CIBA-GEIGY’s GENEVA SUBSIDIARY WILL MARKET GENERIC VOLTAREN
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth