AstraZeneca has confirmed that its cholesterol drug Crestor faces a patent challenge from Canadian company Cobalt pharmaceuticals.
The Anglo-Swedish group reported that it had received a notice letter from Cobalt notifying them that it had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval to market generic resuvastatin calcium tablets.
With this ANDA Cobalt intends to market generic versions of Crestor tablets in 5, 10, 20 and 40mg strengths.
The Canadian pharmaceutical firm stated that its ANDA contained a Paragraph IV certification suggesting that US patents '341 and '460 are not infringed, invalid or unenforceable.
Cobalt are looking to market the generic tablets before the patents expire with the '314 patent due to end in January 2016 and the '460 in August 2020.
AstraZeneca has stated that it is evaluating Cobalt's allegations and certifications and had full confidence in its intellectual property protecting Crestor.
The company now has 45 days within which to commence a patent infringement lawsuit against Cobalt which would automatically stay, or bar, the FDA from approving the ANDA for 30 months.
Earlier this month, AstraZeneca received confirmation from the European Patent Office that its European process patent for Nexium is valid in its amended form following a challenge by the German manufacturer Ratiopharm.See all the latest jobs in Pharmaceutical