ORNIDYL Drug Patent Profile

Which patents cover Ornidyl, and what generic alternatives are available?

Ornidyl is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in ORNIDYL is eflornithine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eflornithine hydrochloride profile page.

Summary for ORNIDYL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	2
Patent Applications:	4,123
DailyMed Link:	ORNIDYL at DailyMed

Recent Clinical Trials for ORNIDYL

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Children's Oncology Group	Phase 2
Drugs for Neglected Diseases	Phase 2/Phase 3

See all ORNIDYL clinical trials

US Patents and Regulatory Information for ORNIDYL

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

Expired US Patents for ORNIDYL

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
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990

International Patents for ORNIDYL

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

Country	Patent Number	Title	Estimated Expiration
Ireland	51300	PROTOZOAL GROWTH-INHIBITING DIAMINES
Sweden	7807691
Australia	7165481
Japan	S5731613	INHIBITION OF PROTOZOAN GROWTH

ORNIDYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ornidyl (Eflornithine)

Introduction

Ornidyl, the injectable form of eflornithine hydrochloride, is a medication with a complex history, particularly in its application against African trypanosomiasis (sleeping sickness) and other potential uses. This article delves into the market dynamics and financial trajectory of Ornidyl, highlighting its production, distribution, and the challenges it has faced.

Historical Context of Ornidyl

Eflornithine, the active ingredient in Ornidyl, was first registered for the treatment of gambiense sleeping sickness in 1990. However, its production was halted in 1995 by Aventis (now Sanofi-Aventis) due to lack of profitability, despite its critical role in treating a life-threatening disease prevalent in African countries[1].

Production and Distribution

The production of eflornithine was restarted in 2001 through a partnership between Aventis and the World Health Organization (WHO). This partnership led to the production of over 200,000 bottles of eflornithine, which were distributed by Médecins sans Frontières (Doctors Without Borders) in endemic areas. This initiative significantly contributed to diagnosing 14 million cases and saving nearly 110,000 lives between 2001 and 2006[1].

Market Challenges

Profitability Issues

The primary challenge for Ornidyl has been its lack of profitability. The drug's main market is in African countries, where the ability to pay is limited. This led Aventis to initially discontinue production, highlighting the tension between humanitarian needs and financial viability[1].

International Pressure and Media Attention

The restart of eflornithine production was largely driven by international pressure and media attention. The launch of Vaniqa, a topical cream containing eflornithine for treating facial hair in women, drew attention to the disparity between the availability of the drug for cosmetic purposes versus its life-saving application against sleeping sickness[1].

Financial Trajectory

Costs and Funding

The production and distribution of Ornidyl have been heavily dependent on partnerships and donations. The WHO and Médecins sans Frontières played crucial roles in ensuring the drug reached those in need. The financial burden was shared, but the costs of manufacturing and administrative tasks were significant[1].

Comparison with Similar Programs

The Mectizan donation program by Merck, which provides ivermectin for river blindness, offers a contrasting example. Merck's program, despite initial financial concerns, has been highly successful due to strong corporate commitment, efficient distribution, and significant health and economic benefits. This model highlights the potential for sustained humanitarian efforts when supported by robust partnerships and funding mechanisms[2].

Current Market Status

Discontinuation in the US

Ornidyl, the injectable form of eflornithine, is currently discontinued in the US market. This decision reflects the ongoing challenges in maintaining a viable market for a drug that is primarily needed in low-income countries[1].

Global Access

Despite its discontinuation in the US, efforts continue to ensure access to eflornithine in regions where it is most needed. The WHO and other international health organizations remain key players in facilitating the distribution of this critical medication[1].

Research and Development Implications

Potential Uses Beyond Sleeping Sickness

Eflornithine has been explored for its potential in chemoprevention, particularly in reducing polyamine levels in colorectal mucosa. However, its effectiveness as a chemotherapeutic agent has been limited due to the body's ability to compensate for the inhibition of ornithine decarboxylase (ODC) through dietary and bacterial means[1].

Societal and Cultural Impact

Access to Medicine Index

The Access to Medicine Index highlights the importance of affordability and access to essential medicines in low- and middle-income countries. Companies like AstraZeneca have implemented pricing strategies based on ability-to-pay analyses, which could serve as a model for making drugs like Ornidyl more accessible[3].

Key Takeaways

• Production Challenges: Ornidyl's production has been halted and restarted due to profitability issues.
• Partnerships and Donations: The drug's distribution relies heavily on partnerships with WHO and Médecins sans Frontières.
• Financial Burden: Significant costs are associated with manufacturing and administrative tasks.
• Discontinuation in US: Ornidyl is no longer available in the US market.
• Global Access Efforts: Continued efforts are made to ensure access in endemic regions.
• Research Implications: Eflornithine has potential beyond sleeping sickness, but its chemotherapeutic use is limited.

FAQs

What is Ornidyl used for?

Ornidyl, the injectable form of eflornithine hydrochloride, is primarily used to treat African trypanosomiasis (sleeping sickness).

Why was the production of Ornidyl halted in 1995?

The production was halted due to lack of profitability, as the main market for the drug was in African countries where the ability to pay is limited.

What led to the restart of eflornithine production in 2001?

International pressure and media attention, particularly following the launch of Vaniqa for treating facial hair, led to the restart of production through a partnership between Aventis and the WHO.

Is Ornidyl still available in the US market?

No, Ornidyl is currently discontinued in the US market.

What other potential uses does eflornithine have?

Eflornithine has been explored for its potential in chemoprevention, particularly in reducing polyamine levels in colorectal mucosa, although its effectiveness as a chemotherapeutic agent is limited.

How has the distribution of Ornidyl been facilitated?

The distribution of Ornidyl has been facilitated through partnerships with the WHO and Médecins sans Frontières.

Sources

1. Wikipedia: Eflornithine
2. World Bank: The Mectizan (Ivermectin) Donation Program
3. Access to Medicine Foundation: Access to Medicine Index 2016
4. NCBI: Nifurtimox plus Eflornithine for Late-Stage Sleeping Sickness
5. ACS Publications: Natural Products as Sources of New Drugs over the Nearly Four Decades from 01JAN1981 to 30SEP2019