Supernus Pharmaceuticals, Inc.’s (SUPN) shares gained 2.5% immediately after the company announced filing of a patent infringement lawsuit against Actavis plc (ACT) accusing the latter of infringement of three patents covering the former’s antiepileptic drug, Trokendi XR. Overall, shares are up 4.3% since the announcement.
Supernus filed the complaint against Actavis in the U.S. District Court for the District of New Jersey alleging the latter of patent infringement by submitting an abbreviated new drug application (ANDA) to the FDA for the approval of its generic version of Trokendi XR before the expiration of the patents covering the product.
Supernus confirmed that Trokendi XR is protected by patents until 2029. Moreover, the U.S. Patents Nos. 8,298,576, 8,298,580, and 8,663,683, which have been allegedly infringed by Actavis, cover once-a-day formulations of Johnson & Johnson’s (JNJ) Topamax and methods of treating seizures using those versions.
With Supernus filing the lawsuit within 45 days of receiving the paragraph IV certification notice letter from Actavis, a 30-month stay period has come into force. Consequently, the ANDA pertaining to Trokendi XR cannot be cleared by the U.S. regulatory body within that time frame (read more: Supernus' Trokendi XR Faces Generic Threat from Actavis).
The company said that it will actively take steps to protect Trokendi XR from generics.
Our Take
Supernus, which has only two marketed products – Trokendi XR and Oxtellar XR – depends highly on the former for growth. In the first six months of 2014, Trokendi XR generated revenues of $26.7 million, comprising almost 69% of total revenues. If generics versions of the drug enter the market, Supernus will have a tough time maintaining its revenues.
Supernus has a number of candidates in its pipeline. The most interesting candidates are SPN-810 (impulsive aggression comorbid associated with attention deficit hyperactivity disorder (ADHD)) and SPN-812 (ADHD). Supernus is looking to move SPN-810 into a phase III study for the treatment of impulsive aggression in patients suffering from ADHD next year. The company is currently designing the study protocol.
Supernus carries a Zacks Rank #2 (Buy). A better-ranked stock in the pharmaceutical sector is Mallinckrodt plc (MNK), carrying a Zacks Rank #1 (Strong Buy).
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