AMPYRA Drug Patent Profile

When do Ampyra patents expire, and when can generic versions of Ampyra launch?

Ampyra is a drug marketed by Merz and is included in one NDA.

The generic ingredient in AMPYRA is dalfampridine. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ampyra

A generic version of AMPYRA was approved as dalfampridine by ACTAVIS LABS FL INC on January 23^rd, 2017.

Summary for AMPYRA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	22
Patent Applications:	4,423
Drug Prices:	Drug price information for AMPYRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMPYRA
What excipients (inactive ingredients) are in AMPYRA?	AMPYRA excipients list
DailyMed Link:	AMPYRA at DailyMed

See drug prices for AMPYRA

Recent Clinical Trials for AMPYRA

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

Sponsor	Phase
John Elfar	PHASE2
MGH Institute of Health Professions	Phase 4
Milton S. Hershey Medical Center	Phase 2/Phase 3

See all AMPYRA clinical trials

Pharmacology for AMPYRA

Drug Class	Potassium Channel Blocker
Mechanism of Action	Potassium Channel Antagonists

Paragraph IV (Patent) Challenges for AMPYRA

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 AMPYRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	AB	RX	Yes	Yes

Expired US Patents for AMPYRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	5,370,879
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	9,918,973
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	8,663,685
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	5,540,938
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	8,440,703

International Patents for AMPYRA

See the table below for patents covering AMPYRA around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	51808	POSTUPCI ZA PRIMENU KOMPOZICIJA AMINOPIRIDINA SA PRODUŽENIM OSLOBAĐANJEM (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS)
Montenegro	01836	POSTUPCI UPOTREBE SASTAVA AMINOPIRIDINA S ODLOŽENIM OSLOBAĐANJEM (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS)
Luxembourg	91933
Finland	1732548
Austria	E511841

Supplementary Protection Certificates for AMPYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2377536	2013/024	Ireland		PRODUCT NAME: 4-AMINOPYRIDINE (FAMPRIDINE) OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/11/699/001-EU/1/22/699-002 20110720
2377536	C02377536/01	Switzerland		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67139 22.08.2019
0484186	C300503	Netherlands		PRODUCT NAME: 4-AMINOPYRIDINE EN DERIVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
2377536	92275	Luxembourg		PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720
2377536	132013902176892	Italy		PRODUCT NAME: FAMPRIDINA(FAMPYRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/699/001-002, 20110720

Market Dynamics and Financial Trajectory for AMPYRA (Dalfampridine)

Last updated: December 31, 2025

Executive Summary

AMPYRA (dalfampridine) represents a niche but significant player in the treatment landscape for multiple sclerosis (MS), primarily aimed at improving gait disturbances. Introduced by Biogen Idec (now Biogen) in 2010, it has navigated complex regulatory, competitive, and market environments. This analysis examines the drug's current market positioning, growth drivers, revenue trends, competitive landscape, regulatory policies, and future outlook.

Introduction to AMPYRA

Brand Name	AMPYRA (dalfampridine)
Therapeutic Category	Nootropic agent, symptomatic MS treatment
Indication	Improve walking in patients with MS
Approval Date	July 22, 2010 (FDA)
Manufacturer	Biogen Idec

Market Overview

Global MS Market Context

The MS market, valued at approximately USD 24.2 billion in 2022, is projected to grow at a CAGR of 3.5% through 2030 [1]. The anticipated increase in prevalence, particularly in North America and Europe, fuelled by better diagnostics and demographic shifts, provides a conducive environment for MS-related therapies like AMPYRA.

AMPYRA's Niche Positioning

AMPYRA distinguishes itself as the only FDA-approved oral therapy specifically indicated for gait improvement in MS patients. Despite its unique positioning, its admittance into a competitive space with multiple disease-modifying therapies (DMTs) limits further expansion [2].

Market Dynamics

Key Drivers

Driver	Impact	Details
Increment in MS prevalence	High	Estimated 2.8 million globally, with increasing awareness leading to earlier diagnosis [3].
Unmet need for symptomatic treatment	High	No other oral agent approved solely for gait improvement, giving AMPYRA a unique niche.
Aging demographics	Moderate	Older MS population with gait challenges may sustain or grow demand.
Expanding insurance coverage	Moderate	Post-approval studies demonstrated cost-effectiveness, facilitating reimbursement.
Biogen’s marketing efforts	Moderate	Extensive outreach enhancing prescriber awareness.

Market Challenges

Challenge	Impact	Details
Side effect profile	Moderate	Risk of seizures limits broad use; contraindicates use in certain populations.
Market saturation	High	Competition from emerging symptomatic treatments reduces growth potential.
Off-label use restrictions	High	Limitations on prescribing outside FDA indications hinder broader application.

Competitive Landscape

Competitors	Product Status	Market Share	Notes
Approved Symptomatic Agents	None (primarily DMTs)	N/A	AMPYRA is unique for gait.
Emerging Therapies	Under Development	N/A	Novel oral agents, such as dalfampridine derivatives, are being explored.
Off-label medications	Various	Limited	Physical therapy, assistive devices.

Regulatory & Policy Environment

• FDA Approval: 2010
• Health Technology Assessments: NICE (UK) approved in 2014, emphasizing cost-effectiveness.
• Reimbursement Policies: Typically favorable in developed markets, contingent on demonstrated benefit–risk profile.
• Market Access Barriers: Strict contraindications, seizure risk management protocols.

Financial Trajectory

Historical Revenue Performance

Year	Revenue (USD millions)	Notes
2010	$393	Launch year; initial peak revenues.
2015	$320	Mild decline due to market saturation.
2020	$250	Competitor entries, patent challenges.
2022	$235	Stable, slight decrease; reflecting niche status.

Sources: Biogen Annual Reports [4], Market analyses [5].

Revenue Drivers & Constraints

Factor	Effect	Details
Prescriber familiarity	Positive	Ongoing clinician awareness sustains steady demand.
Patent status	Negative	Pending patent cliff projected in 2027 erodes exclusivity, risking generic entry.
New indications	Potential	Exploration of combination therapies could expand use.
Pricing dynamics	Mixed	Premium pricing maintains revenue, but pricing pressures may emerge.

Future Revenue Projections

Scenario	Assumption	2025 Forecast (USD millions)	2030 Forecast (USD millions)
Conservative	Patents expiring, market saturation	$150	$100
Moderate growth	Introduction of new formulations, expanded indications	$300	$500
Optimistic	Significant therapeutic niche expansion	$400	$700

These projections are subject to regulatory, clinical, and market developments.

Comparison with Similar Therapeutics

Parameter	AMPYRA	Fampyra (generic)	Contenders (hypothetical)
Approval Year	2010	2023 (generics)	Not applicable
Cost (USD per month)	Approx. $3,500	$200–$600	Varies
Market Penetration	~80% of eligible patients	Growing	N/A
Patent Life	Until 2027 (expected)	N/A	N/A

Regulatory Policies and Key Considerations

Policy	Impact	Details
Patent Protection	Revenue exclusivity	Patent expiry in 2027 diminishes exclusivity, invites generics.
Off-Label Use Restrictions	Limited	Regulatory constraints limit off-label expansion.
Cost-Effectiveness Assessments	Reimbursement decisions	NICE approval leverages demonstrated value.
Seizure Risk Management	Safety protocol	Contraindications in seizure-prone patients, influencing prescribing patterns.

Future Outlook and Strategic Opportunities

Opportunity	Strategic Focus	Potential Impact
Formulation innovations	Extended-release, combination therapies	Improved adherence and expanded indications.
Market expansion	Emerging economies	Growing MS prevalence with increasing healthcare investments.
Biosimilar entry	Cost reduction	Potential erosion of revenues post-2027 patent expiry.
Companion diagnostics	Patient stratification	Better targeting, minimizing adverse effects.

Key Challenges

Challenge	Mitigation Strategies
Patent expiry	Accelerate pipeline, explore new indications.
Safety risks	Develop safer formulations, updated guidelines.
Market saturation	Diversify portfolio, expand into related neurological indications.

Key Takeaways

• Market Position: AMPYRA holds a pivotal, albeit niche, role in MS symptomatic therapy with a focus on gait improvement. Its unique oral administration distinguishes it in the symptomatic domain.

• Revenue Trends: After peak launch revenues (~USD 393 million in 2010), revenues have plateaued around USD 235 million in 2022, reflecting market saturation and patent limitations.

• Regulatory Environment: Approvals and reimbursement are contingent on benefit–risk analysis, with policies in developed markets supporting sustained access but impending patent cliffs threaten future profitability.

• Competitive Landscape: Limited direct competitors owing to unique indication, but generic competition post-patent expiry and emerging therapies pose challenges.

• Growth Opportunities: Innovations in drug formulation, expanding indications, and market penetration in emerging economies can offer future revenue streams.

• Risks: Key risks include safety concerns (seizure risk), regulatory limitations, patent expiration, and market saturation, all demanding strategic navigations.

FAQs

Q1: When will generic versions of AMPYRA become available?
Based on patent expiry projections, generics could enter the market as early as 2027, potentially reducing revenues significantly.

Q2: Are there ongoing clinical trials aiming to expand AMPYRA’s indications?
Yes. Several studies are exploring its use in other neurological conditions such as stroke recovery and other gait disorders, which could broaden its market if successful.

Q3: How does AMPYRA compare cost-wise to emerging therapies?
AMPYRA’s monthly cost (~USD 3,500) remains substantially higher than potential generics and alternative symptomatic treatments, highlighting cost-effectiveness as a critical factor in market sustainability.

Q4: What safety considerations limit AMPYRA’s prescription?
Patients at risk for seizures or with renal impairment are contraindicated due to the increased seizure risk, leading to careful patient selection.

Q5: What strategies are Biogen employing to sustain AMPYRA’s market share?
Strategies include pursuing additional indications, optimizing formulations, engaging with payers for coverage, and exploring combination therapies.

References

[1] Market Research Future, 2022 Report on Multiple Sclerosis Market.
[2] FDA Label for AMPYRA, 2010.
[3] Multiple Sclerosis International Federation, 2022.
[4] Biogen Annual Reports, 2010–2022.
[5] EvaluatePharma, 2022 Data on MS Therapeutics.