When Will Generic Colcrys Be Available?
The first patent for Colcrys is currently set to expire in December 2028. This is the earliest predictable date that a generic version could become available. However, other circumstances could come up to extend or shorten the exclusivity period. This could include such things as lawsuits or other Colcrys patents. Once the medication goes off-patent, several companies may begin manufacturing a generic Colcrys drug.
Substituting Unapproved Colchicine for Colcrys
Depending on your particular state laws, your pharmacist may or may not be able to substitute the older, less expensive unapproved colchicine for the newer, more expensive Colcrys. This is a "gray" area, and your pharmacist may be unsure if it is legal to do so or not.
There are no important physical differences between unapproved colchicine and Colcrys, although it might be argued that Colcrys is a better product, since it is FDA-regulated and the unapproved products are not.
However, it is important to note that the prescribing information for the unapproved products is outdated and (at least in some parts) inaccurate. Even if a person is taking an unapproved version, the more accurate and up-to-date prescribing information for Colcrys should be consulted.
(Note: After September 2010, unapproved colchicine products will no longer be available after current supplies run out. After this time, Colcrys will be the only form of colchicine available in the United States.)