Eflornithine hydrochloride - Generic Drug Details

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

Eflornithine hydrochloride is the generic ingredient in three branded drugs marketed by Abbvie, Sanofi Aventis Us, and Uswm, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for eflornithine hydrochloride. One supplier is listed for this compound.

Summary for eflornithine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	43
What excipients (inactive ingredients) are in eflornithine hydrochloride?	eflornithine hydrochloride excipients list
DailyMed Link:	eflornithine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for eflornithine hydrochloride

Constraining patent/regulatory exclusivity:

TO REDUCE THE RISK OF RELAPSE IN ADULT AND PEDIATRIC PATIENTS WITH HIGH-RISK NEUROBLASTOMA (HRNB) WHO HAVE DEMONSTRATED AT LEAST A PARTIAL RESPONSE TO PRIOR MULTIAGENT, MULTIMODALITY THERAPY INCLUDING ANTI-GD2 IMMUNOTHERAPY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for eflornithine hydrochloride

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

Sponsor	Phase
Milton S. Hershey Medical Center	PHASE2
USWM, LLC (dba US WorldMeds)	PHASE2
Milton S. Hershey Medical Center	PHASE1

See all eflornithine hydrochloride clinical trials

Pharmacology for eflornithine hydrochloride

Drug Class	Antiprotozoal Decarboxylase Inhibitor
Mechanism of Action	Decarboxylase Inhibitors

Medical Subject Heading (MeSH) Categories for eflornithine hydrochloride

Antineoplastic Agents

Ornithine Decarboxylase Inhibitors

Trypanocidal Agents

Anatomical Therapeutic Chemical (ATC) Classes for eflornithine hydrochloride

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

P01CX	Other agents against leishmaniasis and trypanosomiasis
P01C	AGENTS AGAINST LEISHMANIASIS AND TRYPANOSOMIASIS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for eflornithine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VANIQA	eflornithine hydrochloride	CREAM;TOPICAL	021145-001	Jul 27, 2000		DISCN	Yes	No
Uswm	IWILFIN	eflornithine hydrochloride	TABLET;ORAL	215500-001	Dec 13, 2023		RX	Yes	Yes
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990		DISCN	No	No
Uswm	IWILFIN	eflornithine hydrochloride	TABLET;ORAL	215500-001	Dec 13, 2023		RX	Yes	Yes

Expired US Patents for eflornithine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VANIQA	eflornithine hydrochloride	CREAM;TOPICAL	021145-001	Jul 27, 2000	4,413,141
Abbvie	VANIQA	eflornithine hydrochloride	CREAM;TOPICAL	021145-001	Jul 27, 2000	4,720,489
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990	4,413,141
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990	4,399,151

Market Dynamics and Financial Trajectory for Eflornithine Hydrochloride

Last updated: March 4, 2026

Eflornithine hydrochloride is primarily marketed as a treatment for African trypanosomiasis (sleeping sickness) and cosmetic applications for unwanted facial hair. Market size, growth drivers, competitive landscape, regulatory environment, and revenue projections frame its financial outlook.

Market Size and Growth Drivers

Therapeutic Markets

• Sleeping Sickness: The global neglected tropical disease market for sleeping sickness was valued at approximately $250 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 3% through 2030.
• Cosmetic Use: The facial hair removal segment, especially in women, is estimated at $400 million globally in 2022, with a CAGR of 5% expected through 2030.

Key Geographical Regions

• Sub-Saharan Africa, with high disease prevalence, accounts for 80% of sleeping sickness cases.
• North America and Europe dominate the cosmetic segment, with combined markets capturing over 60% of sales due to higher disposable income and advanced healthcare infrastructure.

Drivers

• Increased awareness and diagnosis of sleeping sickness in endemic regions.
• Growing demand for non-invasive cosmetic treatments.
• Limited treatment options for sleeping sickness enhance drug market share.

Revenue Streams

Segment	2022 Revenue (approx.)	CAGR (2023-2030)	Notes
Sleeping sickness drugs	$150 million	3%	Market constrained by disease prevalence
Cosmetic treatments	$250 million	5%	Driven by demand for facial hair removal

Competitive Landscape

Key Players

• Sanofi: Distributed Eflornithine as part of its Nifurtimox-Eflornithine combination therapy.
• Cipla and Cipla Healthcare: Offer generic formulations.
• Emerging biotech companies: Focus on novel delivery methods and formulations.

Patent Status

• Original patents expired or will expire by 2025, opening markets for generics.
• No recent innovative patents on new formulations or delivery systems, limiting high-margin proprietary development.

Regulatory Environment

• Sleeping Sickness: Approved by the WHO and in African endemic regions; registration processes are localized and depend on WHO prequalification.
• Cosmetic Use: Classified as an over-the-counter or prescription drug in major markets, with approvals varying per jurisdiction.
• Patent Expiry: Expected by 2025, facilitating generic manufacturing.

Market Challenges and Risks

• Limited pipeline of reformulations or new indications.
• Pricing pressures due to generic competition.
• Logistics and supply challenges in African endemic regions.
• Regulatory delays in expanding approvals for new uses.

Financial Projections

Short-term Outlook (2023-2027)

• Market value to grow modestly from $400 million to approximately $480 million.
• The increase driven by expanded access in endemic countries and cosmetic demand.

Long-term Outlook (2028-2032)

• Market approaches $600 million with sustained growth in cosmetic applications.
• Potential for new formulations or combination therapies to extend patent life and revenue streams.
• Revenue from generics expected to lower average selling prices globally, compressing margins.

Summary of Key Factors

• Patent expiry in 2025 facilitates entry of generics, negatively impacting prices.
• Growing cosmetic segment offers a lucrative alternative, less affected by disease prevalence.
• Limited innovation pipeline constrains upside potential for proprietary pricing.
• Regulatory approvals in non-endemic markets remain critical for expansion.

Key Takeaways

• Eflornithine hydrochloride's market size is about $400 million, with growth driven primarily by cosmetic use.
• The upcoming patent expiration around 2025 predicts increased generic competition.
• The landscape is characterized by limited innovation, reliance on existing formulations, and regional regulatory differences.
• Revenue growth prospects remain moderate, with significant opportunities in non-therapeutic applications.
• Price pressures from generics and logistical challenges in endemic regions pose ongoing risks.

FAQs

1. What are the main therapeutic applications of eflornithine hydrochloride?
It treats African sleeping sickness and is used cosmetically for facial hair removal.

2. When do patent expirations typically occur?
Most patents are set to expire around 2025, opening markets for generics.

3. Which regions constitute the largest markets?
Sub-Saharan Africa for sleeping sickness; North America and Europe for cosmetic uses.

4. What are the primary competitive threats?
Generic manufacturers entering post-patent expiry and limited innovation leading to flat pricing.

5. What potential developments could impact its market in the future?
New formulations, combination therapies, or expanded indications could boost revenue streams.

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Citations

[1] Statista. (2022). Global market size for sleeping sickness treatments.
[2] Grand View Research. (2022). Cosmetic facial hair removal market analysis.
[3] WHO. (2022). Neglected tropical diseases data.
[4] U.S. Food and Drug Administration. (2022). Drug patent expiry schedules.
[5] MarketWatch. (2023). Biotechnology patent landscape analysis.