Home > Back to Publisher > Report Information

New Dynamics and Challenges in the Generics Market 2007

Informa Healthcare
November 1, 2007
308 Pages - SKU: IFHC1693938

Abstract Table of Contents Search inside this report Related Reports

Countries covered: Global

Discover how the emerging global generics market has advanced over the last 18 months and what this means for the pharma industry.

This report updates you on the key political, legislative, regulatory, operational and commercial developments affecting generic drugs in the major markets over the last 18 months, enabling you to respond to the opportunities and challenges this emerging market presents.

Use this report to:

Gain insights into the continuing global debate over patents, market exclusivity, drug pricing and compulsory licensing in light of the TRIPS agreement and Doha Declaration
Learn about the key issues affecting the industry such as tensions over authorised generics and “reverse” settlements, and how these impact your market
Assess EU harmonisation of the generics market, usage patents, cost-containment and new pricing paradigms and use this knowledge to plan accordingly
Evaluate the potential impact of biosimilars on your market and what the current trend for consolidation amongst generics manufacturers means for the future.

CHAPTER 1 INNOVATION AND ACCESS: THE LEGACY OF THE TRIPS AGREEMENT: 1.1 The origins of TRIPS; 1.2 What TRIPS did; 1.3 Before and after TRIPS; 1.4 The consequences of TRIPS; 1.5 Data exclusivity; 1.6 The patent effect; 1.7 What’s in the box?; 1.8 Novartis’ legal challenge; 1.9 A step further; 1.10 Difficult comparison; 1.11 Different priorities; 1.12 Sanofi-Aventis’ ASAQ concession; 1.13 The bigger picture
CHAPTER 2 THE ROAD TO DOHA: 2.1 The Bolar exemption; 2.2 Compulsory licensing draws blood; 2.3 TRIPS Agreement and Public Health; 2.4 The Doha Declaration
CHAPTER 3 TROUBLE WITH PARAGRAPH 6: 3.1 Back to the barricades; 3.2 The 30 August decision; 3.3 The 30 August provisions; 3.4 Double trouble; 3.5 Economies of scale
CHAPTER 4 IN THE WAKE OF DOHA: 4.1 Loose ends; 4.2 Mixed result in Canada; 4.3 The EU regulation; 4.4 The political debate over ratification; 4.5 The FTA threat; 4.6 US generic resistance; 4.6 More clashes over compulsory licensing; 4.7 Living with patents; 4.8 India abroad; 4.9 Tough enough for the US?
CHAPTER 5 NEW OPPORTUNITIES, NEW RESTRAINTS IN THE US MARKET: 5.1 A solid foundation; 5.2 Consolidation abounds; 5.3 Increasing sales; 5.4 Pricing issues; 5.5 A healthy future?; 5.6 The generic rationale; 5.7 Drug pricing debate persists; 5.5 Wal-Mart’s $4 generic offer
CHAPTER 6 HOW MEDICARE REFORM EASED GENERIC ACCESS IN THE US: 6.1 Modernising for generics; 6.2 Legislative responses; 6.3 The FDA steps in; 6.4 Legal back-up; 6.5 Widening the gap
CHAPTER 7 BAD MOON RISING: NEW STRATEGIES TO SLOW GENERIC ENTRY IN THE US: 7.1 Looking at Medicaid; 7.2 The patent bounty; 7.3 Case study: simvastatin; 7.4 US battle not over; 7.5 Authorising authorised generics; 7.6 Not so exclusive; 7.7 The first-to-file system - Apotex calls for an overhaul; 7.8 Patent settlements under the spotlight; 7.9 Case study: Plavix; 7.10 More about Citizen Petitions; 7.11 More trouble with patents; 7.12 The perils of biodefence; 7.13 Clearing the backlog; 7.14 Towards a generic drug user-fee programme; 7.15 On the fast track for ‘first generics’ and others
CHAPTER 8 MORE QUESTIONS THAN ANSWERS IN EUROPE: 8.1 Everything changes; 8.2 The EU: a singular not single market; 8.3 Factors for growth; 8.4 More on cost-containment and pricing pressure; 8.5 Back to the pharmaceutical review: a fair compromise?
CHAPTER 9 EUROPE: HOW IT ALL WORKS: 9.1 Data exclusivity; 9.2 Defining “significant clinical benefit”; 9.3 The cost of the eight plus two plus one compromise; 9.4 Against data exclusivity; 9.5 Compensations of the legislation; 9.6 More ‘plus ones’; 9.7 Global Marketing Authorisation - a win for generics; 9.8 Defining generics; 9.9 The European Reference Product
CHAPTER 10 EUROPE: HOW IT ALL WORKS (PART 2): 10.1 What Bolar allows; 10.2 Bolar: a back door to patent linkage?; 10.3 A European patent solution?; 10.4 Some harmony in SmPCs; 10.5 The name game; 10.6 Marketing Authorisation: which route to take?; 10.7 Case study: Zalasta goes central; 10.8 The ‘sunset clause’; 10.9 What’s more… criminal measures and paediatric use
CHAPTER 11 EUROPE: ON THE GROUND: 11.1 After the review; 11.2 The impact of P&R; 11.3 Market conditions; 11.4 Sustaining generics medicines markets; 11.5 Mixed messages for the generics industry
CHAPTER 12 THE JAPANESE LAG: 12.1 A positive future for generics?
CHAPTER 13 BEYOND COMPARE? - CLEARING A PATH FOR BIOSIMILARS: 13.1 Biogenerics: uncertainty rules; 13.2 Market potential - varied predictions; 13.3 EPO and the emerging EU biosimilars market; 13.4 Comparatively difficult; 13.5 Data: how much is enough?; 13.6 The interchangeability debate; 13.7 What’s in a name? (INNs); 13.8 The US: a regulatory void; 13.9 Case study: looking back at the Omnitrope conundrum; 13.10 The push for US legislation; 13.11 What’s next for biosimilars?
CHAPTER 14 NEW GENERIC PARADIGMS: CHALLENGES AND OPPORTUNITIES: 14.1 Research-based companies on the defence; 14.2 Less to copy: the R&D productivity issue; 14.3 Doing it for themselves: R&D companies move into generics; 14.4 Supergenerics and more; 14.5 Consolidation bites; 14.6 Consolidation case studies; 14.7 Looking to the future

More Global Generics Drugs Reports

Top 194 Generic Pharmaceuticals (Global) by Plimsoll Publishing Ltd.
This report is an in-depth financial evaluation of the GlobalGeneric Pharmaceuticals. Using the unique Plimsoll method of analysis, each of the top 194 companies included ...

The World Generic Market Report 2012 by Espicom Healthcare Intelligence
Generics, Pharmaceuticals, Healthcare ...

Impact of Patent Expiry on Global Generic Drugs Market - Trends, Opportunities and Challenges Post 2011 by Synergyst
Fueled by ageing populations, growing numbers of patent expirations and government cost-cutting measures, the global generic drugs market continues to grow. In 2010, sales of ...

Generic Pharmaceuticals Market - A Global Analysis by Frost & Sullivan
The research service aims to analyse and assess the global generics pharmaceutical market, map the key trends and dynamics shaping the industry sector and provide ...

Generic Drugs: Global Collaboration Opportunities by Espicom Healthcare Intelligence
In the current economic turmoil affecting many markets around the world, the generic and branded sectors face similar problems. At one time the generic ...

See all reports like this >>

New Dynamics and Challenges in the Generics Market 2007

Share this report

Other tasks

Research Assistance

Related Markets

Generics Drugs Reports

Free Alert Me service