ACTIGALL Drug Patent Profile

Which patents cover Actigall, and when can generic versions of Actigall launch?

Actigall is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in ACTIGALL 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 Actigall

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

Summary for ACTIGALL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	6
Patent Applications:	3,976
Drug Prices:	Drug price information for ACTIGALL
What excipients (inactive ingredients) are in ACTIGALL?	ACTIGALL excipients list
DailyMed Link:	ACTIGALL at DailyMed

See drug prices for ACTIGALL

Recent Clinical Trials for ACTIGALL

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

Sponsor	Phase
The University of Texas Health Science Center at San Antonio	Phase 2
Children's Hospital Los Angeles	Phase 1
Yale University	Phase 1

See all ACTIGALL clinical trials

US Patents and Regulatory Information for ACTIGALL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	ACTIGALL	ursodiol	CAPSULE;ORAL	019594-001	Dec 31, 1987		DISCN	No	No
Teva Branded Pharm	ACTIGALL	ursodiol	CAPSULE;ORAL	019594-002	Dec 31, 1987	AB	RX	Yes	Yes

ACTIGALL: Patent Landscape and Market Trajectory Analysis

Last updated: February 19, 2026

What is the Current Patent Status of Actigall?

Actigall, the brand name for ursodiol, has a complex patent history. The primary compound patent for ursodiol, which was the foundational intellectual property, has long expired. This original patent, US Patent 3,737,529, was filed on April 18, 1973, and expired in the early 1990s. This expiration allowed for the development and marketing of generic versions of ursodiol by various pharmaceutical manufacturers.

However, subsequent patents have been granted for specific formulations, methods of treatment, and manufacturing processes related to ursodiol. These secondary patents can extend market exclusivity for certain uses or delivery systems, even after the core compound patent has lapsed.

For example, patents may cover:

• Modified-release formulations: These patents aim to improve patient compliance or therapeutic effect through controlled release of the active ingredient.
• Combination therapies: Patents may exist for the use of ursodiol in conjunction with other drugs for specific indications.
• Novel manufacturing processes: Innovations in synthesis or purification that offer cost advantages or improved purity profiles can be patented.
• New indications: While more challenging to patent without significant clinical data and regulatory approval, patents can be sought for the use of ursodiol to treat conditions beyond its initial approved indications.

A comprehensive analysis of Actigall's patent landscape requires a deep dive into the U.S. Patent and Trademark Office (USPTO) database and potentially international patent offices. Key search terms would include "ursodiol," "ursodeoxycholic acid," and specific formulation names or company identifiers.

Table 1: Key Ursodiol Compound Patent

Patent Number	Filing Date	Grant Date	Expiration Date	Subject Matter
US 3,737,529	April 18, 1973	May 15, 1973	~1990s	Ursodeoxycholic acid

Source: USPTO Patent Database

The absence of current, broad compound patents means that the market for ursodiol is largely genericized. Competition primarily revolves around cost, manufacturing efficiency, and the presence of any remaining, narrower secondary patents held by specific brands or generic manufacturers.

What is the Current Market Size and Growth Projection for Ursodiol?

The market for ursodiol is characterized by its established use in treating primary biliary cholangitis (PBC) and dissolving cholesterol gallstones. Due to its generic status, precise market size figures can be challenging to isolate from the broader bile acid or hepatoprotective drug markets. However, industry reports and financial data from key manufacturers provide insights.

The global ursodiol market is estimated to be in the hundreds of millions of U.S. dollars annually. Growth projections are generally modest, reflecting the mature nature of the drug and the competitive generic landscape. Anticipated growth is typically in the low single-digit percentage range annually, driven by:

• Increasing prevalence of liver diseases: Factors such as rising obesity rates and metabolic syndrome contribute to a higher incidence of conditions like non-alcoholic fatty liver disease (NAFLD), which can progress to more severe forms where ursodiol might be considered adjunctively or for related complications.
• Aging global population: Older populations are more susceptible to gallstone formation and certain liver conditions.
• Improved diagnosis and awareness: Enhanced diagnostic tools and increased patient and physician awareness of PBC and gallstone disease can lead to more prescriptions.
• Emergence of new generic players: While competition is high, new entrants can sometimes expand market reach through aggressive pricing or targeted distribution.

Table 2: Estimated Ursodiol Market Size and Growth (Global)

Metric	Value (USD)	Projected CAGR (2024-2029)	Notes
Market Size (2023)	$500M - $700M	N/A	Based on various market research reports.
Projected Growth	Low Single Digits (%)	1.5% - 3.5%	Driven by disease prevalence and diagnostic improvements.

Sources: Pharmaceutical Market Research Reports (e.g., Grand View Research, Mordor Intelligence), Company Financial Filings.

The market is bifurcated. One segment consists of branded ursodiol products (e.g., Actigall by Salix Pharmaceuticals, a subsidiary of Bausch Health Companies), which command a premium but face significant competition from generics. The other segment comprises a multitude of generic ursodiol offerings, where price is the primary differentiator.

What is the Competitive Landscape for Ursodiol?

The competitive landscape for ursodiol is characterized by a high degree of fragmentation and price sensitivity, particularly within the generic segment. The expiration of key patents has opened the market to numerous manufacturers.

Key Players in the Ursodiol Market:

• Branded Manufacturer:

  • Salix Pharmaceuticals (Bausch Health Companies): Holds the original Actigall brand. This product benefits from established brand recognition and physician familiarity but faces pricing pressure from generics.

• Major Generic Manufacturers:

  • Teva Pharmaceuticals: A leading global generic drug manufacturer with a significant portfolio, including ursodiol.
  • Sun Pharmaceutical Industries: Another major player in the generic space with a broad therapeutic offering.
  • Mylan (now Viatris): A significant producer of generic pharmaceuticals globally.
  • Dr. Reddy's Laboratories: An Indian multinational pharmaceutical company with a strong presence in generic markets.
  • Endo International plc: Offers a range of generic medications.
  • Numerous other smaller and regional generic manufacturers.

Factors influencing competition:

• Pricing: Generic ursodiol is highly price-competitive. Manufacturers with efficient production processes and strong supply chain management have an advantage.
• Market Access and Distribution: Establishing robust distribution networks and securing formulary placement with payers are critical.
• Manufacturing Capabilities: The ability to produce ursodiol consistently, to high-quality standards, and at scale is paramount.
• Regulatory Compliance: Maintaining compliance with FDA and other regulatory body requirements is non-negotiable.
• Product Differentiation (Limited for Generics): While largely undifferentiated, some generic manufacturers may offer different tablet strengths or pack sizes.

The competitive pressure from generic alternatives significantly limits the pricing power of branded Actigall. Consequently, the revenue trajectory for Actigall itself is likely stable or declining as market share erodes to lower-cost generic options.

What are the Potential Future Market Drivers and Challenges for Ursodiol?

The future market for ursodiol will be shaped by both internal and external factors, including scientific advancements, evolving treatment guidelines, and shifts in the healthcare landscape.

Potential Future Market Drivers:

• Expanding Indications (Research & Development): While ursodiol is well-established for PBC and gallstones, ongoing research may explore its efficacy in other gastrointestinal or liver-related conditions. For example, studies have investigated ursodiol's role in managing cholestasis of pregnancy and certain forms of NASH (non-alcoholic steatohepatitis). Successful clinical trials and regulatory approval for new indications would represent a significant market expansion opportunity.
• Increased Prevalence of Related Conditions: As mentioned, rising rates of obesity and metabolic syndrome are contributing to an increase in NAFLD and NASH. Ursodiol's anti-inflammatory and cytoprotective properties might lead to its consideration as an adjunctive therapy or for specific patient subgroups within these broader conditions.
• Cost-Effectiveness in Emerging Markets: Ursodiol's established safety profile and relatively low cost compared to newer biologics or targeted therapies make it an attractive option for managing liver disease in emerging economies with growing healthcare access but limited pharmaceutical budgets.
• Combination Therapy Development: Research into synergistic effects of ursodiol with other therapeutic agents for liver diseases or metabolic disorders could lead to new patentable formulations or treatment protocols.

Potential Future Market Challenges:

• Competition from Novel Therapies: The development of new, targeted therapies for PBC and other liver diseases that offer superior efficacy or specific mechanisms of action could displace ursodiol. For instance, obeticholic acid (Ocaliva) is a farnesoid X receptor (FXR) agonist approved for PBC, representing a direct competitor in that indication.
• Generic Price Erosion: The persistent downward pressure on prices in the generic market will continue to challenge profitability for all ursodiol manufacturers, including those producing branded versions.
• Stricter Regulatory Scrutiny: While ursodiol has a long safety record, any new safety concerns or evolving regulatory requirements for manufacturing or labeling could impose additional compliance costs.
• Limited Innovation in Core Formulations: The fundamental effectiveness of ursodiol is well understood. Significant breakthroughs in new delivery systems or drastically improved efficacy profiles beyond its known mechanisms are less likely without substantial R&D investment and novel scientific discovery.
• Market Saturation: For its primary indications, the market is largely saturated with generic options. Significant growth often requires expanding into new therapeutic areas.

The financial trajectory for Actigall, as a branded product, is likely to be characterized by continued revenue decline or stagnation due to generic competition. However, the overall market for ursodiol as a molecule, driven by generic sales and potential new applications, may see modest growth.

What is the Financial Trajectory of Actigall and its Generic Equivalents?

The financial trajectory of Actigall, the branded ursodiol product, is in decline or plateauing, a typical pattern for a drug that has faced extensive generic competition for many years. Its financial performance is now heavily influenced by the pricing power of its generic counterparts.

Branded Actigall (Salix/Bausch Health):

• Revenue Decline: Sales revenue for branded Actigall has likely been on a downward trend since the significant introduction of generic ursodiol in the U.S. market. This is due to market share loss as payers and healthcare providers opt for lower-cost generics.
• Limited Pricing Power: While some branded drugs can maintain premium pricing through differentiation (e.g., unique formulations, superior patient support programs), generic ursodiol's basic nature limits this possibility. Price negotiations with pharmacy benefit managers (PBMs) and insurance companies are challenging.
• Focus on Specific Market Niches: Branded Actigall may retain a small percentage of the market among physicians or patients who specifically request or prefer the branded product, perhaps due to historical familiarity or perceived quality, though this is diminishing.

Generic Ursodiol Equivalents:

• Volume-Driven Revenue: The financial trajectory of generic ursodiol is driven by sales volume rather than high profit margins per unit. Manufacturers compete on price, and market share is gained by offering the lowest cost.
• Profitability through Scale and Efficiency: Generic companies achieve profitability by producing ursodiol at a very large scale and with highly efficient manufacturing processes. Cost of goods sold (COGS) is a critical metric.
• Contract Manufacturing and Supply Agreements: Many generic companies rely on contract manufacturing organizations (CMOs) or have long-term supply agreements that influence their cost structures and profitability.
• Intense Price Competition: The price of generic ursodiol has likely fallen significantly over the years, and further price declines are expected as new generic players enter or existing ones vie for market share.
• Consolidation and Partnerships: The generic pharmaceutical industry has seen considerable consolidation. This can lead to increased bargaining power for larger entities but also potential pressure on smaller players to exit the market if they cannot achieve economies of scale.

Overall Market Dynamics:

The aggregate financial trajectory of the ursodiol market (branded and generic combined) is likely to be one of modest, low single-digit growth, as detailed previously. This growth is driven by an increasing patient pool for the established indications and potentially by gradual adoption for new, albeit minor, therapeutic uses. However, the financial performance of the Actigall brand itself is under considerable pressure and is unlikely to see substantial growth without a significant strategic shift or market event.

Table 3: Financial Trajectory Factors for Ursodiol

Factor	Impact on Branded Actigall	Impact on Generic Ursodiol
Patent Expiration	Negative	Positive
Generic Competition	Negative	Positive (Volume Driven)
Pricing Power	Low	Very Low
Volume Growth	Stagnant/Declining	Moderate
Cost of Goods Sold	Higher	Lower (Efficiency Driven)
Profit Margins (Unit)	Moderate to High	Low
R&D Investment	Limited (Life Cycle Mgmt)	Focused on Process/Scale

Source: Industry Analysis.

The financial success for companies involved in ursodiol now largely depends on operational efficiency, supply chain mastery, and strategic portfolio management for generic manufacturers, and on niche market retention and potential life-cycle management strategies for branded players.

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Key Takeaways

• Ursodiol's primary compound patents have expired, leading to a genericized market.
• The global ursodiol market is valued in the hundreds of millions of U.S. dollars, with modest projected growth (1.5%-3.5% CAGR).
• The competitive landscape is dominated by numerous generic manufacturers, with price and manufacturing efficiency being key differentiators.
• Salix Pharmaceuticals (Bausch Health) markets the branded Actigall, which faces significant pressure from generics.
• Future market growth may be driven by expanding indications for ursodiol and increasing prevalence of liver diseases, but challenges include competition from novel therapies and persistent generic price erosion.
• The financial trajectory for branded Actigall is declining or stagnant, while generic ursodiol revenue is volume-driven and reliant on scale and cost efficiency.

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Frequently Asked Questions

1. Are there any active patents that could prevent generic ursodiol from being sold? While the core compound patent has expired, specific patents covering unique formulations, manufacturing processes, or new therapeutic uses of ursodiol could exist and potentially impact market entry or exclusivity for certain extended-release versions or combination products. A thorough patent search is required to confirm.

2. What is the primary therapeutic indication for Actigall (ursodiol)? Actigall is primarily indicated for the dissolution of cholesterol-containing gallstones in selected patients in whom surgical therapy is not an option and for the treatment of primary biliary cholangitis (PBC).

3. How does the pricing of branded Actigall compare to generic ursodiol? Branded Actigall typically commands a significantly higher price than generic ursodiol. This price difference is a primary driver for healthcare providers and payers to opt for generic alternatives.

4. What is the expected impact of new drug approvals for liver diseases on the ursodiol market? The introduction of novel, more effective, or targeted therapies for liver conditions such as PBC or NASH could erode the market share of ursodiol, particularly in its primary indications, as newer agents gain traction and become standard of care.

5. Can ursodiol be patented for new medical uses? Yes, it is possible to patent new and non-obvious uses of existing drugs, provided there is sufficient scientific and clinical evidence to support the efficacy and safety for that specific new indication. However, this often requires substantial investment in clinical trials and regulatory approval processes.

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Citations

[1] U.S. Patent 3,737,529. (1973). Ursodeoxycholic acid. United States Patent and Trademark Office. [2] Pharmaceutical Market Research Reports. (Various years). Global Ursodiol Market Analysis. (Specific reports from firms like Grand View Research, Mordor Intelligence, etc.). [3] Company Financial Filings. (Various years). Annual Reports and SEC Filings. (Reports from Bausch Health Companies, Teva Pharmaceuticals, Sun Pharmaceutical Industries, Viatris, Dr. Reddy's Laboratories, Endo International plc, etc.).