Actavis plc 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 generic version.
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 is earlier.
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, Akorn Inc. (AKRX - Snapshot Report) , Mylan (MYL - Analyst Report) and Dr. Reddy’s Laboratories (RDY - Analyst Report) also look attractive. While Akorn is a Zacks Rank #1 (Strong Buy) stock, Mylan and Dr. Reddy’s are Zacks Rank #2 stocks.