) recently announced that it is looking to get its generic
Endo Health Solutions Inc.
) 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
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,
) Testim (1% testosterone gel).
ACTAVIS INC (ACT): Free Stock Analysis Report
AUXILIUM PHARMA (AUXL): Free Stock Analysis
ENDO PHARMACEUT (ENDP): Free Stock Analysis
MYLAN INC (MYL): Free Stock Analysis Report
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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
Actavis currently carries a Zacks Rank #3 (Hold). Other generic
) currently look better positioned with a Zacks Rank #2