Bayer pulls Dr Reddys in court over generic version of 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.

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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