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Last Updated: May 25, 2022

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
Weill Medical College of Cornell UniversityPhase 1
Hospital for Special Surgery, New YorkPhase 1

See all AMPYRA clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 See Plans and Pricing See Plans and Pricing
>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
Spain 2141706 See Plans and Pricing
Luxembourg 92275 See Plans and Pricing
Spain 2746354 See Plans and Pricing
Spain 2746354 See Plans and Pricing
Hungary 913447 See Plans and Pricing
Australia 8696191 See Plans and Pricing
Slovenia 2377536 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMPYRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2377536 PA2013015 Lithuania See Plans and Pricing PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
0484186 11C0049 France See Plans and Pricing PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001 20110720
2377536 CA 2013 00045 Denmark See Plans and Pricing
0484186 CA 2011 00031 Denmark See Plans and Pricing
2377536 PA2013015,C2377536 Lithuania See Plans and Pricing PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
2377536 25/2013 Austria See Plans and Pricing PRODUCT NAME: 4-AMINOPYRIDIN ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
0484186 C300503 Netherlands See Plans and Pricing 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.