Back to top

Analyst Blog

Shire LLC (SHPG - Analyst Report) recently announced the settlement of its patent infringement lawsuit against Teva Pharmaceuticals (TEVA - Analyst Report) for Shire's attention deficit hyperactivity disorder (ADHD) drug Intuniv.

Teva was looking to launch its generic version of Intuniv and had filed an abbreviated new drug application (ANDA) with the FDA in 2010.

Shire subsequently filed a lawsuit against Teva for infringement of certain patents related to Intuniv, resulting in a stay of approval on the ANDA for up to 30 months.

As per the settlement, Teva has now obtained a license to market either its own generic version of Intuniv or authorized generic versions of Intuniv supplied by Shire in the US.

However, the license will be effective only after the expiration of the 180 day exclusivity period granted to Actavis (ACT - Analyst Report).

Actavis was the first to submit an ANDA for a generic version of Intuniv. We remind investors that in Apr 2013 Shire settled its patent infringement lawsuit against Actavis for Intuniv.

As per the settlement, Actavis is licensed to manufacture and market its generic versions of Intuniv in the US from Dec 1, 2014 or earlier subject to certain limited circumstances.

Shire holds a strong position in the ADHD market. Apart from Intuniv, key drugs in Shire’s ADHD portfolio include Vyvanse and Adderall XR.

The settlement of the Intuniv lawsuits removes an overhang on Shire’s shares. However, the launch of generic versions of Intuniv by Actavis will impact sales going forward. We note that Intuniv generated sales of $287.8 million in 2012, up 29% from a year ago.

We are concerned about the increasing competition in the ADHD market due to the entry of generics. Shire’s share of the US ADHD prescription market declined to 26.6% in Dec 2012 from 27.9% in the year-ago period.

Shire currently carries a Zacks Rank #3 (Hold). Right now, Salix Pharmaceuticals (SLXP - Analyst Report) looks attractive with a Zacks Rank #1 (Strong Buy).

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
UTD THERAPE… UTHR 117.83 +28.51%
TRIQUINT SE… TQNT 20.67 +6.52%
RF MICRO DE… RFMD 12.47 +6.04%
VASCO DATA… VDSI 14.77 +4.68%
BANCO DO BR… BDORY 15.53 +3.95%