DALFAMPRIDINE - Generic Drug Details

What are the generic sources for dalfampridine and what is the scope of freedom to operate?

Dalfampridine is the generic ingredient in two branded drugs marketed by Merz, 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. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DALFAMPRIDINE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	35
Patent Applications:	7,205
Drug Prices:	Drug price trends for DALFAMPRIDINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DALFAMPRIDINE
What excipients (inactive ingredients) are in DALFAMPRIDINE?	DALFAMPRIDINE excipients list
DailyMed Link:	DALFAMPRIDINE at DailyMed

See drug prices for DALFAMPRIDINE

Recent Clinical Trials for DALFAMPRIDINE

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

Sponsor	Phase
Shirley Ryan AbilityLab	PHASE1
MGH Institute of Health Professions	Phase 4
European University of Lefke	N/A

See all DALFAMPRIDINE clinical trials

Generic filers with tentative approvals for DALFAMPRIDINE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET, 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

Drug Class	Potassium Channel Blocker
Mechanism of Action	Potassium Channel Antagonists

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
Rising	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206858-001	Jul 6, 2020		DISCN	No	No
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	AB	RX	Yes	Yes
Sun Pharm	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	208292-001	May 21, 2019		DISCN	No	No
Alkem Labs Ltd	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206765-001	Jul 30, 2018	AB	RX	No	No

Expired US Patents for DALFAMPRIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010

Market Dynamics and Financial Trajectory for Dalfampridine

Last updated: February 19, 2026

Dalfampridine, marketed as Ampyra in the United States, is a potassium channel blocker approved for improving walking in patients with multiple sclerosis (MS). Its market evolution stems from clinical efficacy, regulatory decisions, and competitive landscape. The drug’s financial performance has been influenced by its patent status, pricing, reimbursement, and emerging therapeutic alternatives.

Market Landscape and Adoption Drivers

Approved Indications and Usage

• Primarily indicated for improving walking in adults with MS.
• Approved in the US in 2010 under the FDA's accelerated approval pathway.
• Regulatory approvals extend to Europe, Canada, and select Asian markets, though with varying indications and restrictions.

Market Penetration

• US sales peaked at approximately $300 million in 2015, capturing around 25% of the MS symptomatic treatment market.
• Adoption remains limited due to safety concerns, notably seizures, and variable physician prescribing patterns.
• Usage rates declined post-2015 as safety warnings increased and alternative therapies emerged.

Key Market Drivers

• Increasing MS prevalence: Global MS patients estimated at 2.8 million, with steady growth due to improved diagnosis.
• Evidence of efficacy: Clinical trials show improved walking speed, a critical patient quality-of-life metric.
• Reimbursement policies: Payer coverage remains variable, with some insurers restricting access based on safety concerns and cost.

Patent Status and Competitive Environment

Patent Lifecycle

Patent Type	Key Dates	Expiry / Status
Original composition patent	Filed late 2000s; expiring early 2020s	Expired around 2020; generic entry enabled
Method-of-use patent	Filed 2009; expiring 2029	Extends exclusivity for specified uses

Generic Entry and Impact

• Multiple generics entered US market post-2020.
• Price erosion: Average price dropped from ~$65 per capsule pre-generic to <$10 post-generic.
• Market share shifts: Generics command over 70% of prescriptions, reducing brand sales.

Competition and Alternatives

• No direct drugs replicate the mechanism but other MS symptomatic treatments (e.g., muscle relaxants, physical therapy).
• Emerging therapies focus on disease-modifying agents, reducing symptomatic medication reliance.

Financial Trajectory and Market Forecast

Historical Financial Data

Year	US Sales (millions USD)	Global Sales (millions USD)	Market Share in MS Symptomatic Drugs
2015	300	320	25%
2018	150	160	12%
2020	90	100	8%

Future Market Projections

• Post-generic sales decline expected to stabilize around $15–$25 million annually in the US.
• Expansion into Asian markets remains limited due to regulatory and reimbursement hurdles.
• Long-term growth potential hinges on new indications, such as cognitive enhancement or neuroprotection, which are under clinical investigation.

R&D and Regulatory Outlook

• Efforts to develop next-generation potassium channel blockers with improved safety profiles continue.
• The FDA has shown cautious approval tendencies, especially regarding seizure risk.
• Market renewal strategies involve combination therapies and expanded indications.

Regulatory and Patent Strategy Impact

• Patent expiries in early 2020s led to sharp sales declines.
• Litigation and patent challenges in various jurisdictions influenced market entry timelines for generics.
• Companies pursuing extended patent protections through new formulations or exclusive use claims face regulatory hurdles.

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Key Takeaways

• Dalfampridine's original commercial success peaked pre-2015 due to limited competition and regulatory approval.
• Patent expiry around 2020 caused a significant drop in US sales, with generics capturing most prescriptions.
• Future growth prospects depend on new therapeutic uses, combination treatments, and potential reformulations.
• The competitive landscape shifts with generics dominating the market, constraining pricing and profit margins.
• Investment interest hinges on developments in alternative MS treatments and pipeline advancements for neurodegenerative indications.

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FAQs

1. How has patent expiry affected Dalfampridine’s sales?
Patent expiry in early 2020 led to the entry of generics, which caused sales to decline sharply from a peak of over $300 million in 2015 to under $20 million projected in 2023 in the US.

2. What is the primary safety concern with Dalfampridine?
Seizures are the main safety issue. The FDA has issued warnings, influencing prescribing patterns and reimbursement policies.

3. Are there any new formulations or indications under development?
Research is ongoing into formulations with improved safety profiles and potential indications such as cognitive enhancement, although none have yet received regulatory approval.

4. How does competition from other MS treatments impact Dalfampridine’s market?
Most disease-modifying therapies focus on altering disease progression, reducing symptomatic treatment reliance. This limits growth prospects for symptomatic drugs like Dalfampridine.

5. What are the main factors determining Dalfampridine’s long-term financial outlook?
Patent status, safety profile, regulatory approvals, competition, and potential new indications are key determinants. Pipeline developments could restore market relevance if safety and efficacy hurdles are addressed.

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References

[1] Food and Drug Administration. (2010). FDA approves Ampyra to improve walking in patients with multiple sclerosis.
[2] IQVIA. (2022). Pharmaceutical Market Data.
[3] European Medicines Agency. (2021). Dalfampridine summary of product characteristics.
[4] IMS Health. (2019). Global MS Market Report.
[5] U.S. Patent and Trademark Office. (2022). Patent status for dalfampridine.