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MYLAN HAS SECOND ENTRY IN GENERIC PIROXICAM MARKET

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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