Acorda Therapeutics Inc.
) recently announced that its patent no. 5,540,938 has been
granted a five year patent term extension under the patent
restoration provisions of the Hatch Waxman Act by the US Patent
and Trademark Office (USPTO).
The patent is related to Acorda's lead product Ampyra
(dalfampridine, 10 mg). Post the extension, the patent will
expire in 2018.
We note that in March 2010, Acorda had applied for the extension
of the above-mentioned Ampyra patent based on the provisions of
the Hatch Waxman Act that allow for up to five additional years
of patent protection.
Ampyra was approved by the US Food and Drug Administration (FDA)
in January 2010 for the improvement of walking in multiple
sclerosis patients. Ampyra is available outside the US under the
trade name Fampyra. Acorda has a license and collaboration
) for the development and commercialization of Fampyra outside
Fampyra is approved in the EU, Norway, Iceland, Canada,
Australia and New Zealand. Biogen has launched Fampyra in
Germany, the UK, Denmark, Norway, Iceland, Canada, Australia and
New Zealand and expects to launch Fampyra in most of the
remaining EU countries by year end.
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The company expects net Ampyra revenue in the range of $255
million to $275 million in 2012. Ampyra has the potential to be
approved for additional indications as well. Acorda is currently
studying Ampyra in phase II proof-of-concept studies for cerebral
palsy (results by year end) and post-stroke deficits (results in
We currently have a Neutral recommendation on Acorda.