Supernus Pharmaceuticals, Inc. (SUPN) is facing yet another patent challenge for its epilepsy treatment, Oxtellar XR. This time round, the company has received a Paragraph IV notice from TWi Pharmaceuticals, Inc. which is looking to get its generic version of Supernus’ Oxtellar XR capsules approved in the U.S.
Oxtellar XR was launched in Feb 2013 for the treatment of epilepsy. The drug is protected by four patents listed in the FDA's Orange Book, all of which are slated to expire on Apr 13, 2027.
We remind investors that Actavis (ACT) is also looking to bring its generic version of Oxtellar XR to market. Supernus has filed patent infringement lawsuits against Actavis.
Supernus is currently reviewing the details of the Para IV notice from TWi Pharma. The company will most likely file a patent infringement lawsuit against TWi Pharma.
We note that Oxtellar XR is not the only product in Supernus’ portfolio to face a patent challenge. Supernus is occupied with a number of patent infringement lawsuits related to its other antiepileptic drug, Trokendi XR. Earlier this week, Supernus received a Para IV notice from Par Pharmaceutical, Inc., informing the company about the submission of an abbreviated new drug application for the approval of its generic version of Trokendi XR in the U.S. We expect Supernus to file a patent infringement lawsuit against Par.
Last month, the company had filed a lawsuit against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited, accusing both of infringing three patents covering Trokendi XR.
Trokendi XR and Oxtellar XR are the only marketed products at Supernus. Hence, the earlier-than-expected entry of generic versions of either of these drugs would adversely affect the company’s financials.
Meanwhile, Supernus is making an effort to advance its pipeline in the field of psychiatry. The company is preparing to advance SPN-810 to a phase III study for the treatment of impulsive aggression in patients suffering from attention deficit hyperactivity disorder (ADHD) under the FDA’s Special Protocol Assessment program. Patient dosing is expected to begin in the second half of 2015. SPN-810 has fast track designation for this indication. Additionally, the company intends to initiate the first pivotal study on SPN-812 in the second half of 2015 for the treatment of ADHD.
Supernus carries a Zacks Rank #2 (Buy). Other stocks looking good in the health care sector are Mylan, Inc. (MYL) and Akorn, Inc. (AKRX). Both carry a Zacks Rank #1 (Strong Buy).
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