Ranbaxy Laboratories Ltd informed that Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of the company has reached several agreements with AstraZenca. Two of these agreements concern Esomeprazole magnesium capsules. The third agreement pertains to Omeprazole 40mg tablets, and the fourth agreement pertains to Felodipine ER capsules. All of the agreements are specific to the US market.
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy's submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Esomeprazole magnesium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZenca in the patent litigation are valid and enforceable.
The settlement agreement will allow Ranbaxy to commence exclusive sales of a generic version of Nexium under a license from AstraZeneca on May 27, 2014. During the 180 period following the date, RPI will distribute the only generic Esomeprazole magnesium product in the US market.
Ranbaxy has filed a Consent Judgment with the US district court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.
Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneea announced in 1998, has also entered into the settlement agreement.
"We are pleased with the agreement which will provide certainty as to the launch of a generic formulation of Esomeprazole magnesium in the US market," according to Malvinder M Singh, CEO and managing director of Ranbaxy Laboratories Ltd.
AstraZeneca and Ranbaxy have separately entered into an agreement under which Ranbaxy will formulate a significant portion of AstraZeneca's US supply of Nexium from May 2010, including provisions for the manufacture of Esomeprazoic magnesium, the Active Pharmaceutical Ingredient (API) from May 2009. They have also entered into o separate agreements designating Ranbaxy as the US distributor for the authorized generic versions of Felodipine capsules and Omeprazole 40mg tablets. Ranbaxy will be compensated for its distribution services on standard commercial terms.
In regard to the distribution agreements, Singh added, "It is anticipated that these products will fulfil the needs of the US healthcare system in providing a generic formulation as an option, in addition to the brand. This will support the requirement of patients prescribed these medications, and supports our long-term efforts to increase our product portfolio of generic molecules to meet the needs of Americans."
Esomeprazole magnesium belongs to a class of medicines known as proton-pump inhibitors (PPIs). It works by binding to, and inhibiting, the acid pumps of a particular type of cell which is found in the stomach. In doing so, it lowers the level of acidity in the stomach and helps to heal erosions in the esophagus or ulcers in the duodenum. Felodipine is a calcium antagonist for the treatment of hypertension and angina. Omeprazole was the first PPI and is used for the short-term treatment of acid-related diseases.