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Executive Summary

CIBA-GEIGY's GENEVA SUBSIDIARY WILL MARKET GENERIC VOLTAREN under an out-licensing agreement with the parent company announced July 20. The agreement gives Geneva Pharmaceuticals a year's lead time to receive an ANDA approval and prepare for marketing: exclusivity for the $1 bil.-plus Voltaren (diclofenac) anti- arthritic expires on July 28, 1993. To date, FDA has not issued any tentative approvals for generic diclofenac. Geneva also will market a generic version of Ciba-Geigy's Lopressor (metoprolol tartrate) beta-blocker, the company said. Exclusivity for that product expires Dec. 21, 1993. Mylan received tentative approval for 50 and 100 mg metoprolol tablets on June 29 ("The Pink Sheet" July 6, T&G-3) and Schein has had an approved ANDA since 1989. Although Geneva already sells generic versions of several Ciba-Geigy products (Apresoline, Ludiomil, Tofranil), the Voltaren/Lopressor deal is the first instance of generic competition actually authorized by Ciba-Geigy. Geneva will manufacture both products and introduce them "at the appropriate times," the Broomfield, Colo.-based company said. The two products could significantly increase Geneva's sales, which are currently running at "over $100 mil.," according to the company. Geneva characterized the agreement as a shift in its relationship with Ciba-Geigy. The subsidiary's former "self- standing" status is "changing somewhat" in response to new patterns in the generic marketplace, the company said. The Ciba-Geigy/Geneva announcement is the latest example of growing involvement by innovator firms in generic manufacturing. The trend toward such arrangements has resulted in firms without generic subsidiaries, such as ICI Pharma and Marion Merrell Dow, forming subsidiaries specifically for the purpose of marketing a generic just prior to patent expiration for the branded drug.

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