Wednesday 10 September, 2008

Sodium Phosphate Tablets (Osmoprep): Innovator Salix sued Novel lab to block generic competition

Salix Pharma announced that it as filed a lawsuit in the United States District Court for the District of New Jersey against generic player Novel Labs for infringement of only Orange Book listed patent US5616346 for OSMOPREP(R) (Sodium phosphate monobasic monohydrate 0.398g, USP and Sodium Phosphate dibasic anhydrous, USP, 1.102g) Tablets. Novel Labs recently filed ANDA with Para IV certification against following orange book listed patent:
US5616346 (Expiry: May 18, 2013): which covers an orally administrable composition capable of dispersal in the stomach for inducing purgation of the colon in humans consisting essentially of an effective colonic purgative amount of at least one sodium phosphate salt wherein said composition is in a non-aqueous form selected from the group consisting of tablets and gelatin capsules and wherein one or more additives selected from the group consisting of buffering agents, dispersal agents and binding agents are optionally present.
Earlier, Innovator got approval for this product on March 16, 2006

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