Five-Year Market Exclusivity for VYVANSE(R) Upheld

By Shire Plc, PRNE
Tuesday, November 9, 2010

United States Court of Appeals for the District of Columbia Circuit Reaffirms NCE Exclusivity

PHILADELPHIA, November 10, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that the U.S. Court of Appeals for the
District of Columbia Circuit has affirmed the ruling of the U.S. District
Court for the District of Columbia and the U.S. Food and Drug Administration
to grant five-year New Chemical Entity exclusivity to lisdexamfetamine
dimesylate, currently marketed by Shire U.S. Inc. under the name VYVANSE(R).

The five-year exclusivity period for VYVANSE expires on February 23,
. VYVANSE is further protected by United States patents, the first of
which expires on June 29, 2023. As a result of this confirmation of VYVANSE's
NCE status, generic manufacturers cannot submit an ANDA to FDA until February
23, 2011
at the earliest.

Notes to editors


Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit hyperactivity
disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases as well as opportunities in other therapeutic areas to the extent
they arise through acquisitions. Shire's in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes that a
carefully selected and balanced portfolio of products with strategically
aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website:

ACT OF 1995

Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a number
of risks and uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, the Company's results could be
materially adversely affected. The risks and uncertainties include, but are
not limited to, risks associated with: the inherent uncertainty of research,
development, approval, reimbursement, manufacturing and commercialization of
the Company's Specialty Pharmaceutical and Human Genetic Therapies products,
as well as the ability to secure and integrate new products for
commercialization and/or development; government regulation of the Company's
products; the Company's ability to manufacture its products in sufficient
quantities to meet demand; the impact of competitive therapies on the
Company's products; the Company's ability to register, maintain and enforce
patents and other intellectual property rights relating to its products; the
Company's ability to obtain and maintain government and other third-party
reimbursement for its products; and other risks and uncertainties detailed
from time to time in the Company's filings with the Securities and Exchange

    For further information please contact:

    Investor Relations  Eric Rojas (  +1-781-482-0999

    Media            Jessica Mann (     +44-1256894-280
                     Matthew Cabrey ( +1-484-595-8248

For further information please contact: Investor Relations: Eric Rojas (erojas at, +1-781-482-0999; Media: Jessica Mann (jmann at, +44-1256-894-280; Matthew Cabrey (mcabrey at, +1-484-595-8248.

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