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Serving leading biopharmaceutical companies globally:

Chubb
Covington
Mallinckrodt
Boehringer Ingelheim
McKesson
Merck
McKinsey
Daiichi Sankyo
Colorcon
Cipla

Generated: January 20, 2018

DrugPatentWatch Database Preview

AMPYRA Drug Profile

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Which patents cover Ampyra, and when can generic versions of Ampyra launch?

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

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

The generic ingredient in AMPYRA is dalfampridine. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalfampridine profile page.
Drug patent expirations by year for AMPYRA
Pharmacology for AMPYRA

US Patents and Regulatory Information for AMPYRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for AMPYRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AMPYRA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 10 mg ➤ Subscribe 1/22/2014

Non-Orange Book US Patents for 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 ➤ Subscribe
5,580,580 Formulations and their use in the treatment of neurological diseases ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for AMPYRA

Supplementary Protection Certificates for AMPYRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00004 Denmark ➤ Subscribe
0612 Netherlands ➤ Subscribe 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
00515 Netherlands ➤ Subscribe PRODUCT NAME: FAMPRIDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
2011 00031 Denmark ➤ Subscribe
2012001,C1732548 Lithuania ➤ Subscribe PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
00612 Netherlands ➤ Subscribe 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
2011 00031 Denmark ➤ Subscribe PRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720
2013 00045 Denmark ➤ Subscribe
894 Luxembourg ➤ Subscribe 91894, EXPIRES: 20161101
90033-9 Sweden ➤ Subscribe PRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Cerilliant
McKinsey
Farmers Insurance
QuintilesIMS
Baxter
Teva
Queensland Health
AstraZeneca
Covington

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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