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
Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialties Ltd., 19-2309, 22-1611, 23-1193 (D. Del.)	Lonsurf® (trifluridine / tipiracil tablets)	RE46,284 10,138,223 10,456,399 10,960,004 9,943,537	All claims, counterclaims, and defenses are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees.
Acerta Pharma B.V. v. Natco Pharma Ltd., 22-0155 (D. Del.)	Calquence® (acalabrutinib capsules)	9,290,504 9,758,524 10,239,883 9,796,721 10,167,291 10,272,083	Except pursuant to the settlement agreement, Natco is enjoined from infringing the patents-in-suit. All claims, affirmative defenses, and demands between AstraZeneca, MSD, and Natco are dismissed with prejudice and without costs, disbursements, or attorneys’ fees.
Taiho Pharm. Co., Ltd. v. Natco Pharma Ltd., 19-2368, 22-1480 (D. Del.)	Lonsurf® (tipiracil HCl / trifluridine tablets)	10,456,399 10,960,004 RE46,284 9,527,833 10,457,666	All claims, counterclaims, and defenses are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees.
Bausch Health Ireland Ltd. v. Taro Pharms. Inc., 22-4670, 23-2684 (D.N.J.)	Duobrii® (halobetasol propionate / tazarotene lotion)	8,809,307 10,478,502 10,251,895 10,426,787 11,648,256 11,679,115	Judgment of non-infringement is entered in favor of Defendants. All claims, counterclaims, or affirmative defenses are dismissed without prejudice. Parties waive any right to appeal. Each party shall bear its own costs, disbursements, and attorney fees. Defendants are entitled to maintain their Paragraph IV certification to the patents-in-suit. The 30-month stay with respect to the approval of Taro’s ANDA is terminated.
Eli Lilly & Co. v. Aurobindo Pharma Ltd., 22-1114 (D. Del.)	Olumiant® (baricitinib tablets)	8,158,616 8,420,629	All claims and defenses asserted by Lilly against Aurobindo and all claims and defenses asserted by Aurobindo against Lilly are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Azurity Pharms., Inc. v. Novitium Pharma, LLC, 23-0163 (D. Del.), transferred from 22-5860 (D.N.J.)	Epaned® (enalapril maleate oral solution)	11,040,023 11,141,405	All claims against Novitium Pharma LLC are dismissed and the Clerk shall mark this case closed.
Eisai R&D Management Co., Ltd. v. Sun Pharm. Indus. Ltd., 19-21857 (D.N.J.)	Lenvima® (lenvatinib mesylate capsules)	10,259,791 10,407,393	Sun agrees that the patents-in-suit are valid and enforceable with respect to the Sun ANDA product. Except as authorized by the settlement agreement, Sun is enjoined from infringing the patents-in-suit prior to their expiration. Nothing shall prevent Sun from challenging the validity, enforceabilty, or infringement of the patents-in-suit involving a product other than the Sun ANDA product. All claims, counterclaims, affirmative defenses, and demands are dismissed without costs, disbursements, or attorneys’ fees to any party.
Novo Nordisk Inc. v. Orbicular Pharm. Technologies Pvt. Ltd., 22-0856 (D. Del.)/td>	Saxenda® (liraglutide recombinant solution injection)	8,114,833 8,920,383 9,775,953 9,265,893	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits Orbicular from filing and maintaining a Paragraph IV certification to the patents-in-suit in the Orbicular ANDA for the purposes of receiving or maintaining final approval of the Orbicular ANDA, or prevents FDA from granting final approval of the Orbicular ANDA. Each party will bear its own attorneys’ fees and costs.
Novo Nordisk Inc. v. Orbicular Pharm. Technologies Pvt. Ltd., 23-0179 (D. Del.)	Victoza® (liraglutide recombinant solution injection)	8,114,833 9,265,893	All claims, counterclaims, and affirmative defenses concerning the patents-in-suit are dismissed without prejudice. Nothing prohibits Orbicular from filing and maintaining a Paragraph IV certification to the patents-in-suit in the Orbicular ANDA for the purposes of receiving or maintaining final approval of the Orbicular ANDA, or prevents FDA from granting final approval of the Orbicular ANDA. Each party will bear its own attorneys’ fees and costs.
Pfizer Inc. v. Dexcel Pharma Technologies Ltd., 23-1304 (D. Del.)	Xeljanz® XR (tofacitinib citrate extended-release tablets)	RE41,783	Plaintiffs dismiss all claims asserted in the action without prejudice.
Boehringer Ingelheim Pharms., Inc. v. Alvogen, Inc., 23-3911 (D.N.J.)	Spiriva® HandiHaler® (tiotropium bromide inhalation powder)	9,010,323	All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party. Nothing prohibits Alvogen from maintaining a Paragraph IV Certification to the asserted patent or prohibits FDA from granting final approval to Alvogen’s ANDA. Parties waive their right to appeal.
Actelion Pharms. Ltd. v. Torrent Pharms. Ltd., 24-3990 (D.N.J.)	Opsumit® (macitentan tablets)	7,094,781	Torrent admits that the claims of the ’781 patent are valid and enforceable, and that the claims of the ’781 patent would be infringed by the commercial manufacture, use, sale, offer for sale, or importation of the Torrent ANDA Product prior to expiration of the ’781 patent. Unless authorized by Actelion, Torrent, is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
AstraZeneca Pharms. LP v. Sandoz Inc., 24-0641 (D.N.J.)	Lynparza® (olaparib tablets)	7,449,464	All claims and counterclaims asserted by Plaintiffs and Sandoz in this action related to the infringement and/or invalidity of the ’464 patent shall be and are hereby dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses incurred in connection with the claims dismissed by this stipulation.
Novo Nordisk Inc. v. Lupin Ltd., 23-4031 (D.N.J.)	Saxenda® (liraglutide recombinant solution injection)	8,114,833 8,684,969 8,920,383 9,108,002 9,132,239 9,457,154 9,616,180 9,687,611 9,775,953 9,861,757 10,220,155 10,357,616 10,376,652 11,097,063 11,311,679 RE46,36	All claims, counterclaims, and affirmative defenses between Novo Nordisk and Lupin are dismissed without prejudice. Nothing prohibits Lupin from maintaining a Paragraph IV certification to the patents-in-suit in the Lupin ANDA for the purposes of receiving or maintaining final approval of the Lupin ANDA, or prevents FDA from granting final approval of the Lupin ANDA. Each party will bear its own attorneys’ fees and costs.
Celgene Corp. v. Teva Pharms., Inc., 23-1008 (D. Del.)	Onureg® (azacitidine tablets)	8,846,628 11,571,436	Until their expiration, Teva is enjoined from infringing the patents-in-suit, unless otherwise permitted by the Parties. All claims, counterclaims, affirmative defenses, motions, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Teva from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit or any other patent. Nothing restricts FDA from approving Teva’s ANDA product. Nothing prohibits Teva from engaging in any activity permitted under 35 U.S.C. § 271(e)(1).
Supernus Pharms., Inc. v. Ascent Pharms. Inc., 23-4015 (D.N.J.)	Trokendi XR® (topiramate extended-release capsules)	8,298,576 8,298,580 8,663,683 8,877,248 8,889,19 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790	All claims, counterclaims, and defenses asserted by Supernus and Ascent are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Takeda Pharms. U.S.A., Inc. v. Scilex Pharms. Inc., 23-1264 (D. Del.)	Gloperba® (colchicine oral solution)	7,619,004 7,820,681 7,964,648 8,093,297 8,097,655 8,440,722	The claims of the patents-in-suit are valid and enforceable solely with respect to the Scilex NDA product. All affirmative defenses, claims, and counterclaims raised by Scilex are dismissed with prejudice. Scilex admits that in the absence of a license, it would infringed at least one claim of each of the patents-in-suit. Judgment of infringement by Scilex is entered in favor of Takeda. Except as authorized by Takeda, Scilex is enjoined until their expiration from infringing the patents-in-suit and making any challenge to their validity and enforceability as it relates to the Scilex NDA product. Any protective order shall remain in full force. The parties waive all right to appeal. Each party is to bear its own incurred costs, expenses, and attorneys’ fees. Nothing prohibit Scilex from maintaining Paragraph IV certifications in Scilex’s NDA or FDA from finally approving it.
Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., 22-4248, 23-3393 (D.N.J.)	Arazlo® (tazarotene lotion)	11,311,482 11,679,116	All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Defendants are entitled to maintain their Paragraph IV certification to the patents-in-suit. There is no 30-month stay in effect with respect to the approval of the Padagis ANDA.
AbbVie Inc. v. Alembic Pharms. Ltd., 24-0405 (D. Del.)	Lastacaft® (alcaftadine ophthalmic solution)	8,664,215 10,617,695	The filing of Alembic’s ANDA was a technical act of infringement of the patents-in-suit. All other claims are dismissed without prejudice. Alembic is enjoined from infringing the patents-in-suit until their expiration, absent authorization by AbbVie. The parties waive any right to appeal. The stipulation and order resolving the case is without prejudice to any claim, defense, or counterclaim in any possible future action between Alembic and any of the Plaintiffs regarding the patents-in-suit and a product other than Alembic’s ANDA product.
Bayer Pharma AG v. Aurobindo Pharma Ltd., 23-1372 (D. Del.)	Xarelto® (rivaroxaban tablets)	10,828,310	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Azurity Pharms., Inc. v. Teva Pharms., Inc., 23-1080 (D. Del.)	Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets)	9,066,936 9,169,238 9,387,249	All claims, counterclaims, and defenses between the parties are dismissed in their entirety without prejudice. The parties shall bear their own attorney fees and costs.
Alkermes Pharma Ireland Ltd. v. Slayback Pharma LLC, 23-3794 (D.N.J.)	Anjeso® (meloxicam injection)	10,463,673 10,471,067 10,709,713 10,881,663 11,458,145	All claims, counterclaims, and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Aerie Pharms., Inc. v. Gland Pharma Ltd., 22-1359 (D.N.J.)	Rhopressa® (netarsudil dimesylate ophthalmic solution)	9,415,043 9,931,336 11,185,538 10,588,901	All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Aerie Pharms., Inc. v. Orbicular Pharm. Technologies, 22-1364 (D.N.J.)	Rocklatan® (netarsudil / latanoprost ophthalmic solution)	9,415,043 9,931,336 11,185,538 10,588,901 9,993,470 11,197,853	All claims, counterclaims, and defenses asserted by the parties are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Aragon Pharms., Inc. v. Eugia Pharma Specialities Ltd. (A.K.A. Eugia Pharma Specialties Ltd.), 22-3186 (D.N.J.)	Erleada® (apalutamide tablets)	8,445,507 8,802,689 9,388,159 9,481,663 9,987,261	Plaintiffs and Aurobindo agree that Count I of Plaintiffs’ Second Amended Complaint for alleged infringement of the ’507 patent is dismissed without prejudice. The parties having now resolved all claims and defenses asserted in Aragon’s Second Amended Complaint, this action is dismissed in its entirety without prejudice. Each party shall bear its own costs and attorneys’ fees.
Eli Lilly & Co. v. MSN Labs. Private Ltd., 23-1277 (D. Del.)	Olumiant® (baricitinib tablets)	8,158,616	All claims and defenses asserted are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Acerta Pharma BV v. Alembic Pharms. Ltd., 22-0154, 23-0548 (D. Del.)	Calquence® (acalabrutinib capsules)	9,796,721 10,167,291 10,272,083	Except as specifically authorized, Alembic is enjoined from infringing the patents-in-suit. All claims, affirmative defenses, and demands between AstraZeneca, Merck Sharp & Dohme, and Alembic are dismissed with prejudice and without costs, disbursements, or attorneys’ fees.
Bayer Healthcare LLC v. Aurobindo Pharma Ltd., 24-0399 (D. Del.)	Children’s Astepro® Allergy OTC (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.
Celgene Corp. v. Natco Pharma Ltd., 23-1019 (D. Del.)	Onureg® (azacitidine tablets)	8,846,628 11,571,436	Until expiration of the patents-in-suit, Natco is enjoined from infringing the patents-in-suit, unless specifically authorized by Plaintiffs. All claims, counterclaims, affirmative defenses, motions, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Natco from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit or any other patent. Nothing restricts FDA from approving Natco’s ANDA product. Nothing prohibits Natco from engaging in any activity permitted under 35 U.S.C. § 271(e)(1).
ZS Pharma, Inc. v. Lupin Ltd., 22-1055 (D. Del.)	Lokelma® (sodium zirconium cyclosilicate oral suspension)	8,802,152 8,808,750 8,877,255 9,592,253 9,844,567 9,861,658 9,913,860 10,300,087 10,335,432 10,398,730 10,413,569 10,695,365	Unless specifically authorized, Lupin 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.
Otsuka Pharm. Co., Ltd. v. Mylan Labs. Ltd., 22-1367 (D. Del.)	Abilify Maintena® (aripiprazole extended-release injection)	11,400,087	All claim and counterclaims dismissed without prejudice and without costs and attorneys’ fees.
Novartis Pharms. Corp. v. Hetero USA Inc., 21-1330, 21-1760 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	11,096,918 11,058,667	As a result of the license granted by Novartis to Hetero as part of a settlement agreement, judgment is entered that there no longer exists a cause of action regarding the patents-in-suit and Hetero’s ANDA product. All claims, defenses, demands, and counterclaims are dismissed without prejudice. Hetero is enjoined from infringing the patents-in-suit, subject to the exceptions provided in the settlement agreement. The parties shall bear their own costs and attorney fees. The parties waive any right to appeal.
Ferring Pharms. Inc. v. Eugia Pharma Specialties Ltd., 22-0017 (D. Del.)	Firmagon® (degarelix for injection)	9,579,359 10,729,739 10,973,870 9,415,085 10,695,398 8,841,081 9,877,999 8,828,938	Eugia admits that the asserted claims of the patents-in-suit are valid and enforceable with respect to Eugia’s ANDA product. Eugia admits that, absent a valid license, the patents-in-suit would be infringed by its ANDA product. Unless authorized by the settlemetn agreement, Eugia is enjoined from infringing patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Novartis Pharms. Corp. v. Teva Pharms., Inc., 24-0428 (D. Del.)	Tasigna® (nilotinib HCl capsules)	8,163,904 8,293,756 8,389,537 8,415,363 8,501,760 9,061,029	All claims dismissed without prejudice.
Currax Pharms. LLC v. Ajanta Pharma Ltd., 23-3937 (D.N.J.)	Silenor® (doxepin HCl tablets)	7,915,307 8,513,299 9,107,898 9,486,437 9,572,814 9,861,607 10,238,620 10,653,660 10,653,662 11,110,074	Each of the parties’ claims, counterclaims, and defenses are dismissed without prejudice. The parties’ are to bear their own attorneys’ fees and costs.
Horizon Therapeutics U.S. Holding LLC v. Teva Pharms., Inc., 24-0432 (D. Del.)	Ravicti® (glycerol phenylbutyrate oral liquid)	8,642,012 9,254,278 9,326,966 9,561,197 9,962,359 9,999,608 10,045,958 10,045,959 10,183,002 10,183,003 10,183,004 10,183,005 10,183,006 10,668,040	All claims, counterclaims, and defenses are dismissed without prejudice.
Acerta Pharma B.V. v. Cipla Ltd., 24-0587 (D. Del.)	Calquence® (acalabrutinib tablets)	9,796,721 10,167,291 10,272,083	Except as authorized in the settlement agreement, Cipla is enjoined from infringing the patents-in-suit. Nothing prohibits Cipla from maintaining its existing Paragraph IV Certification to the patents-in-suit or prohibits FDA from granting final approval to Cipla’s ANDA product. All claims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
GW Research Ltd. v. Teva Pharms., Inc., 23-0018, 23-3914, 23-23141 (D.N.J.)	Epidiolex® (cannabidiol)	9,949,937 9,956,183 9,956,184 9,956,185 9,956,186 10,092,525 10,111,840 10,137,095 10,603,288 10,709,671 10,709,673 10,709,674 10,849,860 10,918,608 10,966,939 11,065,209 11,096,905 11,154,516 11,160,795 11,207,292 11,311,498 11,357,741 11,400,055 11,406,623 11,446,258	All claims, counterclaims, and affirmative defenses between Jazz and MSN are dismissed without prejudice, and without costs or attorneys’ fees to the parties. Jazz’s dismissal with respect to MSN shall not result in the dismissal of any claims, defenses and/or counterclaims with respect to any other defendant.
Axsome Malta Ltd. v. Unichem Labs. Ltd., 23-23255 (D.N.J.)	Sunosi® (solriamfetol tablets)	11,753,368 11,771,666 11,771,667 11,779,554 11,793,776	Aall claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. The dismissal of this matter with respect to Unichem shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant.
AbbVie Inc. v. Prinston Pharm. Inc., 24-0152 (D. Del.)	Orilissa® (elagolix sodium tablets)	7,419,983 10,537,572 10,682,351 11,542,239 11,690,845 11,690,854	The filing of Prinston’s ANDA was a technical act of infringement of each of the patents-in-suit. All other claims and defenses are dismissed without prejudice. Except as permitted by the parties settlement agreement, Prinston is enjoined from infringing the patents-in-suit during the life of the patents-in-suit. The parties waive any right to appeal. The dismissal is without prejudice to any claim, defense, or counterclaim in any possible future action between Prinston and any of the Plaintiffs regarding any of the patents-in-suit and a product other than Prinston’s ANDA product.
Actelion Pharms. US, Inc. v. MSN Labs. Private Ltd., 23-0731 (D. Del.)	Uptravi® (selexipag for injection)	8,791,122 9,284,280	Unless otherwise authorized by Plaintiffs, MSN is enjoined from infringing the patents-in-suit until their expiration. The parties waive all right to appeal. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Graviti Pharms. Private Ltd., 23-0068 (D. Del.)	Desyrel® (trazodone HCl tablets)	8,133,893	All claims, counterclaims, and affirmative defenses are dismissed with prejudice, and without costs, disbursements, or attorneys’ fees to any party. The parties waive appeal.
AstraZeneca AB v. Laurus Labs Ltd., 24-0459 (D. Del.)	Brilinta® (ticagrelor tablets)	10,300,065	Unless otherwise specifically authorized, Laurus 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.
Catalyst Pharms., Inc. v. MSN Labs. Private Ltd., 23-1945, 23-1961 (D.N.J.)	Fycompa® (perampanel tablets and capsules)	8,722,497	MSN admits that the claims of the ’497 patent are valid and enforceable, and that the claims would be infringed by the MSN ANDA products. Unless otherwise authorized, MSN is enjoined from infringing the ’497 patent. 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 maintining its Paragraph IV Certification to the ’497 patent.
Galderma Labs., L.P. v. Apotex Inc., 22-0724 (D. Del.)	Oracea® (doxycycline capsules)	7,749,532 8,206,740	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.