URSO FORTE Drug Patent Profile

Which patents cover Urso Forte, and what generic alternatives are available?

Urso Forte is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in URSO FORTE is ursodiol. There are eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Urso Forte

A generic version of URSO FORTE was approved as ursodiol by EPIC PHARMA on March 14^th, 2000.

Summary for URSO FORTE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	5,786
Drug Prices:	Drug price information for URSO FORTE
DailyMed Link:	URSO FORTE at DailyMed

See drug prices for URSO FORTE

Pharmacology for URSO FORTE

Drug Class

Bile Acid

US Patents and Regulatory Information for URSO FORTE

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

Expired US Patents for URSO FORTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675-002	Jul 21, 2004

International Patents for URSO FORTE

See the table below for patents covering URSO FORTE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1318590	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'ACIDE URSODESOXYCHOLIQUE (PHARMACEUTICAL COMPOSITIONS CONTAINING URSODEOXYCHOLIC ACID)
European Patent Office	0269516
France	2607005	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'ACIDE URSODESOXYCHOLIQUE
Japan	S63141929	MEDICINAL COMPOSITION CONTAINING ULSODEOXYCHOLIC ACID

Market Dynamics and Financial Trajectory for URSO FORTE

Last updated: February 20, 2026

What is the current market landscape for URSO FORTE?

URSO FORTE is a trademarked formulation containing ursodeoxycholic acid (UDCA). It is primarily prescribed for cholestatic liver diseases, including primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and certain gallstone conditions.

As of 2023, the global UDCA market is valued at approximately $150 million and is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030. The growth is driven by increasing diagnoses of chronic liver diseases, rising awareness, and expanding indications for UDCA use.

Key geographic markets

Region	Market Size (USD million, 2023)	CAGR (2023–2030)	Drivers
North America	50	7%	High prevalence of liver diseases, strong healthcare infrastructure, and drug reimbursement policies
Europe	45	6.5%	Stringent guidelines supporting UDCA, aging population
Asia-Pacific	30	8%	Increasing liver disease prevalence, expanding healthcare access
Rest of World	25	7%	Better awareness, growing GDP for healthcare investments

Market competition

Major players include:

• Miragon Pharma (US, India)
• Genfit (France)
• Dr. Reddy’s Laboratories (India)
• Chugai Pharmaceutical (Japan)

URSO FORTE's positioning is linked to off-label use in conditions like nonalcoholic fatty liver disease (NAFLD), which is not yet well-established but shows a rising research interest.

How does the regulatory environment influence URSO FORTE's market?

Regulatory approval impacts market access substantially. In the US, most UDCA formulations are marketed as prescription drugs with FDA approval for primary biliary cholangitis. Cholelithiasis and other off-label uses face variable regulatory status.

In Europe, the European Medicines Agency (EMA) approves UDCA for similar indications, with an additional emphasis on quality and safety standards. In some Asian countries, generic versions bypass extensive regulatory hurdles due to regulations favoring local manufacturers.

Patent protection plays a critical role. URSO FORTE’s patent landscape has evolved, with some formulations entering generic markets after patent expiration around 2020.

What are the key factors driving the growth of URSO FORTE?

Rising prevalence of liver diseases

The incidence of cholestatic liver conditions has increased globally, attributed to lifestyle factors, obesity, and aging populations. PBC prevalence estimates: 1-2 per 100,000 females in North America and Europe.

Expanding indication scope

Research indicating potential benefits in nonalcoholic steatohepatitis (NASH) and other metabolic liver diseases boosts off-label demand.

Healthcare access and reimbursement

In developed markets, insurance coverage supports prescription fill rates. The introduction of cost-effective generics further supports utilization.

Clinical research and pipeline

Ongoing trials investigate UDCA’s role in neurodegenerative diseases and gastrointestinal disorders, potentially expanding therapeutic applications.

What are the financial implications?

Revenue forecasts

Based on current market data, global UDCA revenue could reach $220 million by 2028 with a CAGR of approximately 6%. URSO FORTE's share aligns with this trend, considering its penetration in primary biliary cholangitis.

Impact of generics and biosimilars

Patent expirations enable generic manufacturers to enter the market, pressuring prices downward. Price erosion observed in India and parts of Europe in 2020-2022 resulted in revenue declines for branded formulations, but volume sales generally increased.

R&D investments

Investments by pharmaceutical companies in clinical trials aim to extend UDCA's efficacy profile. For example, Genfit’s NGM282 trials for NASH have shown promising preliminary results, which could influence future sales channels.

Market risks

• Off-label use limitations
• Regulatory restrictions
• Competitive generic entrants
• Patent cliff timing

Summary of market size and growth

Year	Estimated Market Size (USD million)	CAGR (2023–2030)
2023	150	—
2025	180	6.4%
2028	220	6%

Key Takeaways

• The global UDCA market, including URSO FORTE, is set to grow steadily, driven by increased liver disease prevalence and expanding indications.
• Regulatory environments influence market access and pricing; generic entries post-patent expiration have compressed margins.
• Clinical research continues to explore new therapeutic roles for UDCA, potentially altering the market landscape.
• Competition from generics and biosimilars could impact branded formulations' revenues, particularly in price-sensitive markets.

FAQs

Q1: What is URSO FORTE primarily prescribed for?

A1: URSO FORTE is prescribed for cholestatic liver diseases, mainly primary biliary cholangitis and certain gallstone conditions.

Q2: How does patent expiry influence URSO FORTE's market?

A2: Patent expiry allows generic manufacturers to produce cheaper versions, increasing competition and potentially reducing revenues for branded formulations.

Q3: What factors could hinder the growth of URSO FORTE?

A3: Regulatory restrictions on off-label use, competitive generic entries, and negative clinical trial results could limit growth.

Q4: Are there emerging indications for UDCA that could expand the market?

A4: Yes, ongoing research suggests potential benefits in NASH and other metabolic liver diseases, which could expand indications.

Q5: How does the regional variation affect URSO FORTE's market?

A5: Developed markets like North America and Europe have higher adoption due to regulation and reimbursement, while Asia-Pacific has growth potential owing to increasing disease prevalence and healthcare improvements.

References

[1] MarketsandMarkets. (2023). Global Ursodeoxycholic Acid Market.
[2] European Medicines Agency. (2022). Summary of Product Characteristics for UDCA.
[3] FDA. (2022). Drug Approvals and Regulatory Decisions.
[4] Global Liver Disease Statistics. (2022). World Health Organization.
[5] Genfit. (2023). Pipeline Data on NASH and Liver Disease Trials.