The Law of 180-Day Exclusivity.

A new history and discussion of 180-day exclusivity.

Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended the provision substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The fundamental goal behind 180-day exclusivity was to provide an incentive for generic drug applicants to challenge inn...

A brief history of 180-day exclusivity under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.

This article summarizes the history of the 180-day exclusivity provision on the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). Part II presents the statutory language, as amended in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and summarizes the law that applies to new abbreviated new drug applications (ANDAs) (those filed after ...

The Myths of Data Exclusivity

This Article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplica...

Position and enforcement practice of the People’s Republic of China’s pharmaceutical data exclusivity protection

The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People's Republic of China's domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People's Republic of China's Dru...

Lecture: patents, product exclusivity, and information dissemination: how law directs biopharmaceutical research and development.