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News Breaks
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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August 25, 2015
16:43 EDTACOROn The Fly: Top stock stories for Tuesday
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09:13 EDTACOROn The Fly: Pre-market Movers
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09:03 EDTACORAcorda has major overhang removed by IPR denials, says Leerink
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August 24, 2015
18:55 EDTACOROn The Fly: After Hours Movers
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18:52 EDTACORJazz, Celgene, Shire up after USPTO rejects Acorda patent challenge
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17:45 EDTACORAcorda Therapeutics up 31.2% after PTAB denies both IPRs of Ampyra patents
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17:44 EDTACORAcorda Therapeutics announces PTAB denies both IPRs of Ampyra patents
Acorda Therapeutics announced that the United States Patent and Trademark Office, or USPTO, Patent Trials and Appeal Board. or PTAB, will not institute the inter partes review, or IPR, of U.S. Patent Nos. 8,663,685 and 8,007,826. The '685 and '826 patents are two of five Orange Book-listed patents that apply to Ampyra Extended Release Tablets, 10 mg, a novel treatment for multiple sclerosis developed by Acorda. Ampyra is a standard of care for improving walking in MS. The '685 and '826 patents are set to expire in 2025 and 2027, respectively.

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