Metformin hydrochloride, sold by Bristol-Myers Squibb under the brand name Glucophage is the most prescribed drug for lowering blood sugar levels in people with type-2 diabetes. Generics are expected to be available in the U.S. in early 2002 - they've been available in Europe for decades (the drug was discoved in 1929).

BMS lobbied aggressively- but unsuccessfully - to extend its domestic monopoly until 2004; attempting to keep generics off the market by exploiting a loophole involving pediatric studies and data exclusivity. The Wall Street Journal summarizes the rationale for the extention as:

• Bristol-Myers Squibb conducts tests of Glucophage on 68 children. (0.3% of people who take this drug are uder 18.)
• Under an existing law, the pediatrics tests entitle the company to six more months of exclusive sales.
• Another law allows Bristol-Myers to be the exclusive marketer of Glucophage to children for three years after Feb. 8, 2001, the day the FDA approved putting the pediatric test results on the drug's label.
• An FDA rule implies that no drugs can be sold without proper pediatric labeling. But generic versions of Glucophage can't copy Bristol-Myers' pediatric labeling because of its three-year exclusivity.