SUPN Supernus Pharmaceuticals Inc.

Supernus Announces Paragraph IV ANDA Filing for XADAGO®

Supernus Announces Paragraph IV ANDA Filing for XADAGO®

ROCKVILLE, Md., May 04, 2021 (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 Newron Pharmaceuticals S.p.A. (“Newron”) received a Paragraph IV Notice Letter (“Notice Letter”) from Aurobindo Pharma Limited, India and its wholly owned subsidiary Aurobindo Pharma USA Inc. (collectively “Aurobindo”), advising Newron of the filing by Aurobindo of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (“FDA”) seeking approval for safinamide tablets. The Notice Letter is directed to the three XADAGO patents with U.S. patent numbers 8,076,515, 8,278,485 and 8,283,380, that expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The Company has a license agreement with Zambon S.p.A., Newron’s partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5 year FDA exclusivity period that expires on March 21, 2022. The Company is currently reviewing the details of this Notice Letter with its partners to respond as appropriate to protect the intellectual property rights relating to XADAGO.

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 epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson’s disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in Parkinson’s disease, epilepsy, depression, and rare CNS disorders.

For more information, please visit .

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; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products; 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 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; 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.

CONTACT:

Jack A. Khattar, President and CEO

Jim Kelly, Executive Vice President and CFO

Supernus Pharmaceuticals, Inc.

Tel: (301) 838-2591

Or

Investor Contact:

Peter Vozzo

Westwicke/ICR

Office: (443) 213-0505

Mobile: (443) 377-4767

Email:



EN
05/05/2021

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Supernus Pharmaceuticals Inc.

 PRESS RELEASE

Supernus Announces Second Quarter 2025 Financial Results

Supernus Announces Second Quarter 2025 Financial Results Net sales of Qelbree® increased 31% in the second quarter of 2025, compared to the same period in 2024. Net sales of Qelbree of $77.6 million and $142.3 million in the second quarter and first six months of 2025, respectively. Net sales of GOCOVRI® increased 16% in the second quarter of 2025, compared to the same period in 2024. Net sales of GOCOVRI of $36.7 million and $67.4 million in the second quarter and first six months of 2025, respectively. ONAPGO™ (apomorphine hydrochloride) launched in April 2025.Total revenues were $165.5 m...

 PRESS RELEASE

Supernus Pharmaceuticals Completes Acquisition of Sage Therapeutics

Supernus Pharmaceuticals Completes Acquisition of Sage Therapeutics Acquisition strengthens Supernus’ leading presence in neuropsychiatric conditions with an innovative commercial product, ZURZUVAE® (zuranolone), and a novel CNS discovery platform, accelerating mid- to long-term revenue and cash flow growth and further diversifying revenue base ROCKVILLE, Md., July 31, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) (“Supernus”) today announced that it has successfully completed its previously announced acquisition of Sage Therapeutics, Inc. (Nasdaq: SAGE) (“Sage”...

 PRESS RELEASE

Supernus Pharmaceuticals Announces Expiration of Hart-Scott-Rodino Wai...

Supernus Pharmaceuticals Announces Expiration of Hart-Scott-Rodino Waiting Period for Sage Therapeutics, Inc. Tender Offer ROCKVILLE, Md., July 28, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc., a Delaware corporation (NASDAQ: SUPN) ("Supernus", and the "Company"), today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act"), with respect to Supernus’ proposed acquisition of Sage Therapeutics, Inc., a Delaware corporation (NASDAQ: SAGE) ("Sage"), expired at 11:59 p.m. Eastern Time on July 25, 2025. On Ju...

 PRESS RELEASE

Supernus Pharmaceuticals to Announce Second Quarter 2025 Financial Res...

Supernus Pharmaceuticals to Announce Second Quarter 2025 Financial Results and Host Conference Call and Webcast on August 5, 2025 ROCKVILLE, Md., July 22, 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 expects to report financial and business results for the second quarter of 2025 after the market closes on Tuesday, August 5, 2025. Jack Khattar, President and CEO, and Tim Dec, Senior Vice Presi...

 PRESS RELEASE

Supernus Pharmaceuticals to Acquire Sage Therapeutics, Strengthening i...

Supernus Pharmaceuticals to Acquire Sage Therapeutics, Strengthening its Neuropsychiatry Product Portfolio Proposed acquisition expected to accelerate mid- to long-term revenue and cash flow growth and further diversify revenue base.Strengthens Supernus’ leading presence in neuropsychiatric conditions with an innovative commercial product, ZURZUVAE® (zuranolone), and a novel CNS discovery platform.Expected to be significantly accretive in 2026 with potential cost synergies of up to $200 million on an annual basis.Upfront cash payment of $8.50 per share, plus one non-tradable contingent valu...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch