caffeine; ergotamine tartrate - Profile

« Back to Dashboard

What are the generic 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, Chartwell Rx, Hikma, Pharmobedient, and Organon Usa Inc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for caffeine; ergotamine tartrate

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	7

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
Novartis	CAFERGOT	caffeine; ergotamine tartrate	SUPPOSITORY;RECTAL	009000-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Cosette	MIGERGOT	caffeine; ergotamine tartrate	SUPPOSITORY;RECTAL	086557-001	Oct 4, 1983		RX	Yes	Yes
Chartwell Rx	CAFERGOT	caffeine; ergotamine tartrate	TABLET;ORAL	084294-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Novartis	CAFERGOT	caffeine; ergotamine tartrate	TABLET;ORAL	006620-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	ERGOTAMINE TARTRATE AND CAFFEINE	caffeine; ergotamine tartrate	TABLET;ORAL	040510-001	Sep 17, 2004		DISCN	No	No
Pharmobedient	ERGOTAMINE TARTRATE AND CAFFEINE	caffeine; ergotamine tartrate	TABLET;ORAL	040590-001	Sep 16, 2005		RX	No	Yes

Investment Analysis of Caffeine and Ergotamine Tartrate in the Pharmaceutical Sector

Last updated: February 17, 2026

This analysis assesses the market fundamentals, regulatory environment, R&D landscape, and commercialization prospects for caffeine and ergotamine tartrate, focusing on their investment potential within the pharmaceutical industry.

---

What Are the Market Sizes and Key Drivers?

Caffeine:

• Global Market Value: Estimated at $4.2 billion in 2022, with a compound annual growth rate (CAGR) of approximately 4% projected through 2027 [1].
• Uses: Pharmacological (headache relief, alertness), nutraceuticals, beverages.
• Key Drivers: Growing consumer demand for natural stimulants, expansion in nutraceutical formulations, and ongoing applications in over-the-counter (OTC) products.

Ergotamine Tartrate:

• Market Size: Significantly smaller due to limited indications; estimated at $150 million globally in 2022.
• Uses: Acute migraine treatment, historically used for vasospastic disorders, albeit with declining exclusivity due to newer agents.
• Key Drivers: Despite its age, continues to be prescribed where newer drugs are contraindicated, and for specialist indications.

---

What Is the Regulatory Environment and Patent Status?

Caffeine:

• Regulatory Status: Generally recognized as safe (GRAS) by the US Food and Drug Administration (FDA), with extensive usage in OTC products.
• Patents: No new patents for caffeine as a basic ingredient exist. Market entry is largely determined by regulatory approval and formulation innovations.
• Implications for Investment: Reaching market saturation; differentiation relies on formulation and delivery innovations rather than patent protections.

Ergotamine Tartrate:

• Regulatory Status: Approved in many countries; classified as a prescription drug due to toxicity risks.
• Patents: Patents have long expired, leading to generic dominance.
• Implications for Investment: Limited R&D-driven exclusivity; focus shifts to manufacturing efficiencies and strategic marketing for existing formulations.

---

What Are R&D Trends and Innovation Opportunities?

Caffeine:

• Research Focus: Enhanced bioavailability, targeted release mechanisms, combination with other bioactives.
• Innovation: Functional foods, customized delivery systems, and novel beverage formats.
• R&D Cost: Low, given established safety profile; primary investments target formulation.

Ergotamine Tartrate:

• Research Focus: Alternative delivery methods to reduce side effects, new therapeutic indications.
• Innovation: Limited due to age and safety concerns; recent efforts focus on replacing ergot derivatives with safer alternatives.
• R&D Cost: High risk with diminishing returns; investment often shifts toward developing new drugs for migraine relief.

---

What Are Commercialization Prospects and Competitive Dynamics?

Caffeine:

• Market Entry: Moderately accessible; well-established manufacturing and distribution channels predominate.
• Competition: Intense among global beverage, supplement, and pharmaceutical firms.
• Pricing Power: Limited, driven mostly by formulation differentiation and brand positioning.

Ergotamine Tartrate:

• Market Entry: Difficult; manufacturing is complex due to toxicity and regulation.
• Competition: Low; most competitors are generics, with limited new entrants.
• Pricing Power: Moderate; constrained by generic competition and regulatory scrutiny.

---

What Are Risks and Barriers for Investors?

• Regulatory Risks: Changes in safety regulations or expanded restrictions on ergot derivatives.
• Market Risks: Declining demand for ergotamine due to newer therapeutic options.
• Intellectual Property Risks: Minimal for both compounds; innovation is limited.

---

Summary of Investment Fundamentals

Aspect	Caffeine	Ergotamine Tartrate
Market Size	$4.2 billion (2022)	$150 million (2022)
Growth Rate	4% CAGR (2022–2027)	Flat to declining
Regulatory Status	GRAS, OTC	Prescription only, approved in multiple markets
Patent Protection	None (commodity-based)	None (generics dominate)
R&D Activity	Low, formulation innovation	Minimal, safety concerns limit R&D
Commercialization Focus	Formulation, delivery systems	Manufacturing efficiencies, generics
Investment Risk	Moderate, market saturation	High, safety and regulatory hurdles

---

Key Takeaways

• Caffeine presents stable, mature market prospects with incremental growth driven by product innovation, but limited potential for patent-driven differentiation.
• Ergotamine tartrate faces declining relevance due to safety concerns and competition from newer migraine therapies, constraining investment returns.
• Investors should primarily focus on formulation innovation for caffeine, while for ergotamine tartrate, opportunities are limited to niche or manufacturing efficiencies.

---

Frequently Asked Questions

1. Are there new formulations of caffeine that can extend market viability?

   • Yes. Novel delivery systems like extended-release formulations and combination products can create incremental differentiation.

2. What are the major competitors for caffeine in the pharmaceutical industry?

   • Major players include Johnson & Johnson, GlaxoSmithKline, and various nutraceutical and supplement firms with proprietary formulations.

3. Can ergotamine tartrate regain market share through reformulation?

   • Unlikely. Safety profile concerns and the availability of superior alternatives limit its growth prospects.

4. What regulatory changes could impact caffeine or ergotamine markets?

   • Stricter regulations on stimulant ingredients, bans on certain formulations, or safety reevaluations could affect both compounds.

5. Are there therapeutic niches where ergotamine remains relevant?

   • Minimal; primarily used where newer drugs are contraindicated, or in specific geographic markets with limited access to newer therapies.

---

References

[1] MarketsandMarkets, "Caffeine Market," 2022.