Colchicine - Generic Drug Details

What are the generic sources for colchicine and what is the scope of freedom to operate?

Colchicine is the generic ingredient in ten branded drugs marketed by Annora Pharma, Aurobindo Pharma Ltd, Granules, Ph Health, Hikma Intl Pharms, Scilex Pharms, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Agepha Pharma Fz, Watson Labs, Merck, Ani Pharms, Beecham, Impax Labs, Novast Labs, Rising, Sandoz, and Lederle, and is included in thirty NDAs. There are forty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colchicine has ninety patent family members in twenty-five countries.

There are sixteen drug master file entries for colchicine. Thirty-four suppliers are listed for this compound.

Summary for colchicine

International Patents:	90
US Patents:	40
Tradenames:	10
Applicants:	25
NDAs:	30
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	316
Patent Applications:	6,686
Drug Prices:	Drug price trends for colchicine
Drug Sales Revenues:	Drug sales revenues for colchicine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for colchicine
What excipients (inactive ingredients) are in colchicine?	colchicine excipients list
DailyMed Link:	colchicine at DailyMed

See drug prices for colchicine

See drug sales revenues for colchicine

Recent Clinical Trials for colchicine

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

Sponsor	Phase
University of North Carolina, Chapel Hill	PHASE3
Johns Hopkins University	PHASE3
National Heart, Lung, and Blood Institute (NHLBI)	PHASE3

See all colchicine clinical trials

Pharmacology for colchicine

Drug Class	Alkaloid
Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions

Medical Subject Heading (MeSH) Categories for colchicine

Gout Suppressants

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for colchicine

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

Paragraph IV (Patent) Challenges for COLCHICINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLOPERBA	Oral Solution	colchicine	0.6 mg/5 mL	210942	1	2020-04-02
COLCRYS	Tablets	colchicine	0.3 mg	022352	1	2019-07-19
MITIGARE	Capsules	colchicine	0.6 mg	204820	1	2016-06-10
COLCRYS	Tablets	colchicine	0.6 mg	022352	1	2011-12-23

US Patents and Regulatory Information for colchicine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Intl Pharms	MITIGARE	colchicine	CAPSULE;ORAL	204820-001	Sep 26, 2014	AB	RX	Yes	Yes	9,789,108
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	8,440,722
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes	11,944,595

International Patents for colchicine

Country	Patent Number	Title	Estimated Expiration
Mexico	375082	TRATAMIENTO O PREVENCIÓN DE EVENTOS CARDIOVASCULARES MEDIANTE LA ADMINISTRACIÓN DE UN DERIVADO DE COLCHICINA. (TREATMENT OR PREVENTION OF CARDIOVASCULAR EVENTS VIA THE ADMINISTRATION OF A COLCHICINE DERIVATIVE)
Mexico	2020012310
Brazil	112015010063

Market Dynamics and Financial Trajectory for Colchicine: An In-Depth Analysis

Last updated: December 27, 2025

Summary

Colchicine, a centuries-old medication primarily used for gout treatment and familial Mediterranean fever, has experienced renewed interest due to its potential applications in cardiovascular diseases, inflammatory disorders, and COVID-19-related complications. This article analyzes current market dynamics, regulatory landscapes, key financial trends, and future growth prospects of colchicine, backed by quantitative data, strategic developments, and critical industry insights.

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What Are the Historical and Current Market Foundations of Colchicine?

Historical Usage and Market Overview

• Historical Background: Derived from Colchicum autumnale, colchicine has been used for centuries in treating gout and related conditions.
• Market Size (2022): Estimated global value of USD 300 million, with stable growth driven by niche indications.
• Approved Indications:
  • Gout flare management
  • Familial Mediterranean fever (FMF)
• Manufacturers & Brands:
  • Original brands include Colcrys (Takeda Pharmaceuticals), Mitigare (Cipla), and generic formulations.

Market Segmentation and Geographical Breakdown

Segment	2022 Market Share	Key Countries
Gout treatment	65%	US, Europe, Japan
FMF management	20%	Middle East, Mediterranean regions
Emerging indications	15%	Global, especially in clinical trials

Patent and Regulatory Status

• Patent Landscape: Most formulations are off-patent, leading to price competition.
• Regulatory Approvals:
  • FDA-approved for gout, FMF.
  • Investigational uses in cardiovascular and COVID-19 contexts.

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What Are the Key Drivers and Restraints Shaping Market Dynamics?

Drivers

Drivers	Impact	Data/Example
Growing prevalence of gout and FMF	Expanding patient base	Gout affects ~4% of US adults, equating to over 8 million individuals [1]
Shift toward repurposing existing drugs for new indications	Increased R&D investment	COVID-19 pandemic accelerated studies for colchicine's anti-inflammatory properties
Cost-effectiveness and established safety profile	Market adoption	Favorable profile compared to biologics in certain indications
Rising awareness of inflammatory pathways and NLRP3 inflammasome	New therapeutic avenues	Studies targeting inflammasome pathways highlight colchicine's versatility [2]

Restraints

Restraints	Impact	Data/Example
Limited patent protection and generic competition	Price pressure	Price erosion observed in US generics markets, impacting margins
Variable clinical efficacy in emerging indications	Clinical uncertainty	Conflicting trial results in cardiovascular and COVID-19 trials
Safety concerns (e.g., toxicity at high doses)	Regulatory scrutiny	Reports of gastrointestinal toxicity; narrow therapeutic window
Regulatory hurdles for off-label uses	Market entry barriers	Divergent approval statuses across regions

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What Is the Current Financial Trajectory of Colchicine?

Market Revenue & Growth Projections (2022–2027)

Year	Estimated Global Market Value (USD millions)	CAGR (Compound Annual Growth Rate)	Comments
2022	300	—	Baseline
2023	330	10%	US & Europe expansion underway
2024	363	10%	Increased acceptance in COVID-19 treatments
2025	399	10%	Emerging markets adoption
2026	439	10%	Clinical evidence enhancing confidence
2027	483	10%	Market maturation with ongoing innovation

Note: The above projections derive from industry reports and trend analyses[3].

Revenue Breakdown by Region

Region	2022 Revenue (USD millions)	2027 projected revenue (USD millions)	Key Drivers
North America	120	180	High prevalence of gout, clinical trials
Europe	80	120	Regulatory approvals, market familiarity
Asia-Pacific	50	100	Growing healthcare infrastructure, population base
Rest of World	50	83	Emerging markets, off-label use potential

Key Market Players and Their Strategies

Company	Market Share	Strategic Focus	Recent Developments
Takeda Pharmaceuticals	~50%	Maintain leadership through brand continuity	Launched Colcrys; expanding clinical trials on cardiovascular and COVID-19 uses
Cipla	~20%	Affordable generics and regional market expansion	Focus on differentiation via cost and distribution networks
Mylan (now part of Viatris)	~15%	Diversified portfolio, off-patent formulations	Increasing presence in emerging markets
Others	~15%	Niche players, clinical-stage firms	Innovative delivery mechanisms, novel indications

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What Are the Emerging Indications and Innovations?

COVID-19 and Acute Respiratory Syndromes

• Multiple clinical trials (e.g., COLCORONA) demonstrate potential in reducing hospitalization and death.
• Trial Data:
  • COLCORONA Trial (NCT04322682): Enrolled ~4,488 patients; showed a 21% relative reduction in hospitalization in colchicine group [4].
  • Regulatory agencies have issued Emergency Use Authorizations (EUAs) in specific jurisdictions.

Cardiovascular Diseases

• Evidence suggests colchicine mitigates atherosclerosis and reduces recurrent cardiovascular events.
• Major trials:
  • LoDoCo2: Demonstrated a 31% relative risk reduction in composite cardiovascular outcomes over 3 years.

Niche Auto-inflammatory and Chronic Inflammatory Diseases

• Role in treating autoinflammatory syndromes remains critical.
• Investigations into mechanisms involving NLRP3 inflammasome expand potential indications.

Delivery Innovations

• Development of slow-release formulations to improve compliance and reduce toxicity.
• New delivery systems are on experimental stages, targeting broader clinical applications.

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How Do Competitive and Policy Landscapes Impact Future Trajectory?

Regulatory Environment

Region	Regulatory Approach	Impact
US (FDA)	Strict approval for new indications, off-label use not recommended	Potential barriers for unapproved uses
Europe (EMA)	Similar to FDA, with some flexible policies	Favorable for expanded uses with robust trial data
Asia-Pacific	Rapid approvals, local regulatory variations	Opportunities for market penetration with localized trials

Pricing and Reimbursement Policies

Region	Reimbursement Status	Impact
US	Reimbursed under Medicare/Commercial plans	Stable revenue source
European countries	Varied; often based on cost-effectiveness	Price pressures; favoring generics
Emerging markets	Limited reimbursement; price-sensitive	Reliance on low-cost generics

Patent and Off-Patent Strategies

• Most formulations are off-patent, increasing competition but also prompting innovation through formulation patents or combinations.
• Some companies explore polymorphic formulations and combination therapies to extend market exclusivity.

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Comparison with Other Gout and Inflammatory Drugs

Parameter	Colchicine	Allopurinol	Febuxostat	Biologics (e.g., Canakinumab)
Mode of Action	Anti-inflammatory, microtubule inhibitor	Uric acid synthesis inhibitor	Uric acid synthesis inhibitor	IL-1β inhibition
Market Size (2022)	USD 300 million	USD 2 billion	USD 1.5 billion	USD 1 billion
Safety Profile	GI toxicity, narrow therapeutic window	Generally well tolerated	Higher cardiovascular risk observed	High safety and cost considerations
Indication Breadth	Gout, FMF, emerging uses	Gout, uric acid reduction	Gout, cardiovascular, others	Autoinflammatory and rare genetic disorders

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What Are the Critical Challenges and Opportunities?

Challenges

• Market Saturation & Price Compression: Especially in developed regions with multiple generics.
• Clinical Efficacy in New Indications: Mixed trial results complicate evidence-based expansion.
• Safety Concerns: Toxicity at higher doses constrains broader application.
• Regulatory Delays: Off-label use and unapproved indications face hurdles, especially concerning COVID-19.

Opportunities

• Repurposing for COVID-19 and Cardiovascular Disease: Proven or emerging efficacy can boost revenues.
• Personalized Medicine Approaches: Identifying patient subgroups most likely to benefit.
• Formulation Innovation: Extended-release products to improve compliance and safety.
• Market Penetration in Emerging Economies: Cost-effective generics thrive in these markets.

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Key Takeaways

• The global colchicine market was valued at approximately USD 300 million in 2022, with a strong growth forecast (~10% CAGR) driven by its repositioning in emerging indications.
• Market expansion depends heavily on clinical trial outcomes, regulatory approval, and reimbursement policies.
• COVID-19 has presented both opportunities and challenges; ongoing studies could significantly influence future profitability.
• Patent expirations have increased competition, pushing companies towards formulation innovation and new therapeutic areas.
• Regulatory jurisdictions significantly influence market strategies; Asia-Pacific and emerging markets offer substantial growth potential.

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Frequently Asked Questions (FAQs)

Q1: What are the main clinical indications for colchicine today?
A: Primarily gout management, familial Mediterranean fever, and emerging indications include cardiovascular disease and COVID-19-related complications.

Q2: How does colchicine’s patent status affect its market?
A: Since most formulations are off-patent, generic competition leads to price erosion, though innovation in formulations and new uses can offer exclusivity opportunities.

Q3: What are the primary safety concerns with colchicine?
A: Gastrointestinal toxicity, neuromuscular effects, and toxicity at higher doses; narrow therapeutic window necessitates careful dosing.

Q4: What is the outlook for colchicine in COVID-19 treatment?
A: Mixed trial results exist; however, some large studies suggest potential benefits in reducing hospitalization, supporting ongoing research and regulatory considerations.

Q5: Which regions represent the most promising markets for colchicine’s growth?
A: North America, Europe, and Asia-Pacific, especially in countries with high gout prevalence and growing healthcare infrastructure, are promising markets.

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References

1. CDC. (2021). Gout Prevalence and Demographics.
2. He et al. (2020). NLRP3 inflammasome in cardiovascular disease. Nature Reviews Cardiology.
3. MarketWatch Reports. (2022). Global Colchicine Market Analysis & Forecast.
4. COLCORONA Trial. (2021). ClinicalTrials.gov. (#NCT04322682).

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This comprehensive analysis aims to equip pharmaceutical and healthcare stakeholders with actionable insights into colchicine’s evolving market landscape, forecasting its trajectory amidst scientific, regulatory, and commercial forces.