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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-one patent family members in twenty-two 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
Formulation / Manufacturing:see details

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: Active, not recruiting 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

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

Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis
Status: Terminated Condition: Transverse Myelitis

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, 2010RXYes8,440,703<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, 2010RXYes8,354,437<disabled><disabled>
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes8,663,685<disabled><disabled>
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes<disabled><disabled>
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International Patent Family for Ingredient: dalfampridine

Country Document Number Publication Date
Serbia51808Dec 31, 2011
Greece3032769Jun 30, 2000
European Patent Office0484186Dec 29, 1999
European Patent Office1732548Mar 21, 2012
Czechoslovakia9103313May 13, 1992
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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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