Colchicine is a medication with a history stretching back thousands of years, traditionally derived from the seeds and corm of the autumn crocus plant, $Colchicum$ $autumnale$. This ancient compound is primarily used in modern medicine to manage inflammatory conditions like gout and Familial Mediterranean Fever (FMF). Determining who manufactures this drug is complex because its long-standing use predates modern regulatory requirements. This created a distinction between older, unapproved versions and the single, newly approved brand-name product later challenged by generic competition.
What Colchicine Is and How It Functions
Colchicine is an alkaloid compound that functions as a powerful anti-inflammatory agent, distinct from common non-steroidal anti-inflammatory drugs (NSAIDs). Its therapeutic effect stems from interference with the body’s cellular structure, specifically targeting the cytoskeleton. Colchicine binds to tubulin, the protein subunit that assembles into microtubules, effectively disrupting their formation and polymerization.
Microtubules are structural components necessary for various cellular functions, including cell division and the activation of white blood cells. By inhibiting microtubule formation, colchicine limits the activation and migration of neutrophils, the immune cells that drive the intense inflammatory response during a gout flare. The drug also interferes with the NALP3 inflammasome, a complex responsible for activating the inflammatory cytokine interleukin-1 beta. This dual action helps suppress the pain and swelling associated with gout and regulates systemic inflammation in FMF. Colchicine is used for the prophylaxis and treatment of acute gout flares, and the long-term management of FMF.
The Regulatory Shift and Brand Name Exclusivity
For decades, colchicine was available in the United States as a low-cost, unapproved drug, grandfathered into the market because its use predated the 1962 requirement for drug efficacy testing. This changed in the mid-2000s when the Food and Drug Administration (FDA) launched its Unapproved Drugs Initiative, aiming to ensure all medications met modern standards. A pharmaceutical company, then URL Pharma, responded by conducting the necessary clinical trials to secure formal FDA approval.
In 2009, the company received approval for its brand-name version for treating acute gout flares and FMF. As an incentive for completing the required studies, the FDA granted the product market exclusivity, preventing other companies from legally marketing an equivalent product. This exclusivity included three years for the acute gout indication and seven years under the Orphan Drug Act for FMF.
The FDA then mandated that all previously unapproved versions of colchicine be removed from the market, creating a temporary monopoly for the newly approved brand. This market shift allowed the sole manufacturer to set the price without competition, leading to a dramatic price increase from pennies per pill to several dollars. This regulatory action ensured the drug met modern testing standards but temporarily blocked access to the once-cheap medication.
Following the initial manufacturer’s acquisition by Takeda Pharmaceuticals, the company continued to hold the exclusive rights, which explained why only one manufacturer controlled the supply and pricing for several years. Market control was maintained through the granted exclusivity periods and subsequent patent litigation.
Current Landscape of Generic Manufacturers
The manufacturing landscape began to change once the primary market exclusivity periods for the brand-name product started to expire. Other companies were then able to seek FDA approval to manufacture generic versions. Generic manufacturers must demonstrate that their product is bioequivalent to the approved brand-name drug, ensuring it works the same way in the body.
Today, the market includes multiple generic manufacturers, which has helped reintroduce competition and lower the price of the medication. Companies like Teva Pharmaceuticals and Hikma Pharmaceuticals now produce FDA-approved generic colchicine tablets. Hikma also manufactures a brand-name capsule version and an authorized generic, which is the exact same product sold without the brand name.