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Supernus announces Paragraph IV ANDA filings for Qelbree

Supernus (SUPN) announced that the company received Paragraph IV Notice Letters from third parties notifying Supernus that the third parties submitted abbreviated new drug applications 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 FDA’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.

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