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Abstract
Brand name drugs have no competition until their patents or other exclusivities run out at which time generic drug products can enter the market. Generic drugs help bring competition to the market driving prices down. However, there are many drugs still without generic competition. This study used an analysis of GDUFA I and GDUFA II ANDA approvals to identify barriers to the generic drug market. Many approvals have been for what are known as “subsequent generics.” Subsequent generics are the consecutive versions of a reference listed drug (RLD) after the 3rd and have a diminished effect in market price. Many prescription drugs without generic competition are complex products which can be difficult and expensive to manufacture. These, among other factors, are continuing to prevent adequate competition in the drug market leaving consumers to pay the price.