URSO 250 Drug Patent Profile

When do Urso 250 patents expire, and what generic alternatives are available?

Urso 250 is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in URSO 250 is ursodiol. There are eight drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Urso 250

A generic version of URSO 250 was approved as ursodiol by EPIC PHARMA on March 14^th, 2000.

Summary for URSO 250

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Patent Applications:	4,631
What excipients (inactive ingredients) are in URSO 250?	URSO 250 excipients list
DailyMed Link:	URSO 250 at DailyMed

Pharmacology for URSO 250

Drug Class

Bile Acid

US Patents and Regulatory Information for URSO 250

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	URSO 250	ursodiol	TABLET;ORAL	020675-001	Dec 10, 1997	AB	RX	Yes	No

Expired US Patents for URSO 250

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

International Patents for URSO 250

See the table below for patents covering URSO 250 around the world.

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

URSO 250 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ursodeoxycholic Acid (URSO 250)

Introduction to Ursodeoxycholic Acid (URSO 250)

Ursodeoxycholic acid (UDCA), commonly known by its brand name URSO 250, is a bile acid naturally produced by the body and extensively used in the pharmaceutical industry for its therapeutic benefits. It is indicated for the management of cholestatic liver diseases, including primary biliary cirrhosis (PBC), and for dissolving gallstones in patients with a functional gallbladder[1][3][4].

Market Size and Growth

The global Ursodeoxycholic Acid (UDCA) market is projected to experience significant growth over the coming years. Here are some key statistics:

• The global UDCA market was valued at approximately $457.9 million in 2022 and is expected to reach around $933.9 million by 2029, with a compound annual growth rate (CAGR) of 10.7%[1].
• Another forecast indicates that the market will be worth around $1,165.2 million by 2031, growing at a CAGR of 10.2% from 2024 to 2031[4].
• A more extended forecast suggests the market will reach $1,133.8 million by 2033, with a CAGR of 11.3% from 2024 to 2033[3].

Market Drivers

Several factors are driving the growth of the UDCA market:

• Increasing Prevalence of Liver Diseases: The rising prevalence of liver diseases such as primary biliary cholangitis (PBC) and non-alcoholic fatty liver disease (NAFLD) is a significant driver. PBC alone has a global prevalence rate of 60-100 cases per million[3].
• Gallstones: The increasing incidence of gallstones, particularly among adults aged 40 and above, is another key driver. Risk factors such as obesity, diabetes, and rapid weight loss contribute to this trend[4].
• Growing Geriatric Population: The elderly are more prone to developing gallstones and liver diseases, offering new opportunities for market growth[4].

Market Restraints

Despite the growth potential, there are several challenges facing the UDCA market:

• High Costs: The high production costs and complex extraction and purification processes make UDCA treatments expensive, which can be a significant barrier to widespread adoption, especially in price-sensitive markets[4].
• Adverse Effects: UDCA has a side-effect profile that can limit its use, particularly in late-stage liver diseases[3].

Market Opportunities

There are several opportunities that could further boost the UDCA market:

• Generic Versions: The growing adoption of generic versions of UDCA can make the treatment more accessible and affordable, potentially increasing market penetration[3][4].
• Research and Development: Increasing research funding for developing alternate treatments and enhancing UDCA formulations can open up new avenues for growth. Several new drug candidates are under clinical trials to overcome the shortcomings of UDCA[4].

Regional Analysis

North America

• North America currently dominates the UDCA market, capturing over 36.6% of the global market share in 2023, with a market value of $142.2 million. This is due to a well-established healthcare infrastructure, high healthcare expenditure, and a large patient pool afflicted with liver-related disorders[3][4].

Asia Pacific

• The Asia Pacific region is emerging as the fastest-growing market, driven by a rising geriatric population, increasing healthcare expenditure, and growing awareness of liver disorders. Countries like China, India, Japan, and South Korea are major contributors to this growth[4].

Dosage Forms and Administration

• Tablets: The most preferred dosage form for UDCA is tablets, which hold more than 52% of the market share due to their ease of administration, cost-effectiveness, and precise dosage accuracy[3].

Financial Trajectory

Revenue Projections

• The launch of generic versions of UDCA, such as the one by Sunshine Biopharma, is expected to contribute significantly to market growth. For instance, Sunshine Biopharma's Canadian subsidiary, Nora Pharma Inc., has launched a generic version of URSO DS, which is part of the broader global UDCA market projected to grow significantly[1].

Cost and Pricing

• The high costs associated with UDCA treatments are a significant challenge. However, the introduction of generic versions can reduce prices by up to 85%, making the treatment more accessible[3][4].

Company Performance

• Companies like Sunshine Biopharma are expanding their product portfolios with new generic drugs, including UDCA. This strategy is part of their growth plan to strengthen their presence in the generic drugs market, which is projected to grow from $9.7 billion in 2023 to $19.2 billion by 2032[1].

Key Takeaways

• The global UDCA market is expected to grow significantly, driven by increasing prevalence of liver diseases and gallstones.
• North America dominates the market due to its robust healthcare infrastructure and high healthcare expenditure.
• The Asia Pacific region is emerging as a fast-growing market.
• Generic versions of UDCA are expected to increase market accessibility and affordability.
• High production costs and adverse effects are significant restraints to market growth.
• Research and development in new formulations and treatments offer future growth opportunities.

FAQs

What is Ursodeoxycholic Acid (UDCA) used for?

UDCA is used for the management of cholestatic liver diseases, including primary biliary cirrhosis (PBC), and for dissolving gallstones in patients with a functional gallbladder.

What is the projected market size of the global UDCA market by 2031?

The global UDCA market is expected to reach around $1,165.2 million by 2031, growing at a CAGR of 10.2% from 2024 to 2031[4].

Which region dominates the UDCA market?

North America currently dominates the UDCA market, capturing over 36.6% of the global market share in 2023[3].

What are the main drivers of the UDCA market growth?

The main drivers include the increasing prevalence of liver diseases and gallstones, and the growing geriatric population[3][4].

What are the challenges facing the UDCA market?

High production costs and adverse effects are significant challenges to the UDCA market, limiting its widespread adoption[3][4].

Sources

1. Sunshine Biopharma Launches a New Generic Prescription Drug - Biospace
2. Harmony Biosciences Reports Strong Third Quarter 2024 Financial Results - Harmony Biosciences
3. Ursodeoxycholic Acid Drug Product Market Size | CAGR Of 11.3% - Market.us
4. Ursodeoxycholic Acid Market Size, Trends And Forecast To 2031 - Coherent Market Insights