ANDA one, ANDA too?


David K.S. Cornwell and Kevin W. McCabe

David Cornwell and Kevin McCabe describe the complex process for obtaining FDA approval for generic and biosimilar drugs, and managing patent disputes with approved companies.

In 1984, 19 percent of prescription drugs sold were generic. In stark contrast, some accounts estimate that up to 75 percent of all prescription drugs sold in the United States 25 years later were generic. Understandably, the desire for generic drugs is fuelled by consumer demand and simple economics—with competition comes price reduction.

However, innovator companies realise that drug pricing must pay for the cost of both basic drug discovery and the cost of obtaining approval from the Food and Drug Administration (FDA). The innovator drug companies therefore continue to rely on an effective patent system to ensure that generic companies cannot easily enter the marketplace.

US ANDA legislation

ANDA, pharmaceuticals