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Last Updated: July 6, 2020

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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. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in nineteen countries.

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

US ANDA 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 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 Y   Start Trial
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   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 C300612 Netherlands   Start 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
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
0484186 CR 2011 00031 Denmark   Start Trial PRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720
2377536 CA 2013 00045 Denmark   Start Trial
1732548 CA 2012 00004 Denmark   Start Trial
1732548 C20120002 00051 Estonia   Start Trial PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Harvard Business School
AstraZeneca
Colorcon
Medtronic

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