2008 Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that it has reached several agreements with AstraZeneca. 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 U.S. 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 AstraZeneca 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-day period following the date, RPI will distribute the only generic Esomeprazole magnesium product in the U.S. market.
Ranbaxy has filed a Consent Judgment with the U.S. 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 AstraZeneca 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 U.S. 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 U.S. supply of Nexium from May 2010, including provisions for the manufacture of Esomeprazole magnesium, the Active Pharmaceutical Ingredient (API) from May 2009.
AstraZeneca and Ranbaxy have also entered into two separate agreements designating Ranbaxy as the U.S. 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 regards to the Distribution Agreements, Mr. Singh added, “It is anticipated that these products will fulfill the needs of the U.S. 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.,
Esomeprazole magnesium is an effective treatment for patients with gastroesophageal reflux disease (GERD), but is particularly appropriate for those suffering from persistent, recurrent GERD which can cause disruptive, long-term symptoms. Esomeprazole magnesium has been demonstrated to provide enduring relief from the impact of GERD amongst patients.
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
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies,” resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.