ANDA Litigation Settlements

Reported settlements in federal district court cases

Second Quarter

GENERICally Speaking

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 

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