., 25-1383 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) |
10,842,780, 11,707,451 12,059,409 12,097,189 |
Pursuant to a settlement and license agreement, all claims are dismissed without prejudice. Each party will bear its own costs and attorneys’ fees. |
| Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 25-0318 (D. Del.) | Jynarque® (tolvaptan tablets) |
8,501,730 10,905,694 8,273,735 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
| Astellas Pharma Inc. v. Cipla Ltd., 24-1333 (D. Del.) | Cresemba® (isavuconazonium sulfate capsules) |
6,812,238 10,206,879 10,603,280 |
Each of the parties’ claims and counterclaims are dismissed with prejudice. The parties shall each bear their own costs. |
| Nexus Pharms., LLC v. Hikma Pharms. USA Inc., 25-0018 (D. Del.) | Emerphed® (ephedrine sulfate for injection) |
11,464,752 11,426,369 11,571,398 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to any party. |
| Allergan, Inc. v. Alembic Pharms. Ltd., 25-6986 (E.D.N.Y.) | Lumigan® (bimatoprost ophthalmic solution) |
7,851,504 | Alembic admits that the ’504 patent is enforceable, valid, and would be infringed by its ANDA product. Alembic admits that the submission of its ANDA was an act of infringement of the ’504 patent under § 271(e)(2)(A). All other claims should be dismissed, without prejudice. Alembic is enjoined from infringing the ’504 patent during the life of the patent, absent a license or authorization from Plaintiffs. |
| Incyte Corp. v. Granules India Ltd., 25-13227 (D.N.J.) | Jakafi® (ruxolitinib tablets) |
7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 |
Granules is enjoined from infringing the patents-in-suit until their expiration, unless specifically authorized by Incyte, and is further enjoined from assisting or cooperating with any third parties in connection with any infringement of the patents-in-suit, unless specifically authorized by Incyte. All claims, counterclaims, affirmative defenses, motions, and petitions are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Granules from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits Granules from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approval Granules’ ANDA. |
| Astellas Pharma Inc. v. Lupin Ltd., 25-13779 (D.N.J.) | Xtandi® (enzalutamide tablets) |
11,839,689 12,161,628 |
All claims and counterclaims are dismissed with prejudice. Parties shall bear their own costs. |
| Astellas Pharma Inc. v. Lupin Ltd., 20-1589, 23-0819, 24-0939, 24-1068 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) |
10,842,780 11,707,451 12,059,409 12,097,189 |
In connection with this litigation and its ANDA, Lupin admits that the patents-in-suit are valid and enforceable, and at least one claim of each of the patents-in-suit is infringed by the Lupin ANDA products. Except as specifically authorized or modified between the parties, Lupin agrees not to infringe the patents-in-suit 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. |
| Astellas Pharma Inc. v. Zydus Lifesciences Ltd., 20-1589, 23-0819, 24-0940, 24-1069 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) |
10,842,780 11,707,451 12,059,409 12,097,189 |
In connection with this litigation and its ANDA, Zydus admits that the patents-in-suit are valid and enforceable, and at least one claim of each of the patents-in-suit is infringed by the Zydus ANDA products. Except as specifically authorized or modified between the parties, Zydus agrees not to infringe the patents-in-suit 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. |
| GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 14-0878 (D. Del.) | Coreg® (carvedilol) |
RE40,000 | All claims, counterclaims, motions, and petitions are dismissed with prejudice. All pending motions are denied as moot. Each party shall bear its own attorneys’ fees and costs. |
| Esperion Therapeutics, Inc. v. Alkem Labs. Ltd., 24-6263 (D.N.J.) | Nexletol® (bempedoic acid tablets)—Nexlizet® (bempedoic acid / ezetimibe tablets) |
11,760,714 11,613,511 10,912,751 11,744,816 |
All claims and counterclaims are dismissed without prejudice, with each party to bear its own costs, fees, and expenses. |
| Otsuka Pharm. Co., Ltd. v. Apotex Inc., 24-1004 (D. Del.) | Abilify Maintena® (aripiprazole extended-release injectable suspension) |
10,525,057 10,980,803 11,154,553 11,344,547 11,400,087 11,648,347 |
The parties agree to the dismissal, without prejudice, of all claims and counterclaims in this action with the parties to bear their own costs and attorneys’ fees. |
| Janssen Products, L.P. v. Ever Valinject GmbH, 24-7319 (N.D. Ill.) | Yondelis® (trabectedin injection) |
8,895,557 | Defendants admit that the claims of the ’557 patent are valid and enforceable with respect to Defendants’ NDA products. Defendants are enjoined from infringing the ’557 patent until its expiration, other than as authorized by Plaintiffs. All affirmative defenses, claims, and counterclaims, which have been or could have been raised with respect to the ’557 patent, are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal. |
| Axsome Malta Ltd. v. Alkem Labs. Ltd., 25-17395 (D.N.J.) | Sunosi® (solriamfetol tablets) |
12,384,743 12,390,419 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and iwthout costs or attorneys’ fees to any party. Dismissal with respect to Alkem shall not result in dismissal of any claims, defenses, or counterclaims with respect to any other defendant. |
| Eli Lilly & Co. v. Qilu Pharm. Co., Ltd., 24-5847, 24-10802, 25-12347 (D.N.J.) | Reyvow® (lasmiditan tablets) |
11,053,214 12,071,423 12,257,246 |
All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. |
| Impax Labs., LLC v. Sciegen Pharms., Inc., 25-1233 (D. Del.) | Rytary® (carbidopa / levodopa extended-release capsules) |
8,557,283 9,089,608 9,463,246 9,533,046 9,901,640 |
This action is dismissed without prejudice, with each party to bear their own attorneys’ fees and costs. |
| Gilead Sciences, Inc. v. Macleods Pharms. Ltd., 26-0094 (D. Del.) | Vemlidy® (tenofovir alafenamide tablets) |
8,754,065 9,296,769 |
All affirmative defenses, claims, and counterclaims, which have been or could have been raised by the parties are dismissed without prejudice. Except as otherwise agreed by the parties, Macleods is enjoined from infringing the patents-in-suit until the date agreed by the parties. The parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees. |
| Impax Labs., LLC v. Biocon Pharma Ltd., 25-1968 (D.N.J.) | Rytary® (carbidopa / levodopa extended-release capsules) |
8,557,283 9,089,608 9,463,246 9,533,046 9,901,640 |
All claims, counterclaims, and affirmative defenses are voluntarily dismissed without prejudice. Each party shall bear its own attorneys’ fees and costs. |
| Teva Pharms. Int’l GmbH v. Almaject, Inc., 25-1168 (D. Del.) | Bendeka® (bendamustine HCl injection) |
8,609,707 9,265,831 9,572,796 9,572,797 9,034,908 9,144,568 9,572,887 9,597,397 9,597,398 9,597,399 9,000,021 9,579,384 10,010,533 10,052,385 11,844,783 11,872,214 12,138,248 12,350,257 12,343,333 |
Teva voluntarily dismisses action against Defendants, including all claims and defenses. |
| Takeda Pharms. U.S.A., Inc. v. Macleods Pharms. Ltd., 26-0042 (D. Del.) | Colcrys® (colchicine tablets) |
7,906,519 7,935,731 8,093,298 7,964,648 8,093,297 7,619,004 7,601,758 7,820,681 7,915,269 7,964,647 7,981,938 8,093,296 8,097,655 8,415,395 8,415,396 8,440,721 8,440,722 |
Takeda voluntarily dismisses without prejudice its complaint. |
| Abraxis BioScience, LLC v. Qilu Pharm. (Hainan) Co., Ltd., 26-0140 (D.N.J.) | Abraxane® (paclitaxel protein-bound particles for injectable suspension) |
7,758,891 8,034,375 8,268,348 9,101,543 9,393,318 9,511,046 9,597,409 |
Until expiration of the patents-in-suit, Qilu is enjoined from infringing the patents-in-suit, unless otherwise authorized by Abraxis. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Qilu from maintaining a Paragraph IV Certification with respect to the patents-in-suit. Nothing restricts FDA from approving the Qilu ANDA. |
| Merck KGaA v. Accord Healthcare, Inc., 22-0974 (D. Del.) | Mavenclad® (cladribine tablets) |
7,713,947 8,377,903 10,849,919 |
All claims, counterclaims, and defenses with respect to the ’919 patent are dismissed without prejudice. Each party shall bear its own costs, expenses, and attorneys’ fees. |
| Exeltis USA, Inc. v. Glenmark Pharms. Ltd., 25-17250 (D.N.J.) | Slynd® (drospirenone tablets) |
9,603,860 10,179,140 10,603,281 10,849,857 10,987,364 11,123,299 11,291,632 11,291,633 11,351,122 11,413,249 11,439,598 11,452,695 11,478,487 11,491,113 11,504,334 11,951,213 12,090,231 12,280,151 |
All claims and defenses are dismissed with prejudice, and without costs or attorneys’ fees to any party. |
| Boehringer Ingelheim Pharms. Inc. v. Dr. Reddy’s Labs. Ltd., 18-1779, 19-1495, 18-1689, 22-1102 (D. Del.) | Jardiance® (empagliflozin tablets) |
9,949,998 10,258,637 11,090,323 |
The patents-in-suit are valid and enforceable with respect to the DRL ANDA. Unless authorized between the parties, DRL is enjoined from infringing the patents-in-suit until their expiration. The parties shall bear their own fees and costs in connection with these actions. The complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice. |
| Pharmacosmos A/S v. Teva Pharms., Inc., 25-3218 (D.N.J.) | Cosela® (trilaciclib injection) |
11,529,352 12,168,666 |
All claims, counterclaims, and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Pharmacosmos A/S v. Dr. Reddy’s Labs., Inc., 25-3967 (D.N.J.) | Cosela® (trilaciclib for injection) |
8,598,186 8,598,197 9,957,276 10,189,849 10,189,850 10,927,120 11,040,042 9,487,530 10,085,992 10,966,984 11,717,523 11,529,352 12,168,666 |
All claims, counterclaims, and affirmative defenses with respect to the ’850, ’120, ’042, ’530, ’992, ’984, and ’523 patents are dismissed with prejudice, including Counts V, VI, VII, VIII, IX, X, and XI of Pharmacosmos’ Amended Complaint against DRL; and Counts IX, X, XI, XII, XIII, XIV, XV, XVI, XVII, XVffl, XIX, XX, XXI, and XXII of DRI’s Answer, Affirmative Defenses, and Counterclaims. Pharmacosmos will not assert that the submission of DRL’s ANDA infringed or will infringe any claim of the ’850, ’120, ’042, ’530, ’992, ’984, and ’523 patents. The stipulation and order does not dismiss or affect any claims, counterclaims, or affirmative defenses pending between the parties relating to any patent other than the ’850, ’120, ’042, ’530, ’992, ’984, and ’523 patents. Each party shall bear its own costs, disbursements, and attorney fees. |
| Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0923, 23-1182 (D. Del.) | Vyndaqel® (tafamidis meglumine capsules) |
7,214,695 7,214,696 |
Pfizer’s action against Aurobindo is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| American Regent, Inc. v. Cipla USA, Inc., 24-8435, 25-16422 (D.N.J.) | Tralement® (trace elements injection 4*, USP) |
11,786,548 11,975,022 11,998,565 |
Unless specifically authorized by ARI pursuant to the settlement agreement or by 35 U.S.C. § 271(e)(1), Cipla 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. Nothing shall preclude FDA from granting final approval to the CIPLA ANDAs or shall preclude Cipla from filing, modifying, or maintaining with FDA any Paragraph IV Certification for the Cipla products. |
| Intra-Cellular Therapies, Inc. v. Alkem Labs. Ltd., 24-4312, 24-8845, 24-10234 (D.N.J.) | Caplyta® (lumateperone capsules) |
RE48,839 9,956,227 10,960,009 11,026,951 11,753,419 11,980,617 12,070,459 12,090,155 12,122,792 12,128,043 12,409,176 12,410,195 |
Alkem admits that the claims of the patents-in-suit are valid and enforceable with respect to the Alkem product and that the claims of the patents-in-suit would be infringed by the manufacture and sale of the Alkem product. Alkem is enjoined from infringing the patents-in-suit until their expiration, other than as authorized by ITCI. All affirmative defenses, claims, and counterclaims that have been or could have been raised are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal. |
| Intra-Cellular Therapies, Inc. v. MSN Labs. Private Ltd., 24-10238 (D.N.J.) | Caplyta® (lumateperone capsules) |
12,090,155 12,122,792 12,128,043 |
MSN admits that the claims of the patents-in-suit are valid and enforceable with respect to the MSN product and that the claims of the patents-in-suit would be infringed by the manufacture and sale of the MSN product. MSN is enjoined from infringing the patents-in-suit until their expiration, other than as authorized by ITCI. All affirmative defenses, claims, and counterclaims that have been or could have been raised are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal. |
| Bausch & Lomb Inc. v. Sandoz Inc., 25-1167 (D.N.J.) | Lotemax® SM (loteprednol etabonate ophthalmic gel) |
10,596,107 11,534,395 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-1030, 24-1022 (D.N.J.) | Tralement® (trace elements injection 4*, USP) |
11,786,548 | Unless specifically authorized by ARI, Somerset 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. Nothing shall preclude FDA from granting final approval to the Somerset ANDAs or shall preclude Somerset from filing, modifying, or maintaining with FDA any Paragraph IV Certification for the Somerset products. |
| Fennec Pharms. Inc. v. Cipla Ltd., 25-5709 (D.N.J.) | Pedmark® (sodium thiosulfate injection) |
12,311,026 | All claims are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Final Approval of Cipla’s ANDA may be granted on the date that this Consent Judgment is entered. |
| Almirall, LLC v. Taro Pharms., Inc., 25-0385 (D. Del.) | Klisyri® (tirbanibulin topical ointment) |
7,300,931 7,851,470 10,323,001 10,617,693 10,669,236 11,497,750 |
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. Taro will not make or sell its ANDA product except as provided for in the parties’ settlement agreement. The stipulation and order shall not act as an adjudication on the merits. |
| Jazz Pharms. Ireland Ltd. v. Granules India Ltd., 25-14606 (D.N.J.) | Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) |
8,591,922 8,772,306 8,901,173 9,050,302 9,132,107 9,486,426 10,195,168 10,213,400 10,675,258 10,864,181 11,253,494 11,426,373 11,554,102 11,986,446 |
Until expiration of the patents-in-suit, Granules is enjoined from infringing the patents-in-suit, unless specifically authorized by Jazz. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Granules from maintaining a Paragraph IV Certification with respect to the patents-in-suit. Nothing prohibits Granules from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Granules’ ANDA. |
| PH Health Ltd. v. Somerset Therapeutics, LLC, 25-1533 (D. Del.) | Vasostrict® (vasopressin injection) |
9,919,026 9,925,233 9,925,234 9,962,422 9,968,649 9,974,827 9,981,006 10,010,575 12,186,362 |
Case voluntarily dismissed without prejudice. Each party shall bear its own attorneys’ fees and costs. |
| Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 25-3790 (D.N.J.) | Yupelri® (revefenacin oral inhalation solution) |
11,484,531 12,048,692 12,285,417 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Mankind, except as licensed by Plaintiffs, will be enjoined from infringing the patents-in-suit until their expiration. Nothing shall prevent FDA from granting final approval to Mankind’s ANDA at any time. Each party will bear its own attorneys’ fees and costs. |
