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Supernus Announces Paragraph IV ANDA Filings for Qelbree®
ROCKVILLE, Md., May 28, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and
About this update from Supernus Pharmaceuticals, Inc.
[{"type":"text","content":"ROCKVILLE, Md., May 28, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company received Paragraph IV Notice Letters from third parties notifying Supernus that the third parties submitted Abbreviated New Drug Applications (ANDAs) for viloxazine extended-release capsules, eq. 100, 150, and 200 mg base. Supernus is currently reviewing the details of these Notice Letters and intends to vigorously enforce its intellectual property rights relating to Qelbree. The U.S. Food and Drug Administration’s Orange Book currently lists six issued United States patents as covering Qelbree, three that expire in September 2029, two that expire in February 2033 and one that expires in April 2035. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. 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 to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate s...