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SYNTEX' TRI-NORINYL PATENT EXPIRES IN 2000, FDA APPROVED Rx DRUG LIST NOTES

Executive Summary

Syntex' Tri-Norinyl patent will expire on June 28, 2000, according to information contained in the most recent (August 1984-November 1984) supplement to FDA's "Approved Rx Drug Products List." The supplement to the Rx listing is the first to contain the patent information mandated by the Hatch/Waxman patent legislation. The list now contains patent "numbers and expiration dates; and for drug products approved after 1982, the date of approval and application number as required" by the new law, a preface to the document explains. The agency added that it intends to publish additional information on exclusivity in the next supplement. The list includes, but does not distinguish between, both ingredient patents and use patents for a particular indication or method of using the product. As a result, severan patent expiration dates are listed (for sample page, see box below). The Syntex low-dose oral contraceptive is one of a handful of products on the initial list, which, according to FDA, have patent protection extending into the next century. Others in the group are Travenol labs' Branchamin (injectible amino acids), and Mylan's Maxzide (oral triamterene/hydrochlorothiazide), both with patents extending to 2001. FDA noted in the supplement that it "invites comments from all interested parties on whether it has excluded any patents that should have been included or included patents that should have been excluded." Chart omitted.

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