ANDA Litigation Settlements

Reported settlements in federal district court cases

Second 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
Viiv Healthcare Co. v. Cipla Ltd., 19-2085 (D. Del.)	Dovato® (dolutegravir / lamivudine tablets)	9,242,986	Except as authorized pursuant to the settlement agreement, Cipla 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.
Janssen Products, L.P. v. MSN Pharms. Inc., 21-14622 (D.N.J.)	Yondelis® (trabectedin for injection)	8,895,557 7,420,051	MSN admits that the claims of the patents-in- suit are valid and enforceable with respect to MSN’s ANDA product. MSN admits that the claims of the patents-in- suit would be infringed by MSN’s ANDA product. MSN is enjoined from infringing the patents-in- suit until expiration, other than as authorized by plaintiffs. All affirmative defenses, claims, and counterclaims, which have been or could have been raised are dismissed with prejudice. The parties shall bear their own fees and costs. The parties waive all right to appeal or otherwise move for relief.
Pfizer Inc. v. Natco Pharma, Inc., 21-0078, 21-1179 (D. Del)	Ibrance® (palbociclib capsules)	10,723,730	Pfizer’s claims with respect to the ’730 patent and Natco’s ANDA products 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.
Pfizer Inc. v. Sun Pharms. Indus., Ltd., 20-1407, 21-185 (D. Del.)	Ibrance® (palbociclib capsules)	10,723,730	Pfizer’s claims with respect to the ’730 patent and Sun’s ANDA products 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.
Chiesi USA Inc. v. MSN Pharms. Inc., 19- 18564 (D.N.J.)	Kengreal® (cangrelor for injection)	8,680,052 9,427,448 9,439,921 9,925,265 10,039,780	Unless specifically authorized under the settlement agreement. MSN 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.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.)	Vemlidy® (tenofovir alafenamide tablets) Descovy® (emtricitabine / tenofovir alafenamide tablets)	7,390,791 8,754,065 9,296,769	All claims, counterclaims, and defenses between Gilead and Laurus relating to the patents-in- suit are voluntarily dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd., 21-1735 (D. Del.)	Letairis® (ambrisentan tablets)	8,377,933 9,474,752 9,549,926	Gilead and Aurobindo stipulate to the dismissal without prejudice of all claims, counterclaims, and affirmative defenses, with each party to bear its own costs, expenses, and attorneys’ fees.
Arbor Pharms., LLC v. Lupin Ltd., 20-0922 (D. Del.)	Edarbi® (azilsartan medoxomil tablets)	7,157,584 7,572,920 9,066,936	The parties stipulate that the action, including all claims, counterclaims, and defenses, are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
Eagle Pharms., Inc. v. Hospira, Inc., 21-1619 (D. Del.)	Bendeka® (bendamustine HCl for injection)	11,103,483	By virtue of a settlement agreement between the parties, Plaintiffs and Defendant stipulate that Plaintiffs’ action against Hospira with respect to Hospira’s NDA product, including all claims and defenses asserted by Plaintiffs against Hospira and all claims and defenses asserted by Hospira against Plaintiffs with, are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
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, Alembic is enjoined from infringing the ’020 patent. All claims, affirmative defenses, and demands between AstraZeneca and Alembic are dismissed with prejudice and without costs, disbursements or attorneys’ fees.
Leo Pharma A/S v. Glenmark Pharms. Ltd., 20-1359 (D. Del.)	Enstilar® (calcipotriene / betamethasone dipropionate foam)	10,617,698 10,660,908 10,682,364 10,688,108 10,716,799	Unless specifically authorized pursuant to the settlement agreement, Glenmark 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.
RxOmeg Therapeutics, LLC v. Granules Pharms., Inc., 20-0898 (D. Del.)	Gloperba® (colchicine oral solution)	9,907,751 10,226,423	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, with each party to bear its own costs, disbursements, and attorney fees.
Pfizer Inc. v. Teva Pharms. USA, Inc., 22- 0192 (D. Del.)	Xeljanz® XR (tofacitinib extended- release tablets)	10,639,309	Plaintiffs dismiss all claims asserted in this action without prejudice. At the time of filing the notice of dismissal, Teva has not served an Answer or Motion for Summary Judgment.
Otsuka Pharm. Co., Ltd. v. Teva Pharms. USA, Inc., 22-0221 (D. Del)	Rexulti® (brexpiprazole tablets)	RE48,059 8,349,840 8,618,109 9,839,637 10,307,419	All claims, counterclaims, affirmative defenses, and demands between Otsuka and Teva are dismissed without predjudice and without costs, disbursements or attorney fees to any party. Until their expiration, Teva is enjoined from infringing the patents-in- suit. Nothing prevents FDA from granting final approval to Teva’s ANDA at any time. Each party will bear its own attorneys' fees and costs.
Sanofi-Aventis U.S. LLC v. Aurobindo Pharma Ltd., 22-0141 (D. Del.)	Jevtana® Kit (cabazitaxel injection)	10,583,110 10,716,777 8,927,592	Each of Plaintiffs’ claims against Defendants with respect to the patents-in- suit is dismissed with prejudice. Nothing prohibits FDA from granting final approval to Aurobindo’s ANDA. The parties are each to bear their own costs.
Teva Branded Pharm. Products R&D, Inc. v. Lupin Ltd., 21-13247 (D.N.J.)	Austedo® (deutetrabenazine tablets)	9,233,959 9,296,739 9,550,780 9,814,708	All all claims, counterclaims, and affirmative defenses asserted by Teva and Lupin are dismissed without predjudice and without costs, disbursements, or attorneys' fees to any party.
Otsuka Pharm. Co., Ltd. v. Hetero Labs Ltd., 19-1954, 20-1531 (D. Del.)	Rexulti® (brexpiprazole tablets)	8,349,840 8,618,109 9,839,637 10,307,419 RE48,059	The patents-in-suit would be infringed by Hetero's ANDA product. Hetero, except as expressly licensed by Otsuka, is enjoined until expiration of the patents in-suit from infringing the patents-in-suit. Each party will bear its own attorneys’ fees and costs. 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. Alembic Pharms. Ltd., 19-2007, 20-1365 (D. Del.)	Rexulti® (brexpiprazole tablets)	8,349,840 8,618,109 9,839,637 10,307,419 RE48,059	The patents-in-suit would be infringed by Alembic’s ANDA product. Alembic, except as expressly licensed by Otsuka, is enjoined until expiration of the patents-in suit. Each party will bear its own attorney's fees and costs.
Fresenius Kabi USA, LLC v. Baxter Healthcare Corp., 21- 1040 (D. Del.)	Naropin® (ropivacaine HCl injection)	7,828,787 7,857,802 8,118,802 8,162,915	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Pfizer Inc. v. Aurobindo Pharma Ltd., 21-0022 (D. Del.)	Xeljanz® (tofacitinib tablets)	6,965,027 RE41,783	All claims and counterclaims are dismissed without prejudice. Any protective orders entered by the Court shall remain in full force and effect notwithstanding the dismissal. The parties waive any right of appeal. Each party shall bear its own costs and fees.
Par Pharm., Inc. v. Eagle Pharms. Inc., 20- 18319 (D.N.J.)	Vasostrict® (vasopressin for injection)	10,844,435	Par provides notice of dismissal.
Pfizer Inc. v. Mylan Pharms., Inc., 21-0839 (D. Del.)	Ibrance® (palbociclib capsules)	10,723,730	Pfizer and Mylan’s claims and counterclaims 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.
Encore Dermatology Inc. v. Glenmark Pharms. Ltd., 20-2509 (D.N.J.)	Impoyz® (clobetasol propionate cream)	9,956,231	Plaintiffs’ action against Glenmark, including all claims and defenses asserted by either party, is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Almirall, LLC v. Aleor Dermaceuticals Ltd., 21-17449 (D.N.J.)	Aczone® (dapsone gel)	9,517,219	Plaintiff’s claims are dismissed with prejudice. Defendant’s counterclaims are dismissed without prejudice. The parties shall bear their own costs, fees, and expenses, including attorneys’ fees.
Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 19-2317 (D. Del.)	Vraylar® (cariprazine capsules)	7,737,142 7,943,621 8,765,765 8,569,496	The filing of Zydus’s ANDA was a technical act of infringement of each of the patents-in-suit. All other claims and defenses asserted by the parties are dismissed without prejudice. Zydus is enjoined from infringing the patents-in- suit until their expiration, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the patents-in- suit are found invalid or unenforceable by a court decision from which no appeal has been or can be taken, other than a petition for a writ of certiorari to the U.S. Supreme Court. The parties waive any right to appeal. This dismissal is without prejudice to any claim, defense, or counterclaim in a future action between Zydus and Plaintiffs regarding the patents-in- suit, and a product other than the Zydus ANDA product.
Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 19-2317 (D. Del.)	Vraylar® (cariprazine capsules)	7737142 7943621	The filing of Sun’s ANDA was a technical act of infringement of each of the patents-in-suit. All other claims and defenses asserted by the parties are dismissed without prejudice. Sun is enjoined from infringing the patents-in-suit until their expiration, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the patents-in-suit are found invalid or unenforceable by a court decision from which no appeal has been or can be taken, other than a petition for a writ of certiorari to the U.S. Supreme Court. The parties waive any right to appeal. This dismissal is without prejudice to any claim, defense, or counterclaim in a future action between Sun and Plaintiffs regarding the patents-in-suit, and a product other than the Sun ANDA product.
Bial – Portela & Ca. ,S.A. v. Apotex Inc., 18-0382, 20-0785, 21-0187 (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 10,912,781	All claims, counterclaims, and defenses are dismissed without prejudice. Each party will bear its own costs and attorneys’ fees.
Pfizer Inc. v. Slayback Pharma LLC, 22-0191 (D. Del,)	Xeljanz® (tofacitinib oral solution)	RE41,783	Plaintiffs dismiss all claims without prejudice.
Journal Medical Corp. v. Padagis Israel Pharms Ltd., 21-1152 (D. Del.)	Amzeeq® (minocycline topical foam)	8,865,139 8,945,516 8,992,896 9,675,700 10,086,080 10,137,200 10,213,512 10,265,404 10,517,882 10,821,187 10,398,641 10,849,847	All claims and counterclaims are dismissed without prejudice. Any stay(s) with respect to approval of Padagis' ANDA is terminated. The parties shall bear their own costs, disburesments, and attorney's fees.
Celgene Corp. v. Oncogen Pharma (Malaysia) Sdn. Bhd., 22-2952 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,465,800 7,855,217 7,968,569 8,530,498 8,648,095 9,101,621 9,101,622	Until expiration of the patents-in-suit, Oncogen is enjoined from infringing the patents-in-suit with respect to the ANDA product, unless specifically 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 Oncogen from maintaining any Paragraph IV Certification with respect to the patents-in-suit. Nothing restricts FDA from approving Oncogen’s ANDA product.
Almirall, LLC v. Amneal Pharms. LLC, 19-0658 (D. Del.)	Aczone® (dapsone gel)	9,517,219	Plaintiff’s claims are dismissed with prejudice. Defendant’s counterclaims are dismissed without prejudice. The parties shall bear their own costs, fees, and expenses, including attorneys’ fees.
Gilead Sciences, Inc. v. Apotex, Inc., 20-0189 (D. Del.)	Descovy® (emtricitabine / tenofovir alafenamide tablets)	7,390,791 8,754,065 9,296,769	All affirmative defenses, claims, and counterclaims are are dismissed without prejudice. Natco is enjoined from infringing the patents-in- suit until permitted under the parties’ agreement. The parties waive all right to appeal. Each party shall bear its own costs and attorneys’ fees.
Almirall, LLC v. Encube Ethicals Pvt. Ltd., 21-18534 (D.N.J.)	Aczone® (dapsone gel)	9,517,219 9,161,926	Almirall’s claim for infringement of, and all of Encube’s counterclaims with respect to ’219 patent are dismissed with prejudice, and that all of Encube’s counterclaims with respect to the ‘926 patent are dismissed without prejudice. The 30-month stay period is terminated. Each party shall bear it's own costs and attorneys' fees.
Journey Medical Corp. v. Padagis Israel Pharms. Ltd., 22-0587 (D. Del.)	Zilxi® (minocycline topical foam)	8,865,139 8,945,516 8,992,896 9,675,700 10,213,512 10,265,404 10,322,186 10,946,101	Journey Medical dismissed the action without prejudice.
United Therapeutics Corp. v. ANI Pharms., Inc., 21-0489 (D. Del.)	Orenitram® (treprostinil extended-release tablets)	7,417,070 7,544,713 8,252,839 8,349,892 8,410,169 8,747,897 9,050,311 9,278,901 9,393,203 9,422,223 9,593,066 9,604,901	All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, expenses, and attorneys’ fees.
Almirall, LLC v. Acrux DDS Pty. Ltd., 21-11948 (D.N.J.)	Aczone® (dapsone gel)	9,517,219	Plaintiff’s claims are dismissed with prejudice, and Acrux’s counterclaims are dismissed without prejudice. The 30-month stay is terminated. The parties shall bear their own costs, fees, and expenses, including attorneys’ fees.
Astellas US LLC v. Aurobindo Pharma Ltd., 21-1269 (D. Del.)	Lexiscan® (regadenoson intravenous solution)	8,106,183 RE47,301 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 or otherwise move for relief.
Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 19-2317 (D. Del.)	Vraylar® (cariprazine capsules)	7,737,142 7,943,621 8,765,765 8,569,496 RE47,350	The filing of Aurobindo’s ANDA was a technical act of infringement of each of the ’142 and ’621 patents. All other claims and defenses are dismissed without prejudice. Aurobindo is enjoined from infringing the ’142 and ’621 patents until their expiration, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the ’142 and ’621 patents are found invalid or unenforceable by a court decision from which no appeal has been or can be taken, other than a petition for a writ of certiorari to the U.S. Supreme Court. The parties waive any right to appeal. This dismissal is without prejudice to any claim, defense, or counterclaim in a future action between Aurobindo and Plaintiffs regarding the patents-in-suit, and a product other than the Aurobindo ANDA product.
Relypsa, Inc. v. Alkem Labs. Ltd., 20-0106 (D. Del.)	Veltassa® (patiromer sorbitex calcium powder for oral suspension)	8,147,873 8,337,824 9,492,476 9,925,212 11,123,363	Unless authorized by the settlement agreement, Alkem 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 Alkem from maintaining a Paragraph IV Certification with respect to the patents-in-suit or any other patent listed in the Orange Book for Veltassa for purposes of receiving final approval of its ANDA product. The 30-month stay is terminated. Nothing restricts FDA from approving Alkem’s ANDA product.
Teva Branded Pharm. Products R&D, Inc. v. Aurobindo Pharma Ltd., 21-13240 (D.N.J.)	Austedo® (deutetrabenazine tablets)	8,524,733 9,233,959 9,296,739 9,550,780 9,814,708 10,959,996	All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Bayer Intellectual Property GmbH v. Changzhou Pharm. Factory, 22-2089 (D.N.J.)	Xarelto® (rivaroxaban tablets)	9,539,218	All claim and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Astellas US LLC v. Hikma Pharms. USA, Inc., 21-1785 (D. Del.)	Lexiscan® (regadenoson intravenous solution)	8,106,183 RE47,301 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 or otherwise move for relief.
Otsuka Pharm. Co., Ltd. v. MSN Labs. Private Ltd., 22-0316 (D. Del.)	Samsca® (tolvaptan tablets)	8,501,730 10,905,694	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys' fees to any party.
Celgene Corp. v. MSN Labs. Private Ltd., 22- 1993 (D.N.J.)	Pomalyst® (pomalidomide capsules)	8,198,262 8,673,939 8,735,428 8,828,427 9,993,467 10,555,939	Until their expiration, MSN is enjoined from infringing the patents-in-suit on its own or in connection with a third party, unless specifically 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 MSN from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving MSN’s ANDA.
Mallinckrodt Pharms. Ireland Ltd. v. Zydus Pharms. (USA) Inc., 22-1592 (D.N.J.)	Ofirmev® (acetaminophen injection)	9.399,012 9,610,265 9,987,238 10,383,834	Mallinckrodt dismisses the matter without prejudice and without costs.
AstraZeneca AB v. Alkem Labs. Ltd., 22- 0354 (D. Del.)	Brilinta® (ticagrelor tablets)	RE46,276 10,300,065	Unless specifically authorized pursuant to the settlement agreement, Alkem 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.
BioMarin Pharm. Inc. v. Aurobindo Pharms. Ltd., 22-2345 (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.
Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 19-1964, 20-1286 (D. Del.)	Rexulti® (brexpiprazole tablets)	8,349,840 8,618,109 9,839,637 10,307,419 RE48,059	Alkem, except as expressly licensed by Otsuka, is enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. All claims and counterclaims are dismissed without prejudice. This dismissal 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 Alkem ANDA product. Each party will bear its own attorneys’ fees and costs.
Alcon Inc. v. Somerset Therapeutics, LLC, 22- 0543 (D. Del.)	Pataday® Once-Daily (olopatadine HCl ophthalmic solution)	8,791,154 9,533,053	Alcon dismissed the action with prejudice.
Indivior Inc. v. Dr. Reddy’s Labs., Inc., 17-7111, 18-1775, 18-5288 (D.N.J.)	Suboxone® (buprenorphine HCl / naloxone HCl sublingual film)	9,687,454 9,855,221 9,931,305	The parties stipulate that the claims and defenses, including the claims brought against Atlantic Specialty Insurance Company and Berkley Insurance Company as third-party defendants, are dismissed with prejudice, with each party to bear its own costs and fees.