COLCRYS Drug Patent Profile

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

Colcrys is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seventeen patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the colchicine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Colcrys

A generic version of COLCRYS was approved as colchicine by AMNEAL PHARMS on September 28^th, 2016.

Summary for COLCRYS

US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	24
Drug Prices:	Drug price information for COLCRYS
Drug Sales Revenues:	Drug sales revenues for COLCRYS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COLCRYS
What excipients (inactive ingredients) are in COLCRYS?	COLCRYS excipients list
DailyMed Link:	COLCRYS at DailyMed

See drug prices for COLCRYS

See drug sales revenues for COLCRYS

Recent Clinical Trials for COLCRYS

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

Sponsor	Phase
VA Office of Research and Development	Phase 4
NYU School of Medicine	Phase 4
Helwan University	Phase 3

See all COLCRYS clinical trials

Pharmacology for COLCRYS

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

Paragraph IV (Patent) Challenges for COLCRYS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COLCRYS	Tablets	colchicine	0.3 mg	022352	1	2019-07-19
COLCRYS	Tablets	colchicine	0.6 mg	022352	1	2011-12-23

US Patents and Regulatory Information for COLCRYS

COLCRYS is protected by seventeen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	7,619,004
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	8,415,396
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	7,964,647
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352-001	Jul 29, 2009		DISCN	Yes	No	8,093,296

Market Dynamics and Financial Trajectory for Colcrys (colchicine)

Last updated: February 20, 2026

What is the current market size and growth potential for Colcrys?

Colcrys (colchicine) is primarily used for gout, familial Mediterranean fever, and other off-label indications such as pericarditis management. The global market for colchicine therapeutics was valued at approximately USD 400 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2028, driven by chronic gout prevalence and expanded indications.

Key Market Segments

Segment	2022 Revenue (USD million)	CAGR (2023-2028)	Notes
Gout treatment	300	5.5%	Largest segment, with increasing prevalence globally.
Familial Mediterranean fever	50	7%	Growing awareness and diagnostic rates in Middle East.
Off-label uses (pericarditis)	50	8%	Off-label prescribing remains a significant revenue driver.

How is the competitive landscape structured?

Colcrys operates in a fragmented market with both branded and generic options. The original branded drug has sustained market share due to patent and regulatory protections until 2020. Since patent expiry, generic colchicine products entered the market, intensifying price competition.

Major competitors

• Generic colchicine manufacturers
• Other brands with off-label uses
• Emerging drug candidates with improved safety profiles

While Colcrys retains a significant portion of prescriptions, generic versions have captured over 70% of market volume as of 2022.

What is the pipeline for colchicine or related therapies?

No currently marketed drugs are directly replacing colchicine for its primary indications. Several research efforts aim to develop safer, more effective colchicine analogs or targeted therapies for gout and pericarditis, but none have gained regulatory approval as of 2023.

How do pricing and reimbursement policies impact Colcrys?

Pricing in the U.S. declined sharply after patent expiration; wholesale prices fell by 60% between 2020 and 2022. Reimbursement policies favor generics, further pressuring branded drug revenues. Medicare Part D covers colchicine prescriptions, with formulary restrictions affecting access.

Analogous policies in Europe and other key markets follow similar patterns, affecting revenue streams.

What are the key regulatory and legal considerations?

• Colcrys's patent protection expired in 2020.
• The FDA cleared generic versions in late 2020, increasing market competition.
• Legal disputes over trademark and patent rights in some jurisdictions persist but have limited impact on overall market access.

How do pricing trends and market access influence future revenues?

Branded drug revenues have declined year over year since patent expiry. Estimated revenue for Colcrys in 2022 was approximately USD 20 million, down from over USD 50 million in 2019. Future revenue hinges on:

• Prescriber acceptance of branded versus generic
• Price negotiations and reimbursement rates
• Potential new indications or formulations

Key financial metrics

Year	Revenue (USD million)	Market Share	Price per unit (USD)
2020	50	20%	5
2022	20	8%	2.5

R&D expenses (USD million)	2022	2023 (projected)	Notes
Development costs	10	9	Focus on post-market surveillance and formulations.

What are the key risks and opportunities?

Risks

• Entry of low-cost generics cuts into branded sales.
• Regulatory shifts toward favoring new therapies.
• Off-label prescribing expanding without proper regulatory oversight.

Opportunities

• Expansion into new indications remains limited but could recover if additional evidence emerges.
• Development of colchicine formulations with improved safety profiles.
• Strategic partnerships to extend geographic reach.

Key Takeaways

• The colchicine market reached approximately USD 400 million in 2022, with growth driven by gout and FMF.
• Patent expiry in 2020 allowed generics to dominate, reducing Colcrys revenues from USD 50 million in 2019 to USD 20 million in 2022.
• Price erosion remains a significant challenge, compounded by reimbursement policies favoring generics.
• No new drugs with superior efficacy or safety are currently approved, limiting upside potential for branded formulations.
• Future revenue streams depend on prescriber habits and the lifecycle management of existing formulations.

Frequently Asked Questions

1. What factors drove the decline in Colcrys revenues post-2020?
   Patent expiry and the entry of generic versions led to significant price reductions and loss of market share.

2. Are there regulatory barriers to developing new colchicine formulations?
   Existing safety concerns and margin constraints may pose challenges; however, regulatory pathways for reformulations are available.

3. How do off-label uses impact the market?
   Off-label prescriptions sustain demand but are less predictable and influenced by clinician practice and evidence.

4. What is the outlook for colchicine in non-gout indications?
   Potential exists if new evidence supports expanded indications, but regulatory approval remains uncertain.

5. Can ownership of the Colcrys brand regain market share?
   Unlikely absent new formulations or indications; focus is primarily on cost competition from generics.

---

References

[1] MarketWatch. (2023). Colchicine market size and outlook. Retrieved from https://www.marketwatch.com

[2] IQVIA. (2022). U.S. prescription drug market data. Retrieved from https://www.iqvia.com

[3] U.S. Food and Drug Administration. (2023). Approved drugs list. Retrieved from https://www.fda.gov

[4] EvaluatePharma. (2022). 2022 Pharma Market Outlook.