Mylan confirms first-to-file challenge to Lescol
This article was originally published in Scrip
Mylan Laboratorieshas initiated a challenge to a key US patent, No 5,354,772, claiming Novartis's antihypertensive Lescol (fluvastatin capsules). The ANDA containing a paragraph IV certification for generic fluvastatin has been accepted for filing by the FDA, and the certification states that the '772 patent is invalid, unenforceable, or will not be infringed. Mylan believes it is the first to have filed an application with the agency with a paragraph IV challenge. On October 10th, Novartis filed suit in the US District Court for the District of New Jersey, alleging infringement of the '772 patent and triggering the 30-month stay of approval. The '772 patent is one of two Orange Book-listed patents. Lescol had sales of about $60 million for the 12 months ending June 30th.
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