) recently announced that it is seeking FDA approval for its
generic versions of Fresenius Kabi's Diprivan and
) Safyral. While Diprivan is an intravenously administered
sedative and anesthetic, Safyral is an oral contraceptive.
Both Fresenius Kabi and Bayer have filed patent infringement
lawsuits against Actavis for their respective drugs. The filing
of the lawsuits within the stipulated time period under the
Hatch-Waxman Act ensures that the FDA cannot grant final approval
to Actavis' generics for up to 30 months or the court's decision,
whichever is earlier.
According to IMS Health, total US sales of branded and generic
versions of Diprivan during the 12 months ended Apr 30, 2013 were
$212 million. Meanwhile, Safyral sales in the US during the same
time period were about $19 million, according to IMS Health.
Actavis believes it was first-to-file an abbreviated new drug
application (ANDA) for a generic version of Safyral - if this is
the case, Actavis would be entitled to 180 days of exclusivity on
gaining FDA approval for its candidate.
Meanwhile, Actavis also launched its generic version of
) Zometa in several countries in the EU. Actavis was first to
market in Germany, Spain, Sweden, Romania and Austria. Zometa is
approved for the prevention of skeletal related events in adults
with advanced malignancies involving bone and the treatment of
adults with tumor-induced hypercalcemia. Zometa sales in Europe,
as per IMS Health, were €269.5 million in 2012.
While Actavis continues to work on driving generic product
sales, the company is also working on strengthening its branded
product portfolio. Last month, Actavis announced its intention to
Warner Chilcott plc
) which will result in the creation of a leading global specialty
pharmaceutical company with combined annual revenues of about $11
billion. The combined company will hold the third position in the
US specialty pharmaceutical market with annual revenues of about
Actavis currently carries a Zacks Rank #2 (Buy). We are
positive on the Warner-Chilcott deal which makes strategic and
ACTAVIS INC (ACT): Free Stock Analysis Report
BAYER A G -ADR (BAYRY): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
WARNER CHIL PLC (WCRX): Free Stock Analysis
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