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news.Actavis has reached a settlement agreement with AstraZeneca to resolve the outstanding patent litigation related to Actavis' generic version of rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of Crestor tablets, as well as Actavis' rosuvastatin zinc alternate salt product.
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As per the agreement, Actavis can introduce its generic version of Crestor 67 days prior to 8 July 2016, the expiration of pediatric exclusivity, at a fee of 39% of net sales to AstraZeneca.
The product launch may occur earlier than the suggested date, and the fee will be eliminated, under certain circumstances.
Egis Pharmaceuticals, Actavis’ partner, will also benefit from sales of the product.
Actavis’ product launch will be based on the company receiving final approval from the US Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic Crestor.
The agreement also permits Actavis to launch its rosuvastatin zinc alternate salt product from 2 May 2016 or earlier under certain circumstances, however, at this time, the company has made no decision regarding a potential launch.
Actavis’ rosuvastatin zinc alternate salt product previously received tentative approval from the FDA in August 2011 but would not be generically substitutable for Crestor and would have required Actavis to convert patients from rosuvastatin calcium.
Actavis president and CEO Paul Bisaro said, " This agreement ensures that consumers will benefit from an earlier launch of a rosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a non-generically substitutable product if Actavis had proceeded to launch the alternate product."