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SEARLE AND MYLAN ARE FIRST GENERIC HALOPERIDOL TABLET MARKETERS

Executive Summary

SEARLE AND MYLAN ARE FIRST GENERIC HALOPERIDOL TABLET MARKETERS after receiving FDA approval on June 10. While a few companies have already received approval for and begun marketing haloperidol oral solution (including Bay Labs, Barre-National, and National Pharmaceutical Manufacturing), Searle and Mylan are the first competitors to CmNeil's Haldol tablets. Both Searle and Mylan received approval to market .5, 1, 2, and 5 mg tablets. Searle additionally received approval for 10 mg tablets, 20 mg tablets (which cannot be marketed until Sept. 24 under exclusivity provisions of the ANDA/Patent Restoration law), and oral concentrate (2 mg/ml) in 120 ml bottles. In a June 11 release announcing the approval, Mylan said that "current annual sales of Haldol are approximately $60 mil. and Mylan expects to ship $3 mil. worth of haloperidol within the next 45 days." Mylan said its product, which it began shipping to customers June 11, is priced 30-to-50% below Haldol. For Searle, the U.S. approval will complement its overseas haloperidol marketing effort. In a June 10 release on the approval, Searle maintains that it "is the number one marketer of haloperidol in 64 countries, with nine manufacturing sites worldwide." Noting that Searle "has manufactured and distributed this anti-psychotic drug outside the U.S. . . for more than a quarter century," Searle VP David Bethune said in the release that the company is "taking advantage of our international experience in producing and marketing haloperidol by now making it available to pharmacists and patients in this country." Searle's haloperidol tablets, with the exception of the 20 mg strength, and oral solution became available to the trade June 11. Searle is offering a special introductory haloperidol deal to whslrs. for one week. Prices for 100 tabs are: $12.60 for the .5 mg, $18.65 for 1 mg tab; $25.70 for 2 mg tabs; $42 for 5 mg tabs; and $54.09 for 10 mg tabs. The introductory price for the 2 mg/ml solution is $19.65 for a 120 ml bottle. Following the introductory offer, regular prices for the products, respectively, will be: $14; $20.72; $28.56; $46.67; $60.10; and $32.75. The one-week special deal price cuts approximately 10% off Searle's regular price for the tablet products and 40% off for the oral solution. Searle's regular prices to whslrs. are approximately 20% below average whsle. prices for McNeil's Haldol prices, according to Redbook figures.
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