Press Release Settlement of Patent Litigation for Generic Revlimid in US
2021-06-22 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗
Sun Pharmaceutical Industries Limited. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office: SPARC, Tandalja, Vadodara – 390 020. India Reaching People. Touching Lives FOR IMMEDIATE RELEASE Sun Pharma Announces Settlement of Patent Litigation for Generic Revlimid® (lenalidomide) in US Mumbai, India, June 22, 2021 - Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) along with one of its wholly owned subsidiaries today announced that they have reached an agreement with Celge ne Corporation (Celgene), a wholly -owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid® (lenalidomide capsules) in the US. Pursuant to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to USFDA approval) certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential dat e that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026. As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid® patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals. ® - All brand names and trademarks are the property of respective owners Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the m eaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect develo pments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Sun Pharmaceutical Industries Limited. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office: SPARC, Tandalja, Vadodara – 390 020. India Reaching People. Touching Lives About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high -quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6-7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live Contacts: Investors: Media: Nimish Desai Gaurav Chugh Tel +91 22 4324 4324, Xtn 2778 Tel Tel Direct +91 22 4324 2778 Tel Direct Mobile +91-98203 30182 Mobile E mail [email protected] E mail +91 22 4324 4324, Xtn 5373 +91 22 4324 5373 +91 98104 71414 [email protected]
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