• Dr. Reddy’s li­censed to sell vol­ume-limited amounts of ge­ner­ic lena­lido­mide in the U.S. be­gin­ning on a con­fi­den­tial date after the March 2022 date pre­vi­ously granted to Natco
• Dr. Reddy’s also li­censed to sell ge­ner­ic lena­lido­mide in the U.S. without vol­ume lim­i­ta­tion be­gin­ning on Jan­u­ary 31, 2026
• The earliest li­censed entry of any ge­ner­ic lena­lido­mide in the U.S. con­tinues to be March 2022, based on set­tle­ments reached

New York, NY (Press Release) – Bristol Myers Squibb (NYSE:BMY) to­day an­nounced that its wholly owned sub­sid­i­ary, Celgene, and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) have set­tled their lit­i­ga­tion re­lated to pat­ents for REVLIMID® (lena­lido­mide).

As part of the set­tle­ment, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin DRL from mar­ket­ing ge­ner­ic lena­lido­mide be­fore the expiration of the pat­ents-in-suit, except as provided for in the set­tle­ment, as described below.

In set­tle­ment of all out­stand­ing claims in the lit­i­ga­tion, Celgene has agreed to provide DRL with a li­cense to Celgene’s pat­ents re­quired to manu­fac­ture and sell cer­tain vol­ume-limited amounts of ge­ner­ic lena­lido­mide in the U.S. be­gin­ning some time after the March 2022 vol­ume-limited li­cense date that Celgene pre­vi­ously provided to Natco. The spe­cif­ic vol­ume-limited li­cense date and per­cent­ages agreed-upon with DRL were not disclosed and are con­fi­den­tial. In addi­tion, Celgene has agreed to provide DRL with a li­cense to Celgene’s pat­ents re­quired to manu­fac­ture and sell an unlimited quan­ti­ty of ge­ner­ic lena­lido­mide in the U.S. be­gin­ning no earlier than Jan­u­ary 31, 2026.

About Bristol Myers Squibb

Bristol Myers Squibb is a global bio­pharma­ceu­tical com­pany whose mis­sion is to dis­cov­er, de­vel­op and de­liver inno­va­tive med­i­cines that help patients prevail over serious dis­eases. For more in­for­ma­tion about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Face­book and Insta­gram.

Celgene and Juno Thera­peutics are wholly owned sub­sid­i­aries of Bristol Myers Squibb com­pany. In cer­tain countries out­side the U.S., due to local laws, Celgene and Juno Thera­peutics are referred to as, Celgene, a Bristol Myers Squibb com­pany and Juno Thera­peutics, a Bristol Myers Squibb com­pany.

About REVLIMID®

In the U.S., REVLIMID® (lena­lido­mide) in com­bi­na­tion with dexa­meth­a­sone is in­di­cated for the treat­ment of patients with mul­ti­ple myeloma. REVLIMID® as a single agent is also in­di­cated as a main­te­nance ther­apy in patients with mul­ti­ple myeloma fol­low­ing au­tol­o­gous hema­to­poietic stem cell trans­plant. REVLIMID® is in­di­cated for patients with transfusion-depen­dent anemia due to low- or in­ter­me­di­ate-1-risk myelo­dys­plastic syn­dromes (MDS) asso­ci­ated with a deletion 5q cytogenetic ab­nor­mal­ity with or without addi­tional cytogenetic ab­nor­mal­i­ties. REVLIMID® is ap­prov­ed in the U.S. for the treat­ment of patients with mantle cell lym­phoma (MCL) whose dis­ease has re­lapsed or progressed after two prior ther­a­pies, one of which in­cluded bor­tez­o­mib. Limitations of Use: REVLIMID® is not in­di­cated and is not rec­om­mended for the treat­ment of chronic lym­pho­cytic leukemia (CLL) out­side of con­trolled clin­i­cal trials.

Cautionary and Forward-Looking State­ment

This press re­lease con­tains “forward-looking state­ments” within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing, among other things, the re­search, de­vel­op­ment and com­mer­cial­i­za­tion of pharma­ceu­tical prod­ucts. All state­ments that are not state­ments of historical facts are, or may be deemed to be, for­ward-looking state­ments. Such for­ward-looking state­ments are based on historical per­for­mance and cur­rent ex­pec­ta­tions and pro­jec­tions about our future fi­nan­cial re­­sults, goals, plans and objectives and in­volve in­her­ent risks, assump­tions and un­cer­tainties, in­clud­ing in­ternal or ex­ternal factors that could delay, divert or change any of them in the next sev­er­al years, that are dif­fi­cult to predict, may be beyond our con­trol and could cause our future fi­nan­cial re­­sults, goals, plans and objectives to differ ma­teri­ally from those ex­pressed in, or im­plied by, the state­ments. No for­ward-looking state­ment can be guar­an­teed. Forward-looking state­ments in this press re­lease should be eval­u­ated to­geth­er with the many risks and un­cer­tainties that affect Bristol Myers Squibb’s busi­ness and mar­ket, par­tic­u­larly those identified in the cautionary state­ment and risk factors dis­cus­sion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended De­cem­ber 31, 2019, as up­dated by our sub­se­quent Quar­ter­ly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Se­cu­ri­ties and Ex­change Com­mis­sion. The for­ward-looking state­ments in­cluded in this doc­u­ment are made only as of the date of this doc­u­ment and except as other­wise re­quired by appli­cable law, Bristol Myers Squibb un­der­takes no obli­ga­tion to pub­licly up­date or revise any for­ward-looking state­ment, whether as a re­­sult of new in­for­ma­tion, future events, changed cir­cum­stances or other­wise.

Source: Bristol Myers Squibb.