) is looking to get its generic version of Reckitt Benckiser's
Suboxone Sublingual Film (buprenorphine hydrochloride and
naloxone hydrochloride sublingual film 2 mg/0.5 mg and 8 mg/2 mg)
approved in the U.S. Suboxone Film is approved for the
maintenance treatment of opioid dependence.
Actavis has submitted an Abbreviated New Drug Application
(ANDA) with the U.S. Food and Drug Administration (FDA) for its
Meanwhile, Reckitt Benckiser Pharmaceuticals, Inc., RB
Pharmaceuticals Limited and MonoSol Rx, LLC have filed a patent
infringement lawsuit against Actavis. 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'
generics for up to 30 months or the court's decision, whichever
Actavis believes it may be first to file an ANDA for a generic
version of Suboxone Film which means it would be entitled to 180
days of generic market exclusivity. According to IMS Health, U.S.
sales of Suboxone Film (2/0.5mg and 8/2 mg) were about $1.2
billion for the 12 months ending Aug 31, 2013.
While Actavis continues to work on driving generic product
sales, the company is also working on strengthening its branded
product portfolio. Earlier this month, Actavis acquired Warner
Chilcott which has led to the creation of a leading global
specialty pharmaceutical company with combined annual revenues of
about $11 billion. The combined company holds the third position
in the U.S. specialty pharmaceutical market with annual revenues
of about $3 billion.
Actavis currently carries a Zacks Rank #2 (Buy). At present,
Dr. Reddy's Laboratories
) also look attractive. While Akorn is a Zacks Rank #1 (Strong
Buy) stock, Mylan and Dr. Reddy's are Zacks Rank #2 stocks.
ACTAVIS PLC (ACT): Free Stock Analysis Report
AKORN INC (AKRX): Free Stock Analysis Report
MYLAN INC (MYL): Free Stock Analysis Report
DOCTOR REDDYS (RDY): Free Stock Analysis
To read this article on Zacks.com click here.