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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
Drug Prices: :see details

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, 2010RXYes5,540,938Jul 30, 2018
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,440,703Apr 8, 2025
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,007,826May 26, 2027
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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
Japan2007532578<disabled in preview>
Serbia51808<disabled in preview>
Japan2012188427<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
894Luxembourg<disabled>91894, EXPIRES: 20161101
2011 00031Denmark<disabled>PRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720
0120002 00051Estonia<disabled>PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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