GENEVA GETS APPROVAL FOR FIRST OUTSIDE GENERIC VERSION OF ICI's TENORMIN

GENEVA GETS APPROVAL FOR FIRST OUTSIDE GENERIC VERSION OF ICI's TENORMIN (atenolol) on Sept. 9, eight days prior to the expiration of ICI's patent covering use of the beta blocker in treating angina. Under a new policy, FDA used the term "tentative approval" to describe the Geneva atenolol clearance for 50 and 100 mg tabs. The launch of Geneva's atenolol atenolol also may be delayed for up to several weeks while FDA validates the firm's production process for the product. FDA's initial approval of atenolol comes 32 months after the ANDAs were filed on Dec. 21, 1988. FDA is using the term "tentatively approved" instead of "delayed effective date" for ANDA approvals granted before patents or Waxman/Hatch exclusivity have expired for innovator products. The policy change is a result of the difficulty FDA experienced in rescinding the ANDAs for Par and American Therapeutics' chlorzoxazone ANDAs in 1989 when it was discovered that the approvals were granted despite continued good manufacturing practices deficiencies. FDA later said that the ANDAs were approved "in error" because the GMP information had been available before the approval letters were issued. A "tentatively approved" application is viewed by FDA as "a hybrid," something between one that is "approvable" and one that is approved. FDA's letters to Geneva state: "This determination is contingent upon information available to the Agency at this time (i.e. information in your application and the status of current good manufacturing practices of the facilities used in the manufacturing and testing of the drug product) and is therefore subject to change on the basis of new information that may come to our attention." Geneva's generic atenolol will only carry labeling for angina because ICI still has patent protection for the use of Tenormin in treating hypertension. The patent covering treatment of hypertension, which ICI has described as "by far the biggest market" for Tenormin, does not expire until Jan. 20, 1993. The atenolol approval is the second big first generic approval for Geneva in the past two months. Tenormin is the market leading beta blocker in the U.S. with 1990 sales of approximately $ 500 mil. On July 31, Geneva received approval for the first legitimate, AB-rated generic version of SmithKline Beecham's Dyazide (triamterene 50 mg/hydrochlorothiazide 25 mg). Following process validation clearance from FDA, Geneva launched its generic version of Dyazide during the week of Sept. 2. ICI has taken several steps to help cushion the impact of generic competition for Tenormin. The company has launched its own generic atenolol at a 16.7% discount from the price to wholesalers for the brandname product ("The Pink Sheet" July 15, p. 3). ICI's generic is formulated, manufactured and packaged by IPR Pharmaceuticals, ICI's recently renamed subsidiary in Puerto Rico. The marketing of IPR's atenolol is being handled separately by HMS Sales & Marketing, a Jacksonville, Fla.-based marketing firm. The generic product, launched on July 15, has reached 100% distribution among all of the 83 pharmaceutical wholesalers in the U.S. To distinguish the brand product Tenormin from its generic competitors, ICI has created a patient education program called the Wellspring program. Available only for the brandname, the Wellspring program provides patients with a newsletter, samples, and discount coupons. In addition, ICI has increased the price of Tenormin by nearly 13% in the past ten months. The most recent price increases for Tenormin occurred at the end of May. According to Medi-Span, the AWP increased 5% to $ 77.71 for 50 mg tablets/100 per bottle, and rose to $ 116.56 for a 100-count bottle of 100 mg tabs. Last November, ICI upped the AWP price for Tenormin by 8%.