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Hearing in October on Hi-Tech's generic exclusivity on Cosopt

This article was originally published in Scrip

Executive Summary

Hi-Tech Pharmacal has filed a complaint against the US FDArequesting a declaratory judgement relating to the company's ANDA for a generic version of Merck & Co's Cosopt (dorzolamide plus timolol ophthalmic solution). Hi-Tech seeks confirmation that it is entitled to 180 days of exclusivity as the first applicant to submit an ANDA containing a paragraph IV certification challenging the validity of the Orange Book-listed patents for Cosopt.

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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

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