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Single Exclusivity Period For Reference Drug Strengths Urged In Petition

This article was originally published in The Tan Sheet

Executive Summary

A single 180-day exclusivity period should exist for all strengths of a reference drug, the D.C. firm Kleinfeld, Kaplan and Becker recommends in a March 29 citizen petition to FDA. The exclusivity "reward" then would be bestowed upon the company that files the first substantially complete ANDA and has won litigation rendering the reference drug patent invalid or unenforceable under the action requested in the petition. The firm does not disclose upon whose behalf it submitted the comments, but more than likely it is a private label ranitidine marketer.

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