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Last Updated: October 17, 2021

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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 Pharms, 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
⤷  Try it Free⤷  Try it Free10MGTABLET, 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
Actavis Labs Fl Inc DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206836-001 Jan 23, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
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
Micro Labs DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 210158-001 Mar 11, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hikma Pharms DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206646-001 Oct 24, 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
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ⤷  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

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 ⤷  Try it Free ⤷  Try it Free
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Mallinckrodt
McKesson
Dow
Moodys

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