Ivax Glucophage XR Generic Exclusivity Extended; New Twist On “Late-List”
Executive Summary
Ivax will gain at least an additional 30 days of generic marketing exclusivity for Bristol-Myers Squibb's Glucophage XR after a federal judge issued a temporary restraining order blocking FDA from approving other metformin extended-release ANDAs
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Glucophage XR generics
Andrx and Teva/Impax join Ivax and Par in the generic metformin extended-release (Bristol's Glucophage XR) market after Ranbaxy drops a lawsuit challenging FDA's decision to offer a second round of exclusivity for the antidiabetic. A federal judge had ordered FDA not to approve any ANDAs until he ruled on the merits of Ranbaxy's case. However, Ranbaxy voluntarily dismissed the suit without prejudice on June 14, clearing the way for additional ANDA approvals. Andrx and Teva/Impax are sharing in a second round of 180-day exclusivity stemming from a late-listed Bristol patent (1"The Pink Sheet" June 7, 2004, p. 8). Ranbaxy's ANDA was approved June 18....
Glucophage XR generics
Andrx and Teva/Impax join Ivax and Par in the generic metformin extended-release (Bristol's Glucophage XR) market after Ranbaxy drops a lawsuit challenging FDA's decision to offer a second round of exclusivity for the antidiabetic. A federal judge had ordered FDA not to approve any ANDAs until he ruled on the merits of Ranbaxy's case. However, Ranbaxy voluntarily dismissed the suit without prejudice on June 14, clearing the way for additional ANDA approvals. Andrx and Teva/Impax are sharing in a second round of 180-day exclusivity stemming from a late-listed Bristol patent (1"The Pink Sheet" June 7, 2004, p. 8). Ranbaxy's ANDA was approved June 18....
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