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Impax Laboratories, Inc.
IPXL and its wholly owned subsidiary, ThoRx
Laboratories, Inc., today confirm that they have initiated a challenge of the
patents listed in the Orange Book in connection with Opana® ER (oxymorphone
hydrochloride extended-release tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30
mg, and 40 mg).
ThoRx filed its Abbreviated New Drug Application (ANDA) containing a paragraph
IV certification for a generic version of Opana® ^ ER with the U.S. Food &
Drug Administration (FDA). Following receipt of the notice from FDA that
ThoRx's ANDA had been accepted for filing, ThoRx notified the New Drug
Application holder and patent owner of its paragraph IV certification.
On November 14, 2012, Endo Pharmaceuticals Inc. and Grunenthal GMBH filed suit
for patent infringement against ThoRx Laboratories, Inc. and Impax
Laboratories, Inc. in the United States District Court for the Southern
District of New York. This action formally initiates the patent challenge
process under the Hatch-Waxman Act.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic
division, intends to commercialize the product.
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