Perrigo recently announced it has acquired the exclusive US store brand rights to sell and distribute Dextromehtorphan Polistirex Extended Release Suspension Cough Suppressant, the generic version of Reckitt Benckiser's Delsym from Tris Pharma. Tris believes it has a first-to-file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Tris and Reckitt Benckiser are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Tris ANDA filing. Under the agreement, Perrigo and Tris will share profits, and Perrigo will pay Tris certain milestone payments. Delsym is indicated for 12-hour cough relief. It is estimated that it has annual sales of approximately $125 million, according to data provided by Information Resources, Inc.

“This is another example of Perrigo's strategic focus on introducing new products that will make quality healthcare more affordable to American consumers,” said Perrigo's Chairman and CEO, Joseph C. Papa.

 “Tris was able to file this first-ever generic of a sustained-release liquid product via Tris’ proprietary OralXR+ technology,” added Tris’ CEO Ketan Mehta. “We are pleased to work with Perrigo, the clear OTC store brand leader, with this important product."

Perrigo Company is a leading global healthcare supplier that develops, manufactures, and distributes OTC and generic prescription pharmaceuticals, nutritional products, infant formula, APIs, and consumer products. The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market.

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 so 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 20 Rx and OTC products in development with pharmaceutical partners. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, NJ.