Dalfampridine Patent Expiration

Dalfampridine is Used for improving walking in patients with multiple sclerosis. It was first introduced by Merz Pharmaceuticals Llc in its drug Ampyra on Jan 22, 2010. 9 different companies have introduced drugs containing Dalfampridine.


Dalfampridine Patents

Given below is the list of patents protecting Dalfampridine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Ampyra US8007826 Sustained release aminopyridine composition May 26, 2027 Merz
Ampyra US8354437 Method of using sustained release aminopyridine compositions Dec 22, 2026 Merz
Ampyra US8440703 Methods of using sustained release aminopyridine compositions Apr 08, 2025

(Expired)

Merz
Ampyra US8663685 Sustained release aminopyridine composition Jan 18, 2025

(Expired)

Merz
Ampyra US9918973 Sustained release aminopyridine composition Dec 13, 2024

(Expired)

Merz
Ampyra US5540938 Formulations and their use in the treatment of neurological diseases Jul 30, 2018

(Expired)

Merz



Dalfampridine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Dalfampridine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma Milton S. Hershey Medical Center NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Double Dose 4-AP on Functional Recovery After Spinal Cord Injury Shirley Ryan AbilityLab NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2


Dalfampridine Generic API Manufacturers

Several generic applications have been filed for Dalfampridine. The first generic version for Dalfampridine was by Actavis Laboratories Fl Inc and was approved on Jan 23, 2017. And the latest generic version is by Rising Pharma Holding Inc and was approved on Jul 6, 2020.

Given below is the list of companies who have filed for Dalfampridine generic, along with the locations of their manufacturing plants worldwide.