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Dalfampridine - Generic Drug Details

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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:5
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

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
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, 2010RXYesYes8,007,826► subscribe ► subscribe
Aurobindo Pharma Ltd
DALFAMPRIDINE
dalfampridine
TABLET, EXTENDED RELEASE;ORAL206811-001Jan 23, 2017RXNoNo► subscribe► subscribe
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYesYes8,440,703► 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
Hong Kong1162971► subscribe
Spain2367707► subscribe
CroatiaP20110497► 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
C/GB11/055United Kingdom► subscribePRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720
C0033France► subscribePRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110725
2012001,C1732548Lithuania► subscribePRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
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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 verifification 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.

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