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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKesson
Mallinckrodt
US Army
McKinsey
Novartis
Daiichi Sankyo
Cerilliant
UBS
Julphar

Generated: October 22, 2017

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 one supplier. 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 nine 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 NDA: 022250

Tradename:
1
Applicant:
1
Ingredient:
1
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 Acorda Therapeutics, Inc. 10144-427 10144-427-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jan 22, 2010TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 22, 2017
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Jul 30, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
Patent:► SubscribePatent Expiration:May 26, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)

Expired Orange Book Patents for NDA: 022250

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda
AMPYRA
dalfampridine
TABLET, EXTENDED RELEASE;ORAL022250-001Jan 22, 2010► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson
Citi
Chinese Patent Office
Accenture
Chubb
Daiichi Sankyo
Queensland Health
Healthtrust
Cerilliant

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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