Pelletized version of the antibiotic, approved on May 31, will replace Minocin brand of minocycline HCl tablets and capsules currently on the market. The NDA for the pelletized product presumably entitles the company to exclusivity under Waxman/Hatch. Minocin, Lederle's largest selling product with sales "in excess of $100 mil.," is off-patent but currently not subject to generic competition. However, the Italian company Biochimica Opos obtained the first ANDA approval for minocycline (in nonsterile bulk) on May 31.
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