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Profile for Tradename: AMPYRA

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Ampyra is a drug marketed by Acorda and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-one patent family members in twenty-two countries.

The generic ingredient in AMPYRA is dalfampridine. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalfampridine profile page.

Summary for Tradename: AMPYRA

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Clinical Trials for: AMPYRA

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

A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Status: Active, not recruiting Condition: Non Arteritic Ischemic Optic Neuropathy

A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
Status: Completed Condition: Parkinson's Disease; Gait Disorders

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 Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
Status: Completed Condition: Healthy

Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Status: Recruiting Condition: Multiple Sclerosis

Short and Long Term Treatment With 4-AP in Ambulatory SMA Patients
Status: Active, not recruiting Condition: Spinal Muscular Atrophy

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

A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis
Status: Active, not recruiting Condition: Multiple Sclerosis, Remittent Progressive; Multiple Sclerosis, Primary Progressive; Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Multiple Sclerosis

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, 2010RXYes5,540,938<disabled><disabled>
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010RXYes<disabled><disabled>
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>
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Paragraph IV activity for: AMPYRA

Drugname Dosage Strength RLD Submissiondate
dalfampridineExtended-release Tablets10 mgAmpyra1/22/2014

International Patent Family for Tradename: AMPYRA

Country Document Number Publication Date
Ireland903952May 22, 1992
Japan5736100Jun 17, 2015
European Patent Office1732548Jun 08, 2011
Czechoslovakia9103313May 13, 1992
CroatiaP20110497Aug 31, 2011
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Preferred citation:

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

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