Abstract
The rise of generics, products at risk and defence strategies
The figures speak for themselves. Of the 150 products detailed in this report, 24 faced generic competition in 2006. This rose to 35 in 2007 and 49 in 2008. By 2012, this will have risen to 73 products on a conservative estimate, and possibly as many as 91.
When is patent protection not patent protection?
Often when it is a pharmaceutical product. At one time the extensive use of patents safeguarded a branded company' s product portfolio against generic competition. Increasingly, however, the fiercely competitive US generic sector has pursued an aggressive policy of earlier and earlier challenges. Compelled by the need for new revenues in the world' s largest pharmaceutical market, and often with the tacit encouragement of cost-conscious health payers, the sector has been buoyed by many successful legal and regulatory decisions well ahead of patent expiry.
In response, the branded industry has employed a range of mechanisms to stop or limit the generics companies' ambitions - with varying success. Traditional defence of right through litigation is a strategy that has been joined by the rise of authorised generics, incremental innovation and the introduction of combination therapies.
The issue has never been more critical. Over the next 5 years over 73 products - including the current leading therapies - will face generic competition with a significant influence on sales, profitability and R&D investment.
A unique business analysis of this crucial issue
At this critical stage, everyone - be they a branded manufacturer, generics company or commercial investor - needs to understand in detail which products are affected and the mounting effect it will have on the leading pharmaceutical companies. This new 188-page report, written by leading generic market analyst Andy Crofts, compares and contrasts at the product level the current situation and looks at how the market will develop to 2012. Packed with facts, figures and novel analysis, this report is essential reading for all senior executives throughout the industry.
This extensive report provides a unique analysis of the likely impact of generic competition in the US pharma market. Now you can...
- Identify the 150 products which could be subject to generic competition over the next 5 years
- Evaluate the level of impact on each product
- Assess the impact of generic competition on 14 leading branded companies
- Understand the strategies being used by companies in defence of their products' position
Table of Contents
- Foreword
- EXECUTIVE SUMMARY
- Industry Overview
- Branded company sales overview
- Leading Originator Companies, Global Pharmaceutical Revenues, 2006-07 (US$ millions)
- Exposure to generics
- % of Global Revenues Likely to Face Generic Competition, 2008-12
- Branded defence strategies
- Incremental innovation
- Extended-release formulations
- Second-generation products
- Citizen petitions
- Deals with generic companies
- Authorised generics
- Incremental innovation
- Biologics
- Leading Originator Companies, PHSA Biologic Revenues 2007
- FDCA biologics
- Generic Approvals and Launches
- Pharmaceutical Products Estimated to Face Widespread Generic Competition by 2012
- Pharmaceutical Products Estimated to Face Limited Generic Competition by 2012
- Pharmaceutical Products Estimated to Face No Generic Competition by 2012
- Biologic Products: No Generic Competition to 2012
- 2007 Global Revenues Subject to Generic Competition by 2012 (US$ millions)
- Generic launches ' at risk'
- Summary of ' at risk' US Generic Launches, 2006-08
- Research-Based Company Profiles
- Abbott Laboratories
- Sales Intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Biaxin
- Depakote/Depakote ER
- Humira
- Kaletra
- Omnicef
- Synthroid
- Tricor
- A mgen
- Sales Intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- US Product Sales Data, 2006-07 (US$ millions)
- Aranesp
- Epogen
- Neulasta
- Neupogen
- Enbrel
- Sensipar
- Vectibix
- AstraZeneca
- Sales Intro
- Exposure to generics 2008-12
- Defence Strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- US Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (US$ millions)
- 2007 US Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Arimidex
- Atacand
- Casodex
- Crestor
- Nexium
- Prilosec
- Pulmicort
- Seroquel
- Toprol XL
- Zoladex
- Zomig
- Boehringer Ingelheim
- Sales Intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (euros millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (euro millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Aggrenox
- Combivent
- Flomax
- Micardis
- Mirapex
- Mobic
- Spiriva
- Bristol-Myers Squibb
- Sales Intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- US Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ billions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (£ billions)
- 2007 US Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Abilify
- Avapro/Avalide
- Baraclude
- Erbitux
- Orencia
- Plavix
- Pravachol
- Reyataz
- Sprycel
- Sustiva
- Eli Lilly
- Sales Intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- US Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (US$ millions)
- 2007 US Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Alimta
- Byetta
- Cialis
- Cymbalta
- Evista
- Forteo
- Gemzar
- Humatrope
- Strattera
- Zyprexa
- Insulin products
- GlaxoSmithKline
- Sales Intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (£ millions)
- US Product Sales Data, 2006-07 (£ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (£ billions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (£ billions)
- 2007 US Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Advair Diskus
- Augmentin
- Avandia
- Avodart
- Combivir
- Coreg
- Epzicom
- Flonase
- Flovent
- Imitrex
- Lamictal
- Paxil
- Requip
- Trizivir
- Valtrex
- Wellbutrin
- Zofran
- Johnson & Johnson
- Sales intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ billions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Aciphex
- Concerta
- Duragesic
- Levaquin
- Procrit
- Remicade
- Risperdal
- Topamax
- Merck & Co
- Sales intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Cancidas
- Cozaar
- Emend
- Fosamax
- Januvia
- Maxalt
- Primaxin
- Proscar/Propecia
- Singulair
- Trusopt/Cosopt
- Zocor
- Novartis
- Sales intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- US Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ billions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (US$ billions)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Diovan
- Exelon
- Famvir
- Femara
- Focalin
- Gleevec
- Lamisil
- Lescol XL
- Lotrel
- Sandostatin
- Trileptal
- Zometa
- Pfizer
- Sales Intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- 2007 Revenues Exposed To Probable Generic Competition, 2008-12 (US$ billions)
- 2007 Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Aricept
- Aromasin
- Caduet
- Camptosar
- Cardura
- Celebrex
- Chantix
- Detrol/Detrol LA
- Genotropin
- Geodon Oral
- Lipitor
- Lyrica
- Neurontin
- Norvasc
- Relpax
- Sutent
- Vfend
- Viagra/Revatio
- Xalatan
- Zithromax
- Zoloft
- Zyrtec
- Zyvox
- Roche
- Sales intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (CHF millions)
- US Product Sales Data, 2006-07 (CHF millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (CHF millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (CHF millions)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Avastin
- Boniva
- CellCept
- Herceptin
- Kytril
- Lucentis
- Nutropin
- Pegasys
- Rituxan
- Tamiflu
- Tarceva
- Valcyte
- Xeloda
- Xenical
- Xolair
- Sanofi Aventis
- Sales intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (euro millions)
- US Product Sales Data, 2006-07 (euro millions)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (euros millions)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Actonel
- Allegra
- Amaryl
- Ambien
- Avapro
- Copaxone
- Deprocon
- Eloxatine
- Lantus
- Lovenox
- Nasacort
- Plavix
- Taxotere
- Altace
- Uroxatral
- Wyeth
- Sales intro
- Exposure to generics 2008-12
- Defence strategies
- Product Summary, 2006-2012
- Summary of Products Reviewed
- Summary by Year
- Global Product Sales Data, 2006-07 (US$ millions)
- US Product Sales Data, 2006-07 (US$ millions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (US$ billions)
- 2007 Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- 2007 US Revenues Exposed To Probable Generic Competition, 2008-12 (£ billions)
- 2007 US Global Revenues Exposed To Probable Generic Competition, 2008-12 (% of Total)
- Effexor
- Prevnar
- Protonix
- Zosyn/Tazocin
- Tygacil
- Appendix: Overview of the generic application and approval system
- Appendix 1: ANDA Approvals
- ANDA Approvals, 2002-08
