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Last Updated: November 26, 2020

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Dalfampridine - Generic Drug Details

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What are the generic drug sources for dalfampridine and what is the scope of patent protection?

Dalfampridine is the generic ingredient in two branded drugs marketed by Acorda, Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma Ltd, Hikma, Micro Labs, Mylan, and Sun Pharm, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for dalfampridine. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

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 1/Phase 2
Weill Medical College of Cornell UniversityPhase 1
Hospital for Special Surgery, New YorkPhase 1

See all dalfampridine clinical trials

Generic filers with tentative approvals for DALFAMPRIDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Micro Labs DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 210158-001 Mar 11, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 208292-001 May 21, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206811-001 Jan 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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:

Colorcon
Boehringer Ingelheim
Mallinckrodt
McKesson
Dow
Moodys

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