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PARSIPPANY, N.J. — Through an agreement with AstraZeneca, Actavis Inc. plans to introduce a generic version of the blockbuster cholesterol-lowering medication Crestor in 2016.
Actavis said Monday that the deal settles outstanding patent litigation related to its rosuvastatin calcium 5-, 10-, 20- and 40-mg tablets, the generic version of AstraZeneca’s Crestor tablets, as well as Actavis’ rosuvastatin zinc alternate salt product.
Under the agreement, Actavis can release its generic version of Crestor 67 days before July 8, 2016, the expiration of pediatric exclusivity, at a fee of 39% of net sales to AstraZeneca. The entry date may be earlier, and the fee eliminated, under certain circumstances, according to Actavis. Egis Pharmaceuticals, Actavis’ partner, will also benefit from sales of the product, the company added.
Actavis noted that the launch of its product depends on receiving final approval from the Food and Drug Administration for generic Crestor. The company said the FDA granted tentative approval on June 6, 2011.
As part of the deal, Actavis can launch its rosuvastatin zinc alternate salt product starting May 2, 2016, or earlier under certain circumstances. The company said, however, that at this time it has made no decision regarding a potential launch. Actavis added that its rosuvastatin zinc alternate salt product had 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.
"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," Actavis president and chief executive officer Paul Bisaro said in a statement.
