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Case Briefing

By ALM Staff | Law Journal Newsletters |
November 10, 2003

TRO Issued in First-to-File Market Exclusivity Battle

Alpharma Inc. has announced that its wholly owned subsidiary, Purepac Pharmace, was granted a temporary restraining order Oct. 29 in a lawsuit in the U.S. District Court for the District of Columbia. Purepac brought this suit seeking first-to-file status on its version of Glucophage XR, a Bristol-Myers Squibb Type 2 diabetes drug. On Oct. 28, Ivax Corp. had announced it had received final approval and confirmation of its first-to-file status on its Abbreviated New Drug Application from the FDA. In obtaining the restraining order, Purepac effectively removed Ivax's product from the market, at least in the short term. Under the terms of the temporary restraining order, the FDA has been instructed to delay the effective date of approval of Ivax's ANDA on extended-release metformin hydrochloride tablets until mid-November, when a hearing on Purepac's claims can be held.

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