Supernus Pharmaceuticals, Inc. (
) announced that it has received a Paragraph IV notice from Actavis
) regarding the latter's abbreviated new drug application (ANDA) to
the FDA for the approval of its generic version of Supernus'
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 (
) and Allergan Inc. (
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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