The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition) by Martin A VoetThe Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition) by Martin A Voet

The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth…

byMartin A Voet

Paperback | September 7, 2016

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This Fifth 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.

Title:The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth…Format:PaperbackDimensions:230 pages, 8.5 × 5.5 × 0.48 inPublished:September 7, 2016Publisher:Universal-Publishers.comLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:1627346171

ISBN - 13:9781627346177

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Table of Contents

Preface to the Fifth EditionPreface to the First EditionIntroductionChapter 1 Overview of PatentsChapter 2 Patent Enforcement and InfringementChapter 3 Pharmaceutical, Biologic and Medical Device PatentsChapter 4 Overview of FDAChapter 5 Exclusivity for Brand Name Innovative Drug ProductsChapter 6 Generic Drugs: Hatch Waxman ActChapter 7 Generics for Biologic DrugsChapter 8 Putting it All Together: Product Life-Cycle ManagementChapter 9 Conclusions and Final ThoughtsGlossary of Terms

Editorial Reviews

I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents. -DENNIS CROUCH, Associate Professor of Law, University of Missouri School of Law, Editor of Patently-O.comAn extraordinary book full of practical, strategic information on the interaction of drug creation, law and regulatory approval. Provides a perceptive and insightful analysis of patent and regulatory laws affecting drug development. A must-read for anyone associated with a pharmaceutical company, from managers and CEOs to CFOs and regulatory professionals, The Generic Challenge will guide readers through the many legal and business pitfalls that arise at every stage of their business. -STEPHEN R. ALBAINY-JENEI, Attorney at Law, Editor of PatentBaristas.com