Supernus Announces Paragraph IV ANDA Filings for Qelbree®
Supernus Pharmaceuticals (SUPN) has received Paragraph IV Notice Letters regarding Abbreviated New Drug Applications (ANDAs) from third parties for its drug Qelbree (viloxazine extended-release capsules) in 100, 150, and 200 mg base formulations. The company plans to vigorously defend its intellectual property rights for Qelbree, which is protected by six U.S. patents listed in the FDA's Orange Book. Three patents expire in September 2029, two in February 2033, and one in April 2035.
Supernus Pharmaceuticals (SUPN) ha ricevuto lettere di notifica Paragraph IV riguardanti le Domande di Nuovi Farmaci Abbreviate (ANDA) da parte di terzi per il suo farmaco Qelbree (capsule a rilascio prolungato di viloxazina) nelle formulazioni da 100, 150 e 200 mg base. L'azienda intende difendere con vigore i propri diritti di proprietà intellettuale su Qelbree, protetto da sei brevetti statunitensi elencati nel Orange Book della FDA. Tre brevetti scadono a settembre 2029, due a febbraio 2033 e uno ad aprile 2035.
Supernus Pharmaceuticals (SUPN) ha recibido cartas de notificación del Párrafo IV relacionadas con Solicitudes Abreviadas de Nuevos Medicamentos (ANDAs) de terceros para su medicamento Qelbree (cápsulas de liberación prolongada de viloxazina) en formulaciones de 100, 150 y 200 mg base. La compañía planea defender vigorosamente sus derechos de propiedad intelectual sobre Qelbree, que está protegido por seis patentes estadounidenses listadas en el Orange Book de la FDA. Tres patentes expiran en septiembre de 2029, dos en febrero de 2033 y una en abril de 2035.
슈퍼너스 파마슈티컬스(SUPN)는 자사의 약물 Qelbree (빌록사진 서방형 캡슐) 100mg, 150mg, 200mg 기본 제형에 대해 제3자로부터 약식 신약 신청서(ANDA)에 관한 Paragraph IV 통지서를 받았습니다. 회사는 FDA 오렌지북에 등재된 6개의 미국 특허로 보호되는 Qelbree의 지적 재산권을 강력히 방어할 계획입니다. 세 개의 특허는 2029년 9월에 만료되며, 두 개는 2033년 2월, 하나는 2035년 4월에 만료됩니다.
Supernus Pharmaceuticals (SUPN) a reçu des lettres de notification au titre du paragraphe IV concernant des demandes abrégées de nouveaux médicaments (ANDAs) de la part de tiers pour son médicament Qelbree (gélules à libération prolongée de viloxazine) en formulations de base de 100, 150 et 200 mg. La société prévoit de défendre vigoureusement ses droits de propriété intellectuelle pour Qelbree, protégé par six brevets américains répertoriés dans l'Orange Book de la FDA. Trois brevets expirent en septembre 2029, deux en février 2033 et un en avril 2035.
Supernus Pharmaceuticals (SUPN) hat Paragraph-IV-Benachrichtigungsschreiben bezüglich Abgekürzter Neue-Arzneimittel-Anträge (ANDAs) von Dritten für sein Medikament Qelbree (Viloxazin Retardkapseln) in den Basisformulierungen 100, 150 und 200 mg erhalten. Das Unternehmen plant, seine geistigen Eigentumsrechte an Qelbree energisch zu verteidigen, das durch sechs US-Patente geschützt ist, die im FDA Orange Book aufgeführt sind. Drei Patente laufen im September 2029 aus, zwei im Februar 2033 und eines im April 2035.
- None.
- Potential generic competition for Qelbree through ANDA filings threatens market exclusivity
- Company may face costly patent litigation to defend intellectual property rights
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 CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591
or
INVESTOR CONTACT:
Peter Vozzo
ICR Healthcare
(443) 213-0505
peter.vozzo@icrhealthcare.com
FAQ
What does the Paragraph IV ANDA filing mean for Supernus (SUPN) and Qelbree?
When do Supernus (SUPN) patents for Qelbree expire?
How is Supernus (SUPN) responding to the Paragraph IV ANDA filings for Qelbree?
What strengths of Qelbree are affected by the ANDA filings against Supernus (SUPN)?
