The generic challenge :: understanding patents, FDA, and pharmaceutical life-cycle management /
"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 I...
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Irvine :
Brown Walker Press,
2020.
|
| Ausgabe: | Sixth edition. |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | "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"-- |
| Beschreibung: | 1 online resource |
| Bibliographie: | Includes bibliographical references and index. |
| ISBN: | 9781627347471 162734747X |
Internformat
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| 245 | 1 | 4 | |a The generic challenge : |b understanding patents, FDA, and pharmaceutical life-cycle management / |c Martin A. Voet. |
| 250 | |a Sixth edition. | ||
| 263 | |a 2007 | ||
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| 505 | 0 | |a 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. | |
| 520 | |a "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"-- |c Provided by publisher. | ||
| 588 | |a Description based on print version record and CIP data provided by publisher; resource not viewed. | ||
| 650 | 0 | |a Drugs |x Generic substitution |x Law and legislation |z United States. | |
| 650 | 0 | |a Drugs |z United States |x Patents. | |
| 650 | 0 | |a Patent extensions |z United States. | |
| 650 | 0 | |a Pharmaceutical biotechnology |x Patents. | |
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| 650 | 6 | |a Médicaments |z États-Unis |x Brevets d'invention. | |
| 650 | 6 | |a Brevets d'invention |x Prolongation de la durée |z États-Unis. | |
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| 650 | 7 | |a Drugs |x Patents |2 fast | |
| 650 | 7 | |a Patent extensions |2 fast | |
| 650 | 7 | |a Pharmaceutical biotechnology |x Law and legislation |2 fast | |
| 651 | 7 | |a United States |2 fast | |
| 655 | 7 | |a Patents |2 fast | |
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| 776 | 0 | 8 | |i Print version: |a Voet, Martin A., 1942- |t The generic challenge |b Sixth edition. |d Irvine : Brown Walker Press, 2020. |z 9781627347464 |w (DLC) 2020018143 |
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| 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. |
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| edition | Sixth edition. |
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| indexdate | 2024-11-27T13:29:51Z |
| institution | BVB |
| isbn | 9781627347471 162734747X |
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| spelling | Voet, Martin A., 1942- author. http://id.loc.gov/authorities/names/n2008180309 The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / Martin A. Voet. Sixth edition. 2007 Irvine : Brown Walker Press, 2020. 1 online resource text txt rdacontent computer n rdamedia online resource nc rdacarrier Includes bibliographical references and index. 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. "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. Description based on print version record and CIP data provided by publisher; resource not viewed. Drugs Generic substitution Law and legislation United States. Drugs United States Patents. Patent extensions United States. Pharmaceutical biotechnology Patents. Pharmaceutical biotechnology Law and legislation. http://id.loc.gov/authorities/subjects/sh92004764 Médicaments États-Unis Brevets d'invention. Brevets d'invention Prolongation de la durée États-Unis. Biotechnologie pharmaceutique Brevets d'invention. Drugs Generic substitution Law and legislation fast Drugs Patents fast Patent extensions fast Pharmaceutical biotechnology Law and legislation fast United States fast Patents fast has work: The generic challenge (Text) https://id.oclc.org/worldcat/entity/E39PCFBcP67Qyb7qKqFv7TX6Dm https://id.oclc.org/worldcat/ontology/hasWork Print version: Voet, Martin A., 1942- The generic challenge Sixth edition. Irvine : Brown Walker Press, 2020. 9781627347464 (DLC) 2020018143 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=2717657 Volltext |
| spellingShingle | Voet, Martin A., 1942- The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / 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. Drugs Generic substitution Law and legislation United States. Drugs United States Patents. Patent extensions United States. Pharmaceutical biotechnology Patents. Pharmaceutical biotechnology Law and legislation. http://id.loc.gov/authorities/subjects/sh92004764 Médicaments États-Unis Brevets d'invention. Brevets d'invention Prolongation de la durée États-Unis. Biotechnologie pharmaceutique Brevets d'invention. Drugs Generic substitution Law and legislation fast Drugs Patents fast Patent extensions fast Pharmaceutical biotechnology Law and legislation fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh92004764 |
| title | The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / |
| title_auth | The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / |
| title_exact_search | The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / |
| title_full | The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / Martin A. Voet. |
| title_fullStr | The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / Martin A. Voet. |
| title_full_unstemmed | The generic challenge : understanding patents, FDA, and pharmaceutical life-cycle management / Martin A. Voet. |
| title_short | The generic challenge : |
| title_sort | generic challenge understanding patents fda and pharmaceutical life cycle management |
| title_sub | understanding patents, FDA, and pharmaceutical life-cycle management / |
| topic | Drugs Generic substitution Law and legislation United States. Drugs United States Patents. Patent extensions United States. Pharmaceutical biotechnology Patents. Pharmaceutical biotechnology Law and legislation. http://id.loc.gov/authorities/subjects/sh92004764 Médicaments États-Unis Brevets d'invention. Brevets d'invention Prolongation de la durée États-Unis. Biotechnologie pharmaceutique Brevets d'invention. Drugs Generic substitution Law and legislation fast Drugs Patents fast Patent extensions fast Pharmaceutical biotechnology Law and legislation fast |
| topic_facet | Drugs Generic substitution Law and legislation United States. Drugs United States Patents. Patent extensions United States. Pharmaceutical biotechnology Patents. Pharmaceutical biotechnology Law and legislation. Médicaments États-Unis Brevets d'invention. Brevets d'invention Prolongation de la durée États-Unis. Biotechnologie pharmaceutique Brevets d'invention. Drugs Generic substitution Law and legislation Drugs Patents Patent extensions Pharmaceutical biotechnology Law and legislation United States Patents |
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