Actavis agreed to launch its generic version of AstraZeneca’s medicine 67 days before Crestor is scheduled to lose pediatric exclusivity on July 8, 2016, according to a press release from Actavis.
Crestor earned more than $6 billion in sales for AstraZeneca in 2012, making its patent expiration a pricey concern. Actavis will supply AstraZeneca with 39% of the net sales of its generic drug until the patent expiration occurs as part of the agreement. While the deal is still pending FDA approval for Actavis’ generic product, the agency granted tentative approval to Actavis’ Abbreviated New Drug Application in June 2011.
Actavis CEO and president Paul Bisario commented on the deal in Actavis’ statement, saying, "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."
Other parties to the agreement with AstraZeneca are Watson Laboratories, EGIS Pharmaceuticals, and Shionogi. AstraZeneca said that under the agreement, the parties "concede that the CRESTOR substance patent is valid, enforceable and would be infringed by Watson’s rosuvastatin zinc product and its rosuvastatin calcium product." Actavis was formerly known as Watson Pharmaceuticals.