AstraZeneca, Ranbaxy Ink Manufacturing Agreements

While settling patent litigation last month over the blockbuster acid reflux disease treatment Nexium, AstraZeneca and Ranbaxy entered into manufacturing agreements for several drugs.

Under the agreements, generic drugmaker Ranbaxy will formulate a portion of AstraZeneca’s U.S. supply of Nexium (esomeprazole magnesium) starting in May 2010. The agreement also allows Ranbaxy to manufacture the active pharmaceutical ingredient in Nexium starting in May 2009.

AstraZeneca also has designated Ranbaxy the U.S. distributor for authorized generic versions of Plendil (felodipine), a treatment for hypertension and angina, and Nexium’s predecessor drug Prilosec (omeprazole) 40 mg.

AstraZeneca originally filed its patent case November 2005. It claimed Ranbaxy had infringed on six patents — ’504, ’192, ’872, ’810, ’085 and ’789 — with the submission of an ANDA for generic Nexium 20 and 40 mg. AstraZeneca asked the court to declare the effective date for any approval of Ranbaxy’s ANDA to be later than May 3, 2020, the expiration of the last patent involved in the suit.

Under the settlement agreement, Ranbaxy conceded that all six patents are valid and enforceable and accepted that four of them would be infringed by the unlicensed sale of the generic. The company will be allowed to sell its generic Nexium when the ’192 and ’872 patents expire in May 2014, AstraZeneca said.