FDA approves Tris Pharma's first-time generic of Methylphenidate Hydrochloride Oral Solution

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved a first-time generic of Methylphenidate Hydrochloride Oral Solution equivalent to brand name Methylin® Oral Solution marketed by Shionogi Pharmaceuticals, Inc.

"Tris pursues selective generic opportunities, especially the difficult to formulate or complex formulations and this is a perfect example of Tris' capabilities," said Ketan Mehta, President and CEO of Tris Pharma. "Methylphenidate Hydrochloride, the active ingredient of many ADHD treatments is unstable in presence of water. Tris not only found a way to formulate this challenging product as an oral solution with requisite stability but did it rapidly by preempting Methylin's orange book patent listing and now launching the product 30 months sooner than it otherwise would have been."

This is the first-ever generic ANDA approved by the FDA for an immediate release methylphenidate hydrochloride oral solution. As part of the first approval, Tris is granted six-month regulatory exclusivity under Hatch-Waxman Act for both strengths of the product. Both strengths of the product, 5 mg/5 mL and 10 mg/5 mL are being launched simultaneously and distributed by Breckenridge Pharmaceutical, Inc.