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Supernus Announces Paragraph IV ANDA Filing for Oxtellar XR®
ROCKVILLE, Md., May 15, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and
About this update from Supernus Pharmaceuticals, Inc.
[{"type":"text","content":"ROCKVILLE, Md., May 15, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that on May 14, 2020 the Company received a Paragraph IV Notice Letter from Apotex Inc. and Apotex Corp advising Supernus of the submission by Apotex of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for oxcarbazepine extended-release tablets. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights (IPR) relating to Oxtellar XR.\n Supernus has previously defended the Oxtellar XR IPR against two earlier generic filers; namely, Actavis and Twi Pharmaceuticals and related entities. In both cases, Supernus prevailed before the district court as well as on appeal. Oxtellar XR is currently protected by nine patents listed in the FDA’s Approved Drugs Product List (Orange Book) that expire no earlier than 2027. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, SPN-820 (NV-5138) for treatment-resistant depression, and SPN-817 for the treatment of epilepsy. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited ...