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Bayer pulls Dr Reddys in court over generic version of cancer drug Nexavar
New Delhi: Bayer Healthcare LLC and Amgen subsidiary Onyx Pharmaceuticals Inc jointly sued India-based drugmaker Dr. Reddy's Laboratories Inc on Wednesday over its proposed generic version of their cancer drug Nexavar.
Dr. Reddy's filed an Abbreviated New Drug Application (ANDA) for U.S. Food and Drug Administration approval of the generic in May, according to the complaint. An ANDA asserts that the relevant drug patent is invalid or would not be infringed by the generic, and opens the applicant to infringement claims from the patent owner.
Bayer, Amgen, and their attorneys Bruce Genderson of Williams & Connolly and Jack Blumenfeld of Morris, Nichols, Arsht & Tunnell didn't immediately respond to a request for comment, and neither did Dr. Reddy's.
Nexavar is used to treat liver, kidney, and thyroid cancer. According to a Bayer report, it sold more than $750 million worth of Nexavar worldwide in fiscal year 2020.
Bayer and Onyx – which co-developed Nexavar – asked the court to block Dr. Reddy's from making and selling the generic, and to order the effective date of any FDA approval to come after their patent expires.
Read also: Dr Reddys expects volatile business growth in current fiscal
The case is Bayer Healthcare LLC v. Dr. Reddy's Laboratories Inc., U.S. District Court for the District of Delaware, No. 1:21-cv-00997.
For Bayer and Onyx: Bruce Genderson of Williams & Connolly, Jack Blumenfeld of Morris, Nichols, Arsht & Tunnell
Read also: Dr Reddys planning to double OTC products sale through Amazon, others in US
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751