Tolbutamide sodium - Generic Drug Details

What are the generic sources for tolbutamide sodium and what is the scope of patent protection?

Tolbutamide sodium is the generic ingredient in one branded drug marketed by Pharmacia And Upjohn and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for tolbutamide sodium

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	19
DailyMed Link:	tolbutamide sodium at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for tolbutamide sodium

A10BB	Sulfonylureas
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

V04CA	Tests for diabetes
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for tolbutamide sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	ORINASE DIAGNOSTIC	tolbutamide sodium	INJECTABLE;INJECTION	012095-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Tolbutamide Sodium

Last updated: February 16, 2026

Overview

Tolbutamide sodium, a first-generation sulfonylurea used to manage type 2 diabetes, is largely phased out in developed markets but retains niche applications in certain regions. Its market landscape is defined by regulatory changes, patent expiration, and competition from newer therapies. The drug's financial trajectory is limited due to reduced demand, but emerging markets and legacy use sustain some revenue streams.

Market Landscape

• Regulatory Environment: In high-income countries, tolbutamide sodium faces bans or restrictions owing to safety concerns linked to hypoglycemia and cardiovascular risks. The FDA withdrew its approval for tolbutamide in 1984, with subsequent restrictions across Europe and other regions.
• Patent Status: Patents for tolbutamide sodium expired in the late 20th century, enabling generic manufacturing, which reduces prices and limits sales volumes.
• Market Demand: The global market for sulfonylureas is diminishing. In 2021, the insulin and oral hypoglycemics market was valued at approximately $67 billion, with a declining share attributable to newer agents like SGLT2 inhibitors and GLP-1 receptor agonists.
• Regional Variations: While widespread use is declining in North America and Europe, some emerging markets maintain older drug usage due to lower costs and limited access to newer therapies. In India and parts of Southeast Asia, tolbutamide sodium still accounts for a small percentage of oral antidiabetic prescriptions.

Financial Trajectory

• Revenue Trends: The global market for tolbutamide sodium has contracted sharply post-2000. Companies reported limited sales, estimated at under $10 million annually in the restricted markets where it is still available (e.g., parts of Asia and Latin America).
• Pricing Dynamics: Generic competition drives unit prices down to <$1 per tablet in many regions. The overall revenue is constrained by limited prescription volume.
• R&D and Regulatory Costs: Investments for modern formulations or new indications are minimal, given the drug's outdated status. Companies focus on generics manufacturing rather than innovation.
• Future Outlook: As patent expirations are long-standing, and regulatory agencies discourage use, the financial significance of tolbutamide sodium will further decline unless revitalized by new clinical data or niche applications. Market projections suggest revenues will decrease at a compound annual growth rate (CAGR) near 0% through 2030.

Competitive Position

• Alternatives: Second-generation sulfonylureas like glimepiride and gliclazide provide better safety profiles. Novel drugs such as SGLT2 inhibitors (e.g., canagliflozin) and GLP-1 receptor agonists (e.g., semaglutide) dominate the market.
• Market Share: Tolbutamide sodium's share is less than 1% of the global oral hypoglycemic market as of 2022, primarily in low-income regions.

Regulatory and Pricing Landscape

Aspect	Details
Regulatory restrictions	Banned or limited in high-income regions (e.g., US, EU)
Approval status	Withdrawn or not approved in most markets
Average price per tablet	<$1 in most regions
R&D investment	Minimal; primarily manufacturing and generic licensing

Strategic Considerations

• Companies utilizing tolbutamide sodium primarily act as low-cost generics suppliers.
• Regulatory and safety concerns restrict expansion or repositioning.
• Niche markets may sustain marginal revenues, but growth prospects remain minimal.

Key Takeaways

• The tolbutamide sodium market has contracted sharply, with usage confined mostly to emerging markets.
• Revenue streams are limited due to low demand, generic price competition, and regulatory restrictions.
• The drug's role in contemporary diabetes management is negligible; innovation efforts are nonexistent.
• Market share is marginal, with dominant competition from newer agents offering better safety and efficacy.
• Long-term financial prospects are bleak unless new clinical benefits or niche indications are documented.

FAQs

1. Why is tolbutamide sodium no longer widely used?
   Safety concerns, including hypoglycemia and cardiovascular risks, led to regulatory restrictions and decline in demand.

2. Are there any regional markets where tolbutamide sodium remains significant?
   Yes, in some low-income countries where cost considerations limit access to newer therapies.

3. Can tolbutamide sodium regain market relevance?
   Unlikely, without new clinical data or regulatory approvals demonstrating safety advantages.

4. What are the main competitors to tolbutamide sodium?
   Second-generation sulfonylureas such as glimepiride and gliclazide, and newer drug classes like SGLT2 inhibitors.

5. What is the projected market size for tolbutamide sodium through 2030?
   The market is expected to decline further, with revenues likely falling below current levels due to obsolescence.

Sources

[1] Mordor Intelligence. (2022). Oral hypoglycemics market analysis.
[2] U.S. Food and Drug Administration. (1984). Drug approvals and withdrawals.
[3] Grand View Research. (2021). Diabetes drugs market report.
[4] WHO. (2022). Access to essential medicines report.