'Generic' Colchicine to Hit Market

— May provide some price relief for gout patients.


A so-called authorized generic version of the colchicine formulation sold as Colcrys for acute gout flares and for treating familial Mediterranean fever will be "widely available" starting later this week, according to Colcrys's manufacturer.

The company, Takeda Pharmaceuticals USA, has agreed to let Prasco Laboratories distribute the colchicine pills as a generic product. Because it's the same product sold as Colcrys, it can automatically be substituted when filling prescriptions written for the branded drug. The announcement from Takeda (which acquired rights to Colcrys in 2012) and Prasco did not indicate how much the authorized generic would cost at the wholesale or retail levels. It will be sold under the Prasco name.


The high price tag on Colcrys became especially controversial in 2010 when, a year after the FDA approved the product, it ordered generic versions off the market, citing the 3-year market exclusivity to which its maker was legally entitled after conducting the clinical trials and other studies needed to win the agency's OK. Those generic versions, which had been sold for decades with little federal oversight, had cost as little as 10 cents per pill.

Since 2006, the FDA has been trying to persuade pharmaceutical companies to perform rigorous safety-and-efficacy testing for drugs that had entered the market before such testing was required. As an inducement, the first company to win a formal approval for one of these "grandfathered" drugs under current standards received 3 years of marketing exclusivity -- 7 years if the drug is for an orphan disease. (Familial Mediterranean fever is an orphan indication.)

Firms taking advantage of the incentive have argued that it -- and the prices they charge while enjoying what amounts to a monopoly -- are needed to allow them to recover their investment in conducting the necessary clinical studies. (Colcrys's sponsor had tested the drug in a 1-week trial involving 185 patients, as well as lab studies to document product purity and consistency.)

A similar controversy had erupted over hydroxyprogesterone caproate for preventing preterm birth in high-risk women. That drug had been widely available from compounding pharmacies, which were ordered to stop producing the drug when a company won approval for a branded version called Makena that it then sold for about $1,500 per injection, compared with $10-$20 from compounding pharmacies.

In that case, the FDA later relented and agreed to allow pharmacies to continue selling their own versions. Makena's maker cried foul and went to court -- unsuccessfully -- to get the FDA to enforce its promised 3-year monopoly. The company eventually went bankrupt.

With colchicine, though, there has been no alternative source. Although the monopoly period for the acute gout flare indicated has since expired, manufacturers of the earlier colchicine versions could not simply restart production since their products had never been approved by the FDA. Companies must go through the Abbreviated New Drug Application process and none have yet done so.