Par Pharmaceutical Acquires Rights to Market and Distribute Generic Seroquel
XR® in the U.S.
Potential for 180-Day Marketing Exclusivity
WOODCLIFF LAKE, N.J., Oct. 29, 2012
WOODCLIFF LAKE, N.J., Oct. 29, 2012 /PRNewswire/ -- Par Pharmaceutical
Companies, Inc. today announced that its Par Pharmaceutical, Inc. operating
subsidiary has entered into an exclusive acquisition and license agreement
with Handa Pharmaceuticals, LLC to acquire Handa's Abbreviated New Drug
Application (ANDA) for quetiapine fumarate extended-release tablets, the
generic version of AstraZeneca's Seroquel XR^®. Handa believes it is the
first applicant to file an ANDA containing a paragraph IV certification for
the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would
potentially provide 180 days of marketing exclusivity. According to IMS
Health data, annual U.S. sales for these strengths of Seroquel XR^® are
approximately $808 million. The ANDA also includes a 400 mg dosage strength.
Under the terms of the agreement, Par has made a payment for the ANDA and for
exclusive rights to market, sell and distribute quetiapine fumarate
extended-release tablets in the U.S. under the ANDA, subject to its final
approval by the U.S. Food and Drug Administration. Par will receive a share
of profits from the sales of the product. Under the terms of a prior
settlement agreement with AstraZeneca, which has been assigned to Par, Par has
a license to enter the U.S. market with quetiapine fumarate extended-release
tablets on November 1, 2016 or earlier under certain circumstances.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty
pharmaceutical company. Through its wholly-owned subsidiary's two operating
divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops,
manufactures and markets high barrier-to-entry generic drugs and niche,
innovative proprietary pharmaceuticals. For press release and other company
information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies, Inc.
Contact: Stephen Mock, Par Pharmaceutical Companies, Inc., +1-201-802-4033
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