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 |
| Array Biopharma Inc. v. Sandoz Inc., 22-1316 (D. Del.) | Mektovi® (binimetinib tablets) |
9,314,464 9,850,229 10,005,761 9,562,016 9,598,376 9,980,944 |
All claims and counterclaims between the parties are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. Sandoz will not make, have made, use, offer for sale, or sell its ANDA product in the US except as provided in the parties’ settlement agreement. The dismissal orde rshall not act as an adjudication on the merits. Nothing prohibits Sandoz from maintaining its existing Paragraph IV certifications to the patents-in-suit or prohibits FDA from granting final approval to Sandoz’s ANDA. |
| Catalyst Pharms., Inc. v. Teva Pharms., Inc., 23-1190 (D.N.J.) | Firdapse® (amifampridine tablets) |
10,626,088 10,793,893 11,060,128 11,268,128 11,274,331 11,274,332 |
Unless specifically authorized by Catalyst, Teva agrees not to infringe 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 at any time to Teva’s ANDA. |
| Allergan Pharms. Int’l Ltd. v. Macleods Pharms. Ltd., 24-0847 (D. Del.) | Savella® (milnacipran HCl tablets) |
7,994,220 | The filing of Macleod’s ANDA was an act of infringement. All other claims, counterclaims, and defenses are dismissed without prejudice. Macleods is enjoined from infringing the ’220 patent for the life of the ’220 patent, absent a license agreement or authorization by Plaintiffs. The parties waive any right to appeal. The dismissal is without prejudice to any claim, defense, or counterclaim in a future action between Macleods and any of the Plaintiffs regarding the ’220 patent, and a product other than the ANDA product. |
| Intra-Cellular Therapies, Inc. v. Sandoz Inc., 24-10239 (D.N.J.) | Caplyta® (lumateperone capsules) |
8,648,077 9,168,258 9,199,995 9,616,061 9,956,227 10,117,867 10,464,938 10,695,345 10,960,009 11,026,951 11,052,084 11,690,842 11,753,419 11,806,348 RE48,825 RE48,839 11,980,617 12,070,459 12,090,155 12,122,792 12,128,043 |
Unless authorized by th parties’ settlement agreement, Sandoz is enjoined from infringing the licensed patents. Nothing shall prevent Sandoz from maintaining Paragraph IV Certifications to the licensed patents or prevent FDA from granting final approval to Sandoz’s ANDA. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Jazz Pharms. Research UK Ltd. v. Teva Pharms., Inc., 23-0018, 23-3914, 23-23141, 24-7550 (D.N.J.) | Epidiolex® (cannabidiol oral solution) |
9,949,937 9,956,183 9,956,184 9,956,185 9,956,186 10,092,525 10,111,840 10,137,095 10,603,288 10,709,671 10,709,673 10,709,674 10,849,860 10,918,608 10,966,939 11,065,209 11,096,905 11,154,516 11,160,795 11,207,292 11,311,498 11,357,741 11,400,055 11,406,623 11,446,258 11,633,369 11,701,330 11,766,411 11,963,937 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. Jazz’s dismissal of these matters with respect to Biophore shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant. |
| Bausch & Lomb Inc. v. Gland Pharma Ltd., 22-4345 (D.N.J.) | Vyzulta® (latanoprostene bunod ophthalmic solution) |
7,273,946 7,629,345 7,910,767 8,058,467 |
Except as authorized pursuant to the settlement agreement, Gland is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Actelion Pharms. US, Inc. v. Lannett Co., Inc., 24-1162 (D. Del.) | Uptravi® (selexipag tablets) |
8,791,122 9,284,280 |
Lannett agrees the patents-in-suit are valid and enforceable. Unless otherwise authorized by Plaintiffs, Lannett is enjoined from infringing the patents-in-suit until after the expiration of the patents-in-suit, including extensions and adjustments. Parties waive all right to appeal. Complaint, claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attonrey fees to any party. |
| Hikma Pharms. USA Inc. v. Cipla USA, Inc., 23-1157 (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, eithout prejudice. Each party shall bear its own costs and attorneys’ fees. |
| Novartis Pharms. Corp. v. MSN Pharms. Inc., 24-1193 (D. Del.) | Kisqali® (ribociclib tablets) |
8,962,630 9,416,136 |
Given the settlement agreement, all claims, counterclaims, and affirmative defenses are dismissed with prejudice. Each party will bear its own attorneys’ fees and costs. |
| American Regent, Inc. v. Dr. Reddy’s Labs., Inc., 24-7799, 24-11114 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless otherwise authorized by ARI or 35 U.S.C. § 271(e)(1), DRL 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 DRL’s ANDA or shall preclude DRL from filing, modifying, or maintaining with the FDA any paragraph IV certification for the DRL ANDA product. |
| Jazz Pharms. Research UK Ltd. v. Teva Pharms., Inc., 23-0018, 23-3914, 23-23141, 24-7550 (D.N.J.) | Epidiolex® (cannabidiol oral solution) |
9,949,937 9,956,183 9,956,184 9,956,185 9,956,186 10,092,525 10,111,840 10,137,095 10,603,288 10,709,671 10,709,673 10,709,674 10,849,860 10,918,608 10,966,939 11,065,209 11,096,905 11,154,516 11,160,795 11,207,292 11,311,498 11,357,741 11,400,055 11,406,623 11,446,258 11,633,369 11,701,330 11,766,411 11,963,937 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. Jazz’s dismissal of these matters with respect to Apotex shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant. |
| Takeda Pharms. U.S.A., Inc. v. Colomba Therapeutics, Inc., 24-0988 (D. Del.) | Myinfla® (colchicine tablets) Colcrys® (colchicine tablets) |
7,964,648 | Takeda voluntarily dismisses all claims in this action without prejudice against Defendants. |
| Impax Labs., LLC v. Dr. Reddy’s Labs., Ltd., 24-7875 (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 pursuant to Fed. R. Civ. P. 41(a)(1)(A)(ii). Each party shall bear its own attorneys’ fees and costs. |
| Teva Branded Pharm. Products R&D, Inc. v. Armstrong Pharms., Inc., 24-0869 (D. Del.) | ProAir® HFA (albuterol sulfate inhalation aerosol) |
9,463,289 | All claims, defenses, and counterclaims are dismissed, with prejudice. Each party shall bear its own costs. |
| Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 23-1695, 23-23142, 24-6489, 24-9535, 24-10938 (D.N.J.) | Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) |
10,780,064 10,925,842 10,940,124 10,966,942 11,717,518 11,730,706 11,752,144 11,839,612 11,844,797 11,883,373 11,896,563 11,925,636 11,969,421 11,986,444 12,036,191 12,042,473 12,146,889 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to any party. |
| Endo USA, Inc. v. Gland Pharma Ltd., 24-11529 (D.N.J.) | 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 |
All claims, counterclaims, causes of action, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
| Par Pharm., Inc. v. Baxter Healthcare Corp., 23-0358 (D. Del.) | Vasostrict® (vasopressin injection) |
9,993,520 11,135,265 11,207,372 |
All claims and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. |
| UCB, Inc. v. Prinston Pharm. Inc., 24-0167 (D. Del.) | Briviact® (brivaracetam tablets) |
6,911,461 | Unless otherwise specifically authorized pursuant to the settlement sgreement, Prinston 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. |
| Gilead Sciences, Inc. v. Lupin Ltd., 21-1621, 23-0508 (D. Del.) | Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide tablets) |
10,039,718 10,786,518 |
The claims of the patents-in-suit are valid and enforceable with respect to Lupin’s ANDA. Unless authorized by Plaintiffs, Lupin and MSN are enjoined from infringing the patents-in-suit. The parties waive all right to appeal or otherwise move for relief. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Gilead Sciences, Inc. v. Apotex Inc., 22-1399, 22-1400 (D. Del.) | Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide tablets) |
10,039,718 10,786,518 |
Submission of the Apotex ANDA infringed claims 1, 4-5, 14-15, 17, 19-20, and 22-23 of the ’718 patent. Apotex’s making and selling the ANDA product would infringe claims 1, 4-5, 14-15, 17, 19-20, and 22-23 of the ’718 patent. The claims of the patents-in-suit are valid and enforceable with respect to the Apotex ANDA. Unless authorized by Plaintiffs, Apotex is enjoined from infringing the patents-in-suit. The parties waive all right to appeal or otherwise move for relief. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Gilead Sciences, Inc. v. Apotex Inc., 23-0774 (D. Del.) | Genvoya® (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide tablets) |
10,039,718 | All affirmative defenses, claims, and counterclaims are dismissed without prejudice. Unless authorized by Gilead or by 35 U.S.C. § 271(e)(1), Apotex and MSN are enjoined from infringing the ’718 patent. The parties waive all right to appeal. Each party shall bear its own costs and attorneys’ fees. Nothing shall prevent FDA from granting final approval to Apotex’s ANDA. |
| American Regent, Inc. v. Meitheal Pharms., Inc., 25-0191 (D. Del.) | Selenious Acid | 11,998,565 12,150,957 |
All claims voluntarily dismissed without prejudice. |
| Astellas Pharma Inc. v. Sandoz, Inc., 23-1214 (D.N.J.) | Xospata® (gilteritinib tablets) |
10,786,500 11,938,130 11,938,131 11,938,132 11,938,133 11,944,620 |
All claims, defenses, and counterclaims are dismissed without prejudice. Sandoz 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. Parties waive any right to appeal. Parties shall bear their own costs. |
| American Regent, Inc. v. Amneal Pharms. of NY, LLC, 24-11503 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless authorized by ARI, Amneal is enjoined from infringing the patents-in-suit. All claims, countercliams, 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 Amneal’s ANDA or shall preclude Amneal from filing, modifying, or maintaining with FDA any Paragraph IV certification for the Amneal ANDA product. |
| Pfizer Inc. v. Alkem Labs. Ltd., 24-1427 (D. Del.) | Xeljanz® (tofacitinib tablets) |
RE41,783 | All claims dismissed without prejudice. |
| Axsome Malta Ltd. v. Hikma Pharms. USA Inc., 24-10620 (D.N.J.) | Sunosi® (solriamfetol tablets) |
12,090,126 12,102,609 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to any party. |
| Mallinckrodt Pharms. Ireland Ltd. v. Baxter Healthcare Corp., 24-1034 (D. Del.) | Ofirmev® (acetaminophen injection) |
9,399,012 9,610,265 9,987,238 10,383,834 |
All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. |
| Novartis Pharms. Corp. v. Cipla Ltd., 25-0216 (D. Del.) | Tasingna® (nilotinib d-tartrate capsules) |
8,389,537 | All claims are dismissed without prejudice. |
| American Regent, Inc. v. Accord Healthcare Inc., 24-7791, 24-11108 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless otherwise authorized by ARI, Accord is enjoined from infringing the patents-in-suit. All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party, except as otherwise agreed to by the parties. Nothing prohibits Accord from maintaining and/or filing a paragraph IV certification with respect to the patents-in-suit. Nothing precludes FDA from granting final approval to Accord’s ANDA. Any stay of approval with respect to Accord’s ANDA is hereby terminated. |
| American Regent, Inc. v. Somerset Therapeutics, LLC, 24-7807, 24-11124, 24-11138 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless otherwise authorized by ARI, Somerset is enjoined from infringing the patents-in-suit. All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party, except as otherwise agreed to by the parties. Nothing precludes FDA from granting final approval to Somerset’s ANDA or shall preclude Somerset from filing, modifying, or maintaining with FDA any paragraph IV certification for the Somerset ANDA product. |
| Sandoz Inc. v. Boehringer Ingelheim Pharms. Inc., 24-1192 (D. Del.) | Ofev® (nintedanib capsules) |
9,907,756 10,105,323 |
Sandoz’s manufacture and sale of its ANDA products does not constitute infringement of the patents-in-suit. Final Judgment on the merits is warranted based on Sandoz’s non-infringement of the patents-in-suit. As a result of this Final Judgment of non-infringement, there remains no controversy between the parties with respect to the patents-in-suit. This Judgment and Order may not be asserted by Sandoz or any other entity against Boehringer, and shall have no preclusive effect, in any proceeding with respect to any product other than the Sandoz ANDA products or with respect to any patent other than the patents-in-suit. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party. The parties shall bear their own fees and costs, including attorneys fees. |
| Currax Pharms. LLC v. Taro Pharm. Indus. Ltd., 24-7446 (D.N.J.) | Silenor® (doxepin HCl tablets) |
7,915,307 8,513,299 9,107,898 9,486,437 9,572,814 9,861,607 10,238,620 10,653,660 10,653,662 11,110,074 |
Each of the parties’ claims, counterclaims, and defenses are dismissed without prejudice. The parties’ are to bear their own attorneys’ fees and costs. |
| Rigel Pharms., Inc. v. Annora Pharma Private Ltd., 22-4732 (D.N.J.) | Tavalisse® (fostamatinib disodium hexahydrate tablets) |
7,449,458 8,263,122 8,652,492 8,771,648 8,951,504 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to any party. |
| Harmony Biosciences, LLC v. Lupin Ltd., 23-1286, 23-1340 (D. Del.) | Wakix® (pitolisant HCl tablets) |
8,207,197 8,354,430 8,486,947 |
Unless authorized by the parties’ settlement agreement, Annora is enjoined from infringing the patents-in-suit. Nothing prohibits Annora from maintaining and/or filing a Paragraph IV certification with respect to the patents-in-suit. All claims, counterclaims, and affirmative defenses that a party asserted or could have asserted are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 25-0350 (D. Del.) | Kisqali® (ribociclib tablets) |
8,324,225 8,415,355 8,685,980 8,962,630 9,416,136 |
All claims are dismissed without prejudice. Each party will bear its respective attorneys’ fees and costs. |
| Ingenus Pharms., LLC v. Accord Healthcare, Inc., 23-0377 (D. Del.) | Cyclophosphamide intravenous solution | 10,993,952 | All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
