Results for tag: "Hatch Waxman Act"

The Hatch-Waxman Act is a United States federal law that provides incentives for the development of generic drugs. It was enacted in 1984 and amended in 1988 and 2003. The Act created a framework for the approval of generic drugs by the Food and Drug Administration (FDA). It also established a system of patent protection for brand-name drugs, allowing generic drug manufacturers to challenge the patents of brand-name drugs. The Act also established a system of patent linkage, which requires generic drug manufacturers to obtain permission from the patent holder before marketing a generic version of a brand-name drug. The Hatch-Waxman Act has had a significant impact on the generic drug market in the United States. It has enabled generic drug manufacturers to enter the market more quickly and at a lower cost than before. This has resulted in increased competition and lower prices for generic drugs. Companies in the Hatch-Waxman Act market include Teva Pharmaceuticals, Mylan, Sandoz, and Dr. Reddy's Laboratories. Show Less Read more