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FDA Accepts Tris Pharma's ANDA with Paragraph IV Certification for a Generic Equivalent to Delsym
Date:7/16/2009

rma's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Tris believes it is the first applicant to file an ANDA with a paragraph IV certification for a generic version of Delsym, and should its product be approved Tris Pharma will be entitled to 180 days of generic market exclusivity.

For the twelve-months ended March 31, 2009, based on the information available from various published sources, Delsym U.S. retail sales are approximately $100 million.

Delsym is a registered trademark of Reckitt Benckiser.

About Tris Pharma:

Tris Pharma is a privately owned, product-focused, specialty pharmaceutical company engaged in the research and development of innovative drug delivery technologies. Through its OralXR+ platform, Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms whereby patients do not have to swallow a pill. Tris' Nobuse platform provides abuse-deterrence for opioids and other abuse-prone drugs. The company has more than 30 Rx and OTC products in development with pharmaceutical partners. Tris' R&D and manufacturing facilities are located in Monmouth Junction, New Jersey. For more information visit http://www.trispharma.com.


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