Actavis seeks approval for additional strength of generic testosterone gel

Generic drug maker challenges patent on AndroGel 1.62%

PARSIPPANY, N.J. — Just a week after the Supreme Court heard the Federal Trade Commission's lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.

Actavis said Monday that it had filed with the Food and Drug Administration for approval of testosterone gel in the 1.62% strength. The drug is a generic version of AbbVie's AndroGel 1.62%. The case that went before the Supreme Court on March 25 concerns the 1% strength of AndroGel.

AbbVie subsidiary Unimed Pharmaceuticals and another company, Besins Healthcare, filed suit against Actavis Friday in the U.S. District Court for the District of Delaware to prevent commercialization of the generic, alleging that Actavis' FDA application violates a patent scheduled to expire in August 2020. The lawsuit puts a stay of FDA approval on the drug for up to 30 months, unless the companies reach a settlement.

AndroGel 1.62% had sales of about $690 million during the 12-month period that ended in January, according to IMS Health.

 

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