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 Pharms, 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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	34
Patent Applications:	6,381
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
MGH Institute of Health Professions	Phase 4
European University of Lefke	N/A
National Institute of Neurological Disorders and Stroke (NINDS)	Early Phase 1

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
Hikma	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206646-001	Oct 24, 2018		DISCN	No	No
Accord Hlthcare	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206863-001	Jul 11, 2018	AB	RX	No	No
Actavis Labs Fl Inc	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206836-001	Jan 23, 2017	AB	RX	No	No
Merz Pharms	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	AB	RX	Yes	Yes
Aurobindo Pharma	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206811-001	Jan 23, 2017	AB	RX	No	No
Micro Labs	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	210158-001	Mar 11, 2019	AB	RX	No	No

Expired US Patents for DALFAMPRIDINE

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

DALFAMPRIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dalfampridine

Introduction to Dalfampridine

Dalfampridine, known by its brand name AMPYRA® in the U.S. and FAMPYRA in Europe, is a pharmacologic therapy designed to improve walking in patients with multiple sclerosis (MS). It is an extended-release formulation of 4-aminopyridine, which works by blocking potassium channels and restoring axonal conduction in demyelinated nerves[3].

Market Size and Growth

The global dalfampridine market is projected to experience significant growth from 2024 to 2031. As of 2023, the market size was substantial, with a compound annual growth rate (CAGR) expected to be notable over the forecast period. The 10 mg segment of dalfampridine accounted for a noticeable share of the global market in 2023 and is expected to continue growing significantly[1].

Segmentation and Regional Analysis

The dalfampridine market is segmented based on type (10 mg and others) and application (hospitals, clinics, and others). The hospitals segment is anticipated to expand at a significant CAGR, retaining its position throughout the forecast period.

Geographically, the market is divided into five major regions: North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. North America, particularly the United States, dominates the market due to high prevalence and better healthcare infrastructure. However, the drug's adoption is limited in developing countries due to financial constraints and the high cost of treatment[1][4].

Key Players and Competitive Landscape

Major players in the dalfampridine market include Acorda Therapeutics, Sun Pharmaceutical, Elan Pharma, Biogen, and Aurobindo Pharma. These companies are focusing on strengthening their product portfolios and expanding their business globally. Acorda Therapeutics, for instance, has been working on commercializing its products outside the U.S. and managing the impact of generic competition on its AMPYRA sales[1][2].

Financial Performance of Key Players

Acorda Therapeutics, the primary manufacturer of AMPYRA, reported significant financial results in 2021. Despite losing patent exclusivity in 2018 and facing generic competition, AMPYRA generated $84.6 million in net revenue for the full year 2021, with $22.5 million in the fourth quarter. The company has been working to maintain fiscal discipline, retire short-term debt, and explore new revenue streams, including royalties from Biogen’s ex-US sales of FAMPYRA[2].

Market Drivers and Opportunities

Several factors drive the growth of the dalfampridine market:

• Increasing Prevalence of MS: The rising number of MS cases globally increases the demand for effective treatments like dalfampridine.
• Clinical Efficacy: Dalfampridine has been shown to improve walking speed and patient-reported perceptions of walking in MS patients, making it a valuable treatment option[3].
• Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in developed regions, support the adoption of dalfampridine.

Market Restraints and Challenges

Despite the growth potential, the market faces several challenges:

• Generic Competition: The loss of patent exclusivity has led to the entry of generic versions, which has reduced the revenue from AMPYRA sales.
• Adverse Events: Dalfampridine is associated with adverse events such as paresthesias, dizziness, anxiety, and seizures, which can affect its adoption and patient compliance[4].
• High Cost of Treatment: The relatively high cost of dalfampridine limits its accessibility in developing countries.

Post-Marketing Safety Surveillance

Post-marketing surveillance has highlighted the need for careful monitoring of adverse events associated with dalfampridine. Data from the FDA's Adverse Event Reporting System (FAERS) from 2010 to 2022 showed a significant number of adverse event reports, with the majority coming from the United States. The most common adverse events include nervous system disorders such as dizziness and paresthesia[4].

Future Prospects and Market Trends

The future of the dalfampridine market looks promising despite current challenges:

• Expanding into New Markets: Companies are focusing on commercializing dalfampridine in new regions, such as Germany and Spain, which is expected to boost revenue.
• Managing Generic Competition: Acorda Therapeutics and other companies are implementing strategies to mitigate the impact of generic competition, such as exploring new revenue streams and maintaining fiscal discipline[2].

Technological and Regulatory Trends

Technological advancements and regulatory approvals play a crucial role in the market dynamics of dalfampridine:

• Regulatory Approvals: Dalfampridine has been conditionally approved by the European Medicines Agency (EMA) and is approved in several countries, which supports its global market presence[4].
• Clinical Studies: Ongoing and future clinical studies will continue to provide insights into the safety and efficacy of dalfampridine, potentially expanding its therapeutic applications.

Consumer Behavior and Healthcare Trends

Consumer behavior and broader healthcare trends influence the market:

• Patient Preferences: Patients with MS are increasingly seeking effective treatments that improve their quality of life, driving demand for dalfampridine.
• Healthcare Policies: Changes in healthcare policies and reimbursement strategies can impact the accessibility and affordability of dalfampridine[1].

Key Takeaways

• The global dalfampridine market is expected to grow significantly from 2024 to 2031.
• The 10 mg segment and hospital applications are key drivers of this growth.
• Major players like Acorda Therapeutics face challenges from generic competition but are exploring new revenue streams.
• Adverse events and high treatment costs are significant market restraints.
• Expanding into new markets and managing generic competition are critical strategies for future growth.

FAQs

Q1: What is dalfampridine used for? Dalfampridine is used to improve walking in patients with multiple sclerosis (MS).

Q2: Who are the major players in the dalfampridine market? Major players include Acorda Therapeutics, Sun Pharmaceutical, Elan Pharma, Biogen, and Aurobindo Pharma.

Q3: How has generic competition affected the dalfampridine market? Generic competition has reduced the revenue from AMPYRA sales since the loss of patent exclusivity in 2018.

Q4: What are the common adverse events associated with dalfampridine? Common adverse events include paresthesias, dizziness, anxiety, insomnia, and seizures.

Q5: Which regions dominate the dalfampridine market? North America, particularly the United States, dominates the market due to high prevalence and better healthcare infrastructure.

Sources:

1. Global Dalfampridine Market Report 2024 Edition - Cognitivemarketresearch.com
2. Acorda Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results - Acorda Therapeutics
3. Development of dalfampridine, a novel pharmacologic approach for multiple sclerosis - PubMed
4. Post-marketing safety surveillance of dalfampridine for multiple sclerosis - Frontiers in Pharmacology