The win for Teva and Amphastar was another loss for Sanofi-Aventis
In exchange for proving that a patent is invalid, the FDA awards a generic-drug maker an exclusive selling period of 180 days. Unfortunately for Teva and Amphastar, that clock will start in about six to eight weeks, regardless of whether the FDA has given approval. So, further delay by the FDA would cut into the competition-free period.
The court decision couldn't have come quickly enough for Novartis
The patent lawsuit and the launches for Lovenox have been as complex as the drug itself. Don't be surprised if there's another wrinkle before a generic version finally gets approved.
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