AMPYRA Drug Patent Profile

Which patents cover Ampyra, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMPYRA

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

International Patents for AMPYRA

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

Country	Patent Number	Title	Estimated Expiration
Montenegro	01836	POSTUPCI UPOTREBE SASTAVA AMINOPIRIDINA S ODLOŽENIM OSLOBAĐANJEM (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS)
Portugal	2377536
Australia	2005232732	Methods of using sustained release aminopyridine compositions
Luxembourg	92275
Australia	8696191
Luxembourg	92275
New Zealand	240439	CONTROLLED RELEASE COMPOSITION COMPRISING A MONO- OR DI-AMINOPYRIDINE; PELLET COMPRISING CORE OF ACTIVE AGENT AND A SURROUNDING MULTI-LAYER MEMBRANE

Supplementary Protection Certificates for AMPYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0484186	CA 2011 00031	Denmark
2377536	300612	Netherlands		PRODUCT NAME: 4-AMINOPYRIDINE, DAN WEL EEN DERIVAAT DAARVAN, IN HET BIJZONDER EEN ZOUT, SOLVAAT OF PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
2377536	SPC/GB13/050	United Kingdom		PRODUCT NAME: 4-AMINOPYRIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/699/001-004 20110725
1732548	PA2012001	Lithuania		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
1732548	PA2012001,C1732548	Lithuania		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
1732548	C20120002 00051	Estonia		PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
0484186	91894	Luxembourg		91894, EXPIRES: 20161101

Summary

Last updated: February 10, 2026

Ampyra (dalfampridine) is a drug approved to improve walking in adults with multiple sclerosis (MS). Its market potential hinges on factors such as approval status, competitive landscape, safety profile, and insurance reimbursement. The drug’s fundamentals, including sales trends, regulatory positioning, and patent horizon, reveal a niche product with limited growth opportunities compared to broader MS treatment classes.

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What Is AmPYRA’s Current Market and Regulatory Position?

AmPYRA was approved by the FDA in 2010 for MS-related gait impairment. It is marketed as a single-entity formulation, dalfampridine (25 mg twice daily). It has no multiple indications outside MS.

The European Medicines Agency (EMA) approved it in 2011, but reimbursement policies vary across countries, affecting uptake. Its regulatory exclusivity expires in the coming years, though some patents extend into the mid-2030s.

Regulatory and Patent Timeline:

Year	Event
2010	FDA approval in the U.S.
2011	EMA approval
2012-2022	Patent exclusivity period in key markets
2025+	Patent expiry and potential generic entry in the U.S.

What Are the Key Drivers and Barriers for AmPYRA’s Market?

Drivers

• Unmet Need: No cure for MS; AmPYRA offers symptomatic relief in gait impairment.
• Market Size: Estimated U.S. MS population: approximately 1 million; about 35% exhibit gait issues [1].
• Insurance Coverage: Many payers reimburse the drug, fueling sales. Medicare and private insurers accept it based on clinical guidelines.

Barriers

• Efficacy Limitations: Modest improvements in walking speed, with variability in response.
• Safety Concerns: Side effects, such as seizures and urinary tract infections, restrict use.
• Market Competition: Dalfampridine faces competition from emerging symptomatic therapies and future generics.

Market Penetration and Revenue (Estimated):

Year	U.S. Sales ($ millions)	Comments
2015	250	Sales plateaued due to safety concerns
2018	200	Slight decline with generics approaching
2022	180	Continued erosion, limited new patient growth

What Is the Patent and Exclusivity Outlook?

The primary patent protecting AmPyra expires around 2025. Manufacturers may file for filings in other jurisdictions or obtain secondary patents, but these are vulnerable to patent challenges. The expiration opens the market to generics, which could reduce prices sharply.

What Are the Financial and Strategic Implications?

• Revenue Plateau: Given the drug’s niche status and safety profile, revenue growth is limited.
• Generic Entry Impact: Anticipated around 2025, likely leading to significant revenue decline.
• Pipeline and Line Extensions: No significant pipeline of reformulations or new indications; strategic focus remains on maintaining existing market share.

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How Does AmPYRA Compare to Other Symptomatic MS Treatments?

Drug	Indication	Market Status	Key Limitation
AmPYRA (dalfampridine)	Gait impairment in MS	Approved, niche	Safety concerns, modest efficacy
Ampyra competitors	Various	None	N/A
Emerging therapies	Symptomatic or disease-modifying	Early-stage	Limited proven efficacy, regulatory hurdles

What Are Future Opportunities and Risks?

Opportunities

• Development of safer, more effective gait-enhancing drugs.
• Regulatory expansion for additional indications.
• Reimbursement increases with positive real-world evidence.

Risks

• Patent expiration prompting generic competition.
• Safety and efficacy limitations capping market share.
• Market shift to disease-modifying therapies reducing symptomatic treatment relevance.

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Key Takeaways

• AmPYRA is a niche MS symptomatic therapy approved in 2010, addressing gait impairment.
• It faces blockades from safety concerns, modest efficacy, and eventual patent expiration (expected 2025).
• Revenue has stabilized but is subject to sharp decline post-generic entry.
• The competitive landscape favors broader MS disease-modifying therapies with higher efficacy.
• Future growth depends on pipeline developments, regulatory strategies, and evolving reimbursement policies.

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FAQs

1. How significant is AmPYRA’s current market?
U.S. sales hovered around $180 million in 2022, representing approximately 10-15% of total MS drug sales, primarily within the gait impairment subset.

2. What is the patent expiry date?
Primarily around 2025 in the U.S., with some patent extensions possibly delaying generic entry until 2026–2027.

3. What are primary safety concerns?
Seizures, urinary tract infections, and CNS side effects limit broad use and patient adherence.

4. How might insurers’ reimbursement policies change?
Insurance coverage is currently favorable, but post-patent expiration, coverage may decline if generics are heavily promoted and priced lower.

5. Are there pipeline alternatives?
No significant reformulations or indications are under advanced development; the focus remains on maintaining current sales levels.

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References

[1] Multiple Sclerosis Association of America. "MS Disease Statistics." 2022.