Tris Pharma Announces Approval of First-Ever Generic to Delsym® Dextromethorphan Polistirex Extended-Release Suspension
MONMOUTH JUNCTION, N.J., May 31; /PRNewswire/ — Tris Pharma, a technology driven specialty pharmaceutical company announced today that the US Food and Drug Administration (FDA) has approved the first-ever generic to Delsym®, an extended-release oral liquid suspension containing dextromethorphan polistirex.
Delsym was approved in 1982 and there has never been any generic alternative approved until now. Tris has pioneered the delivery of drugs in taste-neutral, extended release dosage forms such as liquids, ODT/chewable tablets, and strips that are otherwise associated with immediate release. Tris’ versatile, patented technology avoids the use of toxic organic solvents by employing aqueous-based coating.
“This is the third extended-release liquid product approved by the FDA based on our patented technology, and speaks to Tris’ capabilities to develop and commercialize difficult products” said Ketan Mehta, President & CEO of Tris Pharma. “Leveraging our technology, Tris has built a robust and deep pipeline of unique products that will address many of today’s unmet needs.”
Perrigo is Tris’ exclusive partner in distributing this product as a store-brand alternative to Delsym, and has announced that it will be shipping the product for the coming cough/cold/flu season. Annual sales across the entire Delsym brand are estimated at more than $100 million.
Delsym is a registered trademark of Reckitt Benckiser, which is not associated with Tris Pharma or Tris’ generic product.
About Tris Pharma:
Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, USA. For more information, please visit http://www.trispharma.com