ALLEGAN, Mich. — Perrigo Co. has acquired the exclusive U.S. store-brand rights to sell and distribute the generic version of Reckitt Benckiser’s Delsym liquid cough suppressant from Tris Pharma.
Perrigo said Tris believes it has a first-to-file ANDA application for the generic (dextromehtorphan polistirex extended-release suspension) that can entitle it to 180 days of generic exclusivity upon approval.
According to Perrigo, Tris and Reckitt Benckiser are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Tris ANDA filing.
Under the acquisition deal, terms of which weren’t disclosed, Perrigo and Tris will share profits, and Perrigo will pay Tris certain milestone payments.
Delsym is indicated for 12-hour cough relief. It has estimated annual sales of $125 million, according to data from SymphonyIRI Group Inc.
"This is another example of Perrigo’s strategic focus on introducing new products which will make quality health care more affordable to American consumers," Perrigo chairman and chief executive officer Joseph Papa said in a statement. The company is the world’s largest manufacturer of over-the-counter pharmaceuticals for the store-brand market.
Tris Pharma CEO Ketan Mehta commented, "Tris was able to file this first-ever generic of a sustained-release liquid product via Tris’ proprietary OralXR+ technology. We are pleased to work with Perrigo, the clear OTC store-brand leader with this important product."
