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Executive Summary

MYLAN HAS SECOND ENTRY IN GENERIC PIROXICAM MARKET following FDA's July 31 approval of the firm's generic version of Pfizer's nonsteroidal anti-inflammatory Feldene. Mylan said Aug. 3 that it expects to begin shipping its piroxicam 10 mg and 20 mg capsules "within a week," pending FDA inspection and verification of three production batches of the drug. Mylan's product will enter the market closely behind Schiapparelli-Searle's piroxicam, which was approved May 29 ("The Pink Sheet" June 8, T&G-4). Schiapparelli-Searle has only "recently" begun shiping its generic piroxicam to the trade, the company acknowledged. The launch delay was due to routine premarketing preparations, Searle said. Mylan and Schiapperelli-Searle are each pricing their respective piroxicam products at approximately a 10% discount to Feldene based on average wholesale price (AWP). Mylan's AWP for a 10 mg 100-capsule bottle is $118.77; 20 mg cap 100s carry an AWP of $203.92; and 20 mg 500s have an AWP of $999.21. Schiapperelli-Searle's AWP for 10 mg 100s is $119.36; 20 mg 100s are priced at $204.24 AWP; and 20 mg 500s carry an AWP of $999.91 for the same strengths and sizes, respectively. Pfizer's AWP for Feldene in the July RedBook is $133.64 for 10 mg 100s, $228.69 for 20 mg 100s, and $1,119.55 for 20 mg 500s. Royce Labs received a tentative approval from FDA for its generic piroxicam in September, pending the expiration of Pfizer's Feldene patent on April 6. However, on April 22, Miami, Fla.-based Royce announced that it had received a "not approvable" letter from FDA due to "discrepancies and inconsistencies" in batch records for the test lots of the product ("The Pink Sheet" April 27, T&G-1). For Mylan, the piroxicam approval represents the latest in a string of recently approved ANDAs with large market potential. In March, the company received a tentative approval for generic diltiazem (Marion Merrell Dow's Cardizem), which loses ANDA exclusivity in November. And in June, Mylan received tentative approval for generic metoprolol (Ciba-Geigy's Lopressor), pending the product's patent expiration in December 1993. Mylan also has received ANDA approvals this year for generic methotrexate and atenolol (ICI's Tenormin).

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