Supernus Announces Paragraph IV ANDA Filing for Oxtellar XR(TM)
ROCKVILLE, Md., June 27, 2013 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals,
Inc. (Nasdaq:SUPN) today announced that on June 26, 2013 the Company received
aParagraph IV Notice Letterfrom Watson Laboratories, Inc. ("Watson")
advising Supernus of the filing by Watson of an Abbreviated New Drug
Application seeking approval for oxcarbazepine extended-release tablets.
Supernus is currently reviewing the details of this Notice Letter and intends
to vigorously enforce its intellectual property rights relating to Oxtellar
XR. The product is currently protected by two issued patents that are listed
in the FDA's Orange Book.
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 has one marketed product for
epilepsy, Oxtellar XR^TM (extended release oxcarbazepine), and one tentatively
approved product for epilepsy, Trokendi XR^TM (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 on March 15, 2013 and under the caption "Risk Factors" and the
updates to these risk factors in the Company's quarterly report form 10-Q that
was filed with the commission on May 15, 2013. 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
CONTACT: Jack Khattar, President & CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
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