Impax has 180 days of market exclusivity on its drug.
Impax Laboratories has been granted approval for its generic version of Colestid® tablets (Colestipol Hydrochloride Tablets) 1 gram. Pharmacia and Upjohn Company (Pfizer) markets these tablets as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia who haven’t responded adequately to diet.
Impax will be able to tap into brand Colestid sales, which reached $20 million for the 12 months ended August 31, 2006, in the U.S., according to Wolters Kluwer Health. The company has 180-day market exclusivity for this product as it received first-to-file status.