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Last Updated: December 7, 2021

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DALFAMPRIDINE Drug Patent Profile


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Which patents cover Dalfampridine, and when can generic versions of Dalfampridine launch?

Dalfampridine is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma Ltd, Hikma Pharms, Micro Labs, Mylan, and Sun Pharm. and is included in eight NDAs.

The generic ingredient in DALFAMPRIDINE is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dalfampridine

A generic version of DALFAMPRIDINE was approved as dalfampridine by ACTAVIS LABS FL INC on January 23rd, 2017.

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Drug patent expirations by year for DALFAMPRIDINE
Drug Prices for DALFAMPRIDINE

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Recent Clinical Trials for DALFAMPRIDINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Milton S. Hershey Medical CenterPhase 2/Phase 3
Weill Medical College of Cornell UniversityPhase 1
Hospital for Special Surgery, New YorkPhase 1

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Pharmacology for DALFAMPRIDINE
Paragraph IV (Patent) Challenges for DALFAMPRIDINE
Tradename Dosage Ingredient NDA Submissiondate
AMPYRA TABLET, EXTENDED RELEASE;ORAL dalfampridine 022250 2014-01-22

US Patents and Regulatory Information for DALFAMPRIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206863-001 Jul 11, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206858-001 Jul 6, 2020 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma Ltd DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206811-001 Jan 23, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Colorcon
Boehringer Ingelheim
Medtronic
AstraZeneca

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 verification 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.