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WARNER CHILCOTT GAINS FIRST GENERIC APPROVAL OF LEDERLE’s MINOCIN

Executive Summary

WARNER CHILCOTT GAINS FIRST GENERIC APPROVAL OF LEDERLE's MINOCIN (minocycline HCl) antibiotic. The generic was approved by FDA on July 31, after a review period of nearly three years. Warner Chilcott's minocycline will be available in bottles of 50 100 mg capsules. Neither a launch date nor a price has been established. The firm said it has an application pending for minocycline 50 mg capsules. Last year, the antibiotic was Lederle's top U.S. seller, with an estimated $125 mil. in sales. Warner Chilcott estimates the current market size to be $128 mil. Minocycline has antibacterial activity against a wide range of gram-negative and gram-positive organisms. Lederle's compound patent for minocycline expired in 1982. Warner Chilcott's bulk supplier of minocycline is Nippon Kayaku, based in Tokyo. Nippon received approval for the bulk ingredient in June, almost one month after the Italian company Biochimica Opos gained the first generic approval of bulk minocycline. In May, Lederle received approval for a pelletized version of minocycline ("The Pink Sheet" June 11, "In Brief"). Lederle says the pelletized form, which replaced Minocin capsules and tablets on the market, has smoother absorption and is less affected by food than the other dosage forms. The firm was granted a process patent for the new formulation, which became effective in 1988. To expand the product life of the 18-year old Minocin, Lederle is developing other formulations and indications for the antibiotic, including a once-daily dosage form. Lederle is studying Minocin as a treatment for Lyme Disease and for peritonitis. Studies for peritonitis involve a powder dosage form that is injected directly into periodontal pockets. Lederle expects to file an NDA for the product by early 1991.
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