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
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.