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SYNTEX AFFILIATE HAMILTON PHARMACEUTICALS RECEIVES NAPROXEN ANDA

Executive Summary

SYNTEX AFFILIATE HAMILTON PHARMACEUTICALS RECEIVES NAPROXEN ANDA approval on Oct. 30. An FDA list of generic drug approvals (see list of approvals, T&G-2) during October states that Hamilton Pharmaceuticals Ltd. received ANDA approval for three strengths of naproxen tablets, equivalent to Syntex' flagship nonsteroidal anti-inflammatory drug Naprosyn. The Syntex naproxen patent does not expire until Dec. 21, 1993. Hamilton is a Bermuda-based company formed by Syntex in March 1988. The firm's manufacturing plant is in Puerto Rico. Syntex appears to be joining the growing list of brandname manufacturers creating affiliates to market "authorized" generic versions of their drugs prior to patent expiry. Among firms that have employed the strategy are ICI, whose IPR subsidiary markets a generic atenolol (equivalent to Tenormin), and Marion Merrell Dow, whose Blue Ridge Labs has begun shipping a generic diltiazem (Cardizem). Syntex is tight-lipped about Hamilton. "Hamilton Pharmaceuticals applied for and received approval to market a generic form of naproxen should we choose to participate in the generic market for naproxen," the firm said. As for the possibility of future generics from Hamilton, Syntex said: "We prefer not to talk about potential additional products at this time." Syntex is also pursuing two other strategies to protect its naproxen franchise. The firm is developing an OTC naproxen through a joint venture with Procter & Gamble. In addition, Syntex is seeking to supply bulk naproxen to generic firms developing their own products. At a recent securities analysts meeting, Syntex Chairman Paul Freiman maintained that the firm has "signed up virtually 100% of all generic companies in the U.S." to receive bulk naproxen ("The Pink Sheet" June 15, T&G-2). The first outside generic version of naproxen was approved Oct. 29. Danbury Pharmaceuticals received approval for two strengths of naproxen sodium, equivalent to Syntex' Anaprox. Danbury cannot market the product until expiry of Syntex' patent in December 1993. Asked whether Syntex is providing the bulk chemical to Danbury, Syntex answered opaquely that it "would hope to be Danbury's supplier." Other October ANDA approvals include the first generic version of J&J's OTC vaginal candidiasis treatment Monistat-7. Copley Pharmaceuticals received approval for the miconazole nitrate vaginal cream 2% on Oct. 30. On Nov. 4, Copley announced that Perrigo will have exclusive rights to market the product to the store-brand market. Perrigo said it will launch the product within "a few months." The firm noted that store brands are typically between 30% and 40% cheaper than the brand name product. Monistat had OTC sales of approximately $90 mil. in 1991. J&J says that the product has recently been widening its share lead. Perrigo also received the first ANDA for OTC generic loperamide tablets (equivalent to J&J's OTC Imodium AD) on Oct. 30. Generic loperamide capsules and solutions have been approved previously. Perrigo said it will begin shipping the tablets in January. Also on Oct. 30, FDA granted tentative approval to Abbott Labs for its version of the anesthetic isoflurane. The patent for the brandname product, Anaquest's Forane, expires Jan. 24, 1993. Anaquest recently launched a faster-acting anesthetic, Suprane (desflurane).
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