Back to top

Analyst Blog

Actavis plc (ACT - Analyst Report) 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.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
SUPER MICRO… SMCI 26.98 +10.17%
CANADIAN SO… CSIQ 38.30 +8.07%
CENTURY ALU… CENX 26.97 +7.97%
BANCO DO BR… BDORY 16.72 +7.66%
WILLDAN GRO… WLDN 11.38 +5.86%