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Last Updated: April 22, 2021

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AMPYRA Drug 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

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SponsorPhase
Milton S. Hershey Medical CenterPhase 1/Phase 2
Weill Medical College of Cornell UniversityPhase 1
Hospital for Special Surgery, New YorkPhase 1

See all AMPYRA clinical trials

Pharmacology for AMPYRA
Paragraph IV (Patent) Challenges for AMPYRA
Tradename Dosage Ingredient NDA Submissiondate
AMPYRA TABLET, EXTENDED RELEASE;ORAL dalfampridine 022250 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   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for AMPYRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2377536 25/2013 Austria   Start Trial PRODUCT NAME: 4-AMINOPYRIDIN ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
1732548 PA2012001,C1732548 Lithuania   Start Trial PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
0484186 SPC/GB11/055 United Kingdom   Start Trial PRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720
2377536 92275 Luxembourg   Start Trial PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720
0484186 1190033-9 Sweden   Start Trial PRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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