| Edition |
Sixth edition. |
| Description |
1 online resource |
|
text file |
| Bibliography |
Includes bibliographical references and index. |
| Contents |
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. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Drugs -- Generic substitution -- Law and legislation -- United States.
|
|
Drugs -- Generic substitution -- Law and legislation. |
|
United States. |
|
Drugs -- United States -- Patents.
|
|
Drugs. |
| Genre/Form |
Patents.
|
| Subject |
Patent extensions -- United States.
|
|
Patent extensions. |
|
Pharmaceutical biotechnology -- Patents.
|
|
Pharmaceutical biotechnology. |
|
Patents. |
|
Pharmaceutical biotechnology -- Law and legislation.
|
|
Pharmaceutical biotechnology -- Law and legislation. |
|
Drugs -- Patents. |
| Genre/Form |
Electronic books.
|
| Subject |
Medication. |
| Other Form: |
Print version: Voet, Martin A., 1942- The generic challenge Sixth edition. Irvine : Brown Walker Press, 2020. 9781627347464 (DLC) 2020018143 |
| ISBN |
9781627347471 (ebook) |
|
162734747X |
|
9781627347464 (paperback) |
|
