Overview of patents -- Patent enforcement and infringement -- Pharmaceutical, biological, and medical device patents -- Overview of FDA -- Exclusivity for brand name innovative drug products -- Generic drugs : Hatch Waxman Act -- Generics for biologic drugs -- Putting it all together : product life-cyclemanagement -- Conclusions and final thoughts
Summary
"This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject"-- Provided by publisher
Bibliography
Includes bibliographical references and index
Notes
Description based on print version record and CIP data provided by publisher; resource not viewed