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The Medicare Modernization Act of 2003:The Effect on Entry of Generic Drugs into the Marketplace

The Hatch-Waxman Act, enacted in 1984, first permitted the marketing of generic pharmaceuticals based on a showing of bioequivalence, not safety and efficacy, through the use of an Abbreviated New Drug Application ("ANDA"). By significantly lowering the barrier to entry for generics, this change provided the impetus for rapid growth of the generic pharmaceutical industry in the United States. In exchange for this barrier lowering, Congress provided the holder of the previously approved new drug application ("NDA") with patent term extensions based on FDA regulatory delay.

17 minute readApril 01, 2005 at 11:19 AM
By
Andrea J. Kamage
Robert C. Millonig
The Medicare Modernization Act of 2003:The Effect on Entry of Generic Drugs into the Marketplace

The Hatch-Waxman Act, enacted in 1984, first permitted the marketing of generic pharmaceuticals based on a showing of bioequivalence, not safety and efficacy, through the use of an Abbreviated New Drug Application (“ANDA”).

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