ANDA Litigation Settlements

Reported settlements in federal district court cases

Fourth Quarter

GENERICally Speaking

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
Merck Sharp & Dohme Corp. v. Dr. Reddy’s Labs., Inc., 20-0847, 21-1033 (D. Del.) Januvia® (sitagliptin tablets) Janumet® (metformin / sitagliptin tablets

Janumet® (metformin / sitagliptin tablets)

Janumet® XR (metformin / sitagliptin extended-release tablets)
7,326,708 Unless specifically authorized pursuant to the settlement agreements, DRL is enjoined from infringing the patent-in-suit.
All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Amphastar Pharms. Inc. v. Eli Lilly and Co., 21-1922 (S.D. Ind.) Forteo® (teriparatide injection) 7,517,334 Amphastar’s ANDA product does not infringe the ’334 patent.
Nothing prohibits Amphastar from submitting or maintaining a Paragraph IV certification with respect to the ’334 patent.
The parties shall bear their own costs and attorneys’ fees.


Pfizer Inc. v. Aurobindo Pharma, Ltd., 20-1528 (D. Del.) Ibrance® (palbociclib capsules) 10,723,730 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 agreement. Aurobindo will not infringe the patent-in-suit, except as provided in the settlement agreement.
Horizon Orphan LLC v. Lupin Ltd., 20-10339 (D.N.J.) Procysbi® (cysteamine bitartrate delayed-release capsules) 8,026,284
9,192,590
9,198,882
9,925,156
9,925,157
9,925,158
9,173,851
9,233,077
10,143,665
10,328,037
10,548,859
All claims, counterclaims, and defenses are dismissed without prejudice, and without costs to any party.
Biogen Inc. v. Teva Pharms. Development Inc., 21-0389 (D. Del.) Vumerity® (diroximel fumarate delayed-release capsules) 8,669,281
9,090,558
10,080,733
All claims and counterclaims are dismissed without prejudice and the parties shall bear their own costs and attorneys’ fees.
Galderma Labs., L.P. v. Zydus Pharms. (USA) Inc., 20-19578 (D.N.J.) Soolantra® (ivermectin cream) 9,089,587
9,233,117
9,233,118
9,782,425
10,206,939
The parties’ claims and counterclaims are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Boehringer Ingelheim Pharms. Inc. v. MSN Labs. Private Ltd., 18-1785, 19-1865 (D. Del.) Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® XR (empagliflozin / metformin HCl extended-release tablets) 8,551,957
9,949,998
10,258,637
The patents-in-suit are valid, enforceable, and infringed by the MSN ANDA products. Unless specifically authorized pursuant to the settlement agreement, MSN is enjoined from infringing the patents-in-suit.

All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. 
Pfizer Inc. v. Aizant Drug Research Solutions Pvt. Ltd., 21-0034 (D. Del.) Ibrance® (palbociclib capsules) 10,723,730 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. Aizant will not infringe the patent-in-suit except as provided for in the parties’ settlement and license agreement.
Amgen Inc. v. MSN Pharms., Inc., 20-0137 (D. Del.) Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
MSN admits that the patents-in-suit are valid and enforceable. MSN admits that its ANDA product infringes the patents-in-suit.
Until expiration of the patents-in-suit, MSN is enjoined from infringing the patents-in-suit, except as specifically authorized by Amgen in writing.
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Otsuka Pharm. Co. Ltd. v. Unichem Labs. Ltd., 20-1295 (D. Del.) Rexulti® (brexpiprazole tablets) 7,888,362
RE48,059
8,349,840
8,618,109
9,839,637
10,307,419
All claims, counterclaims, and defenses are dismissed without prejudice.
Each party shall bear its own costs and attorneys’ fees.
Genentech, Inc. v. Lupin Ltd., 19-0109, 19-0110 (D. Del.) Esbriet® (pirfenidone capsules and tablets) 7,566,729
7,635,707
7,767,700
7,816,383
7,910,610
8,013,002
8,084,475
8,318,780
8,383,150
8,420,674
8,592,462
8,609,701
8,648,098
8,754,109
8,778,947
7,696,236
7,767,225
7,988,994
8,753,679
Complaints are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Genentech, Inc. v. Aurobindo Pharma Ltd., 19-0103, 19-0105 (D. Del.) Esbriet® (pirfenidone capsules and tablets) 7,566,729
7,635,707
7,767,700
7,816,383
7,910,610
8,013,002
8,084,475
8,318,780
8,383,150
8,420,674
8,592,462
8,609,701
8,648,098
8,754,109
8,778,947
7,696,236
7,767,225
7,988,994
8,753,679
Complaints are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Mayne Pharma LLC v. Perrigo Israel Pharms. Ltd., 21-0612 (D. Del.) Lexette® (halobetasol propionate topical foam) 10,857,159 The ’159 patent is valid and enforceable. Except as authorized by the settelemnt agrement, Padagis is enjoined from infringing the ’159 patent.
The complaint and all remaining claims are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
The 30-month stay is terminated.
Allergan USA, Inc. v. Alkem Labs. Ltd., 19-1727, 21-1061 (D. Del.) Viberzi® (eluxadoline tablets) 8,691,860
9,115,091
9,364,489
9,675,587
11,007,179
Alkem’s submission of its ANDA was a technical act of infringement of each of the patents-in-suit. All other claims and defenses are dismissed without prejudice.
Alkem is enjoined from infringing the patents-in-suit during the life of the patents-in-suit, unless the patents-in-suit are found invalid or unenforceable by a court decision from which no appeal can be taken.
The parties waive any right to appeal.
This order is without prejudice to any claim, defense, or counterclaim in any possible future action between Alkem and any of the Plaintiffs regarding the patents-in-suit and a product other than the ANDA product.
Allergan USA, Inc. v. Hetero Labs Ltd., 19-1727, 21-1063 (D. Del.) Viberzi® (eluxadoline tablets) 9,675,587
10,188,632
11,007,179
11,090,291
Hetero’s submission of its ANDA was a technical act of infringement of each of the patents-in-suit.
Except for Hetero’s counterclaim of inequitable conduct and Hetero’s affirmative defense of inequitable conduct, all other claims and defenses are dismissed without prejudice.
Hetero’s counterclaim of inequitable conduct and Hetero’s affirmative defense of inequitable conduct are dismissed with prejudice.
Hetero is enjoined from infringing the patents-in-suit during the life of the patents-in-suit, absent a license agreement or other authorization from Allergan.
The parties waive any right to appeal.
This order is without prejudice to any claim, defense, or counterclaim in any possible future action between Hetero and any of the Plaintiffs regarding the patents-in-suit and a product other than the ANDA product.
Genus Lifesciences Inc. v. Lannett Co., Inc., 20-0770 (D. Del.) Goprelto® (cocaine HCl nasal solution) Numbrino® (cocaine HCl nasal solution) 9,867,815
10,016,407
10,420,760
All claims, counterclaims, and affirmative defenses are dismissed with prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Pfizer Inc. v. Apotex Inc., 21-1402 (D. Del.) Chantix® (varenicline tartrate tablets) 6,890,927
7,265,119
All claims are hereby dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees.
Astellas Pharma Inc. v. Alkem Labs. Ltd., 21-0992 (D. Del.) Myrbetriq® (mirabegron extended-release tablets) 7,342,117
7,982,049
8,835,474
10,842,780
RE44,872
Pursuant to a settlement and license agreement, all claims are dismissed without prejudice. The parties will submit their settlement and license agreement to the FTC and DOJ as soon as practicable. Each party will bear its own costs and attorneys’ fees.
Teva Pharms. Int’l Gmbh v. Aurobindo Pharma, Ltd., 20-0632 (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
All claims and defenses are dismissed with prejudice.
Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 20-0753 (D. Del.) Epaned® (enalapril maleate oral solution) 9,669,008
9,808,442
10,039,745
10,154,987
All of Azurity’s infringement claims are dismissed with prejudice, and all other counterclaims, defenses, motions, and petitions asserted in this action are dismissed without prejudice as moot.
This dismissal is without prejudice to Azurity’s ability to re-assert the patents-in-suit against Annora in the event that the Federal Circuit renders a decision whereby collateral estoppel would not apply to bar Azurity’s assertion of the patents-in-suit against Annora.
In the event that Azurity pursues such relief, Annora shall retain the right to respond with any and all defenses and counterclaims.
The 30-month period preventing Annora from receiving final FDA approval shall be terminated. Each party shall bear its own costs and attorneys’ fees.
Purple Biotech Ltd. v. Lupin Ltd., 20-12849 (D.N.J.) Consensi® (amlodipine besylate / celecoxib tablets) 10,350,171
9,408,837
10,925,835
10,945,960
Unless specifically authorized under the settlement agreement, Lupin is enjoined until the entry date (as defined in the setlleinent agreement) or earlier as permitted by the settlement agreement, from infringing the patents-in-suit. Lupin agrees not to challenge or dispute the validity, enforceability or patentability of any of the patents-in-suit solely with respect to the ANDA product. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Boehringer Ingelheim Pharms., Inc. v. Lupin Atlantis Holdings SA, 18-12663, 18-16708 (D.N.J.) Spiriva® HandiHaler® (tiotropium bromide inhalation powder) 7,694,676 Unless specifically authorized, Lupin is enjoined from infringing the ’676 patent.
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Merck Sharp & Dohme B.V. v. Aspiro Pharma Ltd., 20-3112 (D.N.J.) Bridion® (sugammadex for injection) RE44,733 Aspiro is enjoined from infringing the ’733 patent with regards to its ANDA product.
All claims, counterclaims, affirmative defenses, and demands in this action are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Fresenius Kabi USA, LLC v. Gland Pharma Ltd., 20-12347 (D. N.J.) Naropin® (ropivacaine HCl for injection) 8,118,802 The filing of Gland’s ANDA was a technical act of infringement of the ’802 patent.
No final judgment has been obtained regarding the presumptive validity of the ’802 patent and/or whether it infringes the ’802 patent. 
In view of a settlement and license agreement, unless specifically authorized, Gland is enjoined from infringing the ’802 patent.
Each party shall bear its own costs, attorneys’ fees, and expenses. The consent judgment and order is without prejudice to any claim, defense, or counterclaim in any possible future action between Gland and Fresenius Kabi regarding the ’802 patent concerning any drug other than those licensed in the settlement and license agreement.
Pfizer Inc. v. Qilu Pharm. Co., Ltd., 21-0929 (D. Del.) Ibrance® (palbociclib capsules) 10,723,730 All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. Qilu will not infringe the ’730 patent except as provided for in the parties’ settlement and license agreement. The stipulation and order shall not act as an adjudication on the merits.
Nexus Pharms., Inc. v. Nevakar, Inc., 21-15524 (D.N.J.) Emerphed® (ephedrine sulfate injection) 11,090,278
10,869,845
A settlement has been reached by plaintiff Nexus and defendants Endo, Par, and Nevakar. All claims and counterclaims are voluntarily dismissed with prejudice, with each party responsible for its own costs and fees.
Duchesnay Inc. v. Hetero Labs Ltd., 21-0538, 21-1130 (D. Del.) Osphena® (ospemifene tablets) 6,245,819
8,236,861
8,624,079
Hetero admits that the patents-in-suit are valid and enforceable in connection with its ANDA product.
Hetero admits that, unless pursuant to a license from Plaintiffs, it infringes the patents-in-suit. Except as provided in the settlement agreement, Hetero will not dispute or assist others in disputing the infringement, patentability, validity, or enforceability of the patents-in-suit.
Except as authorized in the settlement agreement, Hetero is enjoined from infringing the patents-in-suit until their expiration. All claims, counterclaims, and affirmative defenses, are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Cubist Pharms. LLC v. Mylan Pharms. Inc., 20-0052 (N.D.W.V.) Cubicin RF® (daptomycin for injection) 9,138,456
8,835,382
Until expiration of the patents-in-suit, Mylan is enjoined from infringing the patents-in-suit, unless otherwise specifically authorized by Cubist. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Mylan from maintaining a “Paragraph IV Certification” for the ANDA product with respect to the patents-in-suit or any other patent listed in the Orange Book for Cubicin RF. The 30-month stay is terminated. Nothing restricts FDA from approving Mylan’s ANDA.
AstraZeneca AB v. Zydus Pharms. (USA), Inc., 21-0550 (D. Del.) Tagrisso® (osimertinib mesylate tablets) 10,183,020 Except as authorized pursuant to the settlement agreement, Zydus is enjoined from infringing the ’020 patent. All claims, affirmative defenses, and demands between AstraZeneca and Zydus are dismissed without prejudice and without costs, disbursements or attorneys’ fees.
Bayer Healthcare LLC v. Dr. Reddy’s Labs., Inc., 21-0997 (D. Del.) Nexavar® (sorafenib tosylate tablets) 9,737,488 Plaintiffs’ action against DRL, including all claims and defenses asserted by Plaintiffs against DRL and all claims and defenses asserted by DRL against Plaintiffs, are dismissed with prejudice.
All parties shall bear their own costs, disbursements, and attorneys’ fees.
Bial – Portela & CA. S.A. v. Torrent Pharms. Ltd., 18-0279, 19-1673, 20-0781, 21-0190 (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
10,695,354
10,702,536
10,912,781
Torrent admits that the Aptiom Orange Book patents are patentable, valid, and enforceable. Torrent admits that its ANDA product would infringe the patents-in-suit. Except as provided in the settlement agreement, Torrent shall not challenge or contest infringement of the patents-in-suit in any US litigation or proceeding. Except as authorized in the settlement agreement, prior to the expiration of the patents-in-suit, Torrent is enjoined from infringing the patents-in-suit. The action, including counterclaims and affirmative defenses, is dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Merck Sharp & Dohme Corp. v. Actavis Labs. FL, Inc., 15-6541, 20-0534 (D.N.J.) Dificid® (fidaxomicin tablets) 7,906,489
8,586,551
7,378,508
7,863,249
8,859,510
Unless authorized, Actavis 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 prohibits Actavis from filing or maintaining a Paragraph IV certification with respect to the patents-in-suit. Nothing shall prevent FDA from granting final approval of Actavis’s ANDA product.
Almirall, LLC v. Torrent Pharms. Ltd., 20-1373 (D. Del.) Aczone® Gel (dapsone) 9,517,219 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, and Torrent infringe the patents-in-suit, except as provided for in the agreement. Torrent waives the right to enforce the Court’s September 3, 2021 decision to award reasonable attorney’s fees and costs. This order shall not act as an adjudication on the merits.
Merck Sharp & Dohme Corp. v. Scigen Pharms., Inc., 21-1616 (D. Del.) Januvia® (sitagliptin phosphate tablets) 7,326,708 Unless authorized by the settlement agreement, ScieGen is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands in this action are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-1396 (D. Del.) Ibrance® (palbociclib capsules) 10,723,730 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 agreement. Zydus will not infringe the patent-in-suit, except as provided in the settlement agreement.
Genentech, Inc. v. InvaGen Pharms., Inc., 19-0219 (D. Del.) Esbriet® (pirfenidone capsules and tablets) 7,566,729
7,635,707
7,767,700
7,816,383
7,910,610
8,013,002
8,084,475
8,318,780
8,383,150
8,420,674
8,592,462
8,609,701
8,648,098
8,754,109
8,778,947
Complaint is dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.) Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets) Odefsey® (emtricitabine / rilpivirine / tenofovir alafenamide tablets) 7,390,791
7,803,788
8,754,065
9,296,769
All affirmative defenses, claims, and counterclaims are dismissed without prejudice. Except as provided by the parties’ agreement, Shilpa is enjoined from infringing the patents-in-suit until permitted by the agreement. Parties waive all right to appeal. Each party to bear its own costs and attorneys’ fees.
Azurity Pharms., Inc. v. CoreRx, Inc., 21-1522 (D. Del.) Epaned® (enalapril oral solution) 11,040,023
11,141,405
Plaintiff dismisses without prejudice all claims against CoreRx, Inc. CoreRx has neither served an answer nor a motion for summary judgment in the matter.
Amgen Inc. v. Bionpharma, Inc., 20-0105 (D. Del.) Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
The parties waive all right to appeal. Bionpharma admits that the patents-in-suit are valid and enforceable. Any protective order entered in this case shall remain in full effect. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Merck Sharp & Dohme Corp. v. Laurus Labs Ltd., 21-1173 (D. Del.) Januvia® (sitagliptin phosphate) 7,326,708 Unless authorized under the parties’ 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.
Merck Sharp & Dohme Corp. v. Alkem Labs. Ltd., 21-0824 (D. Del.) Januvia® (sitagliptin phosphate) 7,326,708 Unless authorized under the parties’ settlement agreement, Alkem 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.
TherapeuticsMD, Inc. v. Amneal Pharms., Inc., 20-5256, 20-14933 (D.N.J.) Bijuva® (estradiol / progesterone capsules) 8,633,178
8,846,648
8,846,649
8,987,237
8,993,548
8,993,549
9,006,222
9,114,145
9,114,146
9,301,920
10,052,386
10,206,932
10,806,740
11,033,626
11,103,513
11,103,516
11,110,099
Until expiration of the patents-in-suit, Amneal is enjoined from infringing the patents-in-suit, unless specifically authorized by TherapeuticsMD. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Nothing prohibits Amneal from maintaining Paragraph IV certifications with respect to the patents-in-suit. Nothing restricts FDA from approving the Amneal ANDA product.
Bial – Portela & CA. S.A. v. Dr. Reddy’s Labs., Ltd., 18-0341, 20-0784, 21-0188 (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
10,695,354
10,702,536
10,912,781
DRL admits that the Aptiom Orange Book patents are patentable, valid, and enforceable. DRL admits that its ANDA product would infringe the patents-in-suit. Except as authorized in the settlement agreement, prior to the expiration of the patents-in-suit, DRL is enjoined from infringing the patents-in-suit. The action, including counterclaims and affirmative defenses, is dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Novartis Pharms. Corp. v. Nanjing Noratech Pharm. Co., Ltd., 19-1979 (D. Del.) Entresto® (sacubitril / valsartan tablets) 8,877,938
9,388,134
The court no longer has subject matter jurisdiction in conncection with the Nanjing ANDA. Noratech agrees to notify Novartis of any changes or amendments to Noratech’s ANDA that materially alter the composition of Noratech’s ANDA products. Nothing shall prevent Novartis from seeking relief pursuant to 21 U.S.C. § 355 et seq., 35 U.S.C. § 271 et seq., or any other applicable statute with respect to the ’938 and ’134 patents and with respect to any later paragraph IV certifications, except with respect to any amendments or changes to the ANDA that do not materially alter the composition of Noratech’s ANDA products. The actions are dismissed without prejudice.
Horizon Medicines LLC v. Torrent Pharma Inc., 21-13396 (D.N.J.) Duexis® (ibuprofen / famotidine tablets) 8,067,033
8,067,451
8,309,127
8,318,202
8,449,910
8,501,228
Plaintiffs dismiss with prejudice this action against Defendants.
Celgene Corp. v. Lupin Ltd., 20-8570 (D.N.J.) Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
7,968,569
7,977,357
8,193,219
8,530,498
8,648,095
9,101,621
9,101,622
Until expiration of the patents-in-suit, Lupin is enjoined from infringing the patents-in-suit, unless specifically authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands that relate to Lupin are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Lupin from maintaining any Paragraph IV Certification with respect to the patents-in-suit. Nothing restricts FDA from approving Lupin’s ANDA.
AstraZeneca AB v. Alembic Pharms. Ltd., 20-0202 (D. Del.) Tagrisso® (osimertinib mesylate tablets) 10,183,020 Except as specifically authorized pursuant to the settlement agreement, MSN is enjoined from infringing the ’020 patent. All claims, affirmative defenses, and demands between AstraZeneca and MSN are dismissed with prejudice and without costs, disbursementsc or attorneys’ fees.
Bristol-Myers Squibb Co. v. Alembic Global Holding SA, 21-17926 (D.N.J.) 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.
Vifor (Int’l) AG v. Mylan Labs. Ltd., 20-1647 (D.N.J.) Injectafer® (ferric carboxymaltose for injection) 10,519,252 All claims, counterclaims, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties each waive any right to appeal.
Vifor (Int’l) AG v. Sandoz Inc., 20-1649 (D.N.J.) Injectafer® (ferric carboxymaltose for injection) 10,519,252 All claims, counterclaims, and affirmative defenses are dismissed without prejudice and, except as specifically provided by agreement, without costs, disbursements, or attorneys’ fees to any party.
Amgen Inc. v. Zydus Pharms. (USA) Inc., 20-0075 (D. Del.) Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Zydus admits that the patents-in-suit are valid and enforceable. Zydus admits that the patents-in-suit would be infringed by its ANDA product.
Until expiration of the patents-in-suit, Zydus is enjoined from infringing the patents-in-suit, except as specifically authorized by Amgen in writing.
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Biomarin Pharm. Inc. v. Teva Pharms., Inc., 21-15392 (D.N.J.) Kuvan® (sapropterin dihydrochloride tablets) 7,566,462
7,566,714
7,612,073
7,727,987
8,003,126
8,067,416
RE43,797
8,318,745
9,433,624
All claims are dismissed without prejudice.

Oren D. Langer

Partner

Managing Partner, New York Office

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