) recently announced the settlement of its patent infringement
) for Shire's attention deficit hyperactivity disorder (ADHD)
Teva was looking to launch its generic version of Intuniv and
had filed an abbreviated new drug application (ANDA) with the FDA
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 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
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
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,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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