Supernus Pharmaceuticals, Inc. (SUPN) announced that it has received a Paragraph IV notice from Zydus Pharmaceuticals (USA) Inc. which is looking to get its generic version of Supernus’ Trokendi XR capsules approved in the U.S.
Trokendi XR was launched in Aug 2013 for the treatment of epilepsy. The product has three patents listed in the FDA's Orange Book and is protected till 2027.
Our Take
Supernus, which is currently reviewing the details of the Para IV notice, will most likely file a patent infringement lawsuit against Zydus. We note that Supernus has already filed a patent infringement lawsuit against Actavis plc (ACT) which is also looking to gain FDA approval for its generic version of Trokendi XR.
We note that Supernus has only two marketed products, Trokendi XR and Oxtellar XR, and depends highly on Trokendi XR for growth. In the first half of 2014, Trokendi XR generated revenues of $26.7 million, comprising 68.8% of total revenues. The earlier-than-expected entry of generic versions of Trokendi XR would have a major impact on the company’s financials.
Meanwhile, Supernus is working towards the development of a number of candidates in the field of psychiatry. Currently, it is designing a phase III study protocol for SPN-810 (impulsive aggression comorbid with attention deficit hyperactivity disorder). Supernus intends to start patient dosing in this study in 2015.
Supernus carries a Zacks Rank #2 (Buy). Some well-placed stocks in the health care sector are Mylan, Inc. (MYL) and Mallinckrodt plc (MNK). While Mylan carries a Zacks Rank #1 (Strong Buy), Mallinckrodt holds a Zacks Rank #2 (Buy). Actavis carries a Zacks Rank #1.
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