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

SOUTH BRUNSWICK, N.J., July 16 /PRNewswire/ -- Tris Pharma, Inc., a drug delivery and specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. 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(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.

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.


'/>"/>
SOURCE Tris Pharma
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Victory Pharma, Inc. Announces FDA Accepts MGX006 NDA for Review
2. Specialty Hospitals of America Accepts First Patients in New Long Term Critical Care Hospital Located in South East Washington
3. FDA Accepts Final Section of NDA Filing for LUCASSIN(R)
4. NYSE Amex Accepts China Shenghuos Compliance Plan for Continued Listing
5. NYSE Amex LLC Accepts Plan of Compliance of The Quantum Group, Inc.
6. United States Patent and Trademark Office Accepts CoolTouch's Re-examination Request for Cynosure '873 Patent
7. NYSE Amex Accepts Interleukin Genetics Plan to Meet Continued Listing Standards
8. Gamma Pharmaceuticals Accepts PO From Leading St. Louis Missouri Distributor. Order Valued up to $850,000 Retail Market Value
9. FDA Accepts Nuvos Resubmission For Pennsaid(R)
10. ROXRO Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
11. Andre Konski, M.D., M.B.A., Accepts Radiation Oncology Position at Wayne State University and the Karmanos Cancer Institute
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... February 08, 2016 , ... Stephanie Hebert Insurance ... beginning of a new charity campaign. As part of their ongoing community involvement ... In the belief that children deserve a voice, and in the spirit of ...
(Date:2/8/2016)... ... February 08, 2016 , ... If you are feeling that ... you are not alone. According to the Center for Disease Control and Prevention (CDC), ... 2 diabetes and certain types of cancer, some of the leading causes of preventable ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local insurance agency ... Venice, FL area, has initiated a fundraiser for a two year old little ... days after Christmas. To support this beautiful child who is facing life’s journey ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... frequently. While a significant number of women and men with eating disorders report ... itself, that best predicts the development of an eating disorder. , At ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Association of Home ... and the Home Health and Hospice ICD-10 Transition Workgroup are working closely with ... guidance and clarifications, to address concerns over the use of 'A' as the ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... 2016 Alzheimer Diagnostic Tests - Medical ... Medical Devices sector report , "Alzheimer Diagnostic Tests ... overview of Alzheimer Diagnostic Tests currently in pipeline ... the pipeline products with comparative analysis of the ... reviews major players involved in the pipeline product ...
(Date:2/8/2016)... LONDON , Feb.8, 2016 Aesthetic Devices ... GlobalData,s Medical Devices sector report, "Aesthetic Devices - Medical ... Devices currently in pipeline stage. This ... secondary and primary research by GlobalData,s team of industry ... be removed or altered based on the availability and ...
(Date:2/8/2016)... TOKYO and FAIRFIELD, N.J. ... (Otsuka) and Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that ... exclusive development and commercialization rights for OPA-15406 in the ... agreement also provides manufacturing rights.  OPA-15406 is a topical, ... for atopic dermatitis. --> ...
Breaking Medicine Technology: