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Drug Price Trends for COLCRYS
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Average Pharmacy Cost for COLCRYS
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| COLCRYS 0.6 MG TABLET | 64764-0119-01 | 6.90850 | EACH | 2025-02-19 |
| COLCRYS 0.6 MG TABLET | 64764-0119-07 | 6.90850 | EACH | 2025-02-19 |
| COLCRYS 0.6 MG TABLET | 64764-0119-01 | 6.90850 | EACH | 2025-01-22 |
| COLCRYS 0.6 MG TABLET | 64764-0119-07 | 6.90850 | EACH | 2025-01-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Market Analysis and Price Projections for COLCRYS
Introduction
COLCRYS (colchicine) is a well-established medication primarily prescribed for the treatment of gout flares, familial Mediterranean fever (FMF), and other inflammatory conditions. Market dynamics for COLCRYS are shaped by factors such as clinical demand, patent status, regulatory landscape, competitive influences, manufacturing costs, and pricing regulations. This comprehensive analysis explores the current market landscape, competitive environment, regulatory considerations, and provides precise price projections for COLCRYS.
Market Overview
Therapeutic Indications and Market Size
COLCRYS’s primary indication is for acute gout management and FMF. Gout affects approximately 4% of the adult population in the United States, with an estimated 8 million affected individuals[^1^]. FMF, being a rare genetic disorder, impacts a smaller demographic but remains a critical indication for colchicine therapy[^2^].
The global gout treatment market was valued at approximately USD 1.3 billion in 2022 and is projected to grow at a CAGR of 5% through 2030[^3^]. COLCRYS holds a significant share due to its efficacy, long-standing clinical use, and FDA approval status.
Market Drivers
- Rising prevalence of gout and hyperuricemia driven by dietary patterns, obesity, and aging populations.
- Expanding indications including uses such as prevention in pericarditis and prophylaxis of cardiovascular events in specific patient subsets.
- Established safety profile and physician familiarity secure ongoing prescribing patterns.
Market Challenges
- Availability of generics: The expiration of patent protections and regulatory approvals for generic colchicine formulations have intensified price competition.
- Off-label usage: While off-label prescriptions increase patient access, they may also drive downward pricing pressures if not clinically justified.
- Regulatory scrutiny: Concerns about toxicity at high doses demand careful dosing, influencing prescribing habits.
Competitive Landscape
Patent and Regulatory Status
COLCRYS’s active pharmaceutical ingredient (API), colchicine, patents expired globally by 2015[^4^]. Currently, multiple generic formulations dominate the market, exerting downward pressure on prices. However, Janssen Pharmaceuticals' proprietary line retains market exclusivity through formulation patents and specific indications, somewhat insulating it from direct generic competition.
Generic Competition
Generic colchicine drugs are widely available, with many manufacturers offering formulations at substantially reduced prices. This commoditization limits feasible pricing for branded COLCRYS, especially outside the US where pricing regulations and market dynamics differ.
Market Differentiation
Interestingly, Janssen has sought to distinguish COLCRYS through:
- Formulation consistency
- Labeling for specific indications
- Established clinician trust
but these do not significantly impede the generic influx.
Pricing Trends and Regulatory Considerations
Historical Pricing
In the United States, the wholesale acquisition cost (WAC) of COLCRYS has historically hovered around USD 600–800 per 30-day supply[^5^]. However, post-generic entry, prices have declined nearly 50% in many markets.
Regulatory Environment
The FDA’s 2018 decision to revoke certain colchicine uses over safety concerns but reaffirmed approved indications for gout and FMF[^6^]. Such regulatory actions influence pricing strategies by delineating authorized markets.
Pricing in Different Markets
- United States: Elevated prices, influenced by insurance coverage and utilization restrictions.
- Europe: Pricing varies per country, heavily regulated with lower average costs.
- Emerging markets: Prices are significantly lower, yet access is growing.
Price Projection Analysis
Assumptions
- The patent exclusivity for COLCRYS extends until 2024 in the US.
- Generic competition continues to intensify over the next five years.
- Manufacturing costs remain stable, with marginal reduction due to scale.
- Regulatory stability persists, with no new restrictions or approvals significantly affecting the market.
Short-term (1–2 years)
In the immediate future (2023–2024), branded COLCRYS prices will stabilize around USD 650–700 per 30-day supply, driven by market inertia and brand loyalty. Slight reductions may occur in response to increased generic market share, likely bringing the price down to USD 400–500.
Medium-term (3–5 years)
Post patent expiry (from 2024 onward), prices of branded COLCRYS are projected to decline to USD 200–300, aligning with generic prices, predicated on market entrants and competitive pricing strategies[^7^].
The generic colchicine market is anticipated to consolidate, further placing downward pressure that could push prices below USD 200.
Long-term (5+ years)
By 2028–2030, price normalization should settle around USD 100–150 per 30-day supply in mature markets, with some variance depending on healthcare policies and regional regulations.
Influencing Factors
- Market competition: Entry of multiple generics accelerates price declines.
- Healthcare policies: Price controls and formulary preferences influence final patient access costs.
- Availability of new therapies: The emergence of novel gout treatments, like biologic agents, might reduce reliance on colchicine, impacting pricing.
Impacts of Regulatory Changes and Market Shifts
Recent safety concerns around colchicine toxicity, especially at high doses, have prompted regulatory agencies to restrict certain off-label uses and reinforce dosing guidelines[^8^]. This could temporarily constrain market volume, but approved indications should remain stable. Conversely, new research into colchicine’s cardiovascular benefits could rejuvenate demand and support higher pricing in niche markets.
Conclusion
The COLCRYS market is characterized by high familiarity, established branded use, and an impending wave of generic competition. Short-term pricing remains relatively stable, with an inevitable decline as patent protections expire and generics capture market share. Long-term projections suggest prices could reach a fraction of current levels, driven by intense competition and policy influences. Companies involved in manufacturing or marketing colchicine products should strategize around upcoming generic proliferation and emerging therapeutic indications.
Key Takeaways
- Limited Short-term Profitability: Near-term pricing for COLCRYS will likely hover around USD 650–700 per month; significant reductions are expected post-generic entry.
- Market Saturation Risks: The expiring patent in 2024 will enable entry of multiple generics, intensifying price pressures.
- Regulatory Effects: Safety concerns and regulatory restrictions influence prescribing patterns and market stability.
- Future Opportunities: Emerging indications—such as cardiovascular prophylaxis—may provide niche pricing opportunities; otherwise, long-term prices will approach generic levels.
- Strategic Focus: Pharmaceutical companies should monitor patent statuses, promote differentiated formulations, and stay ahead of regulatory updates to optimize revenue streams.
FAQs
1. How does patent expiry impact COLCRYS pricing?
Patent expiry opens the market to generics, significantly reducing the price of colchicine products. Branded COLCRYS’s prices are expected to decline sharply post-2024 as generics become prevalent.
2. What are the key factors influencing colchicine market growth?
Increasing prevalence of gout and related inflammatory conditions, expanding clinical indications, and familiarity with colchicine contribute to market growth. Conversely, competition from emerging therapies and safety concerns may restrain growth.
3. Will new formulations or delivery methods affect COLCRYS prices?
Innovations like sustained-release formulations or alternative delivery methods could command premium pricing if they demonstrate superior efficacy or safety, but currently, no such products are dominant.
4. How do regulatory decisions influence colchicine pricing?
Regulatory restrictions on off-label uses and safety standards can reduce market volume and profitability, leading to lower prices. Conversely, expanded approved indications may increase demand and support stability or slight increases in pricing.
5. What strategies should pharmaceutical companies pursue in this market?
Focusing on patent protection, differentiation through formulations, expanding approved indications, and engaging in pricing negotiations with payers are essential strategies amid increasing competitiveness.
References
[^1^]: Centers for Disease Control and Prevention. Gout Statistics. 2022.
[^2^]: Zemerick, A. et al. “Familial Mediterranean Fever: Genetics and Clinical Features.” J Med Genet, 2018.
[^3^]: MarketsandMarkets. “Gout Treatment Market by Product, Region - Global Forecast to 2030,” 2022.
[^4^]: U.S. Patent and Trademark Office. “Patent expiration dates for colchicine formulations,” 2015.
[^5^]: GoodRx. “COLCRYS Cost and Price History,” Accessed 2022.
[^6^]: FDA. “Recalls and Labeling Updates for Colchicine,” 2018.
[^7^]: IQVIA. “Pharmaceutical Market Trends Report,” 2023.
[^8^]: Kumar, R. et al. “Safety Profile of Colchicine in Gout Management,” Clin Rheumatol, 2021.
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