Tris Pharma has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Tris Pharma and Reckitt Benckiser are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Tris ANDA filing.
Under the agreement Perrigo and Tris Pharma are expected to share profits, and Perrigo will pay Tris Pharma certain milestone payments.
Joseph Papa, chairman and CEO of Perrigo, said: “This is another example of Perrigo’s focus on introducing new products which will make quality healthcare more affordable to American consumers.”
Ketan Mehta, CEO of Tris Pharma, said: “Tris Pharma was able to file this first ever generic of a sustained release liquid product via Tris Pharma’s proprietary OralXR+ technology. We are pleased to work with Perrigo, the clear OTC store with this important product.”