Supernus Wins Infringement and Validity Case on Trokendi XR® against Torrent
05 Fevereiro 2024 - 10:30AM
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, announced today
that the United States District Court for the District of New
Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary,
Torrent Pharma Inc., infringed U.S. Patent Nos. 8,992,989;
9,549,940; and 9,622,983 by submitting to the U.S. Food and Drug
Administration (FDA) an Abbreviated New Drug Application (ANDA)
seeking permission to market a generic version of Trokendi XR®
before the expiration of Supernus’ patents.
“We are very pleased with the District Court’s
ruling that Torrent infringed our Trokendi XR® patents and the
reaffirmation of the validity of those patents,” stated Jack A.
Khattar, President and Chief Executive Officer of Supernus
Pharmaceuticals. “We are very serious about securing intellectual
property (IP) protection for our innovative products and about
vigorously enforcing such IP rights even if the product is at a
later stage in its lifecycle.”
In addition to the three patents that were the
subject of the District Court’s decision, Trokendi XR® is further
protected by seven other patents. The Orange Book lists a total of
ten patents as covering Trokendi XR.
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, ADHD, hypomobility in
Parkinson's disease (PD), cervical dystonia, chronic sialorrhea,
dyskinesia in PD patients receiving levodopa-based therapy, and
drug-induced extrapyramidal reactions in adult patients. We are
developing a broad range of novel CNS product candidates including
new potential treatments for hypomobility in PD, 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; 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; 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; 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.Tel: (301)
838-2591
Or
INVESTOR CONTACT:
Peter VozzoICR WestwickeOffice: (443) 213-0505Email:
peter.vozzo@westwicke.com
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