URSODIOL - Generic Drug Details

What are the generic drug sources for ursodiol and what is the scope of patent protection?

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, Norvium Bioscience, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Allergan, Endo Operations, Epic Pharma Llc, Glenmark Pharms Ltd, 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:	93
Clinical Trials:	38
Patent Applications:	6,397
Drug Prices:	Drug price trends for URSODIOL
Drug Sales Revenues:	Drug sales revenues 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
Asmaa Abdelfattah Elsayed	Phase 4
University of Minnesota - Clinical and Translational Science Institute	Phase 1
University of Minnesota	Phase 1

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
Chartwell Rx	URSODIOL	ursodiol	CAPSULE;ORAL	213555-001	Aug 17, 2020	AB	RX	No	No
Zydus Lifesciences	URSODIOL	ursodiol	TABLET;ORAL	211145-002	Oct 30, 2018	AB	RX	No	No
Rk Pharma	URSODIOL	ursodiol	CAPSULE;ORAL	214329-001	Jul 28, 2021	AB	RX	No	No

Expired US Patents for URSODIOL

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
Allergan	URSO FORTE	ursodiol	TABLET;ORAL	020675-002	Jul 21, 2004	4,859,660

URSODIOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ursodiol (Ursodeoxycholic Acid)

Introduction to Ursodiol

Ursodiol, also known as ursodeoxycholic acid (UDCA), is a bile acid naturally produced by the body and widely used in the pharmaceutical industry for its therapeutic benefits. It is primarily prescribed for the treatment of primary biliary cholangitis (PBC), certain types of gallstones, and to prevent gallstones in adults undergoing rapid weight loss[2][4].

Global Market Size and Growth

The global Ursodeoxycholic Acid market is experiencing robust growth, driven by several key factors.

• Current Market Size: As of 2024, the global Ursodeoxycholic Acid market size is estimated at USD 612.5 million[1].
• Forecasted Growth: The market is projected to grow at a compound annual growth rate (CAGR) of 10.5% from 2024 to 2031, reaching a significant valuation in the coming years[1].
• Alternative Projections: Some reports suggest the market could reach USD 1.5 billion by 2028, growing at a CAGR of 6-8%[3], while others predict it will reach USD 1133.8 million by 2033, with a CAGR of 11.3%[4].

Regional Market Dynamics

The Ursodeoxycholic Acid market is distributed across various regions, each with its own growth trajectory.

• North America: This region currently dominates the market, holding more than 40% of the global revenue with a market size of USD 245 million in 2024. It is expected to grow at a CAGR of 8.7% from 2024 to 2031. The high prevalence of liver and gallbladder problems, along with the significant presence of top pharmaceutical companies, contributes to this dominance[1].
• Europe: Europe holds around 30% of the global revenue, with a market size of USD 183.75 million in 2024. It is expected to grow at a CAGR of 9.0% from 2024 to 2031[1].
• Asia-Pacific: This region is expected to make significant gains, with the highest CAGR of 12.5% from 2024 to 2031. The growth is attributed to increasing awareness of liver problems, rising healthcare costs, and an aging population[1].
• Latin America and Middle East & Africa: These regions hold smaller market shares, with Latin America at around 5% and the Middle East & Africa at around 2% of the global revenue. However, they are expected to grow at CAGRs of 9.9% and 10.2%, respectively, from 2024 to 2031[1].

Therapeutic Applications and Market Drivers

The demand for Ursodeoxycholic Acid is driven by its therapeutic applications and the increasing prevalence of liver diseases.

• Primary Biliary Cholangitis (PBC): PBC is a major indication for UDCA, accounting for over 80% of its global prescriptions. The global prevalence rate of PBC is significant, with 60-100 cases per million, as reported by the National Institute of Diabetes and Digestive and Kidney Diseases[4].
• Gallstones: UDCA is also used to dissolve cholesterol gallstones in patients with a functional gallbladder and to prevent gallstones in adults undergoing rapid weight loss[2].
• Other Indications: Its application extends to improving liver function in children suffering from cystic fibrosis-associated liver disease[4].

Market Drivers

• Increasing Liver Disease Prevalence: The rising incidence of liver diseases, including non-alcoholic fatty liver disease (NAFLD) affecting 80-100 million Americans, fuels the demand for UDCA[4].
• Growing Awareness and Healthcare Focus: The increasing awareness of liver health and the focus on personalized medicine in global healthcare systems drive the market growth[3].
• Technological Innovations: Ongoing research and development initiatives to uncover broader uses for UDCA drugs and enhance their formulations are key drivers[3].

Market Restraints

Despite the growth, the market faces some restraints.

• Adverse Effects: UDCA can have adverse effects, which may limit its use in late-stage liver diseases[4].
• Limited Efficacy: The drug's efficacy in advanced liver diseases is a challenge to market growth[4].

Market Opportunities

The Ursodeoxycholic Acid market presents several opportunities for growth and expansion.

• Research and Development: Intensified research offers potential to enhance UDCA formulations and explore new therapeutic applications[4].
• Generic Adoption: The growing adoption of generic versions of UDCA, which can reduce costs by up to 85%, broadens the accessibility of the therapy[4].

Financial Considerations

The cost of Ursodiol can vary based on several factors.

• Insurance Coverage: The cost is influenced by the patient's insurance coverage, treatment plan, and the pharmacy used[2].
• Generic vs. Brand Name: Generic versions of Ursodiol are generally cheaper than brand-name drugs like Actigall, Urso 250, and Urso Forte[2].
• Savings Programs: Patients can benefit from savings programs and coupons, such as those offered by Optum Perks, to reduce the cost of the medication[2].

Key Takeaways

• The global Ursodeoxycholic Acid market is projected to grow significantly, driven by the increasing incidence of liver diseases and the rising demand for effective therapies.
• North America currently dominates the market, but the Asia-Pacific region is expected to show the highest growth rate.
• The market is driven by the therapeutic applications of UDCA, particularly in treating PBC and gallstones.
• Despite growth, the market faces challenges such as adverse effects and limited efficacy in late-stage liver diseases.
• Opportunities for growth include intensified research, new therapeutic applications, and the adoption of generic versions.

FAQs

What is Ursodiol used for?

Ursodiol is primarily used to treat primary biliary cholangitis (PBC), dissolve certain types of gallstones, and prevent gallstones in adults undergoing rapid weight loss[2].

How does the cost of Ursodiol vary?

The cost of Ursodiol varies based on factors such as treatment plan, insurance coverage, pharmacy used, and whether a generic or brand-name version is prescribed[2].

Which region dominates the Ursodeoxycholic Acid market?

North America currently dominates the Ursodeoxycholic Acid market, holding more than 40% of the global revenue[1].

What is the projected growth rate of the Ursodeoxycholic Acid market?

The market is projected to grow at a CAGR of 10.5% from 2024 to 2031, with some reports suggesting a CAGR of 6-8% or 11.3% over different forecast periods[1][3][4].

What are the main drivers of the Ursodeoxycholic Acid market?

The main drivers include the increasing prevalence of liver diseases, growing awareness of liver health, and ongoing research and development initiatives[3][4].

Sources

1. Cognitive Market Research: Ursodeoxycholic Acid Market Report 2024 (Global Edition)
2. MedicalNewsToday: Ursodiol cost 2024: Coupons and more
3. MarketResearchIntellect: Drugs Of Ursodeoxycholic Acid Market Size And Projection
4. Market.us: Ursodeoxycholic Acid Drug Product Market Size | CAGR Of 11.3%