Generic Colcrys Availability
Last updated on Apr 10, 2024.
Colcrys is a brand name of colchicine, approved by the FDA in the following formulation(s):
COLCRYS (colchicine - tablet;oral)
Has a generic version of Colcrys been approved?
A generic version of Colcrys has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Colcrys and have been approved by the FDA:
colchicine tablet;oral
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Manufacturer: ALKEM LABS LTD
Approval date: February 8, 2019
Strength(s): 0.6MG [AB] -
Manufacturer: AMNEAL PHARMS
Approval date: September 28, 2016
Strength(s): 0.6MG [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: January 6, 2022
Strength(s): 0.6MG [AB] -
Manufacturer: DR REDDYS
Approval date: September 6, 2019
Strength(s): 0.6MG [AB] -
Manufacturer: GRANULES
Approval date: February 5, 2020
Strength(s): 0.6MG [AB] -
Manufacturer: HETERO LABS LTD V
Approval date: August 13, 2021
Strength(s): 0.6MG [AB] -
Manufacturer: MYLAN
Approval date: September 16, 2019
Strength(s): 0.6MG [AB] -
Manufacturer: PAR PHARM INC
Approval date: August 12, 2021
Strength(s): 0.6MG [AB] -
Manufacturer: STRIDES PHARMA
Approval date: March 10, 2022
Strength(s): 0.6MG [AB] -
Manufacturer: WATSON LABS INC
Approval date: July 31, 2019
Strength(s): 0.6MG [AB] -
Manufacturer: ZYDUS PHARMS
Approval date: February 19, 2019
Strength(s): 0.6MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Colcrys. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Patent 7,601,758
Patent expiration dates:
- February 10, 2029✓
- February 10, 2029
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Patent 7,619,004
Patent expiration dates:
- December 3, 2028✓
- December 3, 2028
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Patent 7,820,681
Patent expiration dates:
- February 17, 2029✓
- February 17, 2029
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Patent 7,906,519
Patent expiration dates:
- February 17, 2029✓
- February 17, 2029
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Patent 7,915,269
Patent expiration dates:
- February 17, 2029✓
- February 17, 2029
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Patent 7,935,731
Patent expiration dates:
- December 3, 2028✓
- December 3, 2028
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Patent 7,964,647
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Patent 7,964,648
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Patent 7,981,938
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Methods for concomitant administration of colchicine and macrolide antibiotics
Patent 8,093,296
Issued: January 10, 2012
Inventor(s): Davis Matthew W.
Assignee(s): Mutual Pharmaceutical Company, Inc.Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits.
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Methods for concomitant administration of colchicine and a second active agent
Patent 8,093,297
Issued: January 10, 2012
Inventor(s): Davis Matthew W.
Assignee(s): Mutual Pharmaceutical Company, Inc.Methods for concomitant administration of colchicine together with one or more second active agents, e.g., ketoconazole and ritonavir, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for concomitant administration of colchicine together with second active agents are also provided.
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Methods for concomitant administration of colchicine and macrolide antibiotics
Patent 8,093,298
Issued: January 10, 2012
Inventor(s): Davis Matthew W.
Assignee(s): Mutual Pharmaceutical Company, Inc.Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits.
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Methods for concomitant administration of colchicine and macrolide antibiotics
Patent 8,097,655
Issued: January 17, 2012
Inventor(s): Davis Matthew W.
Assignee(s): Mutual Pharmaceutical Company, Inc.Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits.
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Colchicine compositions and methods
Patent 8,415,395
Issued: April 9, 2013
Inventor(s): Davis Matthew W. & Feng Hengsheng
Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
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Colchine compositions and methods
Patent 8,415,396
Issued: April 9, 2013
Inventor(s): Davis Matthew W. & Feng Hengsheng
Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.
Patent expiration dates:
- October 6, 2028✓
- October 6, 2028
-
Methods for concomitant administration of colchicine and a second active agent
Patent 8,440,721
Issued: May 14, 2013
Inventor(s): Davis Matthew W.
Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.Methods for concomitant administration of colchicine together with one or more second active agents, e.g., ketoconazole and ritonavir, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for concomitant administration of colchicine together with second active agents are also provided.
Patent expiration dates:
- February 17, 2029✓
- February 17, 2029
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Methods for concomitant administration of colchicine and a second active agent
Patent 8,440,722
Issued: May 14, 2013
Inventor(s): Davis Matthew W.
Assignee(s): Takeda Pharamceuticals U.S.A., Inc.Methods for concomitant administration of colchicine together with one or more second active agents, e.g., verapamil, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for concomitant administration of colchicine together with second active agents are also provided.
Patent expiration dates:
- February 17, 2029✓
- February 17, 2029
More about Colcrys (colchicine)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (23)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: antigout agents
- Breastfeeding
- En español
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.