Supernus Pharmaceuticals, Inc. (SUPN) announced that it has received a Paragraph IV notice from Actavis (ACT) regarding the latter’s abbreviated new drug application (ANDA) to the FDA for the approval of its generic version of Supernus’ Trokendi XR.
Trokendi XR was launched in the third quarter of 2013 for the treatment of epilepsy. The product has three patents listed in the FDA's Orange Book and is protected till 2027.
Supernus is currently reviewing the details of the notice, following which the company will take necessary action to protect Trokendi XR from generics.
We are concerned about Actavis seeking approval for the generic version of Trokendi XR. Supernus, which has only two marketed products, Trokendi XR and Oxtellar XR, depends highly on Trokendi XR 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 enter the market, Supernus will face a tough time maintaining its revenues.
Supernus has a number of candidates in its pipeline, most of which are in the early or mid-stage of development. However, the company is looking to move SPN-810 into a phase III study for the treatment of impulsive aggression in patients suffering from attention deficit hyperactivity disorder next year. The company is currently designing the study protocol.
Supernus carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the pharma sector are Endo International plc (ENDP) and Allergan Inc. (AGN). Both stocks carry a Zacks Rank #1 (Strong Buy).