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Executive Summary

DESYREL (TRAZODONE) GENERIC APPROVALS DELAYED BY COURT under a temporary restraining order issued by the D.C. Court of Appeals Feb. 7. Responding to a same-day filing by Desyrel mfr. Mead Johnson, the court ordered FDA to "refrain from granting effective approval of any new drug application for a generic version of trazodone HCl pending further order by the court." Mead Johnson first requested a stay of generic trazodone approvals on Dec. 16 in conjunction with a same-day complaint against FDA and HHS seeking 10 years marketing exclusivity for Desyrel. The court denied the firm's first petition for a stay of approvals on Feb. 5. Mead Johnson's Feb. 7 filing, however, notes that both Chelsea and Danbury have pending ANDAs for trazodone. Mead Johnson's suit against FDA, filed by the D.C. law firm Kleinfeld, Kaplan and Becker, is in response to FDA's denials of the firm's petitions for Desyrel exclusivity in August and December. Mead Johnson maintains, in its court filings as well as in petitions to FDA, that the approval date for Desyrel was Feb. 1, 1982, the date final labeling was aproved, and that the product is therefore entitled to 10 years marketing exclusivity under the ANDA/patent restoration law. FDA asserts that Desyrel was approved on Dec. 24, 1981, the date the approval letter was issued, and that therefore the product is not entitled to exclusivity under the law. Norwich Eaton filed a similar complaint against HHS and FDA on Dec. 27 regarding its product Buprenex (buprenorphine HCl). The firm maintained that Buprenex is entitled to five years exclusivity based on the date final labeling was approved -- June 28, 1985. FDA said the date of approval was Dec. 29, 1981, when the agency issued an approval letter. The U.S. Patent & Trademark Office has determined Buprenex is not eligible for patent extension.

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