Shire
(
SHPGY
) recently announced that the US Food and Drug Administration (FDA)
has approved the abbreviated new drug application (ANDA) filed by
Actavis for its generic version of Adderall XR. Adderall XR is
indicated for attention-deficit/hyperactivity disorder (ADHD).
The FDA responded to a citizen petition filed by the company for
Adderall XR. The FDA said that all the companies filing an ANDA
should establish bioequivalence using partial area under the curve
measurements for both d- and l- amphetamine at 5 hours and beyond.
The citizen petition was filed by Shire in October 2005.
We note that, at present, Iceland-based Actavis is in the process
of being acquired by
Watson Pharmaceuticals Inc.
(
WPI
).
Our Take
Adderall XR, with $111.4 million revenues in the first quarter of
2012, is one of the top revenue grossers at Shire. As per data
provided by IMS Health National Prescription Audit, Adderall XR
enjoys a 7% share of the US ADHD market.
Apart from this, the company has two authorized generic partners -
Teva Pharmaceuticals
(
TEVA
) and
Impax Laboratories
(
IPXL
). We believe that the entry of additional generic versions of
Adderall XR will eat into Adderall XR revenues.
Shire in engaged in several lawsuits for Adderall XR. On November
1, 2010, Impax filed a suit against Shire claiming a breach of
contract regarding the supply of the generic version of Adderall
XR. Shire has been supplying Impax with the generic version of the
ADHD drug since October 2009. Shire has filed a counterclaim
against Impax.
The company is also entangled in a legal battle with Watson Pharma,
which is also seeking to market generic versions of the drug in
multiple doses. In April 2011, Shire filed a patent infringement
lawsuit and breach of contract against Watson Pharma following the
ANDA filed by Watson with the FDA for its generic version of the
drug.
We currently have a Neutral recommendation on Shire. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
IMPAX LABORATRS (IPXL): Free Stock Analysis
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SHIRE PLC-ADR (SHPGY): Free Stock Analysis
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TEVA PHARM ADR (TEVA): Free Stock Analysis
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WATSON PHARMA (WPI): Free Stock Analysis Report
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