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June 26, 2014
06:03 EDTACOR, ACTAcorda Therapeutics notified of Actavis' ANDA filing for generic Ampyra
Acorda Therapeutics (ACOR) received a Paragraph IV Certification Notice Letter advising that Actavis Laboratories (ACT) submitted an Abbreviated New Drug Application - ANDA - to the FDA requesting permission to manufacture and market a generic version of Ampyra Extended Release Tablets, 10 mg. Acorda is reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Actavis Laboratories in order to trigger a statutory stay period under the Hatch-Waxman Act. This would restrict the FDA from approving an ANDA until July 2017. Ampyra is currently protected by five patents listed in the FDAs Approved Drugs Product List. Acorda intends to vigorously defend its intellectual property rights.
News For ACOR;ACT From The Last 14 Days
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February 11, 2016
06:07 EDTACORAcorda Therapeutics sees FY16 Ampyra revenue $475M-$485M
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06:06 EDTACORAcorda Therapeutics reports Q4 Ampyra net revenue up 11% y-o-y to $122M
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06:05 EDTACORAcorda Therapeutics reports Q4 non-GAAP EPS 28c, consensus 22c
Reports Q4 revenue $130.90M, consensus $128.24M.

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