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GUARDIAN DRUG HAS FIRST GENERIC VERSION OF MARION's GAVISCON

Executive Summary

GUARDIAN DRUG HAS FIRST GENERIC VERSION OF MARION's GAVISCON (aluminum hydroxide gel 80 mg and magnesium trisilicate 20 mg) following FDA approval of the generic firm's ANDA on Sept. 4. The Trenton, New Jersey-based generic drug manufacturer said it began filling orders for the OTC antacid product immediately after receiving approval. Guardian is supplying the chewable tablet product, under the tradename Foamcoat Chewable Tablets, to private label and generic drug marketers. The Gaviscon generic is Guardian's first product via the ANDA regulatory route. The privately-held firm markets approximately 15 OTC antacid products that can be sold under the OTC Antacid monograph. Guardian's products, which include generic and private label versions of Norcliff Thayer's Tums, Rorer's Maalox, Warner-Lambert's Rolaids, and Stuart's Mylanta, are sold exclusively to generic and private label firms. The two-and-a-half year old privately-held firm estimates that its 1987 sales will be about $1 mil. According to Marion's 1986 annual report (year ended June 30), sales of the Gaviscon line, which consist of the tablet product, a liquid, and Gaviscon-2 tablets (aluminum hydroxide 160 mg and magnesium trisilicate 40 mg), were roughly $24 mil. Sales of the OTC antacid products have held steady in the $23-$24 mil. range for the last several years. Gaviscon, an NDAed OTC, had a period of market exclusivity under the Waxman/Hatch law that expired Sept. 24, 1986.
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