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August 21, 2014
07:38 EDTSUPN, ACTSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
Supernus Pharmaceuticals (SUPN) announced that on August 20, the company received a Paragraph IV Notice Letter from Actavis Laboratories FL advising Supernus of the filing by Actavis (ACT) 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.
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