) announced that it is seeking U.S. Food and Drug Administration
(FDA) approval for its generic versions of
) Multaq and
Takeda Pharmaceutical Company Limited
) Colcrys. While Multaq is an antiarrhythmic drug for reducing
the risk of hospitalization for atrial fibrillation (AF) in
patients in sinus rhythm with a history of paroxysmal or
persistent AF, Colcrys is used for the prevention and treatment
of gout flares.
ACTAVIS PLC (ACT): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
TAKEDA PHARMACT (TKPYY): Get Free Report
To read this article on Zacks.com click here.
Both Sanofi and Takeda 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 versions for up to 30 months (until Jan 1, 2017 in
Multaq's case) or the court's decision, whichever is earlier.
According to IMS Health, total U.S. sales of Multaq during the 12
months ended Dec 31, 2013, were $319 million. Meanwhile, Colcrys
sales in the U.S. during the same time period were about $629
million, according to IMS Health. Actavis believes that it was
first-to-file an abbreviated new drug application (ANDA) for a
generic version of Multaq - if that is the case, Actavis would be
entitled to 180 days of exclusivity on gaining FDA approval for
We are pleased with the progress of Actavis' generic pipeline.
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 acquire
Forest Laboratories Inc.
). The acquisition will lead to the creation of a specialty
company with sales of more than $15 billion per year, a
well-diversified portfolio and a presence in varied geographical
areas. The Forest Labs acquisition will push up Actavis' branded
products revenues to 50% of total combined revenues from the
current level of 30% of the standalone company's revenues. The
Forest Labs acquisition will also bring about significant
synergies and boost earnings and revenues.
Actavis and Forest Labs both carry a Zacks Rank #2 (Buy).