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. 19You may also be interested in...
Warning Letter Roundup & Recap – 10 December 2019
No device-related warning letters were released by the US FDA the week of 10 December.
Immuno-Oncology Continues To Draw Pharma Companies To The Deal Table
Immuno-oncology development trends are revealed through an analysis of deals between cancer drug developers over the past five years.
What’s Next After 20 Years Of NICE?
Meindert Boysen, head of NICE’s Centre For Health Technology Evaluation, shares advice for companies aiming to get their medicine to patients. His golden rules: engage in early advice and be more realistic about pricing.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: