Supernus Sues TWi for Infringement of Oxtellar XR(R) Patents
January 21 2015 - 4:30PM
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that it sued
generic drug makers TWi Pharmaceuticals, Inc. and TWi International
LLC (d/b/a TWi Pharmaceuticals USA) (collectively "TWi") for
infringement of four patents covering its antiepileptic drug
Oxtellar XR®. Supernus' United States Patents Nos. 7,722,898,
7,910,131, 8,617,600 and 8,821,930 cover once-a-day oxcarbazepine
formulations and methods of treating seizures using those
formulations. Patent protection for Oxtellar XR expires in
2027.
The Complaint — filed on January 16, 2015 in the U.S. District
Court for the District of New Jersey — alleges that TWi infringed
Supernus' Oxtellar XR patents by submitting to the Food and Drug
Administration ("FDA") an Abbreviated New Drug Application ("ANDA")
seeking to market a generic version of Oxtellar XR prior to the
expiration of Supernus' patents. Filing its Complaint within
45 days of receiving TWi's Paragraph IV certification notice
entitles Supernus to an automatic stay preventing the FDA from
approving TWi's ANDA for 30 months.
Supernus President and CEO Jack Khattar confirmed that "Supernus
intends to vigorously enforce 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 Oxtellar 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
21, 2014 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 12, 2014. 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:
COCKRELL GROUP
877-889-1972
investorrelations@thecockrellgroup.com
cockrellgroup.com
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