Cipro generics approved

Executive Summary

Dr. Reddy's will take its generic ciprofloxacin to market with 180 days of exclusivity for a 100 mg tablet. Pediatric exclusivity for Bayer's Cipro expired June 9, prompting FDA approval of 13 ciprofloxacin ANDAs by various manufacturers. Dr. Reddy's generic is the only 100 mg dose approved; the other ANDAs cover 250 mg, 500 mg and 750 mg dosage strengths. Barr, which is one of the 13 ANDAs approved, has been marketing an "authorized" generic version of ciprofloxacin (250 mg, 500 mg, 750 mg) since June 2003 (1"The Pink Sheet" June 16, 2003, In Brief). Concerns about potential terrorist attacks involving anthrax prompted debate in 2001 over whether HHS should override Bayer's patent exclusivity to allow generics to come to market (2"The Pink Sheet" Oct. 22, 2001, p. 11)...