Supernus Prevails in Oxtellar XR® ANDA Litigation
February 08 2016 - 7:30AM
Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system diseases,
today announced that following a seven-day bench trial, Judge Renee
Marie Bumb of the United States District Court for the District of
New Jersey ruled that Actavis Inc. and its subsidiaries infringed
U.S. Patent Nos. 7,722,898 and 7,910,131 by submitting to the FDA
an ANDA seeking permission to market a generic version of Oxtellar
XR® before the expiration of Supernus' patents. Judge Bumb
also ruled that U.S. Patent Nos. 7,722,898, 7,910,131, and
8,617,600 are valid. The FDA's Orange Book lists all three
patents as expiring on April 13, 2027.
“We are pleased with the court’s ruling that Actavis will
infringe two of our patents on Oxtellar XR, and the finding that
all three patents are valid,” stated Jack Khattar, President and
Chief Executive Officer of Supernus Pharmaceuticals. “We will
continue to vigorously defend our novel products and build upon our
strong intellectual property to provide our products the protection
they are entitled to."
In addition to the above three patents that were subject to the
Federal Court decision, Oxtellar XR is further protected by two
other patents that are also listed in the Orange Book and that have
an expiration date that is no earlier than 2027. Finally, as of the
date of this press release, we are not aware of any FDA approval
for the Actavis ANDA.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system diseases. The Company has two
marketed products for epilepsy, Oxtellar XR® (extended-release
oxcarbazepine) and Trokendi XR® (extended-release topiramate). The
Company is also developing several product candidates to address
large market opportunities in psychiatry, including SPN-810 for the
treatment of impulsive aggression in patients with ADHD in
conjunction with standard ADHD treatment and SPN-812 for ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding
the Company's ability to defend and enforce its intellectual
property rights covering Oxtellar XR or Trokendi XR. Actual results
may differ materially from those in these forward-looking
statements as a result of various factors, including, but not
limited to, the ability of Supernus to finance potential litigation
and to prevail in any such proceeding to successfully defend its
intellectual property rights. For a further description of these
and other risks facing the Company, please see the risk factors
described in the Company's Annual Report Form 10-K that was filed
with the United States Securities and Exchange Commission
("Commission") on March 12, 2015 under the caption "Risk Factors"
and the updates to these risk factors in the Company's Quarterly
Report form 10-Q filed with the Commission on November 9, 2015.
Forward-looking statements speak only as of the date of this press
release, and the Company undertakes no obligation to update or
revise these statements, except as may be required by law.
CONTACT:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
Or
Investor Contact:
Peter Vozzo
Westwicke Partners
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
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