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CHADDS FORD, Pa.,
Sept. 26, 2012 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions (Nasdaq: ENDP), announced today that the company has received Paragraph IV Certification Notices from Teva Pharmaceuticals and Amneal Pharmaceuticals each advising of the filing of Abbreviated New Drug Applications (ANDAs) for generic versions of OPANA
® ER (Oxymorphone HCl).
Endo intends to vigorously defend OPANA ER's intellectual property rights and will pursue all available legal and regulatory pathways in defense of OPANA ER. The company is currently reviewing the details of these notices.
"With the decision last week by FDA to designate a reference listed drug for the new formulation of OPANA ER, we are not surprised by the receipt of the filing of ANDAs for a generic version of OPANA ER. OPANA ER remains an important growth driver for Endo and we expect the product to retain exclusivity for many years to come," said
Julie McHugh, chief operating officer of Endo Health Solutions. "We anticipate that over the next few months FDA will establish standards for developing abuse deterrant drugs that will require generic manufacturers to do additional studies for their ANDAs to be approved. We continue to believe that any ANDA referencing OPANA ER should contain data and information demonstrating that the proposed product is similarly crush-resistant to the reformulated OPANA ER. We also believe in OPANA ER's very strong patent estate, including patents currently under review by the U.S. Patent and Trademark Office. We expect these patents will be allowed shortly and will provide additional protection for the new formulation of OPANA ER."
The Paragraph IV certification notices refer to U.S. Patent Nos. 8,075,872, 8,114,383, 8,192,722 and 7,851,482, which collectively cover the formulation and drug substance of OPANA ER, an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time. These patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book and expire in
September 2025 and
July 2029, respectively.