SAN FRANCISCO (Thomson Financial) - Endo Pharmaceuticals Holdings Inc. and
Penwest Pharmaceuticals Co. said late Friday they've been notified that Actavis
South Atlantic LLC has filed an abbreviated new drug application (ANDA)
containing a Paragraph IV certification for oxymorphone hydrochloride
extended-release tablets.
The Actavis Paragraph IV certification notice refers to Penwest patents
covering the formulation of Opana, a pain reliever.
In addition to the patents, Opana ER has a new dosage form exclusivity that
prevents final approval of any application by the FDA until the exclusivity
expires on June 22, 2009, Endo and Penwest said.
The companies said they plan to pursue all available legal and regulatory
avenues in defense of Opana ER.
Endo and Penwest announced previously that Impax Laboratories Inc. filed an
ANDA containing Paragraph IV certifications for Opana ER in late 2007.
Patent infringement suits against Impax are pending in the U.S. District
Court for the District of Delaware, the companies said.
Shares of Endo closed at $25.16, while shares of Penwest closed at $3.71.
Gabriel Madway
gm
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