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Last Updated: February 4, 2023

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, Hikma, Micro Labs, Rising, 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. Eleven 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
European University of LefkeN/A
National Institute of Neurological Disorders and Stroke (NINDS)Early Phase 1
Shirley Ryan AbilityLabEarly Phase 1

See all dalfampridine clinical trials

Generic filers with tentative approvals for DALFAMPRIDINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10MGTABLET, 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 Strength NDA ANDAs Submitted Submissiondate
AMPYRA Extended-release Tablets dalfampridine 10 mg 022250 8 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
Hikma DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206646-001 Oct 24, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206863-001 Jul 11, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206811-001 Jan 23, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206765-001 Jul 30, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206858-001 Jul 6, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for dalfampridine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 See Plans and Pricing See Plans and Pricing
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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