Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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
UsernamePublicRestriction

Register

PS050068

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel