By Sherri Oslick --
Last week, GlaxoSmithKline and Cypress Pharmaceutical filed a joint stipulation of dismissal in their pending lawsuit over generic Zantac® syrup. The suit was filed on June 25, 2007 in the Southern District of New York (see our previous report).
Under the terms of the settlement, GSK has agreed not to assert its patent against Cypress’ new alcohol-free generic ranitidine oral syrup. Cypress expects to launch its generic product as soon as it receives final approval from the FDA. The patent-in-suit, U.S. Patent No. 5,068,249 ("Aqueous Ranitidine Compositions Stabilized with Ethanol," issued November 26, 1991) will expire on November 26, 2008. With Glaxo’s six months of pediatric exclusivity, Cypress will not receive final FDA approval until May 26, 2009.
For additional information regarding the settlement, please see:
- Cypress' press release
So does that amount to a conversion to a Para III, or is Cypress allowed to launch in advance (possibly enjoying exclusivity) if they get approval in advance of the patent expiration?
Posted by: Sean | February 04, 2008 at 04:33 PM