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Executive Summary

SCHEIN GENERIC METOPROLOL LAUNCH MUST BE DELAYED until the expiration date of Ciba-Geigy's Lopressor patent is determined in court, FDA told the generic manufacturer in a Feb. 8 approval letter. The approval of Schein's metoprolol marks the first time the agency has approved an ANDA without making an initial determination on the patent expiration date of the innovator product. Schein Pharmaceutical received prospective approval for both 50 mg and 100 mg generic metoprolol tablets. Lopressor is Ciba-Geigy's top-selling product in the U.S., with sales in the $ 150-200 mil. range. According to FDA's "Orange Book," Ciba-Geigy has two patents for Lopressor, one expiring in April 1992 and another expiring in December 1993. Schein challenged the patent expiration date in December 1986 and notified Ciba-Geigy and AB Hassle. Hassle is a subsidiary of the Swedish firm Astra and owns the product and use patents for metoprolol. Ciba-Geigy and Hassle subsequently filed a patent infringement suit against Schein on Jan. 21, 1987 in the New York Federal Court. Last February Schein requested that pretrial procedures be postponed while the firm's counsel prepared another patent challenge -- against Merck's Flexeril patent -- for Schein's subsidiary Danbury. Briefs in that case have been filed in the Court of Appeals for the Federal Circuit. In its response, Ciba-Geigy and Hassle agreed to postpone the litigation with the understanding that Schein will not market metoprolol before there is a final decision in the case. The brief states that Schein "hereby consents to the entry of an appropriate order by this court . . . lengthening the 30-month period until such time as a final decision in this case is rendered, during which period ]FDA[ may not make effective any approval of defendant's pending ANDA for metoprolol." The metoprolol patent infringement case is slated to go to trial on May 15, Schein said.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989

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