A multisource drug product is a drug product that contains the same active drug substance in the same dosage form and is marketed by more than one pharmaceutical manufacturer.
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Single-source drug products are drug products for which the patent has not yet expired or has certain exclusivities so that only one manufacturer can make it. Single-source drug products are usually brand-name (innovator) drug products. After the patent and other exclusivities for the brand-name drug expires, a pharmaceutical firm may manufacture a generic drug product that can be substituted for the branded drug product. Since the formulation and method of manufacture of the drug product can affect the bioavailability and stability of the drug, the generic drug manufacturer must demonstrate that the generic drug product is bioequivalent and therapeutically equivalent to the brand-name drug product.
