Tris Pharma, Inc, a drug delivery and specialty pharmaceutical company, confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market its 12-hour sustained release Dextromethorphan liquid suspension product prior to the expiration of a patent listed in the FDA's orange book for Reckitt Benckiser's Delsym product. Delsym, a leading OTC brand and the only FDA approved 12-hour liquid product for cough is different from most brands of cough medicine as the active ingredient is 'time released' in liquid syrup. If approved, Tris Pharma's dextromethorphan polistirex suspension will be the generic version of Reckitt Benckiser's Delsym.
Tris Pharma's proposed dextromethorphan product is a LiquiXR 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 US 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, US 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.
For the twelve-months ended March 31, 2009, based on the information available from various published sources, Delsym US retail sales are approximately $100 million. Delsym is a registered trademark of Reckitt Benckiser.
Tris Pharma is a privately owned, product-focused, specialty pharmaceutical company engaged in the research and development of innovative drug delivery technologies.