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Generic Version of Oxycontin Granted Tentative Approval by FDA
Final approval is contingent upon the earlier of (1) the resolution of pending patent-infringement litigation brought by Purdue Pharma against IMPAX, or (2) the expiration of the 30-month stay process under the Hatch-Waxman Amendments; and the expiration of any generic marketing exclusivity. Final approval is also dependent upon FDA's evaluation of any new information subsequent to this tentative approval.
IMPAX Laboratories previously announced FDA acceptance of the Company's ANDA filing for Oxycodone Hydrochloride Extended Release Tablets, 80 mg in December 2001 and commented on the filing of a lawsuit by Purdue Pharma alleging patent infringement relating to the ANDA in April 2002. The litigation with Purdue Pharma is still ongoing.
In addition, IMPAX currently has ANDAs pending at the FDA for Oxycontin Controlled Release Tablets, 10, 20 and 40 mg strengths with combined U.S. sales of approximately $1.2 billion for the 12 months ended July 31, 2003, according to NDCHealth data.
"This tentative approval is our fifth ANDA approval this year," said Larry Hsu, Ph.D. IMPAX's President. "We are pleased to see our new product pipeline continue to progress through FDA and add to our growing portfolio of products."
IMPAX currently has 18 applications pending at the FDA, including four tentatively approved, which address approximately $7.1 billion in U.S. branded product sales for the twelve months ended June 30, 2003. Fifteen of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.
Source: IMPAX Laboratories, Inc.