- Subject index
With escalating healthcare costs, changes to the regulatory control on pharmaceutical industries and the inevitable adjustments made in policies and investment in healthcare there is enormous interest in the commercial as well as the scientific aspects of today's healthcare industry.
The SAGE Handbook of Healthcare provides an authoritative analysis of the current (and anticipated) developments in the global healthcare industries. Providing a unique perspective that interfaces between the science and business aspects, it combines information on the latest scientific developments with applied, commercial business data from the global marketplace.
The Handbook focuses on the aspects of paramount importance in the healthcare sector: Pharmacoeconomics; Pharmacogenomics; Therapeutics; Diagnostics
Areas covered include: The role of nanotechnology, genomics and cell therapy in medicine; Diagnostics; Biomarkers and technological advances; Case studies in oncology ...
Chapter 6: Authorized Generics: Look Before You Leap
Authorized Generics: Look Before You Leap
Paragraph IV Challenges: An Overview
In an effort to help retain revenue and lessen the impact of generic erosion, research-based pharmaceutical companies have used a variety of tactics to extend the life of a patented drug with varying degrees of success. One such tactic that has garnered a lot of attention – and spurred a lot of debate – is the use of authorized generics. The term authorized generic refers to a brand-name drug that the originating company repackages and markets as a generic, to ward off pending generic competition.
The 1984 Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act encourage early generic entry by providing an incentive for generics companies to challenge brand-name drug ...