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Executive Summary

SANDOZ AND WYETH ARE IN TEMAZEPAM ANDA BATTLE to market a soft elastic gelatin version of the anti-insomnia drug in the U.S. Wyeth initiated the ANDA race for a new soft elastic gelatin version of the product with an ANDA suitability petition to FDA in January ("The Pink Sheet" Jan. 28, T&G-7). Sandoz answered with an ANDA suitability petition of its own on March 27 for a soft elastic gelatin product which it intends to call Restoril LC (liquid capsule). In apparent preparation for the patent expiration on temazapam in January 1984, Sandoz submitted an NDA for Restoril LC in August 1983. However, the firm was told by FDA that an NDA for the soft elastic gelatin formulation would require "total characterization of the clinical performance. . . ." Sandoz argues in its ANDA suitability petition that the product qualifies for an ANDA under the new mutant rules for products containing the identical active ingredient with a different dosage form and/or strength. The existing Restoril product is marketed at 15 mg and 30 mg strengths in hardshell caps. The ANDAs are for 10 mg and 20 mg. soft elastic gelatin forms. The jockeying between Sandoz and Wyeth for a new ANDAed dosage of temazepam is one of the first head-to-head battles between major brandname firms to use the new generic approval route for a top-selling product. Restoril ranked 50th among retail products in total Rxs in 1984. The temazepam situation arises from the history of the product: Wyeth owns the patent and markets the product outside the U.S.; Sandoz has licensing rights to the original hardshell cap product in the U.S. Wyeth pointed out in its ANDA petitions for 10 mg and 20 mg dosage formulations that it has been marketing the soft elastic gelatin product since 1977 in overseas markets. "The composition of the product we propose to market," Wyeth said, "would be the same as that of the product (Normison) currently marketed by Wyeth Internatl. Ltd. That product is marketed in 39 countries and has been approved in 21 other countries, but not yet marketed. Sandoz attempts to piggyback off the Wyeth internatl. experience. Sandoz contends: "The composition of the product we propose to market . . . is the same as that of the product (Normison) currently marketed by Wyeth Internatl. Ltd. The inactive ingredient and capsule shell constitutents are all safe substances acceptable for use in pharmaceutical products in the U.S." The Sandoz petition also references studies on LC presumably prepared for the previous NDA filing -- two sleep lab studies "to evaluate the LC at 20 mg on the usual polysomnography parameters" and a 24-subject crossover bioavailability study.

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