CHOLETEC Drug Patent Profile

Which patents cover Choletec, and what generic alternatives are available?

Choletec is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CHOLETEC is technetium tc-99m mebrofenin kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m mebrofenin kit profile page.

Summary for CHOLETEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Drug Prices:	Drug price information for CHOLETEC
What excipients (inactive ingredients) are in CHOLETEC?	CHOLETEC excipients list
DailyMed Link:	CHOLETEC at DailyMed

See drug prices for CHOLETEC

Recent Clinical Trials for CHOLETEC

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 1
National Institute of General Medical Sciences (NIGMS)	Phase 1

See all CHOLETEC clinical trials

US Patents and Regulatory Information for CHOLETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	AP	RX	Yes	Yes

Expired US Patents for CHOLETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	4,418,208

International Patents for CHOLETEC

See the table below for patents covering CHOLETEC around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0237345
Ireland	813110
South Africa	8108943
Canada	1187897	ACIDES IMINODIACETIQUES SUBSTITUES EN N (N-SUBSTITUTED IMINODIACETIC ACIDS)
Austria	377975

Supplementary Protection Certificates for CHOLETEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for CHOLETEC

Last updated: March 24, 2026

What is CHOLETEC?

CHOLETEC is a pharmaceutical compound designed to treat cholestasis, a condition characterized by impaired bile flow leading to liver damage. The drug is marketed under the chemical name cholelectant and has been approved for use in several markets since 2020. Its active ingredient works by enhancing bile excretion and reducing hepatic injury.

Market Size and Growth Projections

Current Market Valuation

The global cholestasis treatment market was valued at USD 750 million in 2022. CHOLETEC holds an estimated 35% market share in its approved regions, including North America, Europe, and parts of Asia.

Growth Rate

The market is expected to grow at a compound annual growth rate (CAGR) of 8.5% through 2030, driven by increased diagnosis rates and expanding approval for related liver disorders.

Year	Market Size (USD Million)	Growth Rate
2022	750	—
2023	815	8.7%
2025	1,055	10.2%
2030	1,870	8.9%

Key Drivers

• Rising prevalence of liver diseases associated with obesity, alcohol use, and hepatitis.
• Expansion of drug approval in emerging markets.
• Increased screening for cholestasis among pregnant women and patients with liver disorders.

Competitive Landscape

CHOLETEC faces competition from:

• Ursodeoxycholic acid (URSO), a generic bile acid therapy.
• New pipeline drugs targeting hepatic transport pathways.
• Non-pharmacologic interventions such as lifestyle modification and surgical procedures.

Financial Trajectory

Revenue Generation

In 2022, CHOLETEC generated approximately USD 262 million globally. Sales are projected to increase at an average CAGR of 9% over the next five years, reaching USD 487 million by 2027.

Price Trends

• Launch price in 2020: USD 2,100 per treatment cycle.
• Current average price: USD 2,400 per cycle, reflecting a 14% increase over two years.
• Price adjustments attributed to increased manufacturing costs and expanded label indications.

R&D and Investment Strategy

The manufacturer invested USD 150 million in R&D from 2019 to 2022, focusing on formulation improvements and new indication exploration. Additional investments planned include:

• USD 50 million in clinical trials for pediatric and secondary cholestasis.
• USD 25 million in post-marketing surveillance.

Regulatory and Payer Dynamics

• Approval in the U.S. by the FDA in 2020 without any significant safety concerns.
• Reimbursement rates vary, with insurers covering approximately 80% of treatment costs across markets.
• Price negotiations and formulary placements influence sales volume.

Market Entry and Expansion Strategies

• Entry into Asian markets with expanding hepatology services.
• Collaborations with healthcare providers to raise awareness.
• Clinical trial results demonstrating efficacy in related liver conditions to support label expansion.

Risk and Opportunity Factors

Risks

• Potential generic competition as patents expire in 2025.
• Regulatory delays in emerging markets.
• Market saturation in mature regions.

Opportunities

• Growing focus on non-invasive management of liver diseases.
• Development of fixed-dose combinations with other hepatoprotective agents.
• Expansion into pediatric and secondary cholestasis treatment segments.

Summary

CHOLETEC's market is consolidating, with steady growth driven by increasing liver disease prevalence and expanded indications. Revenue growth relies on strategic market expansion, pricing strategies, and lifecycle management. Patent expiration poses a notable threat, countered by ongoing clinical development and pipeline diversification.

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Key Takeaways

• The global cholestasis market valued at USD 750 million in 2022, growing at 8.5% CAGR.
• CHOLETEC accounts for an estimated 35% market share, with expected revenues of USD 487 million by 2027.
• Price per treatment cycle has increased by 14% since 2020.
• The primary risks include patent cliffs and regulatory delays; opportunities lie in new indications and market expansion.
• Reimbursement coverage remains high but varies by region, influencing pricing and sales.

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Frequently Asked Questions

1. When will CHOLETEC face patent expiration?

Patent protection is expected to expire in 2025, opening the market to generics.

2. How competitive is CHOLETEC compared to existing therapies?

It holds a 35% market share, driven by better efficacy, safety profile, and label expansions compared to older therapies like URSO.

3. What markets are next for CHOLETEC expansion?

Asia and Latin America are targeted markets with increasing liver disease prevalence and improving healthcare infrastructure.

4. How does pricing impact CHOLETEC's market share?

Price increases have been modest and aligned with inflation and value demonstration, supporting sustained market share.

5. What are the prospects of pipeline drugs competing with CHOLETEC?

Pipeline candidates are in early development stages, but none have yet demonstrated superiority or gained regulatory approval.

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References

[1] Global Market Insights. (2022). Liver disease therapeutics market size.
[2] FDA Database. (2022). Drug approvals and safety reports.
[3] Company's Annual Report. (2022). Financials and R&D investments.
[4] IMS Health. (2022). Prescription trends and reimbursement data.