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CORD METHYLDOPA LAUNCH SET FOR AUTUMN; ALDOMET PATENT EXPIRES IN SEPTEMBER

Executive Summary

Ciba-Geigy's Cord subsidiary may be the first to break into Merck's $200 mil. Aldomet franchise when methyldopa goes off patent in September. FDA approved a paper NDA for the generic version of Merck's antihypertensive June 29. Cord said it would not market its methyldopa 250 and 500 mg. tabs before Merck's use patent expires nor would it use Merck's trade dress colors. The generic firm has not yet priced the product. Cord will manufacture methyldopa in the U.S. The Cord methyldopa approval will set up an interesting marketing test for Ciba-Geigy to see whether its expertise in the cardiovascular area can carry over into generics. With Lopressor and Transderm-Nitro, as well as older reserpine and hydralazine compounds, cardiovasculars have been one of the Ciba-Geigy's major product areas. Aldomet is the second major Merck product facing generic competition this year. Several firms including Mylan and Zenith received approvals for generic versions of Indocin this spring. Aldomet was ranked fifth in McKesson's Pharmaceutical Data Services 1983 list of Top Twenty Rx Drugs, with $200 mil. sales at retail acquisition cost. In a July 10 press release, Merck said it has "recognized the likelihood of generic competition" when the use patent on Aldomet expires Sept. 26. "Our plans have been developed very thoroughly in response to this probable circumstance," the company stated. Noting that Aldomet has faced generic competition overseas for a number of years, Merck said the drug "has remained one of the leading products there for the treatment of hypertension. Similarly, in this country, we believe that Merck's long experience with the product will stand us in good stead with our professional customers in the years ahead." Merck has at least one line extension in clinical trials, a sustained release methyldopa ester. Aldomet labeling states that the usual daily dose is 500 mg to 2 gm in two to four doses with a maximum daily recommended Daily dosage of 3 gm. The methyldopa paper NDA approval underscores one of the key issues being debated in the patent restoration/post-1962 ANDA legislation, generic drug testing prior to patent expiration. The firms opposing the legislation in its current form have maintained that the Waxman/Hatch bill undercuts pioneer mfrs.' patent rights by allowing pre-expiration testing. In addition, in the Roche v. Bolar case, an appellate court ruled that such testing is infringement. Merck is one of the companies opposed to the bill. Aldomet, approved in 1962, has enjoyed 22 years of exclusive marketing. A ban on pre-patent expiration testing would have added several more years to that exclusivity period.

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