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Supernus Announces Paragraph IV ANDA Filings for Qelbree®

1. Supernus received Paragraph IV Notice Letters regarding viloxazine capsules. 2. The company plans to enforce its intellectual property rights on Qelbree. 3. Six patents for Qelbree are listed in the FDA’s Orange Book. 4. Three patents expire in September 2029, two in February 2033. 5. Supernus is focused on CNS disease treatments and ongoing product development.

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FAQ

Why Bearish?

The received ANDA filings may lead to generic competition for Qelbree, impacting revenue negatively, similar to previous instances where generics entered the market for other proprietary drugs, reducing market share and pricing power.

How important is it?

The announcement indicates potential threats to current and future revenues of Qelbree, directly impacting market perception of SUPN’s growth prospects.

Why Short Term?

The impact is likely to be felt soon as competitors could introduce generics rapidly, affecting short-term sales projection for Qelbree.

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PRTAPTCTNTRPACAD
May 28, 2025 16:05 ET  | Source: Supernus Pharmaceuticals, Inc. 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 strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591 or INVESTOR CONTACT:Peter VozzoICR Healthcare(443) 213-0505peter.vozzo@icrhealthcare.com

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