AstraZeneca PLC (NYSE:AZN) has filed a citizen petition requesting the FDA not approve any more generics of Crestor which is the drug company’s drug for cholesterol control. The petition cites a rare disease clause which would give the company exclusivity until 2023.
The petition outlines a number of legal reasons as to why the FDA cannot interfere with that exclusive period nor approve Crestor generics. If the FDA agrees with what the petition says, which is doubtful, then AstraZeneca and Watson Pharmaceuticals, an Allergan PLC (NYSE:AGN) subsidiary will have the rosuvastatin market all to themselves.
As a result AstraZeneca sales amounting to $5 billion would be protected. While other drug companies no longer have patents, AstraZeneca’s dropped while competing with a single generic drug version. However the numbers started going up when the market was hit with copycat drugs.
It was on May 2 this year that Watson released rosuvastatin under a patent settlement with AstraZeneca.
An FDA blog also cites the fact that AstraZeneca wants to roll out its new version yet there was no information on the official label concerning an orphan indication in colon cancer.
Many legal experts believe that the petition will not work. However, AstraZeneca thinks that it has found a way to a pediatric indication through orphan exclusivity by which other generics would be blocked. They believe that FDA cannot get out of this but actually the agency has been dealing with such cases in the past and found clever ways of getting around ‘same labeling rules’.
AstraZeneca seems to be pushing FDA to quickly act on its petition since the Crestor pediatric exclusivity reaches expiration on July 8 which could leave the door open for other generics to gain approval. The regulatory agency has given the okay to several companies including one which is said to be possibly vying for Watson despite the AstraZeneca patent.
The stakes seem to be quite high for AstraZeneca which has been working to increase sales for new drugs. This year they revealed a $1.5 billion restructuring plan that involved retrenching due to Crestor generics.