On Sept. 24, 1984 the Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act) was passed to encourage development of generic prescription drugs.

The Act, named for its sponsors, Representative Henry Waxman of California and Senator Orrin Hatch of Utah, established a process whereby marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic; allows 180 day exclusivity to companies that are the “first-to-file” an ANDA against holders of patents for branded counterparts; and streamlined the process for approving generic drugs by requiring only that manufacturers demonstrate “bioequivalence” to an already approved innovator drug.