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Home Industry News AstraZeneca files against generic Crestor ANDAs

AstraZeneca files against generic Crestor ANDAs

12th December 2007

AstraZeneca has filed patent infringement actions against a series of Abbreviated New Drug Applications (ANDAs) for the pharmaceutical company’s Crestor product.

Nine generic drug manufacturers have now submitted ANDAs after Cobalt Pharmaceuticals first notified AstraZeneca that it had submitted its application to the US Food and Drug Administration (FDA) at the start of November.

Cobalt’s ANDA attempts to gain approval to market generic versions of Crestor tablets prior to the expiration of patents covering the product.

The application contained a Paragraph IV Certification suggesting that the US patents owned by AstraZeneca had not been infringed as a result of the ANDA.

Since Cobalt’s notice-letter, AstraZeneca has received Paragraph IV Certification notice-letters from eight further manufacturers all seeking approval to market generic versions of Crestor before the expiration of the AstraZeneca patent.

AstraZeneca has announced that it will file patent infringement actions against seven of these drug manufacturers: Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan and Sun.

Crestor is a prescription drug belonging to a group of medicines called statins that are used to treat high cholesterol.

Last month, AstraZeneca announced that it had received a six month paediatric exclusivity patent extension from the FDA for Armidex.

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