Generic company Actavis and its partner EGIS Pharmaceuticals have agreed not to appeal a decision by the US Court of Appeals for the Federal Circuit, and will pay AstraZeneca a 39% royalty on sales of the drug until July 8, 2016 when exclusivity expires.
Both Actavis and EGIS conceded that Crestor’s substance patent is valid and enforceable.
The settlement agreement permits Actavis to begin selling is generic version of Crestor and its rosuvastatin zinc product on May 2, 2016.
Crestor generated $6.25bn worth of sales in 2012, down from $6.6bn in 2011 after losing patent protection in certain regions.
All claims and counterclaims will be dismissed in a consent judgment entered by the United States District Court for the District of Delaware.
AstraZeneca said in a statement that it will file the settlement agreement with the United States Federal Trade Commission and United States Department of Justice.
Earlier this month, AstraZeneca lost a lawsuit in Australia seeking to defend its patents for Crestor, which were challenged by Canadian generic drug maker Apotex.
The Federal Court of Australia ruled that three patents protecting Crestor (rosuvastatin) were invalid, overturning a prior ruling delivered in May 2012 which upheld the validity of AZ’s intellectual property.
Image: AstraZeneca headquarters in Paddington, London. Photo: Courtesy of AstraZeneca.