Drug firm Sandoz Inc has filed a petition with the USFDA asking the health regulator to withdraw 180-days marketing exclusivity granted to Ranbaxy Laboratories for a generic version of Nexium, a drug used to treat stomach ulcer.
In its citizen petition to Commissioner of Food and Drugs of the US Food and Drug Administration, Sandoz said Ranbaxy failed to obtain tentative approval of its abbreviated new drug application (ANDA) for generic Nexium within the stipulated 30 months period.
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"Based on the apparent date on which Ranbaxy's ANDA was submitted to FDA and the date on which it received tentative approval, Ranbaxy has forfeited its 180-day exclusivity under forfeiture condition," the petition said.
When contacted Ranbaxy officials declined to comment.
Citing data on USFDA website, Sandoz in its petition further said Ranbaxy received tentative approval of its ANDA for 20 mg and 40 mg of Nexium (esomeprazole magnesium) on February 5, 2008, although the actual date of submission ANDA application has not been publicly disclosed.
According to it, Ranbaxy's 30-month period to obtain a tentative approval ended on February 4, 2008.
"In other words, February 4, 2008 is the last day that is "within" 30 months of August 5, 2005. Ranbaxy's tentative approval date of February 5, 2008 is one day after expiration of the statutory 30-month period," it said.
Under this reasoning, Ranbaxy did not receive tentative approval "within" 30 months of ANDA submission as required, and has thus forfeited its 180-day exclusivity rights under forfeiture condition.
Ranbaxy had settled patent litigation with AstraZeneca in 2008 over Nexium and by virtue of being the first company to file ANDA challenging the patent it was given the approval to sell the generic version of the drug for 180-days when the patent expires in May 2014.