ANDA Litigation Settlements

Reported settlements in federal district court cases

Fourth Quarter

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
Otsuka Pharm. Co., Ltd. v. MSN Labs. Pvt. Ltd., 19-2009, 20-1428 (D. Del.)	Rexulti® (brexpiprazole tablets)	8,349,840 8,618,109 9,839,637 10,307,419 RE48,059	The patents-in-suit are valid and enforceable. The patents-in-suit would be infringed by MSN’s ANDA product. All affirmtive defenses, claims, and counterlcaims are dismissed without prejudice. Each party will bear its own attorneys’ fees and costs.
Otsuka Pharm. Co., Ltd. v. Zenara Pharma Private Ltd., 19-1938, 20-1599, 22-1269 (D. Del.)	Rexulti® (brexpiprazole tablets)	8,349,840 8,618,109 9,839,637 10,307,419 RE48,059	All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice. Zenara, except as licensed by Plaintiffs, is enjoined from infringing the patents-in-suit. Nothing prevents FDA from granting final approval to Zenara’s ANDA. Each party will bear its own attorneys’ fees and costs.
Celgene Corp. v. Qilu Pharm. Co., Ltd., 22-3753 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,465,800 7,855,217	Until expiration of the patents-in-suit, Qilu is enjoined from infringing the patents-in-suit, unless 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 Qilu from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits Qilu from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Qilu’s ANDA.
Eisai Co., Ltd. v. Aurobindo Pharma Ltd., 22-3610 (D.N.J.)	Banzel® (rufinamide tablets)	6,740,669	The ’669 patent is enforceable and valid. Aurobindo ANDA product technically infringes the ’669 patent. Except as permitted by the Settlement Agreement, Aurobindo is enjoined from infringing the ’669 patent until the license to the ’669 patent provided in the Settlement Agreement becomes effective. All claims and counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties each expressly waive any right to appeal.
Otsuka Pharm. Co., Ltd. v. Apotex Inc., 19-2006 (D. Del.)	Rexulti® (brexpiprazole tablets)	10,307,419	The ’419 patent is valid and enforceble. The ’419 patent would be infringed by Apotex’s ANDA product. Apotex is enjoined from infringing the ’419 patent. Each party will bear its own costs and attorneys’ fees.
Bayer Healthcare LLC v. Aurobindo Pharma Ltd., 21-1575 (D. Del.)	Astepro® (azelastine HCl nasal spray)	8,071,073 8,518,919 9,919,050	All claims and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Astellas Pharma Inc. v. Sandoz Inc., 21-13177 (D.N.J.)	Xtandi® (enzalutamide tablets)	7,709,517 8,183,274	All claims and counterclaims are dismissed with prejudice. The parties shall each bear their own costs.
Tris Pharma, Inc. v. Ascent Pharms., Inc., 21-12867 (D.N.J.)	QuilliChew ER® (methylphenidate HCl extended-release chewable tablets)	8,999,386 9,295,642 9,545,399 9,844,544	Ascent’s submission of the Ascent ANDA was a technical act of infringement of the patents-in-suit and the commercial sale of the ANDA product would infringe the patents-in-suit. The asserted claims of the patents-in-suit are not invalid and are not unenforceable. Except as specifically authorized pursuant to the settlement agreement, Ascent is enjoined until the expiration of the last to expire patents-in-suit from infringing the patents-in-suit. The parties waive any right to appeal. Final judgment is to be entered in favor of Tris and against Ascent Each party is to bear its own costs, attorneys’ fees, and disbursements. Any claims, counterclaims, affirmative defenses, and demands that are not adjudicated by the Consent Judgment are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Astellas Pharma Inc. v. Aurobindo Pharma Ltd., 21-0425 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	10,842,780	All claims asserted by Plaintiffs against Actavis and all counterclaims asserted by Actavis against Plaintiffs are hereby dismissed without prejudice, and further, that all defenses to such claims and counterclaims are hereby dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 22-0210 (D. Del.)	Ibrance® (palbociclib tablets)	11,065,250	Plaintiffs’ claims with respect to the ’250 patent and Zydus’ ANDA product are dismissed without prejudice. Each party shall bear its own costs, expenses, and attorneys’ fees. The stipulation and order shall not act as an adjudication on the merits.
Insys Therapeutics, Inc. v. Teva Pharms. USA, Inc., 17-01303, 18-0414, 18-1308, 18-1775 (D. Del.)	Subsys® (fentanyl sublingual spray)	8,486,972 8,486,973 8,835,459 8,835,460 9,241,935 9,289,387 9,642,797 9,642,844 10,016,403	N/A
Bial-Portela & Ca S.A. v. Aurobindo Pharma Ltd., 21-1682, 22-1270 (D. Del.)	Aptiom® (eslicarbazepine acetate tablets)	8,372,431 9,206,135 9,566,244 9,643,929 9,750,747 9,763,954 10,675,287 10,702,536 10,695,354 10,912,781 11,364,247	Aurobindo admits that the patents-in-suit are patentable, valid, and enforcable. Aurobindo admits that unless pursuant to a license from Plaintiffs, it’s ANDA product infringes the patents-in-suit. Except as provided in its settlement agreement, Aurobindo will not challenge or assist others in challenging the patents-in-suit in any US legal or administrative proceeding. Except as authorized in the settlement agreement, until their expiration, Aurobindo is enjoined from infringing the patents-in-suit. Actions are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Novo Nordisk Inc. v. Alvogen, Inc., 22-0299 (D. Del.)	Ozempic® (semaglutide injection)	9,132,239 9,687,611 10,220,155 11,097,063 RE46,363	All claims and counterclaims concerning the patents-in-suit are dismissed with prejudice. Novo may assert the patents-in-suit against any other ANDA or agaisnt Alvogen’s ANDA if the device currently described in Alvogen’s ANDA is replaced or modified in a material way. Each party to bear its own costs, expenses, and attorneys’ fees.
Currax Pharms. LLC v. MSN Labs. Private Ltd., 20-1064 (D. Del.)	Silenor® (doxepin HCl tablets)	7,915,307 9,532,971 9,572,814 9,907,780 10,548,871 10,653,660	The parties’ claims and defenses are dismissed without prejudice. MSN is enjoined from infringing the patents-in-suit, absent a license or other authorization from Currax, except as permitted by the settlement agreement. The parties expressly waive any right to appeal. Each party shall bear its own fees and costs, including attorneys’ fees.
Sanofi-Aventis U.S. LLC v. Apotex Corp., 20-0804 (D. Del.)	Jevtana® Kit (cabazitaxel injection)	10,583,110	The parties claims and counterclaims are dismissed with prejudice. Parties to bear their own costs.
Novartis Pharms. Corp. v. Alkem Labs. Ltd., 19-1979, 21-1330, 22-0032 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	8,101,659 8,796,331 11,096,918 11,058,667	Judgment is entered that all asserted claims of the patents-in-suit are valid and enforceable. Judgment is entered that Alkem’s ANDA product infringes. By virtue of the license granted by Novartis to Alkem, judgment is entered that there no longer exists a cause of action for infringement of the patents-in-suit. Final Approval of Alkem’s ANDA may be granted on the date that this Consent Judgment is entered. Pursuant to the terms of the settlement agreement, all other Novartis claims are dismissed without prejudice and all of Alkem’s defenses, demands and counterclaims are dismissed with prejudice. Alkem is enjoined from infringging the patents-in-suit subject to the exceptions provided in the settlement agreement. Each party shall each bear its own costs and fees. Novartis and Alkem each expressly waive any right to appeal. Nothing shall prevent FDA from granting final approval to Alkem’s ANDA.
Pfizer Inc. v. Glenmark Pharms. Ltd., 19-1209 (D. Del.)	Inlyta® (axitinib tablets)	8,791,140	Pfizer’s action against Glenmark, and Glenmark’s counterclaims against Pfizer, including all claims and defenses asserted by Pfizer against Glenmark, and all claims and defenses asserted by Glenmark against Pfizer, are hereby dismissed without prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Abraxis BioScience, LLC v. Jiangsu Hengrui Pharms. Co., Ltd., 22-2745 (D.N.J.)	Abraxane® (paclitaxel protein-bound particles for injectable suspension)	7,820,788	Until expiration of the ’788 patent, Hengrui is enjoined from infringing the ’788 patent unless specifically 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 shall prohibit Hengrui from maintaining a “Paragraph IV Certification” with respect to the ’788 patent. Nothing shall restrict FDA from approving the Hengrui ANDA.
AstraZeneca AB v. Annora Pharma Private Ltd., 22-1209 (D. Del.)	Brilinta® (ticagrelor tablets)	10,300,065	Unless specifically authorized pursuant to the settlement agreement, Hetero is enjoined from infringing the ’065 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Astellas Pharma Inc. v. Prinston Pharm. Inc., 20-1589 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	10,842,780	All claims asserted by Plaintiffs against Prinston and all counterclaims asserted by Prinston against Plaintiffs are dismissed without prejudice, and all defenses to such claims and counterclaims are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
AstraZeneca AB v. Torrent Pharms. Ltd., 21-1116 (D. Del.)	Brilinta® (ticagrelor tablets)	10,300,065	Unless authorized by the settlement agreement, Torrent is enjoined from infringing the ’065 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Astellas Pharma Inc. v. Aurobindo Pharma Ltd., 21-0425 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	10,842,780	All claims asserted by Plaintiffs against Aurobindo and all counterclaims asserted by Aurobindo against Plaintiffs are dismissed without prejudice, and further, that all defenses to such claims and counterclaims are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Astellas Pharma Inc. v. Apotex Inc., 21-1141 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	10,842,780	All claims asserted by Plaintiffs against Apotex and all counterclaims asserted by Apotex against Plaintiffs are dismissed without prejudice, and further, that all defenses to such claims and counterclaims are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Teva Branded Pharm. Products R&D, Inc. v. Aurobindo Pharma Ltd., 20-14833 (D.N.J.)	Qvar® (beclomethasone dipropionate inhalation aerosol)	9,463,289 9,808,587 10,022,509 10,022,510 10,086,156 10,561,808 10,695,512	All claims and counterclaims are dismissed, without prejudice. Each party shall bear its own costs.
Fresenius Kabi USA, LLC v. Zydus Pharms. (USA) Inc., 22-1702 (D.N.J.)	Levothyroxine sodium powder for injection	9,006,289 9,168,238 9,168,239	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Corcept Therapeutics, Inc. v. Hikma Pharms. USA Inc., 21-5034 (D.N.J.)	Korlym® (mifepristone tablets)	10,195,214 10,500,216 10,842,800 10,842,801	Hikma has not rebutted the statutory presumption that the patents-in-suit are valid and enforceable. The submission of Hikma’s ANDA was a technical act of patent infringement with respect to one or more claims of each of the patents-in-suit. Until their expiration, Hikma is enjoined from infirnging the patents-in-suit, unless specifically authorized by Corcept. All remaining claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party, except that Hikma’s counterclaims of invalidity or enforceability are dismissed as moot. Nothing prohibits Hikma from maintaining any Paragraph IV certification with respect to the patents-in-suit. Nothing restricts FDA from approving Hikma’s ANDA.
Eagle Pharms., Inc. v. Accord Healthcare Inc., 22-0704 (D. Del.)	Belrapzo® (bendamustine HCl injection)	11,103,483	Based on the doctrine of collateral estoppel in view of the prior non-infringement judgment associated with Slayback and Apotex, final judgment of non-infringement is entered in favor of Accord and against Eagle. All other counterlcaims are dismissed without prejudice as moot, and subject to Accord’s right to reassert the dissmissed counterlcaims in the event that the prior non-infringement judgment is modified, reversed, or vacated on appeal. Each party shall bear its own costs and attorneys’ fees.
Bayer Healthcare LLC v. Apotex Inc., 21-1429 (D. Del.)	Astepro® (azelastine HCl nasal spray)	8,071,073 8,518,919 9,919,050	All claims, counterclaims, and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Boehringer Ingelheim Pharms. Inc. v. Aurobindo Pharma Ltd., 18-1757, 19-1862, 21-1485 (D. Del.)	Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® (empagliflozin / metformin tablets) Synjardy® XR (empagliflozin / metformin extended-release tablets)	8,551,957 9,949,998 10,258,637 11,090,323	The patents-in-suit are valid, enforceable, and infringed by the Aurobindo ANDA products. Unless authorized or modified by the parties, Aurobindo is enjoined from infringing the patents-in-suit. The complaints, all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Alcon Inc. v. Aurobindo Pharma Ltd., 22-1391 (D. Del.)	Pataday® (olopatadine HCl ophthalmic solution)	8,791,154 9,533,053	Plaintiffs dismiss the case with prejudice.
Merck Sharp & Dohme Corp. v. Zydus Worldwide DMCC, 21-0315 (D. Del.)	Januvia® (sitagliptin phosphate tablets)	7,326,708	All claims, counterclaims, affirmative defenses, and demands in this action are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Puma Biotechnology, Inc. v. Sandoz Inc., 21-19918 (D.N.J.)	Nerlynx® (neratinib tablets)	7,399,865	All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Journey Medical Corp. v. Teva Pharms., Inc. 22-0288 (D. Del.)	Qbrexza® (glycopyrronium cloth)	8,618,160 8,859,610 9,259,414 9,744,105 10,004,717 10,052,267 10,543,192 10,548,875	All claims and counterclaims are dismissed without prejudice. Any stay(s) with respect to the approval of Teva’s ANDA is terminated. Each of the parties shall bear its own costs, disbursements, and attorneys’ fees.
Merck Sharp & Dohme LLC v. Laurus Labs Ltd., 22-1348 (D. Del.)	Janumet® (metformin HCl / sitagliptin phosphate tablets)	7,326,708	Unless specifically authorized by the settlement agreement, Laurus is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Helsinn Healthcare S.A. v. Gland Pharma Ltd., 22-4635 (D.N.J.)	Akynzeo® (fosnetupitant chloride HCl / palonosetron HCl injection)	8,426,450 8,895,586 9,186,357 9,403,772 9,908,907 10,208,073 10,624,911 10,717,721 10,828,297 11,312,698	Gland has not rebutted the statutory presumption that the Helsinn Patents are valid and enforceable in the Litigation. Gland admits that the submission of its ANDA containing paragraph IV certifications before the expiration of the Helsinn patents was a technical act of infringement. All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Gland is enjoined from infringing the Helsinn patents until a confidential date certain, or such earlier date as agreed to by the parties. The parties each expressly waive any right to appeal.
AstraZeneca AB v. Changzhou Pharm. Factory, 21-1284 (D. Del.)	Brilinta® (ticagrelor tablets)	8,425,934	Unless specifically authorized by the settlement agreement, Changzhou is enjoined from infringing the ’934 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
AstraZeneca AB v. Alembic Pharms. Ltd., 21-0875, 22-1216 (D. Del.)	Brilinta® (ticagrelor tablets)	8,425,934 10,300,065	Unless specifically authorized by the settlement agreement, Changzhou 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.