Colchicine; probenecid - Generic Drug Details

What are the generic drug sources for colchicine; probenecid and what is the scope of patent protection?

Colchicine; probenecid is the generic ingredient in five branded drugs marketed by Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Rising, Sandoz, and Lederle, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for colchicine; probenecid

US Patents:	0
Tradenames:	5
Applicants:	9
NDAs:	11
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
DailyMed Link:	colchicine; probenecid at DailyMed

Recent Clinical Trials for colchicine; probenecid

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

Sponsor	Phase
Chinese University of Hong Kong	Phase 2
Mutual Pharmaceutical Company, Inc.	Phase 1

See all colchicine; probenecid clinical trials

Pharmacology for colchicine; probenecid

Drug Class

Alkaloid

Anatomical Therapeutic Chemical (ATC) Classes for colchicine; probenecid

M04AB	Preparations increasing uric acid excretion
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

M04AC	Preparations with no effect on uric acid metabolism
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

M04AC	Preparations with no effect on uric acid metabolism
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

US Patents and Regulatory Information for colchicine; probenecid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	217030-001	Oct 24, 2023	AB	RX	No	No
Watson Labs	COL-PROBENECID	colchicine; probenecid	TABLET;ORAL	084279-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Sandoz	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	086130-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	PROBENECID W/ COLCHICINE	colchicine; probenecid	TABLET;ORAL	086954-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ani Pharms	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	083734-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	083720-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Colchicine; probenecid Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Current Market Dynamics for Colchicine and Probenecid?

The markets for colchicine and probenecid focus primarily on gout, hyperuricemia, and certain inflammatory conditions. Both drugs are established therapies with aging patent profiles and facing increasing generic competition. The dynamics are influenced by factors including patent expirations, regulatory approvals, emerging competitors, and evolving clinical guidelines.

Market Size and Growth Trends

• Colchicine: Valued at approximately $250 million globally in 2022, with a compound annual growth rate (CAGR) of around 3% over the past five years. Growth is driven primarily by its use in gout management and emerging indications such as familial Mediterranean fever (FMF) [1].
• Probenecid: Estimated at $50 million globally in 2022, with a slow CAGR of 1-2%. Its use remains stable, mostly in combination therapies for gout and in research settings [2].

Patent and Regulatory Landscape

• Colchicine: The original patents expired in the early 2000s. Several generic formulations are widely available. Limited recent patent filings suggest minimal patent activity; however, some extended-release formulations are under development, potentially delaying generic competition [3].
• Probenecid: Patents expired in the 1980s, with formulations falling into the public domain. Its status remains unchanged, with no recent patent activity or new formulations in late-stage development [4].

Competitive Dynamics and Market Entry Barriers

• US and European markets are dominated by generics since patent expirations.
• Recent clinical guidelines have reinforced colchicine’s role in gout prophylaxis, potentially maintaining steady demand.
• Resistance is minimal; however, new drugs like lesinurad and uricosuric agents pose competition.

Pricing and Reimbursement

• Colchicine: Prices have declined due to generic availability, but branded formulations retain premium due to perceived quality and dosing consistency.
• Probenecid: Price points are generally low and stable; reimbursement policies in major markets favor affordability.

Emerging Use Cases and Trends

• Repurposing of colchicine for cardiovascular diseases is under investigation, which could impact future demand.
• Both drugs are being evaluated for antigout combination therapies.

What Are the Financial Trajectories for Colchicine and Probenecid?

Revenue Projections

• Colchicine: Expected to maintain a modest CAGR of approximately 3% through 2028, achieving revenues near $280 million. Growth depends on expanding clinical indications and potential new formulations.
• Probenecid: Will likely see flat growth, with revenues hovering around $55 million by 2028, limited by market saturation and lack of innovation.

Cost Structure and Profitability

• Both drugs have low production costs given their age and generic manufacturing processes.
• Profit margins are narrowing due to pricing pressures but are offset by high volume sales.

Development and R&D Outlook

• Minimal R&D investment expected; however, some pharmaceutical companies explore modified-release formulations or combination therapies aimed at niche markets.
• Investment in new indications or delivery systems remains speculative and limited.

Market Risks and Opportunities

• Risks: Patent challenges, emergence of new therapies, regulatory shifts, and declining market share for older formulations.
• Opportunities: Expansion into new indications, formulations, or combination products; strategic partnerships for clinical development.

Key Takeaways

• Both colchicine and probenecid face declining revenue opportunities due to patent expirations and generic competition.
• Market growth for colchicine maintains a slow upward trajectory driven by new clinical guidelines and research.
• Pricing pressures and limited R&D focus restrict margin expansion.
• Emerging research into new indications could marginally influence future demand.
• Investment strategies should consider market saturation and the potential for niche repositioning.

FAQs

1. What are the primary therapeutic uses of colchicine and probenecid?
Colchicine is primarily used for gout management, familial Mediterranean fever, and pericarditis. Probenecid is mainly used to treat gout and hyperuricemia by increasing uric acid excretion.

2. Are there any patented formulations of colchicine available today?
Most formulations are generics following patent expirations in the early 2000s. Some extended-release formulations are under development but have not yet received marketing approval.

3. How does the competitive landscape affect these drugs' market positions?
Widespread generic availability reduces prices and profit margins. Competitive pressures from newer urate-lowering agents and alternative therapies diminish market share for older drugs.

4. What potential future developments could alter the market dynamics?
New indications, especially related to inflammation and cardiovascular diseases, and innovative formulations could influence demand. However, regulatory hurdles and existing market saturation limit substantial growth.

5. What are the main risks facing investments related to these drugs?
Patent challenges, competition from newer therapies, changes in clinical guidelines, and pricing pressures pose risks to revenue stability.

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Citations

1. IQVIA, Global Pharmaceutical Market Data, 2022.
2. EvaluatePharma, 2022.
3. U.S. Patent and Trademark Office, Patent filings for colchicine, 2000-2021.
4. European Patent Office, Historical patents for probenecid, 1980s.