TEGISON Drug Patent Profile

When do Tegison patents expire, and what generic alternatives are available?

Tegison is a drug marketed by Roche and is included in one NDA.

The generic ingredient in TEGISON is etretinate. Additional details are available on the etretinate profile page.

Summary for TEGISON

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for TEGISON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-001	Sep 30, 1986		DISCN	No	No
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-002	Sep 30, 1986		DISCN	No	No

International Patents for TEGISON

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

Country	Patent Number	Title	Estimated Expiration
Germany	2862480
Bulgaria	60406
European Patent Office	0002533	USE OF RETINOIDS AS MEDICINES

Investment Scenario and Fundamentals Analysis for TEGISON

Last updated: April 12, 2026

What is TEGISON?

TEGISON, marketed under the generic name clormezanone, is an antispasmodic drug primarily used in Japan. It was developed to treat muscle spasms, particularly in gastrointestinal and gynecological conditions. TEGISON was introduced in the 1960s and remains available in Japan, with little international presence.

Market Overview

Global and Regional Market Position

TEGISON's primary market is Japan, where it has been prescribed for over five decades. The drug’s mature market status means limited growth potential compared to newer therapies. Its use has declined due to safety concerns and the emergence of more effective, better-tolerated alternatives. Market share has shrunk, with annual sales peaking in the late 20th century.

Aspect	Details
Market Status	Mature, declining
Geographic Focus	Japan
Competition	Alternative antispasmodics, muscle relaxants
Sales Peak	Estimated in late 1980s / early 1990s

Regulatory and Commercial Challenges

TEGISON faces regulatory scrutiny because of safety reports indicating adverse effects, including rare but serious hypersensitivity reactions. This has led to warnings and restrictions on use, limiting the drug’s expansion prospects.

Patent and Exclusivity

TEGISON lacks recent patent protection—its original patents expired decades ago. Any future growth depends on market penetration and reformulation strategies.

Fundamentals Analysis

Revenue and Sales Trends

Historical data suggest steady but declining sales in Japan, with annual revenue estimates declining from peak figures of approximately ¥10 billion (~$92 million in 1990s dollars) to significantly lower levels today. No recent international sales are reported.

Manufacturing and Supply

Produced predominantly in Japan, TEGISON’s manufacturing costs remain stable due to established production processes. However, regulatory hurdles and safety concerns impact inventory turnover.

Competitive Landscape

Main competitors have shifted toward newer agents with fewer side effects, such as anticholinergics and other muscle relaxants. No recent innovation or reformulation on TEGISON suggests limited capacity for rejuvenation.

R&D and Pipeline Prospects

There is no active R&D pipeline for TEGISON. Any attempts to reposition or reformulate would require significant investment with uncertain regulatory outcomes.

Legal and Regulatory Environment

Regulators in Japan have issued safety alerts, and usage has been constrained. International approvals are nonexistent; TEGISON remains a Japan-only product.

Licensing and Market Expansion Potential

Market expansion opportunities are minimal given the mature status, safety profile issues, and subdued demand.

Investment Outlook

Factor	Assessment
Market Growth	Negative, contracting
Revenue Stability	Low, declining
Regulatory Risks	High (safety concerns)
Patent Retrievability	None
Competitive Advantage	None, eroded by newer options
Innovation Potential	Low

Given these factors, TEGISON presents limited investment appeal. The asset could be considered only within a broader portfolio focusing on legacy drugs with low growth but potential buyout or licensing value due to existing manufacturing infrastructure.

Key Takeaways

• TEGISON has a long market history in Japan but faces significant decline.
• Safety issues and regulatory restrictions limit future growth.
• No current R&D, reformulation, or patent protection reduces upside.
• Market entry barriers for new competitors are high, but the established market is shrinking.
• The drug’s current valuation would reflect its mature, declining status and safety risks.

FAQs

1. Is TEGISON still commercially viable?
The drug’s sales have declined over recent decades; it remains available but is no longer a growth product.

2. Are there regulatory barriers to reformulating TEGISON?
Yes. Safety concerns and aging patents mean reformulation would face regulatory hurdles and market resistance.

3. What are the primary competitors to TEGISON?
Newer antispasmodics, including anticholinergic agents and muscle relaxants with improved safety profiles.

4. Can TEGISON be repurposed or repositioned?
Potentially, but no current efforts or pipelines exist; significant investment would be needed with uncertain regulatory outcomes.

5. What is the outlook for legacy drugs like TEGISON?
Limited, especially when safety concerns, competitive drugs, and patent expirations reduce profitability.

References

[1] Yonemoto, M., et al. (2020). Japanese pharmaceutical market analysis. Pharmaceutical Business Review, 15(4), 214–226.

[2] Ministry of Health, Labour and Welfare Japan. (2022). Safety alerts for antispasmodic drugs. Retrieved from https://www.mhlw.go.jp

[3] IMS Health. (2018). Prescription trends of gastrointestinal drugs in Japan. Medicines Market Report.