Supernus Announces Settlement With Par on Trokendi XR(R) Patent Litigation
October 15 2015 - 8:30AM
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that it has
entered into a settlement agreement with Par Pharmaceutical
Companies, Inc. and Par Pharmaceutical, Inc. (collectively "Par")
involving the ongoing patent litigation regarding Par's filing of
an Abbreviated New Drug Application (ANDA) seeking approval to
market a generic version of Supernus' Trokendi XR®
(extended-release topiramate) capsules. The settlement permits Par
to begin selling a generic version of Trokendi XR® on April 1,
2025, or earlier under certain circumstances. The agreement is
subject to entry of a consent judgment by the U.S. District Court
for the District of New Jersey. In the consent judgment, Par
acknowledges that the Orange Book-listed patents for Trokendi XR®
owned by Supernus, namely United States Patent Nos. 8,298,576,
8,298,580, 8,663,683, 8,877,248, 8,889,191, and 8,992,989, are
valid and enforceable with respect to Par's ANDA product, and would
be infringed by Par's ANDA product. The agreement will be submitted
to the applicable governmental agencies.
The patent litigation continues against Actavis and Zydus, the
other two ANDA filers. Patent protection for Trokendi XR® expires
no earlier than 2027 and Supernus intends to continue its vigorous
enforcement of its patent rights.
Supernus is represented by attorneys from Frommer Lawrence and
Haug LLP and its corporate counsel, Saul Ewing LLP.
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, or CNS, diseases. The Company
markets two products for epilepsy, Oxtellar XR® (extended-release
oxcarbazepine) and Trokendi XR® (extended-release topiramate). The
Company is also developing several product candidates in psychiatry
to address large market opportunities in ADHD, including ADHD
patients with impulsive aggression. These product candidates
include SPN-810 for impulsive aggression in ADHD 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 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 on March 12, 2015 under
the caption "Risk Factors". 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.
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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