FDA’s latest generic exclusivity dilemma is Merck’s Cosopt

Executive Summary

FDA is soliciting comments on how to handle approval of generics for Merck's Cosopt (dorzolamide/timolol ophthalmic solution). The product's pediatric exclusivity expires Oct. 28, and both Hi Tech and Apotex have tentatively approved ANDAs. There are two complications, FDA notes in its 1request for comment: "at least one applicant became eligible for 180-day exclusivity" by virtue of a Paragraph IV certification on Oct. 11, 2005, but more than 30 months have elapsed since then, seeming to pull one part of the trigger that would force the applicant to forfeit exclusivity. Also, Merck has requested delisting of the product's other patents, which expire in 2011, a move that could pull the part of the forfeiture trigger regarding "failure to market relating to the withdrawal of patent information." Comments on the docket (FDA-2008-N-0483) are due Sept. 19