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AMPYRA Drug Profile

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Ampyra is a drug marketed by Acorda and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-five patent family members in twenty-three countries.

The generic ingredient in AMPYRA is dalfampridine. There are seven drug master file entries for this compound. One supplier is listed for this compound. There are seven tentative approvals for this compound. Additional details are available on the dalfampridine profile page.

Summary for Tradename: AMPYRA

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Clinical Trials for: AMPYRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes5,540,938<disabled> <disabled>
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,440,703<disabled> <disabled>
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,007,826<disabled> <disabled>
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Expired Patents for Tradename: AMPYRA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 20105,370,879<disabled>
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Paragraph IV activity for: AMPYRA

Drugname Dosage Strength RLD Submissiondate
dalfampridineExtended-release Tablets10 mgAmpyra1/22/2014

Non-Orange Book Patents for Tradename: AMPYRA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,370,879 Formulations and their use in the treatment of neurological diseases<disabled in preview>
5,580,580 Formulations and their use in the treatment of neurological diseases<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AMPYRA

Country Document Number Estimated Expiration
Canada2054822<disabled in preview>
Denmark1732548<disabled in preview>
Hong Kong1162971<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AMPYRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/055United Kingdom<disabled>PRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720
2012001,C1732548Lithuania<disabled>PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
00612Netherlands<disabled>PRODUCT NAME: 4-AMINOPYRIDINE, DAN WEL EEN DERIVAAT DAARVAN, IN HET BIJZONDER EEN ZOUT, SOLVAAT OF PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
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