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Details for Generic Name: dalfampridine

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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-four patent family members in twenty-three countries.

There are seven drug master file entries for dalfampridine. One supplier is listed 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

Clinical Trials for: dalfampridine

Ampyra for Optic Neuritis in MS
Status: Completed Condition: Multiple Sclerosis; Optic Neuritis

An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)
Status: Completed Condition: Multiple Sclerosis

A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Status: Completed Condition: Non Arteritic Ischemic Optic Neuropathy

Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis

Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury
Status: Recruiting Condition: Spinal Cord Injury

Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
Status: Completed Condition: Cerebral Palsy (CP)

Dalfampridine and Gait in Spinocerebellar Ataxias
Status: Completed Condition: Spinocerebellar Ataxias Type 1; Spinocerebellar Ataxias Type 2; Spinocerebellar Ataxias Type 3; Spinocerebellar Ataxias Type 6

Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
Status: Recruiting Condition: Sleep Apnea, Obstructive

A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis

A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke
Status: Recruiting Condition: Post-Ischemic Stroke

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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, 2010RXYes<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

These historical archives are available as an add-on to one-year subscriptions

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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International Patent Family for Ingredient: dalfampridine

Country Document Number Publication Date
Japan2007532578Nov 15, 2007
Slovenia2377536Jul 31, 2013
World Intellectual Property Organization (WIPO)2004082684Sep 30, 2004
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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