Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, has received final approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for omeprazole delayed-release capsules USP in the 10mg, 20mg and 40mg strengths.
Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 40mg strength. Watson's marketing exclusivity will begin upon commercial launch. The company plans to launch its Omeprazole delayed-release product during the third quarter of 2008. The specific launch date will depend upon the timing of product validation activities and manufacturing of launch quantities. Watson plans to launch only the 40 mg strength, a company press release stated.
Omeprazole is the generic equivalent to AstraZeneca's Prilosec delayed-release capsules USP and is indicated for the short-term treatment of active duodenal ulcer. For the 12-months ending March 2008, Prilosec delayed-release capsules and its generic equivalents had total US sales of approximately $240 million, according to IMS Health.