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Dalfampridine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dalfampridine?

Dalfampridine is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Actavis Labs Fl Inc, and Acorda, and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-five patent family members in twenty-three countries.

There are nine drug master file entries for dalfampridine. One supplier is listed for this compound. There are eight tentative approvals for this compound.

Summary for Generic Name: dalfampridine

Tradenames:2
Patents:6
Applicants:3
NDAs:3
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list101
Clinical Trials: see list22
Patent Applications: see list1,824
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dalfampridine at DailyMed

Pharmacology for Ingredient: dalfampridine

Tentative approvals for DALFAMPRIDINE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL10MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL10MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL10MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYesYes8,440,703► Subscribe ► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYesYes► Subscribe► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYesYes8,354,437► Subscribe ► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYesYes8,663,685► Subscribe ► Subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYesYes5,540,938► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dalfampridine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 20105,370,879► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dalfampridine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,580,580 Formulations and their use in the treatment of neurological diseases► Subscribe
5,370,879 Formulations and their use in the treatment of neurological diseases► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: dalfampridine

Country Document Number Estimated Expiration
MexicoPA06011648► Subscribe
Portugal1732548► Subscribe
Japan2015157861► Subscribe
Japan2007532578► Subscribe
Canada2870734► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DALFAMPRIDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012001Lithuania► SubscribePRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
2011100058Germany► SubscribePRODUCT NAME: FAMPYRA - ZUSAMMENSETZUNG UMFASSEND FAMPRIDIN SOWIE SALZE ODER ESTER DAVON; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
90033-9Sweden► SubscribePRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720
00515Netherlands► SubscribePRODUCT NAME: FAMPRIDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
C0049France► SubscribePRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001 20110720
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