Tris Pharma’s proposed dextromethorphan product is a LiquiXR(TM)( )formulation built on the Company’s proprietary OralXR+(TM) platform, which allows Tris to formulate sustained release oral formulations that do not require patients to swallow a “pill.” Other OralXR+ dosage forms include sustained release chewable tablets, orally disintegrating tablets, and film strips. Earlier this year, the FDA accepted for filing Tris Pharma’s New Drug Applications for the first ever 24-hour sustained release oral liquid products.
Tris Pharma’s ANDA seeking approval for a generic version of Delsym was filed earlier this year, and upon FDA’s acceptance of the submission Tris notified the NDA holder and patent holder of its paragraph IV certification. Reckitt Benckiser filed suit against Tris on June 26, 2009, in the U.S. District Court for the District of New Jersey seeking to prevent Tris from commercializing its product prior to expiration of the Orange Book patent listed for Delsym, U.S. Patent 5,980,882. Reckitt Benckiser’s suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Tris Pharma’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.
About Tris Pharma:
SOURCE Tris Pharma
CONTACT: Peter Ciano for Tris Pharma, +1-908-264-8719
Web site: http://www.trispharma.com/
