Perrigo Co. (PRGO) Tuesday said it has submitted an Abbreviated New Drug Application with the U.S. Food and Drug Administration, or FDA, for testosterone gel 1.62 percent, or Androgel 1.62, in treatment in males with low or no testosterone.
Perrigo has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
On February 15, the Unimed Pharmaceuticals subsidiary of AbbVie and Besins Healthcare filed suit against Perrigo in the U.S District Court for the District of Delaware, alleging patent infringement.
This action formally initiates the process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
Perrigo earlier filed a New Drug Application for testosterone gel 1.0 percent and that it notified Abbott Products Inc., the owner of the Reference Listed Drug of its filing.
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