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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022250

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NDA 022250 describes AMPYRA, which is a drug marketed by Acorda and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AMPYRA profile page.

The generic ingredient in AMPYRA is dalfampridine. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
Summary for 022250
Tradename:AMPYRA
Applicant:Acorda
Ingredient:dalfampridine
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 022250
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 022250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-0509 0378-0509-91 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0509-91)
AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250 NDA Acorda Therapeutics, Inc. 10144-427 10144-427-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)
Paragraph IV (Patent) Challenges for 022250
Tradename Dosage Ingredient NDA Submissiondate
AMPYRA TABLET, EXTENDED RELEASE;ORAL dalfampridine 022250 2014-01-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jan 22, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 26, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
Patent:  Start TrialPatent Expiration:Dec 22, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
Patent:  Start TrialPatent Expiration:Apr 8, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)

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