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 Skinmedica, 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:	37
Patent Applications:	2,924
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
United States Department of Defense	Phase 2
Prostate Cancer Foundation	Phase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2

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
Uswm	IWILFIN	eflornithine hydrochloride	TABLET;ORAL	215500-001	Dec 13, 2023		RX	Yes	Yes
Skinmedica	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
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990
Skinmedica	VANIQA	eflornithine hydrochloride	CREAM;TOPICAL	021145-001	Jul 27, 2000
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990

EFLORNITHINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eflornithine Hydrochloride

Introduction to Eflornithine Hydrochloride

Eflornithine hydrochloride, a small molecule and ornithine decarboxylase inhibitor, has a diverse history of applications ranging from the treatment of African trypanosomiasis (sleeping sickness) and female hirsutism to its latest approval for reducing the risk of relapse in high-risk neuroblastoma (HRNB)[4][5].

Historical Market Context

Initially developed in the late 1970s for cancer treatment, eflornithine was later found to be highly effective in treating African trypanosomiasis and reducing hair growth. The drug was first approved for sleeping sickness in 1990 and later for facial hirsutism in women under the brand name Vaniqa in 2000[5].

Current Market Approval and Indications

As of December 2023, eflornithine has been approved by the FDA under the brand name IWILFIN for oral maintenance therapy to reduce the risk of relapse in adult and pediatric patients with HRNB who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy[1][4].

Clinical Efficacy and Impact

The approval for HRNB is based on a multi-site, single-arm, externally controlled study that showed a 52% reduction in the risk of relapse and a 68% reduction in the risk of death in patients treated with eflornithine. This significant clinical efficacy is expected to drive demand and positively impact the financial trajectory of the drug[1][4].

Market Drivers

Increasing Demand for Effective Cancer Therapies

The rise in incidence of high-risk neuroblastoma and the need for effective maintenance therapies are key drivers for the market growth of eflornithine. The drug's ability to reduce relapse and improve survival rates makes it a critical component in the treatment regimen for HRNB patients[1][4].

Expanded Indications

The recent FDA approval for HRNB expands the market potential of eflornithine beyond its previous indications. This expansion into a new and critical therapeutic area is expected to increase revenue and market share[1][4].

Regulatory Support

The FDA's priority review, breakthrough designation, and orphan drug designation for eflornithine indicate strong regulatory support, which can accelerate market access and adoption[1].

Financial Trajectory

Current Market Value

While specific current market values for eflornithine are not detailed, the recent FDA approval and expanded indications suggest a significant increase in its market value. The drug's inclusion in the FDA's expedited programs further indicates its potential for rapid market penetration and revenue growth[1].

Future Projections

Given the critical need for effective treatments in HRNB and the drug's proven efficacy, the financial trajectory of eflornithine is expected to be positive. The market is likely to see substantial growth as more patients and healthcare providers adopt this therapy. However, exact financial projections would depend on various factors including market competition, pricing strategies, and the overall healthcare landscape[1][4].

Competitive Landscape

The market for cancer therapies, particularly for rare and high-risk conditions like HRNB, is highly competitive. However, eflornithine's unique mechanism of action and its recent FDA approval position it as a significant player in this space. The drug's performance will be closely watched by competitors and potential entrants into the market[1].

Challenges and Considerations

Resistance and Efficacy

Historically, eflornithine has faced challenges with resistance in treating African trypanosomiasis. While this is less relevant in the context of HRNB, monitoring for any potential resistance or reduced efficacy over time will be crucial[5].

Adverse Reactions

The common adverse reactions associated with eflornithine, such as otitis media, diarrhea, and hearing loss, may impact patient compliance and overall market acceptance. Effective management and mitigation strategies for these side effects will be important[1].

Regional Analysis

The market for eflornithine will likely be global, with significant focus on regions with advanced healthcare systems and high incidence rates of HRNB. The drug's approval and adoption in the U.S. and Europe will set a precedent for other regions, where regulatory approvals and market access will be sought[1].

Distribution and Access

The distribution of eflornithine will be facilitated through traditional pharmaceutical channels, including direct sales to healthcare providers and pharmacies. Given its orphan drug designation, there may also be specialized programs to ensure access to this critical therapy for patients with HRNB[1].

Key Takeaways

• Expanded Indications: Eflornithine's recent FDA approval for HRNB significantly expands its market potential.
• Clinical Efficacy: The drug's ability to reduce relapse and improve survival rates in HRNB patients is a strong market driver.
• Regulatory Support: Priority review, breakthrough designation, and orphan drug designation by the FDA support rapid market access.
• Financial Growth: The financial trajectory is expected to be positive, driven by increased adoption and expanded indications.
• Challenges: Monitoring for resistance and managing adverse reactions will be crucial for long-term market success.

FAQs

What is the latest FDA approval for eflornithine hydrochloride?

The latest FDA approval for eflornithine hydrochloride is for reducing the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) under the brand name IWILFIN[1][4].

How does eflornithine hydrochloride work in treating HRNB?

Eflornithine hydrochloride works by inhibiting ornithine decarboxylase, an enzyme critical for cell growth, thereby reducing the risk of relapse in HRNB patients who have demonstrated at least a partial response to prior therapies[1][4].

What are the common adverse reactions associated with eflornithine hydrochloride?

Common adverse reactions include otitis media, diarrhea, cough, sinusitis, pneumonia, upper respiratory tract infection, conjunctivitis, vomiting, pyrexia, allergic rhinitis, decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection[1].

How has the FDA supported the market access of eflornithine hydrochloride?

The FDA has supported market access through priority review, breakthrough designation, and orphan drug designation, which streamline the approval process and highlight the drug's critical therapeutic value[1].

What is the expected financial impact of the recent FDA approval on eflornithine hydrochloride?

The recent FDA approval is expected to significantly increase the market value and revenue of eflornithine hydrochloride due to its expanded indications and proven clinical efficacy in treating HRNB[1][4].

Sources

1. FDA Approves Eflornithine for Adult and Pediatric Patients with High-Risk Neuroblastoma. FDA.
2. Dimethicone in the Pharmaceutical Sector: Market Dynamics and Financial Trajectory. DrugPatentWatch.
3. Eflornithine Hydrochloride 13.9% Cream: A Retrospective Clinical Review. Journal of the American Academy of Dermatology.
4. Eflornithine: Uses, Interactions, Mechanism of Action. DrugBank.
5. Eflornithine. Wikipedia.