AstraZeneca asks FDA to delay ANDAs for Crestor generics

AstraZeneca has filed a citizen petition to the US Food and Drug Administration (FDA) requesting it to wait until 2023 before approving generic versions of Crestor (rosuvastatin calcium), a cholesterol treatment.

The FDA is currently in a position where it could approve generics of Crestor next month, as the drug’s patent is due to expire on July 8.

There are already several generic companies which have filed Abbreviated New Drug Applications with the FDA, further pressuring AstraZeneca to request its petition to be expedited.

The drug company claims in its petition, released on June 6, that the FDA does not have the authority to approve generics for Crestor until the requested date of 2023 due to orphan drug exclusivity.

The FDA has the right to award seven years of marketing exclusivity to reward companies for developing drugs to treat rare conditions and diseases under the Orphan Drug Act of 1983.

AstraZenaca has predicted revenue losses in 2016 and warned its investors back in February about its potential loss of patent protection in the US.