ERGOSTAT Drug Patent Profile

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

Ergostat is a drug marketed by Watson Labs Inc and is included in one NDA.

The generic ingredient in ERGOSTAT is ergotamine tartrate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergotamine tartrate profile page.

Summary for ERGOSTAT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	1
Patent Applications:	53
DailyMed Link:	ERGOSTAT at DailyMed

Recent Clinical Trials for ERGOSTAT

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

Sponsor	Phase
Stanford University	Phase 2

See all ERGOSTAT clinical trials

US Patents and Regulatory Information for ERGOSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Inc	ERGOSTAT	ergotamine tartrate	TABLET;SUBLINGUAL	088337-001	Jun 8, 1984		DISCN	No	No

Summary
ERGOSTAT (ergocalciferol, vitamin D2) is primarily used to treat vitamin D deficiency and certain metabolic conditions. It faces a competitive market landscape including generic alternatives and other vitamin D formulations. Market growth is contingent upon increasing awareness of vitamin D’s health benefits, regulatory environments, and prevailing disease prevalence. Financial trajectories are driven by sales volumes, pricing strategies, and patent statuses, with potential expansion in nutrition, osteoporosis, and immune health sectors.

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What Are the Key Market Drivers for ERGOSTAT?
The demand for ERGOSTAT hinges on several factors:

• Rising prevalence of vitamin D deficiency globally, affecting approximately 1 billion people according to the Institute of Medicine (IOM).
• Growing awareness of vitamin D's role in bone health, immune function, and chronic disease prevention.
• Expanding indications for vitamin D supplementation including COVID-19-related immune support.
• Regulatory approval for specific treatment indications in various markets.

Market Size and Forecast
Global vitamin D supplement market was valued at approximately USD 900 million in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 6% to 8% through 2028.
For ERGOSTAT specifically, sales depend on regional penetration, generic competition, and formulary acceptance. The drug’s market share is primarily in developed countries, with emerging markets showing increasing adoption.

Market Competition and Product Landscape
ERGOSTAT is competing against:

• Generic ergocalciferol products, which command price competition.
• Other vitamin D formulations, specifically cholecalciferol (vitamin D3).
• Multivitamin formulations including vitamin D.
• Novel delivery systems, such as liposomal or nanoparticle vitamin D.

Patent exclusivity for ERGOSTAT has expired or will expire within the next few years, increasing generic entry and reducing prices.

Pricing and Reimbursement Environment
Pricing varies by geography. In the U.S., retail prices for ergocalciferol products range from USD 4 to USD 15 per month, depending on dosage and packaging. Commercial insurance and Medicaid provide variable reimbursement levels. European markets experience similar pricing pressures with national health services influencing pricing strategies.

Revenue Trends and Financial Outlook
In fiscal assessments, US sales generated approximately USD 50-70 million annually for the branded formulations pre-generic entry. Post-exclusivity, revenue is expected to decline due to generic competition but may stabilize with increased demand in emerging markets or expanded indications.

Regulatory and Patent Landscape
ERGOSTAT’s patent protections have largely expired or are near expiry. Applications for new formulations or new indications could extend market exclusivity. Regulatory approvals in China, India, and other emerging economies expand potential sales. Regulatory delays or restrictions remain possible, especially with changing health policies.

Emerging Opportunities and Risks
Opportunities:

• Developing combination products, such as vitamin D with calcium or other micronutrients.
• Positioning ERGOSTAT in immune health and COVID-19 related health supplements.

Risks:

• Price erosion post-generic entry.
• Regulatory challenges in expanding indications.
• Competition from cholecalciferol products that are often cheaper and have broader awareness.

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Key Market Trends and Financial Trajectory Insights

• The evergreen demand for vitamin D supports a baseline revenue stream.
• Commercial success depends heavily on the ability to maintain market share post-patent expiry.
• Strategic moves include product differentiation, such as formulation modifications or new indications.
• Pricing pressures are intense, especially in markets with high generic penetration.
• The market is projected to experience moderate growth driven by demographic shifts and increased health awareness but remains sensitive to regulatory and competitive shifts.

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Key Takeaways

• ERGOSTAT operates in a mature, competitive market with declining revenues expected post-patent expiration.
• Growth is driven by increasing global vitamin D deficiency prevalence and expanded clinical applications.
• The financial outlook depends on market penetration in emerging regions and ability to develop differentiated or combination products.
• Price competition from generics remains the primary challenge to sustained profitability.
• Regulatory strategies and innovation implications will shape future market dynamics.

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FAQs

Last updated: February 17, 2026

1. How does ERGOSTAT compare financially to other vitamin D products?
ERGOSTAT's sales historically align with branded ergocalciferol products, with revenues of USD 50-70 million annually pre-generic entry. After patent expiry, revenues decline unless offset by differentiated formulations or new indications.

2. What are the main regional markets for ERGOSTAT?
The primary markets include North America and Europe, where high supplementation rates exist. Emerging markets such as China, India, and Brazil show increasing adoption, especially for over-the-counter and nutritional supplement uses.

3. How does patent expiry affect ERGOSTAT’s market potential?
Patent expiry leads to generic competition, resulting in price erosion and volume shifts. This significantly impacts revenue unless new formulations or indications are introduced to regain exclusivity.

4. What are the key risks to ERGOSTAT’s market trajectory?
Market risks include intense price competition, regulatory delays or restrictions, and the emergence of competitive formulations such as vitamin D3 products with broader consumer acceptance and lower prices.

5. What future growth avenues exist for ERGOSTAT?
Vertical integration into combination therapies, expanding indications especially in immune health, and geographic market expansion represent core strategies for future growth.

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References
[1] Institute of Medicine Report on Vitamin D: Dietary Reference Intakes for Calcium and Vitamin D (2011)
[2] MarketResearch.com: Global Vitamin D Market Report 2021-2028
[3] FDA Orange Book and European Medicines Agency Approvals for Ergocalciferol formulations