GURGAON, HARYANA, INDIA - Ranbaxy Laboratories Limited (Ranbaxy) announced in a press release 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 US was related to Astellas’ US 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 US 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 US 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 US 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, USA, 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 US healthcare system.
Ranbaxy Laboratories Limited 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.
