Friday 31 October, 2008

Dorzolamide Hydrochloride-Timolol Maleate (COSOPT and TRUSOPT): Prasco ready to launch generic form, Hi-Tech Pharma lose 180 days exclusivity

Prasco has begun shipping generic forms of Dorzolamide Hydrochloride-Timolol Maleate and Dorzolamide Hydrochloride Ophthalmic Solutions, comparable to Merck’s COSOPT® and TRUSOPT®.
Trusopt (Dorzolamide hydrochloride ophthalmic solution) is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Trusopt is used to lower increased intraocular pressure in open-angle glaucoma and ocular hypertension.
Cosopt (Dorzolamide hydrochloride & Timolol maleate) is a drug for lowering pressure in the eye to normal levels, and a treatment for glaucoma.
(Source: Prasco press release)
Also, Hitech and apotex has got final approval to market on October 28, 2008.
Cosopt 180 days exclusivity
The USFDA has denied Hitech pharma 180 days exclusivity for Cosopt (Dorzolamide hydrochloride & Timolol maleate) FDA law blog has reviewed the Hitech’s forfeiture of 180 days exclusivity due to failure to market in details Here
Earlier news of IPPharmadoc on this litigation here

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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