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Last Updated: July 15, 2024

AMPYRA Drug Patent Profile


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When do Ampyra patents expire, and when can generic versions of Ampyra launch?

Ampyra is a drug marketed by Acorda and is included in one NDA.

The generic ingredient in AMPYRA is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ampyra

A generic version of AMPYRA was approved as dalfampridine by ACTAVIS LABS FL INC on January 23rd, 2017.

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Drug patent expirations by year for AMPYRA
Drug Prices for AMPYRA

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Recent Clinical Trials for AMPYRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
MGH Institute of Health ProfessionsPhase 4
Milton S. Hershey Medical CenterPhase 2/Phase 3
Weill Medical College of Cornell UniversityPhase 1

See all AMPYRA clinical trials

Pharmacology for AMPYRA
Paragraph IV (Patent) Challenges for AMPYRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AMPYRA Extended-release Tablets dalfampridine 10 mg 022250 8 2014-01-22

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AMPYRA

See the table below for patents covering AMPYRA around the world.

Country Patent Number Title Estimated Expiration
Portugal 1732548 ⤷  Sign Up
European Patent Office 2422782 Utilisation de compositions d'aminopyridine à libération soutenue (Methods of Using Sustained Release Aminopyridine Compositions) ⤷  Sign Up
European Patent Office 0484186 Formulations et leur utilisation dans le traitement de maladies neurologiques (Formulations and their use in the treatment of neurological diseases) ⤷  Sign Up
Germany 69131880 ⤷  Sign Up
Montenegro 01721 POSTUPCI ZA PRIMJENU KOMPOZICIJA AMINOPIRIDINA SA PRODUŽENIM OSLOBAĐANJEM (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS) ⤷  Sign Up
Portugal 2377536 ⤷  Sign Up
Denmark 2377536 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMPYRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0484186 11C0049 France ⤷  Sign Up PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001 20110720
2377536 132013902176892 Italy ⤷  Sign Up PRODUCT NAME: FAMPRIDINA(FAMPYRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/699/001-002, 20110720
1732548 C20120002 00051 Estonia ⤷  Sign Up PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
1732548 C300515 Netherlands ⤷  Sign Up PRODUCT NAME: 4-AMINOPYRIDINE EN DERIVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
1732548 CA 2012 00004 Denmark ⤷  Sign Up
2377536 C02377536/01 Switzerland ⤷  Sign Up PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67139 22.08.2019
2377536 13C0033 France ⤷  Sign Up PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.