Actavis, Inc. (ACT) recently announced that it is looking to get its generic version of Endo Health Solutions Inc.’s (ENDP) Fortesta (testosterone gel 10mg/0.5g) approved in the US. The company has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for its candidate.
Fortesta is approved for use as a replacement therapy in males for conditions associated with the lack or absence of endogenous testosterone.
Endo and Strakan International have filed a patent infringement lawsuit against Actavis in the US District Court for the Eastern District of Texas Marshall Division. The filing of the lawsuit within the stipulated time period under the Hatch-Waxman Act ensures that the FDA cannot grant final approval to Actavis’ generic for up to 30 months or the court’s decision, whichever is earlier.
Actavis believes it may be the first-to-file an ANDA for a generic version of Fortesta – if this is the case, Actavis would be entitled to 180 days of exclusivity on gaining FDA approval for its candidate. As per IMS Health data, Fortesta sales were $50 million in 2012 in the US.
We note that Actavis is seeking FDA approval for its generic version of another testosterone gel product, Auxilium Pharma’s (AUXL) Testim (1% testosterone gel).
Actavis is the third largest player in the global generics market and has a presence in more than 60 countries. As of Dec 31, 2012, the company had more than 185 ANDAs pending FDA approval. These include 49 first-to-file opportunities of which 33 could be exclusive first-to-files.
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