Brand-name Colcrys (colchicine) is currently protected by a patent that expires in December 2028. After the drug goes off-patent, generic versions of Colcrys may become available. In some cases, a pharmacist may be able to substitute unapproved colchicine for Colcrys. There are no important physical differences between the two products; however, unapproved colchicine is not regulated by the FDA.
Can I Buy Generic Colcrys?Colcrys® (colchicine) is a prescription medication that has been approved for treating gout. It is also approved for treating a rare genetic condition known as familial Mediterranean fever (FMF). Colcrys is the only colchicine medication that has been approved by the U.S. Food and Drug Administration (FDA).
Colcrys is manufactured by AR Scientific, Inc., for Mutual Pharmaceutical Company, Inc. Technically, there are no generic versions of Colcrys available in the United States. However, this is a unique and confusing situation, since there were once older, "unapproved" colchicine medications (available in the exact same strength) that many people considered to be generic for Colcrys. However, this is technically not the case, since unapproved drugs cannot be considered generic versions.
Approved vs. Unapproved Colcrys
Colchicine was previously available in pharmacies as a medication that was never approved by the FDA. As with many older medications, it was "grandfathered" into the current system without needing to undergo the rigorous studies that are now required.
Consequently, these older colchicine products were not regulated by the FDA. Many patients (and even healthcare providers) are surprised to learn that most colchicine products were unapproved.
Unapproved prescription drugs are relatively common. The FDA has begun to try to identify these drugs and fix the situation by offering manufacturers a period of exclusivity (like a brand-new drug would receive) in exchange for the manufacturers completing studies and new drug applications (both of which are costly endeavors).
In 2009, one company completed this process and received FDA approval for their colchicine product (Colcrys). At this time, Colcrys is the only FDA-approved, single-ingredient colchicine product on the market (combination colchicine and probenecid products have been approved for quite some time).
In September 2010, the FDA ordered manufacturers of unapproved colchicine products to stop making and selling their products.