CAFFEINE; ERGOTAMINE TARTRATE - Generic Drug Details

What are the generic drug sources for caffeine; ergotamine tartrate and what is the scope of freedom to operate?

Caffeine; ergotamine tartrate is the generic ingredient in four branded drugs marketed by Novartis, Cosette, Sandoz, Hikma Intl Pharms, Mikart, and Organon Usa Inc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for CAFFEINE; ERGOTAMINE TARTRATE

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	CAFFEINE; ERGOTAMINE TARTRATE at DailyMed

Pharmacology for CAFFEINE; ERGOTAMINE TARTRATE

Drug Class	Central Nervous System Stimulant Ergotamine Derivative Methylxanthine
Physiological Effect	Central Nervous System Stimulation

Anatomical Therapeutic Chemical (ATC) Classes for CAFFEINE; ERGOTAMINE TARTRATE

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

N02CA	Ergot alkaloids
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

N06BC	Xanthine derivatives
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for CAFFEINE; ERGOTAMINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mikart	ERGOTAMINE TARTRATE AND CAFFEINE	caffeine; ergotamine tartrate	TABLET;ORAL	040590-001	Sep 16, 2005		RX	No	Yes
Cosette	MIGERGOT	caffeine; ergotamine tartrate	SUPPOSITORY;RECTAL	086557-001	Oct 4, 1983		RX	Yes	Yes
Novartis	CAFERGOT	caffeine; ergotamine tartrate	TABLET;ORAL	006620-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	CAFERGOT	caffeine; ergotamine tartrate	SUPPOSITORY;RECTAL	009000-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hikma Intl Pharms	ERGOTAMINE TARTRATE AND CAFFEINE	caffeine; ergotamine tartrate	TABLET;ORAL	040510-001	Sep 17, 2004		DISCN	No	No
Organon Usa Inc	WIGRAINE	caffeine; ergotamine tartrate	TABLET;ORAL	086562-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sandoz	CAFERGOT	caffeine; ergotamine tartrate	TABLET;ORAL	084294-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

CAFFEINE; ERGOTAMINE TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Caffeine and Ergotamine Tartrate

Introduction

Ergotamine tartrate, often combined with caffeine, is a medication widely used to treat and prevent vascular headaches, including migraines and cluster headaches. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Global Supply and Demand

The global market for ergotamine tartrate is influenced by several key factors:

Top Suppliers

The Czech Republic, India, and Italy are the leading suppliers of ergotamine tartrate, with the Czech Republic holding a significant 54% market share, followed by India with 38% and Italy with 3%[1].

Top Importers

Ecuador, India, and Paraguay are the top importers of ergotamine tartrate. Ecuador leads with 93 shipments, accounting for 24% of the global market, followed by India with 76 shipments (19%), and Paraguay with 49 shipments (12%)[1].

Clinical Use and Applications

Ergotamine tartrate is primarily used to treat migraine headaches and other vascular headaches.

Treatment Options

It is often administered in combination with caffeine, available in tablet form, with a typical dosage of 1 mg ergotamine and 100 mg caffeine per tablet. The medication is used at the onset of a migraine attack, with subsequent doses taken as needed, not exceeding 6 tablets per day or 10 tablets per week[3].

Topical Applications

There is also a nomination for the inclusion of ergotamine tartrate on the 503B Bulks List for use as a topical or mucosal cream, gel, or ointment, highlighting potential future applications[2].

Market Drivers

Several factors drive the demand for ergotamine tartrate:

Increasing Prevalence of Migraines

The rising prevalence of migraine and cluster headache disorders, particularly in regions like Saudi Arabia, drives the demand for ergotamine tartrate. Lifestyle factors such as stress and irregular sleep patterns contribute to this increasing incidence[4].

Healthcare Infrastructure

Improvements in healthcare infrastructure and awareness campaigns about neurological disorders further boost the market for ergotamine tartrate[4].

Market Challenges

Despite the growing demand, the market faces several challenges:

Regulatory Environment

Strict regulatory controls and safety concerns associated with ergot alkaloids can impact the market. Ensuring tight control and monitoring to prevent misuse and potential health risks is essential[4].

Dependency and Side Effects

Ergotamine tartrate can lead to physical dependency, characterized by a self-sustaining headache-medication cycle. This dependency can render patients refractory to other preventative therapies, highlighting the need for careful management[5].

Financial Trajectory

The financial performance of the ergotamine tartrate market is influenced by several factors:

Market Size and Growth

The Saudi Arabia ergotamine market, for example, has experienced significant changes due to the COVID-19 pandemic. Despite a temporary decline in demand, the market is expected to stabilize and grow as healthcare services return to normalcy[4].

Revenue and Volume

The market revenues and volume are expected to increase, driven by the growing demand for ergotamine tartrate. Pharmaceutical companies like Sandoz, Novartis, and Mylan are key players in this market, contributing to its financial growth[4].

Import and Export Dynamics

The global import and export of ergotamine tartrate are critical components of its market dynamics.

Global Trade

Over 49 countries are involved in the global import of ergotamine tartrate, with detailed information available on more than 137 active global buyers. Volza's database provides insights into shipment counts, buyer details, and supplier information, facilitating international trade[1].

Regional Market Analysis

Regional markets, such as Saudi Arabia, provide valuable insights into the market's financial trajectory.

Saudi Arabia Market

The Saudi Arabia ergotamine market is driven by the increasing prevalence of migraines and cluster headaches. The market has faced challenges due to the COVID-19 pandemic but is expected to recover and grow as healthcare services normalize[4].

Key Players and Competitive Landscape

The competitive landscape of the ergotamine tartrate market includes several key players:

Pharmaceutical Companies

Companies like Sandoz, Novartis, and Mylan are significant players in the market, manufacturing medications containing ergotamine tartrate. These companies play a crucial role in meeting the global demand for this medication[4].

Future Outlook

The future outlook for the ergotamine tartrate market is promising but also comes with challenges.

Growing Demand

The increasing prevalence of migraines and improvements in healthcare infrastructure are expected to drive the demand for ergotamine tartrate. However, the market must navigate regulatory challenges and safety concerns associated with ergot alkaloids[4].

Innovative Applications

Potential future applications, such as topical or mucosal creams, gels, or ointments, could expand the market further, offering new treatment options for patients[2].

Key Takeaways

• Global Supply Chain: The Czech Republic, India, and Italy are the leading suppliers of ergotamine tartrate.
• Demand Drivers: Increasing prevalence of migraines, healthcare infrastructure improvements, and lifestyle factors drive the demand.
• Challenges: Regulatory environment, safety concerns, and potential dependency issues.
• Financial Trajectory: Expected growth driven by increasing demand, despite temporary declines due to the COVID-19 pandemic.
• Regional Markets: Saudi Arabia is a significant market, with key players like Sandoz, Novartis, and Mylan contributing to its growth.

Frequently Asked Questions (FAQs)

1. What are the primary uses of ergotamine tartrate? Ergotamine tartrate is primarily used to treat and prevent vascular headaches, including migraines and cluster headaches.

2. Which countries are the top suppliers of ergotamine tartrate? The Czech Republic, India, and Italy are the leading suppliers of ergotamine tartrate.

3. What are the potential future applications of ergotamine tartrate? There is a nomination for the inclusion of ergotamine tartrate on the 503B Bulks List for use as a topical or mucosal cream, gel, or ointment.

4. What challenges does the ergotamine tartrate market face? The market faces challenges related to the regulatory environment, safety concerns associated with ergot alkaloids, and potential dependency issues.

5. How has the COVID-19 pandemic impacted the ergotamine tartrate market? The pandemic led to a temporary decline in demand due to reduced healthcare facility visits and disruptions in the global supply chain, but the market is expected to recover as healthcare services normalize.

Cited Sources

1. Volza: Ergotamine Tartrate Imports in World - Volza
2. University of Maryland, Baltimore: Ergotamine tartrate - University of Maryland, Baltimore
3. Mayo Clinic: Ergotamine and caffeine (oral route) - Mayo Clinic
4. 6Wresearch: Saudi Arabia Ergotamine Market (2024-2030) Outlook - 6Wresearch
5. PubMed: Ergotamine tartrate dependency: features and possible mechanisms