LILLY's TWICE-DAILY KEFTAB WILL BE AVAILABLE AT RETAIL BY MID-NOVEMBER

Executive Summary

LILLY's TWICE-DAILY KEFTAB WILL BE AVAILABLE AT RETAIL BY MID-NOVEMBER; Lilly announced FDA approval of the new cephalexin salt on Oct. 30. Available in 250 mg and 500 mg tablets, Keftab "can be prescribed in 500 mg doses, twice daily, to treat many bacterial infections," Lilly said in its Oct. 30 announcement. The "usual" adult dose of Lilly's Keflex (cephalexin) is 250 mg q.i.d., according to Keflex labeling. Lilly said Keftab would reach pharmacy shelves in the next "two to three weeks." Keftab pricing may cannibalize some sales from Keflex, which is already beleaguered by generic competition. Lilly said it is pricing Keftab to wholesalers at a 10% discount to Keflex. Lilly's patent for Keflex expired in April, and a number of generic cephalexin products have since reached the market. While Keftab is chemically related to Keflex, Lilly said that it is protected by a separate patent and that "a separate NDA was filed with the FDA for the compound." Keftab carries the same indications as Keflex with the exception of otitis media, Lilly said. Keftab also has no pediatric dosage form.