Healthcare Industry News:  benign prostatic hyperplasia 

Biopharmaceuticals Generics Litigation

 News Release - November 8, 2007

Ranbaxy and Astellas/Boehringer Ingelheim Enter Into an Agreement to Resolve Tamsulosin U.S. Patent Litigation

Ranbaxy to Launch on an Exclusive Basis in 2010

GURGAON, India and PRINCETON, N.J., Nov. 8 (HSMN NewsFeed) -- Ranbaxy Laboratories Limited (Ranbaxy) announced today that the Company has reached an agreement with Astellas/Boehringer Ingelheim to stipulate a remand of the pending Federal Circuit appeal and subsequent vacatur of the District Court decision in regards to Flomax® (Tamsulosin capsules). The case between Ranbaxy and Astellas/Boehringer Ingelheim has been dismissed without prejudice. The lawsuit in the U.S. was related to Astellas' U.S. Patent No. 4,703,063 ('063 patent), covering Tamsulosin and its use in the treatment for functional symptoms of BPH (benign prostatic hyperplasia).

Under the agreement, Ranbaxy will enter the U.S. market on March 2, 2010, eight weeks prior to expiration of the pediatric exclusivity, which is likely to be granted to the innovator company. During this time period of pediatric exclusivity, Ranbaxy will be the only generic manufacturer to commercialize this product in the U.S. market. Ranbaxy believes that its Tamsulosin ANDA is the first substantially complete ANDA with a Paragraph IV certification to the '063 patent. The total annual sales of Flomax are estimated to be USD 1.2 Bn (source IMS).

On June 20, 2007, Ranbaxy received tentative approval from the U.S. FDA in regards to its Tamsulosin ANDA No. 77-451.

Ranbaxy will continue to pursue a strategy to effectively optimize its pipeline of First-to File (FTF) opportunities. The Company believes that it has a FTF status on approximately 17 Paragraph IV ANDA filings representing a market size of ~ USD 26 Bn valued at innovator prices.

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, headquartered in India, 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.


Source: Ranbaxy Laboratories

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