Supernus Pharmaceuticals, a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases, has received a Paragraph IV Notice Letter from Actavis Laboratories FL, Inc. (Actavis) advising Supernus of the filing by Actavis of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules.
Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Trokendi XR. The product is currently protected by three issued patents that are listed in the FDA's Orange Book and expire no earlier than 2027.