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Last Updated: March 19, 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
Milton S. Hershey Medical CenterPhase 2/Phase 3
Hospital for Special Surgery, New YorkPhase 1
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try a Trial ⤷  Try a Trial
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AMPYRA

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

Country Patent Number Title Estimated Expiration
European Patent Office 2377536 Procédés d'utilisation de compositions d'aminopyridine à libération prolongée (Methods of Using Sustained Release Aminopyridine Compositions) ⤷  Try a Trial
Poland 1732548 ⤷  Try a Trial
Canada 2562277 UTILISATION DE COMPOSITIONS D'AMINOPYRIDINE A LIBERATION SOUTENUE (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS) ⤷  Try a Trial
Portugal 1732548 ⤷  Try a Trial
Slovenia 2377536 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMPYRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2377536 2013/024 Ireland ⤷  Try a Trial PRODUCT NAME: 4-AMINOPYRIDINE (FAMPRIDINE) OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/11/699/001-EU/1/22/699-002 20110720
1732548 CA 2012 00004 Denmark ⤷  Try a Trial
1732548 PA2012001 Lithuania ⤷  Try a Trial PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
2377536 300612 Netherlands ⤷  Try a Trial 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
1732548 C300515 Netherlands ⤷  Try a Trial PRODUCT NAME: 4-AMINOPYRIDINE EN DERIVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
>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.