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ANDA APPLICATIONS ARE LEVELING OFF; FIRST HALF OF FISCAL YEAR 1987 SHOWED THE SAME MONTHLY AVERAGE OF APPLICATION SUBMISSIONS AS PREVIOUS YEARS

Executive Summary

ANDA applications received by FDA in fiscal 1987 to date remain level with the rate of submissions in the immediate post Waxman/Hatch period, FDA Generic Drugs Division Review Support Branch Chief David Rosen recently indicated. "A monthly average of 89.1 ANDAs (both pre and post-62) were received so far this fiscal year [and] this is virtually the same number of applications as were received in previous years," Rosen said at the National Association of Pharmaceutical Manufacturers' (NAPM) midyear meeting June 25 held in Arlington, Virginia. A total of 713 new applications have been submitted to the agency so far in fiscal 1987, and "525 of these applications were for generic versions of drug products approved since 1962," Rosen said. "A total of 463 ANDAs were approved or conditionally approved [and] of these, 344 were for post-62 products." Rosen noted that the agency's generic drug division remains concerned about a developing backlog resulting from the flow of new ANDAs and supplemental applications. The generic division in December 1985 had 540 unapproved applications awaiting review and in December 1986 the division had 734 submissions pending, Rosen reported. "And just 25 days ago this backlog had grown to 844." As for supplements, in December 1985 there were 856 unapproved supplements awaiting review, and in December 1986, the number had grown to 1,111 and on May 31 the backlog was 1,244, Rosen stated. The backlog problem is a continuing concern of the Generics Division which has been publicly discussed by staffers previously. Generic Drugs Division Deputy Director Kent Johnson commented on the backlog problem earlier this year at NAPM's annual meeting in Puerto Rico in January ("The Pink Sheet" Jan. 26, p. 5). The division faces an even greater workload in the next two years because more than a dozen commercially important products will be coming off patent and eligible for ANDA review. Rosen told NAPM that "about 15 non-antibiotic type products with reasonable sales figures" will come off patent by the end of 1989. According to FDA's "Orange Book", three Merck products -- Blocadren, Timoptic and Clinoril -- will be open to generic competition within the next two years, and a fourth, Dolobid, comes off patent although it is protected by exclusivity. In addition Merck's process patent for its indomethacin product Indocin is also scheduled to expire soon. A number of patents for antihypertensives are slated to expire through 1989. All three calcium channel blockers that are currently on the market will then be off patent. Nifedipine (Miles' Adalat and Pfizer's Procardia), Marions' Cardizem (diltiazem) and verapamil (Searle's Calan and Knoll's Isoptin), which lost its marketing exclusivity on Sept. 24, 1986, will all be off patent. Cardizem is the only calcium channel blocker with exclusivity, which runs until Nov. 5, 1992. Other antihypertensives with expiring patents are: Stuart's Tenormin and Tenoretic, and Wyeth's Wytensin and Merck's Blocardren. Wytensin is protected from generic competition until Sept. 7, 1992, the date its exclusivity runs out. Two important bronchodilators, Boehringer Ingelheim's Atrovent and Glaxo's Ventolin have patents expiring in 1989. Schering has a comarketing agreement with Glaxo for the bronchodilator and markets the anti-asthma product as Proventil. Two cholesterol lowering agents, Upjohn's Colestid (cholestyramine) and Merrell Dow's Lorelco (probucol), also have patent protection ending within the two year period. Chart omitted.
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