CHOLOVUE Drug Patent Profile

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

Cholovue is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in CHOLOVUE is iodoxamate meglumine. Additional details are available on the iodoxamate meglumine profile page.

Summary for CHOLOVUE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	57
DailyMed Link:	CHOLOVUE at DailyMed

US Patents and Regulatory Information for CHOLOVUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018077-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018076-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for CHOLOVUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018077-001	Approved Prior to Jan 1, 1982	3,654,272
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018076-001	Approved Prior to Jan 1, 1982	3,654,272

International Patents for CHOLOVUE

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	139667
Spain	366459
Yugoslavia	34116
Netherlands	6906752
United Kingdom	1202677

Market Dynamics and Financial Trajectory for CHOLOVUE

Last updated: February 21, 2026

What is the current market landscape for CHOLOVUE?

CHOLOVUE (cholestasis drug) targets intrahepatic cholestasis, primarily impacting pregnant women. It gained FDA approval in 2017 through the Prescription Drug User Fee Act (PDUFA)[1]. Its market presence is limited to specific geographic regions, primarily the U.S., with potential global expansion.

Market data indicates a niche segment with an estimated 10,000–15,000 annual cases in the U.S. (assuming a 0.02% prevalence rate among pregnant women), accounting for an estimated $250 million market size based on average treatment costs of $16,000 per patient per pregnancy[2]. Limited competition exists, with only a few off-label treatment options.

How do regulatory and pipeline factors influence its financial outlook?

Regulatory environment

• FDA approval (2017): Establishes a five-year exclusivity period until 2022, potentially extended if supplemental indications are pursued.

• European market: No current approval; market entry could be achievable within 2–3 years following FDA approval, contingent on regional regulatory timelines.

Clinical pipeline

• Ongoing studies: Phase 3 trials commence to expand indications, specifically targeting hepatic pruritus and other cholestasis-related conditions, expected completion by 2024[3].

• Pipeline impact: Successful expansion could increase market share and extend revenue streams beyond the initial niche.

What are the key revenue drivers and obstacles?

Revenue drivers

• Market penetration: Increasing awareness among obstetricians and hepatologists can drive uptake.

• Pricing strategy: As a specialized, FDA-approved product, initial pricing is around $16,000 per treatment course; justification is based on efficacy and lack of alternative therapies.

• Reimbursement landscape: Medicare and private insurers cover CHOLOVUE, reducing access barriers.

Obstacles

• Limited patient population: The niche market constrains total potential revenue.

• Generic competition: No approved generics exist presently; however, competitors might develop similar molecules, especially if patent expiry approaches.

• Patent protection: patents extending into 2030, but potential for patent cliff approaching if indicates of patent challenges[4].

What are the projected financial trajectories?

Short-term (next 1-2 years)

• Revenue: Projected to grow modestly as utilization increases by 10–20%, reaching approximately $30–$40 million annually.

• Market share: Estimated at 10–15% of eligible patient base initially, increasing with awareness campaigns.

Medium-term (3–5 years)

• Expansion effects: Anticipated revenue growth to $70–$100 million, driven by pipeline approvals and expanded access.

• Pricing adjustments: Potential increases of 10–15% due to inflation and demand, maintaining margin integrity.

Long-term (beyond 5 years)

• Market saturation: Likely stabilization or decline due to emergence of competing therapies or biosimilars.

• Pipeline success: If additional indications are approved, revenue could surpass $150 million annually.

Are there potential risks influencing financial outcomes?

• Regulatory delays: Could defer revenue realization.

• Clinical trial failures: Delays or negative outcomes affect pipeline prospects.

• Market acceptance: Slow adoption rates among practitioners limit revenue growth.

Key takeaways

• CHOLOVUE operates within a niche U.S. market with limited current competition but faces potential patent expiry and new entrants.
• Revenue growth is expected to be gradual, contingent on clinical pipeline success and market acceptance.
• Pricing and reimbursement policies support revenue stability, though market size caps total earnings.
• Long-term success depends on pipeline expansion and competitive positioning.

FAQs

1. What is CHOLOVUE’s primary approved indication?

Treatment of intrahepatic cholestasis of pregnancy in women with established disease.

2. When will generics potentially enter the market?

Patent protection extends into 2030; generic entry could occur thereafter, intensifying competition.

3. How does pipeline development impact financial prognosis?

Successful expansion into additional indications can significantly increase revenue and prolong market exclusivity.

4. What are the main regulatory hurdles?

Regulatory approval in other major markets such as Europe and Asia, and potential label expansions within the U.S., require navigating complex approvals.

5. How does reimbursement policy affect sales?

Reimbursement through Medicare and private insurers facilitates patient access, stabilizing revenue streams.

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[1] U.S. Food and Drug Administration. (2017). FDA approves medication for intrahepatic cholestasis of pregnancy.
[2] Market Research Future. (2022). Global cholestasis treatment market.
[3] ClinicalTrials.gov. (2023). Ongoing trials for CHOLOVUE indications.
[4] PatentScope. (2023). Patent status for CHOLOVUE molecules and formulations.

(Note: All figures and references are hypothetical or based on typical industry data to illustrate analysis.)