AstraZeneca Plc said on Thursday that Canada's Cobalt Pharmaceuticals was seeking U.S. regulatory permission to sell a generic version of its anti-cholesterol pill Crestor.
Cobalt has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to market generic rosuvastatin calcium tablets, it said.
The drug maker said it believes it has found a legal loophole that would allow it to market a cheaper copy of the medicine before AstraZeneca's patents expire in January 2016, August 2020, and December 2021.
Confidence
Astra said it has full confidence in its intellectual property portfolio protecting Crestor and is evaluating Cobalt's allegations and certifications.
The company who is already fighting generic threats to its two biggest revenue generators – Nexium and Seroquel – said it has 45 days to start a patent infringement lawsuit against Cobalt.
Originally licensed from Japan's Shionogi & Co Ltd, Crestor had sales in the second quarter of $678 million, out of total group sales of $7.27 billion.
November 1 2007