Suppliers and packagers for COLCRYS

COLCRYS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352	NDA	Proficient Rx LP	63187-292-03	3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-292-03)	2009-09-01
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	63629-2166-1	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-2166-1)	2018-07-01
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	63629-2167-1	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-2167-1)	2018-07-01
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352	NDA	Takeda Pharmaceuticals America, Inc.	64764-119-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-01)	2009-09-01
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352	NDA	Takeda Pharmaceuticals America, Inc.	64764-119-06	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06)	2009-09-01
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352	NDA	Takeda Pharmaceuticals America, Inc.	64764-119-07	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-07)	2009-09-01
Takeda Pharms Usa	COLCRYS	colchicine	TABLET;ORAL	022352	NDA	Takeda Pharmaceuticals America, Inc.	64764-119-10	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-10)	2009-09-01

COLCRYS Drug Supply Chain Analysis

Last updated: February 19, 2026

This report details the patent landscape, active pharmaceutical ingredient (API) manufacturers, and key excipient suppliers for COLCRYS (colchicine), a drug used for the treatment of gout flares and familial Mediterranean fever. The analysis focuses on entities with direct or indirect involvement in COLCRYS's production and supply chain, with particular attention to patent expiry and potential market entry for generics.

Who Holds the Primary Patents for COLCRYS?

The primary patents protecting COLCRYS relate to its formulation and methods of use. These patents are crucial for understanding the exclusivity period and the potential for generic competition.

• Formulation Patents: Patents covering specific crystalline forms of colchicine and their use in pharmaceutical compositions. For example, U.S. Patent No. 7,902,238, titled "Colchicine Crystals," was a significant patent related to the crystalline form of colchicine used in COLCRYS. This patent was granted on March 8, 2011.
• Method of Use Patents: Patents that claim specific therapeutic applications of colchicine, often related to reduced dosage or improved efficacy for certain conditions.
• Patent Expiry: The expiry dates of these core patents are critical for generic manufacturers. U.S. Patent No. 7,902,238 expired in 2028. Additional patents and extensions may have influenced the effective market exclusivity. For instance, Hatch-Waxman Act extensions and pediatric exclusivity periods could have deferred generic entry.

What are the Key Active Pharmaceutical Ingredient (API) Manufacturers for Colchicine?

The supply of the API, colchicine, is fundamental to COLCRYS production. Identifying manufacturers involved in its synthesis is vital for understanding supply chain robustness and potential alternative sourcing.

• Global API Landscape: Colchicine API is synthesized by a limited number of global manufacturers. Historically, Teva Pharmaceutical Industries Ltd., the originator of COLCRYS, may have had integrated API production or proprietary supply agreements.
• Generic API Suppliers: With patent expiries, generic API manufacturers can enter the market. Companies specializing in complex API synthesis are key. Potential suppliers include:
  • Nantong Acrobio Co., Ltd.: A Chinese manufacturer known for producing various APIs, including potentially colchicine.
  • Dishman Carbogen Amcis Ltd.: A global contract development and manufacturing organization (CDMO) that could be involved in custom API synthesis.
  • Various Indian Pharmaceutical Companies: India is a major hub for API manufacturing. Companies like Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, and Cipla have broad API portfolios and could produce colchicine. Specific confirmation of their involvement in colchicine supply requires detailed market intelligence and supply chain audits.

Table 1: Potential Colchicine API Manufacturers and Their Capabilities

Manufacturer Name	Country of Origin	Specialization	Potential for Colchicine API Production
Teva Pharmaceutical Ind.	Israel	Integrated Pharmaceutical Manufacturing	High (Originator)
Nantong Acrobio Co., Ltd.	China	Fine Chemicals, APIs	Moderate to High
Dishman Carbogen Amcis Ltd.	Switzerland/India	CDMO, Complex Synthesis	Moderate (Custom Synthesis)
Sun Pharmaceutical Ind.	India	Generic APIs, Finished Dosage Forms	Moderate
Dr. Reddy's Laboratories	India	APIs, Generic Formulations	Moderate

Note: Direct confirmation of current supply agreements for COLCRYS with specific generic API manufacturers requires proprietary data access.

Who Supplies the Excipients for COLCRYS?

Excipients are inactive ingredients that play a critical role in drug formulation, stability, and delivery. Identifying these suppliers provides insight into the formulation's composition and potential vulnerabilities. While specific COLCRYS formulations are proprietary, common excipients for oral solid dosage forms include binders, fillers, disintegrants, and lubricants.

• Common Excipient Categories and Potential Suppliers:
  • Binders:
    • Microcrystalline Cellulose (MCC): Widely used. Suppliers include FMC Corporation (Avicel®) and JRS Pharma.
    • Povidone (PVP): Suppliers include BASF (Kollidon®) and Ashland.
  • Fillers/Diluents:
    • Lactose Monohydrate: Suppliers include DMV-Fonterra Excipients and Pharmatose.
    • Starch: Suppliers include Cargill and Roquette.
  • Disintegrants:
    • Croscarmellose Sodium: Suppliers include FMC Corporation (Ac-Di-Sol®) and Ashland (Primellose®).
    • Sodium Starch Glycolate: Suppliers include JRS Pharma and Ashland.
  • Lubricants:
    • Magnesium Stearate: A common choice. Suppliers are numerous, including Mallinckrodt Pharmaceuticals and United Chemical Company.
    • Stearic Acid: Suppliers include BASF and Univar Solutions.
  • Coatings (if applicable):
    • Hypromellose (HPMC): Suppliers include Colorcon and Dow Chemical Company.

Table 2: Key Excipients and Leading Global Suppliers

Excipient Category	Common Examples	Leading Global Suppliers (Examples)
Binder	Microcrystalline Cellulose	FMC Corporation, JRS Pharma
Binder	Povidone (PVP)	BASF, Ashland
Filler/Diluent	Lactose Monohydrate	DMV-Fonterra Excipients, Pharmatose
Filler/Diluent	Starch	Cargill, Roquette
Disintegrant	Croscarmellose Sodium	FMC Corporation, Ashland
Disintegrant	Sodium Starch Glycolate	JRS Pharma, Ashland
Lubricant	Magnesium Stearate	Mallinckrodt Pharmaceuticals, United Chemical Co.
Lubricant	Stearic Acid	BASF, Univar Solutions
Coating (Film-Forming)	Hypromellose (HPMC)	Colorcon, Dow Chemical Company

The specific grade and supplier for each excipient used in COLCRYS are determined by the drug manufacturer's proprietary formulation and quality control standards. Sourcing decisions also consider regulatory compliance (e.g., USP/NF, Ph. Eur.) and supply chain reliability.

What is the Patent Expiry Timeline for COLCRYS-Related Patents?

Understanding the patent expiry timeline is critical for forecasting the entry of generic competition and assessing the remaining market exclusivity for the innovator product.

• Core Formulation Patent: U.S. Patent No. 7,902,238, covering a specific crystalline form of colchicine, expired in 2028. This patent was central to the original market exclusivity of COLCRYS.
• Other Potential Patents: Additional patents may exist covering specific manufacturing processes, polymorphs, or novel therapeutic uses. These would need to be individually assessed for their expiry dates and scope of protection.
• Orphan Drug Exclusivity: COLCRYS was granted Orphan Drug Designation for Familial Mediterranean Fever (FMF) in the U.S. This provides an additional seven years of market exclusivity in the U.S. for the approved orphan indication, starting from the drug's approval date for that indication.
• Pediatric Exclusivity: If pediatric studies were conducted and accepted by regulatory authorities, this could grant an additional six months of market exclusivity.

The interplay of these patent rights and exclusivity periods determines the effective market protection for COLCRYS. Generic manufacturers closely monitor these dates to plan their market entry strategies.

What are the Regulatory Hurdles for Generic COLCHICINE?

Bringing a generic version of COLCRYS to market involves navigating significant regulatory requirements.

• Abbreviated New Drug Application (ANDA): Generic drug manufacturers must file an ANDA with the U.S. Food and Drug Administration (FDA). This application demonstrates that the generic drug is bioequivalent to the reference listed drug (COLCRYS).
• Bioequivalence Studies: These studies compare the rate and extent to which the active ingredient is absorbed from the generic drug and the reference drug in healthy human volunteers.
• Quality and Manufacturing Standards: Generic manufacturers must demonstrate that their product meets the same high standards of quality and manufacturing as the reference drug. This includes Good Manufacturing Practices (GMP).
• API Sourcing and Quality: The API used in the generic product must be sourced from FDA-approved facilities, and its quality must be rigorously tested and documented.
• Intellectual Property Challenges: Generic applicants must certify their compliance with existing patents. This often leads to patent litigation between the innovator and generic companies, which can delay market entry.

What is the Market Landscape for Colchicine Products?

The market for colchicine-based treatments has evolved, with COLCRYS representing a significant branded product.

• Originator Product: COLCRYS by Teva Pharmaceutical Industries Ltd. established a branded presence.
• Generic Competition: As patents expire, generic versions of colchicine have entered or are expected to enter the market. The presence of generics intensifies price competition and expands patient access.
• International Markets: Availability and regulatory approval of COLCRYS and its generic equivalents vary by country. Different patent laws and regulatory bodies in regions like Europe (via EMA) and Canada (via Health Canada) create distinct market dynamics.
• Alternative Formulations: Research and development may lead to newer formulations or delivery methods for colchicine, potentially creating new intellectual property and market opportunities.

Key Takeaways

• The patent landscape for COLCRYS is characterized by formulation patents, with a key patent expiring in 2028, opening avenues for generic entry.
• Colchicine API is synthesized by a concentrated group of global manufacturers, with potential for increased participation by generic API suppliers post-patent expiry.
• Excipient sourcing for COLCRYS involves common pharmaceutical ingredients supplied by major global manufacturers across categories such as binders, fillers, and disintegrants.
• Regulatory approval for generic colchicine requires demonstrating bioequivalence and adherence to stringent quality manufacturing standards.
• The market is transitioning from a branded-only environment to one with increasing generic competition, impacting pricing and access.

FAQs

1. What is the primary active pharmaceutical ingredient (API) in COLCRYS? The primary API in COLCRYS is colchicine.

2. When did the key formulation patent for COLCRYS expire in the U.S.? A key formulation patent (U.S. Patent No. 7,902,238) related to a specific crystalline form of colchicine expired in 2028.

3. Who are some potential suppliers of colchicine API? Potential suppliers include Teva Pharmaceutical Industries, Nantong Acrobio Co., Ltd., and Dishman Carbogen Amcis Ltd., among others.

4. What are common categories of excipients used in oral solid dosage forms like COLCRYS? Common excipient categories include binders, fillers/diluents, disintegrants, and lubricants.

5. What is required for a generic version of COLCRYS to be approved by the FDA? A generic version must file an Abbreviated New Drug Application (ANDA) and demonstrate bioequivalence to COLCRYS, along with meeting all quality and manufacturing standards.

Citations

[1] United States Patent and Trademark Office. (n.d.). U.S. Patent No. 7,902,238. Retrieved from USPTO database.