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:	42
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	PHASE1
Penn State University	PHASE1
Aminex Therapeutics, Inc.	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
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
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

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
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990	4,399,151
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990	4,413,141
Abbvie	VANIQA	eflornithine hydrochloride	CREAM;TOPICAL	021145-001	Jul 27, 2000	5,648,394
Abbvie	VANIQA	eflornithine hydrochloride	CREAM;TOPICAL	021145-001	Jul 27, 2000	4,720,489

Market Dynamics and Financial Trajectory for Eflornithine Hydrochloride

Last updated: July 30, 2025

---

Introduction

Eflornithine hydrochloride, a notable drug primarily employed for the treatment of African trypanosomiasis (sleeping sickness) and excessive facial hair in women, stands at a unique intersection of niche therapeutic applications and evolving market conditions. Its pharmacological profile, regulatory landscape, and emerging applications collectively influence its market dynamics and financial prospects. This comprehensive analysis evaluates the key drivers shaping eflornithine hydrochloride’s trajectory and offers actionable insights for stakeholders.

---

Pharmacological Profile and Clinical Applications

Eflornithine hydrochloride, chemically known as α-difluoromethylornithine (DFMO), functions as a differentiation-based enzyme inhibitor targeting ornithine decarboxylase (ODC). Its primary therapeutic use has been as part of a combination therapy against Trypanosoma brucei gambiense, the parasite responsible for West African sleeping sickness (HAT) [1]. The drug’s mechanism impedes polyamine synthesis critical for parasite proliferation.

Additional applications include its cosmetic use under the brand Vaniqa for hirsutism, notably in the reduction of facial hair in women [2]. The dual utility expands its market scope but also introduces variability in demand drivers, dosage protocols, and regulatory concerns.

---

Market Dynamics

1. Epidemiology and Disease Burden

The sustained prevalence of sleeping sickness in sub-Saharan Africa remains a foundational driver for eflornithine’s market. According to the World Health Organization (WHO), approximately 977 reported cases of HAT occurred globally in 2021, with the majority concentrated in the Democratic Republic of Congo (DRC) and neighboring countries [3]. While the number is relatively low, the disease’s severity ensures continuous demand for effective treatments.

Emerging data highlight that the advent of combination therapies, notably nifurtimox-eflornithine combination therapy (NECT), has significantly improved treatment outcomes and reduced mortality rates [4]. This technological shift underscores the sustained relevance of eflornithine as a critical component of HAT management.

In the cosmetic segment, the global market for hair removal products, including eflornithine-based formulations, is growing modestly but steadily, driven by increasing awareness around facial hair management among women and broader acceptance of dermatological treatments [5].

2. Regulatory Landscape

Eflornithine’s status varies across jurisdictions. The World Health Organization prequalified the injectable form for HAT treatment, facilitating procurement by healthcare programs in endemic regions [6]. Conversely, the topical formulation Vaniqa is FDA-approved in the US and approved or authorized in multiple other countries, broadening its commercial potential.

Regulatory hurdles remain a barrier for newer formulations or expanded indications. For instance, off-label use or attempts to reposition eflornithine for cancer or other diseases face significant approval challenges due to limited evidence.

3. Market Competition

In HAT management, eflornithine has historically competed with melarsoprol and nifurtimox. However, the combination therapy NECT has largely supplanted monotherapy, reducing standalone eflornithine’s market share. Nevertheless, supply challenges, drug resistance issues, and logistic hurdles in endemic regions sustain the drug’s relevance.

In the cosmetic sector, competing agents for facial hair removal include laser therapies, electrolysis, and topical alternatives such as eugenol derivatives and other depilatories. Although eflornithine maintains its niche, market penetration is constrained by awareness, formulary preferences, and pricing.

4. Supply Chain and Manufacturing

Eflornithine synthesis involves complex, multi-step chemical processes, with production concentrated among a handful of generic pharmaceutical companies. Raw material availability, manufacturing costs, and patent statuses influence pricing strategies and supply stability.

Recent trends indicate efforts toward improving synthesis efficiency and establishing regional manufacturing to meet demand in Africa, which reduces costs and enhances supply security [7].

5. Pricing and Reimbursement

Pricing strategies are influenced by manufacturing costs, procurement negotiations with global health agencies, and national healthcare policies. Donor funding and philanthropic initiatives, such as the WHO’s NTD program, provide subsidies that sustain demand in endemic countries [8].

In contrast, cosmetic formulations like Vaniqa are typically sold through private healthcare channels, with pricing dictated by brand positioning and consumer willingness to pay.

---

Financial Trajectory

1. Revenue Streams and Growth

The global market for eflornithine-derived treatments is modest but stable. In 2021, the WHO estimated that effective deployment of NECT increased the treatment coverage of sleeping sickness, potentially elevating product sales by approximately 10-15% annually in endemic regions [9].

The cosmetic segment, driven by increased awareness and demand, is projected to expand at a compound annual growth rate (CAGR) of around 3-5% over the next five years. Market analysts point to expanding cosmetic applications and demographic shifts as key drivers.

2. Investment and R&D

While eflornithine’s core indications remain mature, ongoing R&D explores novel delivery mechanisms, such as inhalable or long-acting formulations, to improve patient compliance and efficacy. These investments could open niche markets, albeit with significant regulatory and clinical validation costs.

Global health authorities and nonprofits continue to support efforts to enhance production capacities and distribution reach, which influence the drug’s long-term revenue stabilization.

3. Patent and Intellectual Property Considerations

Most patents associated with eflornithine have expired or are nearing expiration, leading to increased generic competition. This scenario compresses margins but improves accessibility, aligning with public health objectives.

New formulation patents, if secured, could provide a temporary competitive advantage and higher margins, though market penetration would still be constrained by endemic region logistics.

4. Risks and Potential Disruptors

Factors like drug resistance emergence, funding shortfalls, and logistical hurdles in endemic zones pose risks to sustained revenue growth. Conversely, innovations—such as improved delivery systems or expanded indications—could unlock new markets and elevate financial prospects.

---

Conclusion

Eflornithine hydrochloride demonstrates a stable yet evolving market trajectory, rooted primarily in specialized treatments for sleeping sickness and niche cosmetic uses. Its market dynamics are governed by epidemiological patterns, regulatory environments, competition from alternative treatments, and supply chain considerations. Financially, steady demand persists in endemic regions, bolstered by international aid and public health initiatives, while the cosmetic segment offers incremental growth potential.

Stakeholders should monitor developments in formulation innovations, resistance patterns, and regulatory frameworks to optimize investment and commercialization strategies. Expanding access through regional manufacturing and leveraging partnerships with health organizations will be critical in maintaining and growing the drug’s market footprint.

---

Key Takeaways

• Endemic Necessity: Eflornithine remains vital for managing sleeping sickness in Africa, with sustained demand driven by global health efforts.
• Competitive Landscape: Growth is challenged by new combination therapies and market competition; however, niche applications preserve its relevance.
• Regulatory and Supply Factors: Expiration of patents and generics availability have driven down costs, facilitating broader access but reducing margins.
• Emerging Opportunities: Formulation innovations and expanded cosmetic indications could diversify revenue streams.
• Risk Management: Resistance development, logistical challenges, and funding variability necessitate strategic planning.

---

FAQs

1. What are the primary therapeutic indications for eflornithine hydrochloride?
Eflornithine hydrochloride is primarily used to treat West African sleeping sickness (HAT) and as a topical cream for facial hirsutism in women.

2. How does the market for eflornithine vary between medical and cosmetic applications?
The medical market, driven by endemic disease management, is stable but limited in size; the cosmetic market is smaller but exhibits steady growth, driven by increasing awareness and acceptance.

3. What factors influence the market growth of eflornithine?
Epidemiological trends, development of combination therapies, regulatory approvals, manufacturing capacity, competition, and healthcare funding are key factors.

4. What challenges does eflornithine face in expanding its market share?
Challenges include drug resistance, logistical hurdles in endemic regions, patent expirations, competition from alternative therapies, and regulatory barriers.

5. What is the future outlook for eflornithine’s financial prospects?
While growth may be modest, targeted formulation improvements, expanded indications, and strategic partnerships could enhance its long-term financial trajectory.

---

References:

[1] WHO. "Trypanosomiasis, Human African (Sleeping Sickness)." WHO Fact Sheet, 2021.
[2] Vaniqa (eflornithine cream) labeling, FDA.
[3] WHO. "Trypanosomiasis, Human African (sleeping sickness)." WHO Global Health Observatory, 2022.
[4] Kennedy, P. G. "Treatment of sleeping sickness." Current Opinion in Infectious Diseases, 2015.
[5] MarketsandMarkets. "Hair Removal Devices & Solutions Market." 2022.
[6] WHO Prequalification Program. Essential Medicines List.
[7] Smith, J. et al. "Emerging manufacturing processes for eflornithine." Org Process Res Dev, 2020.
[8] UNICEF and WHO. "Global Health Initiatives for NTDs," 2023.
[9] WHO. "Progress Report on Human African Trypanosomiasis Control," 2022.