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Dalfampridine - Generic Drug Details

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Dalfampridine is the generic ingredient in one branded drug marketed by Acorda and is included in one NDA. 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 seven drug master file entries for dalfampridine. One supplier is listed for this compound. There are seven tentative approvals for this compound.

Summary for Generic Name: dalfampridine

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Tentative approvals for DALFAMPRIDINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL10MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL10MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL10MG

Clinical Trials for: dalfampridine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,663,685<disabled> <disabled>
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,007,826<disabled> <disabled>
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,440,703<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: dalfampridine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 20105,370,879<disabled>
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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<disabled in preview>
5,370,879 Formulations and their use in the treatment of neurological diseases<disabled in preview>
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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
Japan2015157861<disabled in preview>
European Patent Office0484186<disabled in preview>
World Intellectual Property Organization (WIPO)2004082684<disabled in preview>
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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
0120002 00051Estonia<disabled>PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
2011100058Germany<disabled>PRODUCT NAME: FAMPYRA - ZUSAMMENSETZUNG UMFASSEND FAMPRIDIN SOWIE SALZE ODER ESTER DAVON; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
00612Netherlands<disabled>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
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