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Executive Summary

Cost savings from generic drugs can be tied directly to consumer initiative in requesting MDs and pharmacists to fill Rxs with generics, HHS Secty. Heckler maintained at the Sept. 4 press conference coinciding with the approval of generic diazepam by FDA. Noting that Valium is the ninth of the 10 top-selling Rx drugs, in terms of units sold in the U.S., to become multisource, Heckler said that generic alternatives to the nine products "can save consumers perhaps half a billion dollars to a billion dollars a year if the drug-using public follows a very, very simple action plan: Ask doctors to prescribe -- - ask pharmacists to dispense -- - generic drugs." Heckler noted that diazepam is the fourth drug among the 10 top selling products in the U.S. which has become multisource since the enactment of the Waxman/Hatch patent restoration-ANDA law last year. The others are propranolol (Ayerst's Inderal,) ibuprofen (Upjohn's Motrin and Boots' Rufen) and propoxyphene napsylate (Lilly's Darvocet-N). Valium is the fourth largest-selling Rx drug in the U.S., according to Roche. The firm said it sold $240 mil. in tablets and another $30 mil. in the injectable form during 1984. The other Rx drugs with unit sales in the top ten compete with generics that were approved with full or paper NDAs or with pre-1962 ANDAs: Dyazide, Lanoxin, Tylenol with Codeine, Amoxil, and Lasix. SmithKline's Tagamet is the only top-ten seller that is still on patent. Heckler maintained that "swift and very effective implementation" of the post-1962 ANDA/patent restoration law, which was enacted this month one year ago, has been a "key priority of mine and of the President's as well."

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