ANDA Litigation Settlements of Q2 - Spring 2023 | Hatch-Waxman

Reported settlements in federal district court cases

Second Quarter

This ANDA Litigation Settlements 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
Alcon Inc. v. Alembic Pharms. Ltd., 23-0194 (D. Del.)	Pataday® (olopatadine HCl ophthalmic solution)	8,791,154 9,533,053	Plaintiffs dismissed the action with prejudice.
Cosette Pharms., Inc. v. Azurity Pharms., Inc., 23-0018 (D. Del.)	Firvanq® Kit (vancomycin HCl oral solution)	10,493,028 10,688,046 10,959,946 10,959,947 10,959,948 10,959,949	The court grants final judgment and finds that Cosette’s ANDA product will not infringe the patents-in-suit. Final judgment of noninfringement of the patents-in-suit is hereby entered in favor of Cosette as to Cosette’s ANDA product. Cosette shall pro
Teva Pharms. Int’l GmbH v. Dr. Reddy’s Labs., Ltd., 21-0695 (D. Del.)	Bendeka® (bendamustine HCl for 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	All claims and defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 19-2053, 21-1330, 22-0498 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	8,101,659 8,796,331 8,877,938 9,388,134	Final approval of DRL’s ANDA may be granted on or after the date of the consent judgment. Under the settlement agreement, all other Novartis claims are dismissed without prejudice and all of DRL’s defenses, demands, and counterclaims are dismissed withou
Acadia Pharms. Inc. v. Zydus Pharms. (USA) Inc., 22-1386 (D. Del.)	Nuplazid® (pimavanserin tartrate capsules)	11,452,721	The parties stipulate to dismiss all claims and counterclaims without prejudice.
Novartis Pharms. Corp. v. Aurobindo Pharma USA Inc., 19-1979, 21-1330, 21-1407 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	8,101,659 8,796,331 11,096,918 11,058,667	The asserted claims are valid and enforceable. The filing of Aurobindo’s ANDA infringed the asserted claims, and Aurobindo’s ANDA product would infringe the asserted claims. The Consent Judgment constitutes a “consent decree” such that Final Approval o
Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 22-4499 (D.N.J.)	Xtandi® (enzalutamide tablets)	7,709,517	All claims and defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Novartis Pharms. Corp. v. Sun Pharm. Indus. Ltd., 21-1656 (D. Del.)	Xiidra® (lifitegrast ophthalmic solution)	11,058,677 8,927,574 9,353,088 9,890,141 9,085,553	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Bristol-Myers Squibb Co. v. ScieGen Pharms., Inc., 23-0393 (D. Del.)	Eliquis® (apixaban tablets)	9,326,945	All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Horizon Medicines LLC v. Apotex Inc., 22-0640 (D. Del.)	Pennsaid® (diclofenac sodium topical solution)	9,066,913	The parties stipulate that the action be dismissed with prejudice, including all claims, counterclaims, defenses, and demands, with each to bear its own attorneys’ fees and costs. The parties request that the court grant the release, to Plaintiffs, of th
Astellas US LLC v. Baxter Healthcare Corp., 22-1390 (D. Del.)	Lexiscan® (regadenoson intravenous solution)	8,106,183 RE 47,301 8,524,883	All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Astellas US LLC v. Curia Missouri, Inc., 22-0199 (D. Del.)	Lexiscan® (regadenoson for injection)	6,403,567	Plaintiffs dismiss all claims against Curia.
Abraxis Bioscience, LLC v. Hainan Shuangcheng Pharms. Co., Ltd., 23-0750 (D.N.J.)	Abraxane® (paclitaxel injection)	7,820,788 7,923,536 8,138,229	Until expiration, HNSP is enjoined from infringing the patents-in-suit, unless specifically authorized by Abraxis. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ f
Bayer Intellectual Property GmbH v. Sciegen Pharms., Inc., 23-0335 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218 10,828,310	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Anacor Pharms., Inc. v. Padagis Israel Pharms. Ltd., 21-1351 (D. Del.)	Eucrisa® (crisaborole ointment)	8,168,614 8,501,712 9,682,092	All claims, counterclaims, and defenses between the parties are voluntarily dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees with respect to any claim, counterclaim, or defense.
Hikma Pharms. USA Inc. v. Annora Pharma Private Ltd., 23-0231 (D. Del.)	Mitigare® (colchicine capsules)	8,927,607 9,399,036 9,555,029 9,675,613 9,789,108	Hikma provides notice of dismissal of all claims without prejudice. No Answer or responsive pleading had been filed by Defendants. Each party shall bear its own costs and attorneys’ fees.
Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 22-0298 (D. Del.)	Ozempic® (semaglutide injection)	8,129,343 8,920,383 9,132,239 9,457,154 9,687,611 9,775,953 10,220,155 10,335,462 11,097,063 RE46,363	Sealed.
Ingenus Pharms., LLC v. Nevakar Injectables, Inc., 22-7603 (D.N.J.)	Cyclophosphamide intravenous solution	10,993,952	The parties stipulate and agree that all claims are dismissed without prejudice.
Fresenius Kabi USA, LLC v. Xiromed Pharma Espana, S.L., 22-6220 (D.N.J.)	levothyroxine sodium for injection	9,006,289 9,168,238 9,168,239	Patents-in-suit are enforceable and valid and would be infringed by Defendant’s ANDA product. All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Taro Pharm. Indus. Ltd. v. Encube Ethicals Pvt. Ltd., 21-1614 (D. Del.)	Ovide® (malathion lotion)	7,560,445 7,977,324	Unless specifically authorized by the parties’ Settlement and License Agreement, Encube is enjoined from infringing the patents-in-suit until the expiration of the last to expire of the patents-in-suit, and the period of any pediatric exclusivity associat
Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 22-0377 (D. Del.)	Steglatro® (ertugliflozin tablets)	8,080,580	Unless specifically authorized by the parties’ Settlement Agreement, Aurobindo is enjoined from infringing the ’580 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or atto
Merck Sharp & Dohme Corp. v. Hetero Labs Ltd., 22-0378 (D. Del.)	Steglatro® (ertugliflozin tablets)	8,080,580	Unless specifically authorized by the parties’ Settlement Agreement, Hetero is enjoined from infringing the ’580 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorn
Merck Sharp & Dohme Corp. v. Zenara Pharma Private Ltd., 22-0379 (D. Del.)	Steglatro® (ertugliflozin tablets)	8,080,580	Unless specifically authorized by the parties’ Settlement Agreement, Zenara is enjoined from infringing the ’580 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorn
Alcon Inc. v. Gland Pharma Ltd., 23-0303 (D. Del.)	Pataday® Once-Daily Relief 0.7% (olopatadine HCl ophthalmic solution)	8,791,154 9,533,053	Alcon dismissed the action with prejudice.
Novartis Pharms. Corp. v. Crystal Pharm. (Suzhou) Co., Ltd., 19-1979, 20-2930, 21-1452, 22-1395 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	8,101,659 8,877,938 9,388,134 11,058,667 11,096,918	Sealed.
Pfizer Inc. v. Apotex Inc., 23-0445 (D. Del.)	Xeljanz® (tofacitinib) tablets	RE41,783	Plaintiffs dismissed all claims without prejudice.
Keryx Biopharmaceuticals, Inc. v. Zydus Worldwide DMCC, 23-0331 (D. Del.)	Auryxia® (ferric citrate tablets)	7,767,851 8,093,423 8,299,298 8,338,642 8,609,896 8,754,257 8,754,258 8,846,976 8,901,349 9,050,316 9,387,191 9,328,133 9,757,416 10,300,039	All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each expressly waive any right to appeal.
Silvergate Pharms., Inc. v. Annora Pharma Private Ltd., 21-0196 (D. Del.)	EpanedÒ (enalapril maleate oral solution)	10,772,868 10,786,482 10,799,476	All claims and counterclaims between Azurity and Annora and Camber 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 o
Anacor Pharms., Inc. v. Teva Pharms. Development, Inc., 21-1353 (D. Del.)	Eucrisa® (crisaborole ointment)	8,168,614 8,501,712 9,682,092	Sealed.
Azurity Pharms., Inc. v. Accord Healthcare, Inc., 23-0373 (D. Del.)	Thyquidity® (levothyroxine sodium oral solution)	9,050,307	All claims dismissed without prejudice.
Bristol-Myers Squibb Co. v. Biocon Pharma Ltd., 23-0392 (D. Del.)	Eliquis® (apixaban tablets)	9,326,945	All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each expressly waive any right to appeal.
Currax Pharms. LLC v. Aurolife Pharma LLC, 21-20765 (D.N.J.)	Silenor® (doxepin HCl)	7,915,307 8,513,299 9,107,898 9,486,437 9,532,971 9,572,814 9,861,607 9,907,780 10,238,620 10,548,871 10,653,660 10,653,662 11,096,920 11,110,074	Action dismissed with prejudice and without costs.
Bayer Intellectual Property GmbH v. USV Private Ltd., 22-1492 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218 10,828,310	Plaintiffs’ action against USV and USV’s action against Plaintiffs are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Bristol-Myers Squibb Co. v. Handa Oncology, LLC, 22-6968 (N.D. Cal.)	Sprycel® (dasatinib tablets)	7,491,725 8,680,103	All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Supernus Pharms., Inc. v. Apotex Inc., 22-0322 (D.N.J.)	Oxtellar XR® (oxcarbazepine extended-release tablets)	11,166,960	All claims, counterclaims, and defenses asserted by the parties are dismissed without prejudice. The 30-month stay is terminated. Nothing prevents FDA from granting final approval to ANDA No. 213369 at any time. Each party shall bear its own costs an
Merck Sharp & Dohme LLC v. Gland Pharma Ltd., 22-5461 (D.N.J.)	Noxafil® (posaconazole injection)	9,023,790 9,358,297	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.
Arbor Pharms., LLC v. Amneal Pharms., LLC, 22-2323 (D.N.J.)	Nymalize® (nimodipine oral solution)	7,070,581 8,517,997 10,342,787 10,576,070 11,207,306	All claims and counterclaims are dismissed without prejudice. Plaintiffs and Amneal shall bear their own fees and costs.
Supernus Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 22-4705 (D.N.J.)	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 asserted by the parties are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Exela Pharma Sciences, LLC v. Hikma Pharms. USA, Inc., 23-0137 (D. Del.)	Elcys® (cysteine HCl injection)	10,583,155 11,510,941	The case is dismissed without prejudice with each party bearing its own costs and attorneys’ fees. Hikma shall produce any correspondence from FDA [redacted] ANDA No. 213073 within three business days of receiving such correspondence. Hikma shall notify