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World Generic Market Report 2007

Publication Date November 2006
Publisher Espicom
Product Type Report
Pages 483
ISBN Number not applicable
Product Code ESP985

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Summary

To understand the generic market, Espicom, the publisher of the respected twice-monthly business publication World Generic Markets, has published The World Generic Market Report 2007. Packed with facts, figures, analysis and statistics, the 480+ page report provides the most thorough report available on generic markets, products and companies and the issues they face.

Industry consolidation, emerging generic markets, biosimilars plus much, much more

Published in November 2006, this report draws on primary research with companies, statistics offices, health ministries and trade associations worldwide and provides standard, comparative data and discussion on key issues such as:

Industry consolidation and the emergence of "super" generic companies
Double digit generic market growth - but where?
Biosimilars: now live in Europe - but elsewhere?
Authorised generics and other 180-day exclusivity issues in the US
Key legal challenges
The political and funding background
Intellectual property issues

Report Contents

Global Overview
Industry consolidation
Current issues in the USA
The widening influence of India
WTO Agreement
Biosimilars
Current issues in the European Union
Prospects for growth.

Country Market Data Covering:

Key facts
Generic market value & 5-year forecast
Patent protection/IP
Pricing/reimbursement.

Countries covered:

Australia
Brazil
Canada
France
Germany
India
Italy
Japan
Netherlands
South Africa
Spain
UK
Switzerland
USA

Company Data Covering:

Financial Performance
ANDAs and launched products
M&A activity and litigation.

Companies covered:

Apotex
Aspen Pharmacare
Barr Laboratories
Cipla
Dr Reddy's
EGIS
Hospira
KRKA
Lannett
Mayne Pharma
Merck Generics
Mylan Labs
Par Pharmaceuticals
Perrigo
Pliva
Ranbaxy
ratiopharm
Gedeon Richter
Sandoz
Sawai
Stada Arzneimittel
Teva Pharmaceutical Industries
Towa Pharmaceuticals
Watson Pharmaceuticals
Winthrop
Wockhardt
Zentiva
Zydus Cadila

The changing face of the generics industry

The pace of corporate consolidation grows ever faster. Nine acquisitions were announced in 2006 including well known companies such as Andrx and Pliva. Increasingly the industry is being rationalised and dominated by fewer and fewer larger players. Teva and Sandoz may be fighting it out for the top spot but the speed of change is seeing the corporate landscape change continuously.

Emerging markets to 2011

Established generic markets may currently account for the bulk of generic prescribing and value, but where is the industry going in the future? In terms of growth not one of the leading markets features, but look to France, Spain, Brazil and Italy if you want significant double digit growth to 2011.

Content

Foreword
Global Overview
- Introduction
- Generic Market Data
- Major Generic Manufacturers
- Current Issues in the USA
  - Authorised generics
  - Senate Committee Discusses Regualtory Delays, Authorised Generics, Citizen Petitions
  - Shared exclusivity
- Industry consolidation
  - Where next in the USA?
  - Where next in Europe?
- Biosimilars
  - Access to Life-Saving Medicine Act (HR 6257)
- Access to Generic Drugs in the Developing World: WTO Agreement
  - 2003 Agreement
  - TRIPS patent ruling on least-developed countries, 2002
  - Canada
  - European Union
  - Clinton Foundation
  - PEPFAR
- Current Issues in the European Union
  - European Union Regulatory Reforms Take Effect, November 2005
  - European Commission regulations for paediatric medicines due in 2007
  - Enlargement of the European Union
  - Parallel Trade in the enlarged EU
- The widening influence of Indian companies
- Prospects for Future Growth
  - Relative strength of intellectual property laws
  - Pricing/reimbursement regimes
  - Prescriber/patient habits
Country Profiles
- Australia
  - Introduction
  - Key Facts
  - Generic Market
  - Health Minister announces PBS consultation on further generic incentives
  - Projections/Outlook
  - Patent Protection & Intellectual Property Rights
  - Australian Senate passes IP Amendment Bill
  - US Free Trade Agreement, Generic Amendments
  - Pricing & Reimbursement
  - Rise in Co-payment rates, 2005
  - Therapeutic Group Premiums
  - US Free Trade Agreement
  - Government announces new pricing measures for newly listed drugs, 2005
- Brazil
  - Introduction
  - Key Facts
  - Generic Market
  - Projections/Outlook
  - Patent Protection & Intellectual Property Rights
  - Pricing & Reimbursement
- Canada
  - Introduction
  - Key Facts
  - Generic Market
  - Projections/Outlook
  - Domestic Production
  - Patent Protection & Intellectual Property Rights
  - New rules come into effect, October 2006
  - Jean Chretien Pledge to Africa Act
  - Pricing & Reimbursement
  - Provincial Formularies
  - The Quebec 15-year rule
  - Ontario Bill 102
  - Drug Insurance Programmes
- France
  - Introduction
  - Key Facts
  - Generic Market
  - Projections/Outlook
  - Patent Protection/Intellectual Property Rights
  - Pricing & Reimbursement
  - 2006 Social Security Finance Bill targets generic price cut
  - Pharmacy margins aim to promote generic use
  - Reimbursement
  - Dispensing Agreement, 2006-07
- Germany
  - Introduction
  - Generic Market
  - Domestic Production
  - Projections/Outlook
  - Patent Protection/Intellectual Property Rights
  - Pricing & Reimbursement
  - Reimbursement
  - Generic Substitution Policies
  - Compulsory Manufacturer Rebates
  - AVWG, 2006
- India
  - Introduction
  - Key Facts
  - Generic Market
  - Market Projections
  - Patent Protection/Intellectual Property Rights
  - The Patents (Amendments) Bill, 2005
  - Pharmaceutical Product Patents, One Year On
  - Compulsory Licensing
  - Pre- & Post-Grant Opposition
  - Mailbox Applications
  - Other Issues
  - Pricing and Reimbursement
  - Drugs (Prices Control) Amendment Order, 2006
- Italy
  - Introduction
  - Key Facts
  - Generic Market
  - Branded & Unbranded Generic Medicines
  - Unbranded Generic Medicines
  - Domestic Generic Production
  - Total Generic Market Projections
  - Patent Protection/Intellectual Property Rights
  - National Supplementary Protection Certificate
  - Pricing & Reimbursement
  - Generic Pricing
- Japan
  - Introduction
  - Key Facts
  - Generic Market
  - Positive signs?
  - New generic regulation, 2005
  - MHLW Stable Supply Requirements, 2006
  - Projections/Outlook
  - Patent Protection/Intellectual Property Rights
  - Data exclusivity
  - Exclusion of Use
  - Patent term extensions
  - Pricing & Reimbursement
  - Yakkasa
  - Price reductions
  - Generic drug pricing & reimbursement
  - Generic substitution reforms, 2006
- Netherlands
  - Introduction
  - Key Facts
  - Generic Market
  - Projections/Outlook
  - Patent Protection/Intellectual Property Rights
  - Pricing & Reimbursement
- Russia
  - Introduction
  - Key Facts
  - Generic Market
  - Projections/Outlook
  - Patent Protection & Intellectual Property Rights
  - Counterfeit Medicines
  - Pricing & Reimbursement
  - Reimbursement
- South Africa
  - Introduction
  - Key Facts
  - Generic Market
  - Projections/Outlook
  - HIV/AIDS drugs
  - Patent Protection/Intellectual Property Rights
  - Pricing & Reimbursement
  - Essential Drugs List
  - Pricing Reforms, 2003
  - Medical Scheme formularies
- Spain
  - Introduction
  - Key Facts
  - Generic Market
  - Generic Registrations
  - Generic Producers
  - The 2nd Iberian Conference on Generics
  - Projections/Outlook
  - SWOT Analysis of Generics in Spain
  - Patent Protection/Intellectual Property Rights
  - Pricing & Reimbursement
  - Reimbursement
- Switzerland
  - Introduction
  - Key Facts
  - Generic Market
  - Domestic Producers
  - Projections/Outlook
  - Patent Protection/Intellectual Property Rights
  - Pricing & Reimbursement
  - Generic pricing survey, 2005
  - Pricing & Reimbursement Sector Development
  - 2001 Drug Price System
- United Kingdom
  - Introduction
  - Key Facts
  - Generic Market
  - Scotland
  - Wales
  - Investigations into price fixing
  - Marketing Authorisations
  - Projections/Outlook
  - Manufacturers
  - Patent Protection/Intellectual Property Rights
  - Pricing & Reimbursement
  - PPRS
  - Unbranded Generic Pricing
  - DOH Holds consultations regarding branded generics in the PPRS
- USA
  - Introduction
  - Key Facts
  - Generic Market
  - Projections/Outlook
  - Generic Approval Process
  - Bolar Amendment
  - Patent Protection & Intellectual Property Rights
  - Pricing & Reimbursement
  - Public Drug Procurement
  - Recent Developments
  - Wal-Mart begins generic drug price war?
  - FTC reports summary of pharmaceutical company agreements filed in FY2005
  - Hatch-Waxman reform ends multiple 30 month stays
  - Major product approvals
  - ANDAs Approved in 2005
  - ANDAs Approved in 2006
  - Forthcoming US patent expiries
  - The Plavix case
Company Profiles
- Actavis
  - Executive Summary
  - Background
  - Products
  - Own Brand Products
  - Third Party Products
  - Actavis Totowa (formerly Amide Pharmaceutical)
  - Financials
  - Major developments
  - Actavis loses Pliva to Barr Pharmaceuticals
  - Actavis to acquire Romanian generic oncology specialist, Sindan
  - Actavis acquires Alpharma's Human Generics business
  - Actavis acquires Kri Pharma Generics
  - Actavis agrees to acquire Higia
  - Actavis sells Bulgarian API plant, retains dosage form capacity
  - Actavis acquires Amide Pharmaceutical
  - Actavis building new R&D centre in Iceland
  - Acquisition of Pharma Avalanche
  - Actavis expands presence in India
  - Actavis acquires Biovena
- Andrx Corporation
  - Introduction
  - Background
  - New Strategic Focus On Generics Announced
  - Andrx to be acquired by Watson
  - CGMP Compliance Issues
  - FDA issues new Form 483 for Andrx, April 2006
  - Products
  - Financials
  - Major developments
  - Andrx to be acquired by Watson
  - InvaGen
- Apotex
  - Introduction
  - Background
  - Products
  - Financials
  - Cangene
  - Major developments
- Aspen Pharmacare
  - Introduction
  - Background
  - Products
  - HIV/AIDS drugs
  - Financials
  - Segment Data
  - Major developments
  - Tamilfu agreement with Roche
  - Bristol-Myers Squibb
  - Lupin Laboratories
  - Gilead
  - Matrix Laboratories
  - William J Clinton Presidential Foundation
  - Eli Lilly
  - GlaxoSmithKline
  - Strides Arcolab
- Barr Pharmaceuticals
  - Introduction
  - Background
  - Products
  - Financials
  - Major developments
  - Barr looks set to prevail in battle to control Pliva
  - Barr and Shire enter three agreements
  - Barr/Pliva sign agreement to develop and market generic version of G-CSF in US and Canada
  - Barr gains generic fentanyl agreement
- Cipla
  - Introduction
  - Background
  - New Plant Announced, June 2006
  - Products
  - Financials
  - Segment Data
  - Geographic Segment Data
  - Major developments
  - HIV/AIDS
  - Compulsory licensing in Malaysia
  - Mergers, acquisitions and agreements
  - Cipla to supply API to IVAX
  - Akorn
- Dr Reddy's
  - Introduction
  - Background
  - Products
  - Financials
  - Segment Data
  - Major developments
  - Dr Reddy's acquires betapharm
  - Dr Reddy's and Argenta announce R&D collaboration
  - Dr Reddy's signs agreement to acquire Roche's Mexico API facility
  - Perlecan formed as India's first integrated drug-development company; Dr Reddy's invests and signs alliance
  - Dr Reddy's/Pharmascience sign multi-product agreement
  - Dr Reddy's and ICICI form ANDA partnership
  - Trigenesis Therapeutics
  - Dr Reddy's Laboratories (Proprietary)
  - BMS Laboratories and Meridian Health Care
  - American Remedies and Cheminor Drugs
  - Pliva
  - Leiner Health Products
- Egis
  - Introduction
  - Background
  - Products
  - Financials
  - Major developments
  - Acquisitions
- Hospira
  - Introduction
  - Background
  - Manufacturing facilities
  - Summary of Hospira Manufacturing Facilities
  - McPherson, Kansas Expansion Programme
  - Products
  - Financials
  - Major Developments
  - Mayne Pharma
  - Hikma and Hospira enter European marketing agreements
  - Hospira announces strategic alliance with Pharmalink and Zuellig Pharma in Asia
- KRKA
  - Introduction
  - Background
  - Products
  - Financials
  - Major developments
  - Facilities
  - Representative offices
- Lannett
  - Introduction
  - Background
  - New facility leased, 2006
  - Products
  - Financial
  - Major developments
  - Olive Healthcare
  - Azad Pharma
  - Wintac
  - Orion Pharma
  - Unichem Laboratories
  - Jerome Stevens Pharmaceutical
- Mayne Pharmaceuticals
  - Introduction
  - Background
  - Manufacturing sites
  - Manufacturing site review, 2006
  - Products
  - Financial
  - Major Developments
  - Hospira announces A$2.6 billion acquisition of Mayne Pharma
  - Pliva and Mayne update biosimilar G-CSF partnership; EPO dropped
  - Orchid enters into exclusive marketing alliance with Mayne
  - IVAX and Mayne sign European distribution deal
  - Cadila and Mayne sign agreement to set up JV to manufacture specialty oncology products
  - Mayne and Strides enter cytotoxic and anti-infective product agreements
  - Mayne acquires Spanish generics business
  - Mayne acquires Wasserburger
  - aaiPharma sells injectable multivitamin products to Mayne
  - IVAX and Mayne enter EU paclitaxel agreement
- Merck Generics
  - Introduction
  - Background
  - Alphapharm
  - Generics (UK)
  - Genpharm
  - Merck Generics (South Africa)
  - Merck Gnriques (France)
  - Merck Dura
  - Merck Hoei
  - McDermott Laboratories (Gerard)
  - Dey Inc
  - Products
  - Financials
  - Major developments
  - Glenmark and Merck Generics form European marketing agreement
  - Merck KGaA purchases Spain's Prasfarma
  - NM Pharma
  - Litigation: Generics (UK)
- Mylan Laboratories
  - Introduction
  - Background
  - Mylan Pharmaceuticals
  - Mylan Technologies
  - UDL Laboratories
  - Bertek Pharmaceuticals
  - Products
  - Financials
  - Major developments
  - Matrix Laboratories
  - King Pharmaceuticals merger called off
- Par Pharmaceuticals
  - Introduction
  - Background
  - Kali Laboratories
  - Products
  - Teva/IVAX Drugs Divested to Par Pharmaceutical Companies
  - Financial
  - Major Developments
  - Spectrum Pharmaceuticals
  - Par divests FineTech
  - Bradley and Par enter licensing agreement for Adoxa
  - MN Pharmaceuticals
  - Orchid Chemicals & Pharmaceuticals
- Perrigo
  - Introduction
  - Background
  - Products
  - Financials
  - Segment Sales
  - Major developments
  - Perrigo to close two facilities
  - Dexcel Pharma Technologies
  - Agis Industries
  - Collaboration with Bentley Pharmaceuticals
- Pliva
  - Introduction
  - Background
  - Strategic review, more focus on generics
  - Pliva opens biostudy centre in Goa
  - Products
  - Biosimilars
  - Financials
  - Segment Results
  - Revenues by Region
  - Major developments
  - Barr looks set to prevail in battle to control Pliva
  - Pliva signs agreement with Unichem for new products in the US
  - Uso Racional
  - Pliva exits proprietary business
  - Pliva's AWD.pharma divests manufacturing plant
  - Pliva subsidiary divests branded product, terminates agreements with Legacy Pharma
  - Pliva signs new bulk azithromycin supply agreement with Pfizer
- Ranbaxy
  - Introduction
  - Background
  - Ranbaxy announces focus on pharmaceuticals business
  - Goa plant receives UK MHRA approval
  - Ranbaxy launches in Canada
  - Products
  - Antiretrovirals
  - Financials
  - Segment Data
  - Geographic Segment Results
  - Major developments
  - FDA issues warning letter to Ranbaxy
  - Ipca and Ranbaxy sign deal for US market
  - Ranbaxy signs Canadian licensing and supply agreement
  - Ranbaxy to acquire GSK's Mundogen generic business in Spain
  - Ranbaxy completes Terapia acquisition
  - Ranbaxy forms strategic oncology partnership with Zenotech
  - Ranbaxy to co-market Ferring's desmopressin in India
  - Ranbaxy and Nippon Chemiphar consolidate relationship
  - Ranbaxy to market Lupin's TB brands in Africa
  - Ranbaxy acquires generic product portfolio from Efarmes
  - UK Department of Health legal action settled
- ratiopharm
  - Introduction
  - Background
  - Products
  - Financials
  - Major developments
  - Orbus signs agreement with ratiopharm Canada
  - IntelliPharmaCeutics enters generic agreements with ratiopharm
  - Neose and BioGeneriX enter new agreement
  - Magnafarma
  - BioGeneriX signs agreement with Cangene
  - Ribosepharm
- Gedeon Richter
  - Introduction
  - Background
  - Products
  - Financials
  - Product Segment Data
  - Geographic Segment Data
  - Major developments
  - Themis Medicare India starts trial production at Vapi site
  - US deal with KV Pharmaceutical
  - Consortium bid for Hungaropharma successful
  - GZF Polfa
  - Biogen International
- Sandoz
  - Introduction
  - Background
  - Canada
  - Products
  - Financials
  - Major developments
  - Omnitrope approved in EU and USA
  - Momenta enters expanded collaboration agreement with Sandoz
  - Lek opens new facility in Slovenia
  - Sandoz completes purchase of Hexal and Eon Labs
- Sawai Pharmaceutical
  - Introduction
  - Background
  - Products
  - New government supply rules, 2006
  - Financials
  - Major developments
  - Towa, Sawai and Nichi-iko sign agreement for stable supply of generic products
  - Medisa Shinyaku
  - Nihon Schering's Mobara factory
  - Japan Generic Drug Research Group
- Stada Arzneimittel
  - Introduction
  - Background
  - Products
  - EPO submitted to EMEA
  - Financial
  - Segment Data
  - Geographic Segment Data
  - Major developments
  - Hemofarm
  - Stada sells US subsidiary to DAVA
  - ProStrakan signs branded generic agreement with Genus Pharmaceuticals
  - Beijing Center-Lab Pharmaceutical, majority stake
  - Advancis enters amoxicillin PULSYS agreement with Stada's Clonmel Healthcare
  - Strides enters agreement with Stada in the US
  - Stada acquires Portuguese generics supplier
  - Orchid enters US market agreement with Stada Pharmaceuticals
  - Stada acquires Nizhpharm
- Teva Pharmaceutical Industries
  - Introduction
  - Background
  - Teva to close Puerto Rican manufacturing facility
  - Products
  - Financials
  - Segment Data
  - Geographic Segment
  - Major developments
  - Teva increases stake in Hualida
  - Teva completes IVAX acquisition; Par and Barr benefit
  - Teva and Barr sign agreement covering fexofenadine
  - Teva and TransPharma sign transdermal drug delivery agreement
  - Dorom
  - Microbia
  - Sicor
  - Impax
- Towa Pharmaceutical
  - Introduction
  - Background
  - Products
  - Financials
  - Major developments
  - Eisai's lawsuit against manufacturers/distributors of generic Selbex dismissed
  - Japanese Generic companies form agreement for stable generic supply
- Watson Pharmaceuticals
  - Introduction
  - Background
  - New business strategy,
  - Watson to acquire Andrx
  - Watson to divest Arizona injectable manufacturing facility
  - Further restructuring announced, Puerto Rico plant to close
  - Watson dedicates new distribution facility
  - Products
  - Financials
  - Major developments
  - Watson completes acquisition of Sekhsaria Chemicals
  - Watson to acquire Andrx
  - Other acquisitions and collaborations
  - Watson to distribute OxyContin authorised generic
  - Interpharm and Watson commence ibuprofen manufacturing and supply agreement
  - Bupropion authorised generic agreement with GSK
- Winthrop Pharmaceuticals
  - Introduction
  - Background
  - Czech Republic
  - France
  - Germany
  - Portugal
  - United Kingdom
  - Products
  - Financials
  - Major Developments
  - sanofi-aventis acquires 25% of Zentiva's shares
- Wockhardt
  - Introduction
  - Background
  - Wockhardt receives warning letter from the FDA
  - Products
  - Financials
  - Major developments
  - Wockhardt to raise up to US$800 million to fund overseas acquisitions
  - Pharmaceutical plants
  - Joint Ventures
  - Mergers, acquisitions and agreements
- Zentiva
  - Introduction
  - Background
  - Products
  - Financials
  - Major developments
  - sanofi-aventis
  - Sicomed
- Zydus Cadila
  - Introduction
  - Background
  - Products
  - Financials
  - Major Developments
  - Evolupharn and Aerocid
  - Joint venture with Bharat Serums and Vaccines
  - Joint venture with Mayne Pharma
  - Venus Remedies
  - Alliance with Mallinckrodt
  - MoU with Zambon
  - Alpharma France
  - Merger into Cadila Healthcare
Sources
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