Colcrys (Colchicine): New FDA Approved Authorized Generic

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Colcrys (colchicine) is used for the prevention and treatment of gout flares in adults. Colchicine was previously available as an inexpensive generic, unapproved by the FDA, but became patented as brand-name Colcrys in 2009. Now, finally, a generic is available again, which may mean prices will start to come back down.

What is gout?

Gout is a type of arthritis that can cause sudden and severe attacks of pain, typically in the big toe. These attacks can cause inflammation, swelling, and tenderness in the affected joint(s).

Gout is caused by an accumulation of uric acid in the blood which in turn can cause urate crystal formation in the joint. The increase in uric acid can be due either to overproduction or to decreased removal from the body.

Gout can happen to anyone, but some factors may put a person at a higher risk of developing gout. For example, a diet high in red meat, seafood, and drinks with fructose or alcohol can increase risk, as can certain conditions like obesity, diabetes, heart disease and kidney disease.

When will the Colcrys authorized generic be available?

Generic Colcrys (colchicine) is available now. Check with your local pharmacy to make sure they have it in stock.

What happened that allowed Colcrys to be patented?
Colchicine had been used and sold in the US for many years but had not been reviewed by the FDA for safety and efficacy. The manufacturer of Colcrys submitted an application for review to the FDA in 2009, and they were awarded a three-year exclusivity period (meaning they were the only ones who could market Colcrys in the US).

But colchicine is now considered an authorized generic—what does that mean?

An authorized generic basically means that the company that makes the brand name product has made a deal to give their EXACT recipe to another company that specializes in making authorized generic products.

This means that if you are used to receiving the brand name product, the authorized generic will be almost identical to what you have received in the past.

The only noticeable differences with your authorized generic medication may be:

In this case, the company that makes Colcrys, Takeda Pharmaceuticals, still manufactures the authorized generic, which is then distributed by Prasco Laboratories. This means an identical product at a lower generic price for patients.

Authorized generics can financially benefit both the company that created the brand medication and the patient since the medication is offered at a lower cost.

How are Colcrys and colchicine available?
Colcrys and colchicine are available as a scored tablet. Colchicine is also now available as a capsule. However, only the tablet may be automatically substituted for brand-name Colcrys at the pharmacy.

How is this medication usually taken?

Once a gout flare has occurred, the typical dose of colchicine is to take 2 tablets at the first sign of the flare, then take a second dose of 1 tablet one hour later.

To prevent a future gout flare, the typical dose is 1 – 2 tablets once daily.

What type of medication is Colcrys (colchicine)?

Although colchicine is considered an anti-inflammatory agent, it is not exactly known how the active ingredient works to treat and prevent gout flare.

What the side effects of colchicine?

The most common side effects include diarrhea and throat pain.

Also important to note:

If you are taking colchicine do not drink grapefruit juice or eat grapefruit. The consumption of grapefruit products can cause colchicine to build up in your body and not be eliminated properly, which can lead to serious side effects.

Update 2/13/2015: Correction and clarification added. We previously described the Colcrys authorized generic as manufactured by Prasco, and we’ve included more information on substituting Colcrys and the authorized generic.

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