Who Owns Metformin?

Metformin's chemistry traces to the guanidine compounds studied in the early 20th century. The molecule itself was synthesized in 1922 by Emil Werner and James Bell at Trinity College, Dublin, as part of research into guanidine derivatives related to the natural compound galegine.

French physician Jean Sterne recognized its clinical potential and pioneered its use for diabetes in the 1950s, coining the name Glucophage, or "glucose eater." It launched in France in 1957-1959 and spread through Europe, but its US arrival was delayed by the era's association between the related biguanide phenformin and lactic acidosis, which kept regulators cautious for decades.

The FDA finally approved Glucophage on December 29, 1994, and Bristol-Myers Squibb launched it into an American market that had gone without a new oral diabetes class in years. Glucophage became a major product through the late 1990s, and the extended-release Glucophage XR followed. Pediatric approval came in 2000 and pediatric exclusivity pushed BMS's effective patent protection to September 2001.

Once generic entry began in 2002, metformin became one of the great commodity drug stories in modern medicine. Its use was reinforced by landmark evidence, including the UK Prospective Diabetes Study showing cardiovascular benefit, and treatment guidelines established it as the undisputed first-line therapy for type 2 diabetes, a position it retains decades later despite the rise of GLP-1 and SGLT2 drugs.

By the 2020s, metformin ranked among the top five most prescribed medications in the United States, with more than 80 million annual prescriptions, almost entirely as a generic supplied by Teva, Viatris, and dozens of other manufacturers. It is also used off-label for polycystic ovary syndrome and has attracted sustained research interest in longevity and cancer prevention.