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Executive Summary

Pfizer, Roche and Upjohn each have at least four drugs which will receive 10 years of guaranteed marketing exclusivity under the Waxman/Hatch bill. The bill, which with House passage Sept. 6 is nearing the end of the legislative road (see related stories, beginning p. S-1), bars FDA from approving for 10 years generic versions of new chemical entities cleared between Jan. 1, 1982 and the measure's enactment. The 10-year period extends from the date of the new compound's approval. During that timeframe, Pfizer, for example, has received FDA approval of three major drugs, the third generation cephalosporin Cefobid, the once daily non-steroidal anti-inflammatory Feldene, and the oral hypoglycemic Glucotrol. The company also received approval for an OTC antifungal Trosyd, which is currently being test marketed. Overall, the transition provision will affect at least 56 drugs and 30 companies (for a list of new drug chemical entities approved from Jan. 1, 1982 to date, see box left). The bill's provisions could set up an interesting race in the period remaining until the bill is signed into law. Because the bill provides only a five-year guarantee of exclusivity -- patent status aside -- once it becomes law, the timing of approvals in the near future could become an important factor in some products' marketing lives. Several compounds, including Hoechst-Roussel's Merital are currently at the "approvable" stage. The transition provisions in the bill concerning non-new chemical entities would also provide some added protection from generic competition for several drugs coming off patent. The legislation provides two-year monopolies for non-new chemical entities, for which full NDAs were required, and which were approved in the transition period. The two-year monopoly begins with the bill's enactment. For example, while attention has focused on American Home's loss of its exclusive propranolol franchise, the firm is getting monopoly extensions for at least two products: sustained release propranolol, Inderal L.A., and OTC ibuprofen Advil. Chart omitted.

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