By Sherri Oslick --
Ranbaxy Laboratories, Astellas Pharma US, Inc., and Boehringer Ingelheim Corporation have announced their agreement to enter into a joint stipulation of dismissal without prejudice in their lawsuit over FLOMAX® (tamsulosin hydrochloride, used to treat benign prostatic hyperplasia).
Under the terms of the settlement agreement, Ranbaxy will have the opportunity to launch its generic tamsulosin on March 2, 2010, eight weeks prior to the expiration of the expected pediatric exclusivity. Ranbaxy received tentative approval for its tamsulosin product on June 20, 2007.
The case is 3:05-cv-02563, filed May 13, 2005 in the District Court of New Jersey, and was filed by Astellas and Boehringer in response to Ranbaxy's paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of FLOMAX®. The patent in suit is U.S. Patent No. 4,703,063 ("Sulfamoyl Substituted Phenethylamine Derivatives and Process of Producing Them," issued October 27, 1987). On February 21, 2007, the district court entered final judgment in favor of plaintiffs, and Ranbaxy appealed. The parties briefed the case before the Federal Circuit, and oral arguments were held on August 8. On October 30, the parties filed a motion with the CAFC to remand the case to the lower court 
for further action to effectuate the settlement. On November 7 the parties moved the lower court to vacate its prior order and dismiss the case; the motion was granted the same day.
For additional information regarding this case, please see:
- Ranbaxy's press release
- Astellas Pharma's press release
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