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Serving leading biopharmaceutical companies globally:

Chubb
Baxter
Cerilliant
Accenture
Fuji
Express Scripts
Medtronic
Citi
UBS
Queensland Health

Generated: October 24, 2017

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-five patent family members in twenty-three countries and twenty-two supplementary protection certificates in nine 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.

Summary for Tradename: AMPYRA

US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list101
Clinical Trials: see list19
Patent Applications: see list2,701
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AMPYRA at DailyMed

Pharmacology for Tradename: 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;ORAL022250-001Jan 22, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: AMPYRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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► Subscribe
5,580,580 Formulations and their use in the treatment of neurological diseases► Subscribe
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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
MexicoPA06011648► Subscribe
Serbia53371► Subscribe
Luxembourg92275► Subscribe
Slovenia1732548► Subscribe
CroatiaP20110497► Subscribe
Germany69131880► Subscribe
Japan2007532578► Subscribe
JapanH04273820► Subscribe
Spain2406604► Subscribe
European Patent Office2460521► Subscribe
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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
00515Netherlands► SubscribePRODUCT NAME: FAMPRIDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
C0033France► SubscribePRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110725
2012001Lithuania► SubscribePRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
275Luxembourg► SubscribePRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720
00503Netherlands► SubscribePRODUCT NAME: 4-AMINOPYRIDINE EN DERIVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
0120002 00051Estonia► SubscribePRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
C/GB11/055United Kingdom► SubscribePRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720
2012 00004Denmark► Subscribe
2011 00031Denmark► SubscribePRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720
2013015Lithuania► SubscribePRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Novartis
Chinese Patent Office
Citi
McKesson
Deloitte
Fuji
Express Scripts
Covington
Chubb
Medtronic

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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