Ursodiol - Generic Drug Details

What are the generic sources for ursodiol and what is the scope of freedom to operate?

Ursodiol is the generic ingredient in four branded drugs marketed by Teva Branded Pharm, Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Hibrow Hlthcare, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Quagen, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Abbvie, Epic Pharma Llc, Glenmark Pharms Ltd, Ph Health, and Teva Pharms Usa, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for ursodiol. Twenty-nine suppliers are listed for this compound.

Summary for ursodiol

US Patents:	0
Tradenames:	4
Applicants:	21
NDAs:	24
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Patent Applications:	7,416
Drug Prices:	Drug price trends for ursodiol
What excipients (inactive ingredients) are in ursodiol?	ursodiol excipients list
DailyMed Link:	ursodiol at DailyMed

See drug prices for ursodiol

See drug sales revenues for ursodiol

Recent Clinical Trials for ursodiol

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

Sponsor	Phase
Egyptian Chinese University	PHASE4
Ain Shams University	PHASE4
Amira Adel Fouly	PHASE4

See all ursodiol clinical trials

Pharmacology for ursodiol

Drug Class

Bile Acid

US Patents and Regulatory Information for ursodiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675-002	Jul 21, 2004		DISCN	Yes	No
Strides Pharma	URSODIOL	ursodiol	CAPSULE;ORAL	210344-001	Jan 22, 2021	AB	RX	No	No
Teva Pharms Usa	URSODIOL	ursodiol	TABLET;ORAL	079184-002	May 13, 2009		DISCN	No	No

Expired US Patents for ursodiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	URSO 250	ursodiol	TABLET;ORAL	020675-001	Dec 10, 1997	4,859,660
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675-002	Jul 21, 2004	4,859,660

Market Dynamics and Financial Trajectory for Ursodiol

Last updated: February 19, 2026

Ursodiol (ursodeoxycholic acid) has maintained a stable position in the treatment of cholestatic liver diseases, primarily biliary cirrhosis and gallstones. Its market is driven by indications, generic availability, and regulatory factors, shaping a predictable revenue trajectory.

Market Size and Growth Drivers

Global Market Value:
The global ursodiol market was valued at approximately USD 300 million in 2022. It is projected to reach USD 450 million by 2030, with a compound annual growth rate (CAGR) of 5.2% (Research and Markets, 2023).

Key Growth Drivers:

• Increase in gallstone disease prevalence, notably in the aging population.
• Rising diagnosis rates of primary biliary cholangitis.
• Off-label use in non-alcoholic fatty liver disease.
• Expansion into emerging markets with improving healthcare infrastructure.

Market Segmentation

Segment	Market Share (2022)	Growth Outlook	Notes
Prescription (Brand)	65%	Declining	Mostly brand-name products with patent protections; limited new entry.
Prescription (Generic)	35%	Growing	Largest segment driven by patent expirations.

Indications:

• Gallstone dissolution (primary)
• Biliary cirrhosis (secondary)
• Cholestatic liver disorders (emerging indication)

Competitive Landscape

Major Players (2022):

• Sanofi (Original patent holder)
• Multiple generics manufacturers globally

Patent and Regulatory Status:

• The original Sanofi patent expired in 2002.
• Several generic formulations are approved worldwide.
• Regulatory approval processes remain streamlined in most regions, facilitating market entry for generics.

Pricing and Reimbursement Trends

• Brand-name pricing: USD 30-50 per daily dose.
• Generic pricing: USD 10-20 per daily dose, with bid competition lowering prices further in emerging markets.
• Reimbursement policies favor cost-effective generics, contributing to increased adoption.

Financial Trajectory

Revenue Patterns:

• Steady decline in brand-name sales due to patent expiry.
• Robust growth in generic sales, compensating for brand revenue decline.
• US sales accounted for 60% of the market, driven by high prescription volume.
• Emerging markets in Asia and Latin America show high growth potential.

Projection (2023-2030):	Year	Estimated Revenue	Notes
2023	USD 330 million	Slight growth from 2022 levels.
2025	USD 375 million	Market expansion accelerates.
2030	USD 450 million	Reached projected CAGR of 5.2%.

Risks and Challenges

• Regulatory changes restricting off-label uses.
• Price erosion from generics.
• Slow adoption of new indications, like primary biliary cholangitis, limits growth potential.

Summary

Ursodiol faces a mature market with declining brand revenues and expanding generic sales. The overall market remains stable with moderate growth, primarily influenced by regional healthcare infrastructure and aging populations. The financial trajectory indicates incremental revenue growth, with potential acceleration in emerging markets.

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Key Takeaways

• Ursodiol's global market was valued at USD 300 million in 2022, expected to reach USD 450 million by 2030 at a CAGR of 5.2%.
• Patent expirations have shifted revenue dominance from brand to generics.
• US market contributes 60% of sales; emerging markets show growth potential.
• Pricing is influenced heavily by generic competition and reimbursement policies.
• Patent status, regulatory environment, and off-label use trends are principal risk factors.

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FAQs

1. What factors are influencing the growth of ursodiol globally?
Aging populations, rising gallstone prevalence, increased diagnosis of cholestatic conditions, and expanding use in emerging markets fuel growth.

2. How do patent expirations impact ursodiol's market?
Patent expiry in 2002 led to a surge in generic formulations, decreasing brand-name revenues and shifting market share to generics.

3. What are the main barriers to market expansion for ursodiol?
Regulatory restrictions on off-label uses, price competition from generics, and slow adoption of newer indications.

4. Which markets dominate ursodiol sales?
North America, particularly the US, accounts for the majority, with significant growth in Asia and Latin America.

5. How do reimbursement policies affect ursodiol pricing?
Policies favor cost-effective generics, leading to lower prices and increased adoption in price-sensitive regions.

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References

[1] Research and Markets. (2023). "Ursodiol Market Forecast 2023-2030."
[2] U.S. Food and Drug Administration (FDA). (2002). "Patents and Exclusivities."
[3] GlobalData. (2022). "Pharmaceutical Market Trends."
[4] IQVIA. (2022). "Worldwide Prescriptions Data."