Elite Pharmaceuticals announced highly positive results from a pivotal bioequivalence study for an undisclosed generic anticoagulant drug. This is a significant milestone because the study successfully demonstrated that their generic product is bioequivalent to a branded product that currently dominates a $27 billion annual market with no generic competition. Elite conducted an open-label, randomized, single oral dose, crossover study in healthy adults under fasting conditions, and the results confirmed their generic equivalence. The company is now compiling the data to file an Abbreviated New Drug Application (ANDA) with the FDA, which is the next crucial step towards potential commercialization. However, the path to market entry still faces hurdles, including FDA approval and the need to address the unexpired patent protection held by the branded drug.