The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States.

Sep 19, 2024 · Recognizing these concerns, in 1984, Congress passed Senator Orrin Hatch (R-UT) and Representative Henry Waxman’s (D-CA) bipartisan Drug Price Competition and Patent Term Restoration Act, better known today as the Hatch-Waxman Act.

Sep 28, 2016 · Through amendments to both the patent law and the food and drug law, the Hatch-Waxman Act established several practices intended to facilitate the marketing of generic pharmaceuticals while providing brand-name firms with incentives to innovate.

The Hatch-Waxman Act: A Primer. CRS PRODUCT (LIBRARY OF CONGRESS) Hide Overview . CRS Product Type: Reports: Publication Date: 09/28/2016: Author: Thomas, John R. Download PDF (978KB) Site Content. Legislation; Committee Reports; Committee Meetings; Committee Publications; Congressional Record; Congressional Record Index;

Dec 18, 2000 · Act) - commonly known as the "Hatch-Waxman Act" - made several significant changes to the patent laws designed to encourage innovation in the pharmaceutical industry while facilitating the speedy introduction of lower-cost generic drugs.

The Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act, is a comprehensive legal framework enacted by Congress in 1984 to streamline the process for generic pharmaceutical

An Act To amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug appHcations, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes. Be it enacted by the Senate and House of Representatives of the

Congress carefully crafted the Hatch-Waxman Act to address two competing goals: to spur new pharmaceutical development and to encourage greater public access to generic drugs. To that end, the Act contains important provisions directed to fulfilling each goal, including provisions favorable to eithe …

The Hatch-Waxman Act is formally known as the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub.L. No. 98-417). It amended the Food, Drug, and Cosmetic Act to establish the Food and Drug Administration's (FDA) generic drug approval process and the patent litigation process for generic drugs.

The Hatch-Waxman Act established several practices intended to facilitate the marketing of generic drugs while permitting brand name companies to recover a portion of their intellectual property rights lost during the pharmaceutical approval process.