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World Generic Market Report 2008

Published by: Espicom Healthcare Intelligence

Published: Dec. 19, 2007 - 700 Pages


Table of Contents


VOLUME I



Current Issues in the USA

Authorised generics

FTC investigation

Moves in Congress

PhRMA responds

GPhA responds

More studies, more arguments

Senate Committee Discusses Regulatory Delays, Authorised Generics, Citizen Petitions

Gary Buehler

Jon Leibowitz

Heather Bresch

Shared exclusivity



Industry consolidation

Where next in the USA?

Where next in Europe?



Biosimilars

Political pressure

Access to Life-Saving Medicine Act (H.R)

Biologics Price Competition and Innovation Act of 2007 (S.1695)

House Committee on Oversight and Government Reform

Henry Waxman



Access to Generic Drugs in the Developing World: WTO Agreement

2003 Agreement

TRIPS patent ruling on least-developed countries, 2002

Canada

European Union

European Parliament pushes for greater access to generic drugs

Thailand

Brazil

Clinton Foundation

PEPFAR



Current Issues in the European Union

European Union Regulatory Reforms Take Effect, November 2005

Product definition

Data exclusivity

European Commission regulations for paediatric medicines introduced 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



Major Generic Manufacturers



Actavis

Introduction

Background

Products

Own-label Products

Third-Party Products

Financials

Segment Data

Major developments

Actavis building new R&D centre in Iceland

Actavis opens Albania office

Actavis opens a representative office in Vietnam

Mergers, acquisitions and agreements

Actavis partners with Germany’s AOK

Actavis acquires Indian manufacturing plant

Actavis and Orchid form European licensing and distribution alliance

Actavis strengthens its position in India

Actavis acquires Abrika

Actavis purchases majority stake in Russian manufacturing facility

Actavis to acquire Romanian generic oncology specialist, Sindan

Actavis acquires Alpharma’s Human Generics business

Fako

Actavis acquires Denmark's Ophtha

Actavis acquires Kéri Pharma Generics

Actavis acquires Higia

Actavis sells Bulgarian API plant, retains dosage form capacity

Actavis acquires Amide Pharmaceutical

Acquisition of Pharma Avalanche

Actavis expands presence in India

Actavis acquires Biovena



Apotex

Introduction

Background

Products

Financials

Cangene

Major developments

Rwanda issues first notification under WTO Paragraph 6 system

Akorn and Apotex sign ophthalmics agreement

Orchid Chemicals & Pharmaceuticals

BioGeneriX

Litigation

Plavix (clopidogrel)

Allergan sues Apotex for infringement of brimonidine tartrate patents

Apotex invalidates amlodipine patent, setting off stream of activity

Unigene/Upsher-Smith file patent infringement lawsuit against Apotex

Allergan wins Acular patent infringement lawsuit



Aspen Pharmacare

Introduction

Background

Products

HIV/AIDS drugs

South African government ARV tender

Financials

Segment Data

Major developments

Pharmaceutical firms form new South African industry association

Mergers, acquisitions and agreements

Acrux enters oestradiol marketing agreement with Aspen Pharmacare in Australia

Darunavir access plan with Tibotec

Lupin and Aspen terminate TB MoU

Roche

Oseltamivir

Saquinavir

Bristol-Myers Squibb

Gilead

Matrix Laboratories

Fine Chemicals Corporation

William J Clinton Presidential Foundation

Eli Lilly

GlaxoSmithKline

Strides Arcolab



Barr Pharmaceuticals

Introduction

Background

Products

Financials

Fiscal year 2006

Major developments

Barr and Apotex launch Canada’s first generic oral contraceptive

US Supreme Court denies review of tamoxifen citrate antitrust lawsuit

Barr successfully acquires 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

Major developments

HIV/AIDS

Thai government in talks with Cipla over antiretroviral ingredients

AHF and Cipla quarrel over AIDS drugs prices

Clinton Foundation and UNITAID announce agreements to reduce ARV prices

Compulsory licensing in Malaysia

South African antiretroviral tender

Mergers, acquisitions and agreements

Akorn signs contract with Cipla for injectable ANDA product

Akorn and Cipla sign agreement for oral organ transplant rejection drug

Cipla enters malaria agreement with DNDi

Cipla to supply API to IVAX

Cipla Medpro sold to Enaleni

Pentech Pharmaceuticals

Avestha Gengraine Technologies

Morton Grove Pharmaceuticals

Watson Pharmaceuticals

Stada, Hexal and Fujisawa



Dr Reddy’s Laboratories

Introduction

Background

Products

Financials

Segment Data

Active pharmaceutical ingredients and intermediates (API)

Formulations

Generics

Custom pharmaceuticalservices (CPS)

Critical care andbiotechnology

Major developments

Dr Reddy’s opens Manila office

Dr Reddy’s begins operations in Nigeria

Dr Reddy’s joins USP’s Pharmaceutical Ingredient Verification Programme

Dr Reddy’s and Torrent sign Russian lisinopril agreement

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

Preliminary results for the year ended 30th September, fiscal 2007

Fiscal 2006 results

Major developments

Hungaropharma

Serdix



Hospira

Introduction

Background

Products

Financials

Segment Results

Major Developments

Mayne Pharma

FTC sets conditions, clearing the way for Hospira’s acquisition of Mayne Pharma

Hikma and Hospira enter European marketing agreements

Hospira announces strategic alliance with Pharmalink and Zuellig Pharma in Asia



KRKA

Introduction

Background

Products

EMEA recommends MA for Krka product

Financials

Major developments

Facilities

Slovenia

Russia

Poland

Representative offices

Litigation

Simvastatin

Atorvastatin

Enalapril



Lannett

Introduction

Background

New facility leased, 2006

Products

Financials

Major developments

Lannett acquires unnamed API supplier

PharmaSeed Bioservices

Olive Healthcare

Azad Pharma

Wintac

Orion Pharma

Unichem Laboratories

Jerome Stevens Pharmaceutical



Merck Generics

Introduction

Background

Alphapharm

Generics (UK)

Genpharm

Merck Generics (South Africa)

Merck Dura

Dey Inc

Products

Financials

Major developments

Mylan agrees to acquire Merck Generics for 4 billion euros

Glenmark and Merck Generics form European marketing agreement

Merck KGaA purchases Spain's Prasfarma

NM Pharma

Litigation

Generics (UK)



Mylan

Introduction

Background

Products

Financials

Segment Data

Total Revenues by Geographic Region

Major developments

Mylan agrees to acquire Merck Generics for 4 billion euros

Matrix Laboratories

King Pharmaceuticals merger called off



Par Pharmaceuticals

Introduction

Background

Kali Laboratories

Products

Financials

Major Developments

Hana Biosciences licenses North American ondansetron rights to Par Pharmaceutical

IntelliPharmaCeutics announces equity investment by Par Pharmaceutical

AstraZeneca/Par enter agreement for generic version of Toprol-XL

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 divests two facilities

Perrigo acquires Qualis

Perrigo acquires generic dermatological products from Glades

Dexcel Pharma Technologies

Agis Industries

Collaboration with Bentley Pharmaceuticals

Litigation

Adams receives notice of Paragraph IV certification against patents for Mucinex SE

Triamcinolone (Barr Laboratories)

Connetics

FTC investigation

Phenylpropanolamine



Pliva

Introduction

Background

Products

Biosimilars

Financials

Segment Results

Revenues by Region

Major developments

Pliva to acquire ORCApharm

Barr successfully acquires 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

Products

Antiretrovirals

Ranbaxy forms JV in South Africa to market antiretrovirals

Gilead signs eight TDF agreements with Indian companies

Financials

Segment Data

Geographic Segment

Major developments

Ranbaxy acquires dermatology brands from Bristol-Myers Squibb

Ranbaxy signs first biosimilars agreement

Ranbaxy signs new R&D agreement with GlaxoSmithKline

Ranbaxy acquires Be-Tabs for US$70 million

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

BioGeneriX

Merckle Biotec

Merckle

PulmoTec

ratiopharm direct

Products

Financials

Major developments

German bribery investigation

Mergers, acquisitions and agreements

Hikma acquires ribosepharm from ratiopharm

BioGeneriX and Neose update on biosimilar collaboration

Orbus signs agreement with ratiopharm Canada

IntelliPharmaCeutics enters generic agreements with ratiopharm

Magnafarma

BioGeneriX signs agreement with Cangene

Ribosepharm



Gedeon Richter

Introduction

Background

Products

Financials

Segment Results

Geographic Segment Data

Major developments

Gedeon Richter acquires Romania’s Dita Group

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

Production Facilities

Sandoz Canada to invest C$80 million in Boucherville facilities

Products

Financials

Lek

Major developments

EU epoetin alpha approval

Omnitrope approved in EU and USA

EU

USA

Momenta enters expanded collaboration agreement with Sandoz

Lek opens new facility in Slovenia

Sandoz completes purchase of Hexal and Eon Labs

Sabex

Durascan

Amifarma



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

Financials

Segment Data

Geographic Segment Data

Major developments

Stada reorganises biosimilar projects; Hospira to acquire erythropoietin rights

Mergers, acquisitions and agreements

Forum Bioscience Group

Makiz

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

Products

Financials

Segment Data

Geographic Segment

Major developments

BioSante and Teva restart testosterone product development

Teva and Synerx form US marketing partnership

Teva signs biopharmaceuticals agreement with Procognia (Israel)

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

Litigation

Federal appeals court upholds Lexapro patent decision

Novartis' motion for preliminary injunction against Teva's Lotrel generics denied

Court rules in Eisai's favour over Aciphex ANDAs

Pfizer wins Celebrex patent challenge by Teva

Biovail reaches comprehensive settlement related to Wellbutrin XL

Teva files patent infringement complaints against sertraline manufacturers

Teva and Pfizer reach agreements for anti-infective and cancer products

Impax prevails in ALZA's appeal over generic Ditropan XL

Purdue and Teva agree deal to end OxyContin patent lawsuit

Court of Appeals rules in Teva's favour on Biaxin XL preliminary injunction

Alcon files patent infringement suit against Teva regarding Vigamox

Esomeprazole magnesium

Adderall

Fexofenadine

Modafinil

Missouri AG alleges firms involved in AWP inflation scheme

Donezepril hydrochloride

Quetiapine fumarate

Gatifloxacin tablets

Lovenox

Astellas/ITEM/King file lawsuit against Teva for Adenoscan patent infringement

Moexipril



Towa Pharmaceutical

Introduction

Background

Products

Financials

Major developments

Towa, Sawai and Nichi-iko reach supply agreement

Eisai's lawsuit against manufacturers/distributors of generic Selbex dismissed

Japanese Generic companies form agreement for stable generic supply



Watson Pharmaceuticals

Introduction

Background

Andrx

Products

Generics Division

Brand Division

Distribution Division

Financials

Segment Results

Major developments

Depomed enters promotion agreement with Watson

Sandoz' ANDA for generic Toprol-XL approved further to agreement with Watson

Watson completes acquisition of Sekhsaria Chemicals

Watson completes acquisition of 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 to build global manufacturing hub in India

Products

Financials

Major developments

Wockhardt to raise up to US$800 million to fund overseas acquisitions

Pharmaceutical plants

Barotiwala, India

Luton, United Kingdom

Aurangabad, India

Joint Ventures

Mergers, acquisitions and agreements

Negma Laboratories

Pinewood Laboratories

Li-Taka Pharmaceuticals

esparma GmbH

CP Pharmaceuticals Ltd

Ranbaxy



Zentiva

Introduction

Background

Products

Financials

Major developments

Zentiva to acquire control of Eczacibasi's generic pharmaceuticals business

Zentiva acquires Hungarian generic products from sanofi-aventis

sanofi-aventis

Sicomed



Zydus Cadila

Introduction

Background

Products

Financials

Major Developments

Quimica e Farmaceutica Nikkho do Brasil

Zydus acquires Japan’s Nippon Universal Pharmaceutical

Zydus acquires Liva Healthcare

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

Litigation

Ribavirin




VOLUME II



Overview

Population

GDP per capita

Health Expenditure

Total Pharmaceutical Expenditure

Generic Pharmaceutical Expenditure

Generic Market Projections



Australia

Introduction

Pharmaceutical Market

Generic Market

Size

Outlook & Projections

Regulation

Intellectual Property

US Free Trade Agreement, Generic Amendments

Parliament passes patent springboarding Bill

Pricing & reimbursement

Rise in Co-payment rates, 2005

Therapeutic Group Premiums

US Free Trade Agreement

Government announces new pricing measures for newly listed drugs

Government announces further PBS reforms, 2006

Manufacturing

Alphapharm

Genepharm Australasia

Mayne Pharma (Hospira)

Sigma Pharmaceuticals Pty Ltd.



Brazil

Introduction

Pharmaceutical Market

Generic Market

Size

Outlook & Projections

Production of Oral Generic Contraceptives & Hormones

More Uniform Market Penetration Across all the Regions

Unsustainable Reliance on Original HIV/AIDS Medicines

Intellectual Property

Lobbying Against Patent Extensions in the Pipeline System

Deal Agreed to Reduce the Price of Abbott‟s Kaletra

Upcoming Patent Expiries

Pricing & reimbursement

Implications for the Industry

Excessive Taxes on Drugs

New Drug Discounts in the Public Sector

Pricing of Generic Medicines

Manufacturing

ALANAC

ALFOB

Pró-Genéricos

Aché

Americano de Farmacoterapia (FARMASA)

Arrow (Erowlabs)

Brainfarma

Cimed

Cristália

EMS Sigma Pharma

Eurofarma

Hipolabor

LAFEPE

Medley

Neo Química

Prati, Donaduzzi

Teuto

União Química

Multinational Producers of Generic Medicines In Brazil

Apotex

Mepha - ratiopharm

Merck KGaA

Ranbaxy

Sandoz



Canada

Introduction

Pharmaceutical Market

Generic Market

Size

Study: generic savings not passed onto customers

Outlook & Projections

Intellectual Property

New rules come into effect, October 2006

Canada‟s Access to Medicine Regime

Pricing & reimbursement

PMPRB issues first report on non-patented prescription drug prices

Price increases between 2004 and 2005

Study comparing drugs prices in Canada and the USA released

Provincial Formularies

The Quebec 15-year rule

Ontario Bill 102

Drug Insurance Programmes

Manufacturing

Apotex

Genpharm

Novopharm

Orbus Pharma

Pharmascience

Ranbaxy

ratiopharm

Sandoz



France

Introduction

Pharmaceutical Market

Generic Market

Size

Outlook & Projections

Outcomes of the New Reference Pricing System

Increasing Prescribing of Generics

Generic Drugs to Reduce Health Expenditure by 912 Million Euros in 2006

France Transposes EU Pharmaceutical Directive

Pharmacists Associations Agree New Generics Target for 2007

Intellectual Property

Supplementary Protection Certificates

Pricing & reimbursement

Pricing

Pricing of Reimbursable Medicines in the Retail Pharmacy Market

Price Revisions

Pricing Activity

Pharmacy Margins

Reference Pricing (TFR)

Pricing of Hospital Medicines

Reimbursement

Manufacturing

Local Manufacturers

Arrow Génériques

Biogaran

Bouchara-Recordati

EG-Labo

Merck Génériques

Ranbaxy

ratiopharm

Sandoz

Teva

Winthrop

Wockhardt

Zydus France



Germany

Introduction

Pharmaceutical Market

Generic Market

Size

GKV Generic Use

Outlook & Projections

Intellectual Property

Pricing & reimbursement

Pricing

Reimbursement

AOK negotiates pharmaceutical discount contracts

Generic Substitution Policies

Compulsory Manufacturer Rebates

AVWG, 2006

Manufacturing

1A Pharma GmbH

AbZ-Pharma GmbH

Acceco Arzneimittel GmbH

Aliud Pharma

Actavis Deutschland

AWD.pharma

Basics

betapharm

CT-Arzneimittel

Heumann Pharma Generics/Torrent Pharmaceuticals

Hexal

Hospira Deutschland GmbH

Merck Dura

Neuraxpharm

ratiopharm

Ribosepharm

Sandoz

Stada Arzneimittel

Teva Generics

Winthrop Arzneimittel



Italy

Introduction

Pharmaceutical Market

Generic Market

Size

Outlook & Projections

Intellectual Property

National Supplementary Protection Certificate

Pricing & reimbursement

EU Directive on the Transparency of Pricing & Reimbursement

Reimbursement

Manufacturing

ASSOGENERICI

Local Manufacturers

Angenerico

DOC Generici

Eurogenerici

Hexan

Merck Generics Italia

Pliva Pharma

Ranbaxy

ratiopharm Italia

Sandoz

Teva Pharma Italia



Japan

Introduction

Pharmaceutical Market

Generic Market

Size

Generic substitution plans

Outlook & Projections

Regulations

Generic regulation, 2005

Intellectual Property

Data Exclusivity

Exclusion of Use

Patent term extensions

Pricing & reimbursement

Yakkasa

Price reductions

Generic drug pricing

Manufacturing

MHLW Stable Supply Requirements, 2006

Overseas players



Netherlands

Introduction

Pharmaceutical Market

Generic Market

Size

Outlook & Projections

Intellectual Property

Pricing & reimbursement

Price reductions, 2005

Manufacturing

Actavis

Centrapharm BV

Disphar International BV

Katwijk Farma BV

Merck Generics

Pharmachemie BV

Ratiopharm Nederland

Sandoz



Russia

Introduction

Pharmaceutical Market

Generic Market

Size

Outlook & Projections

Intellectual Property

Counterfeit Medicines

Pricing & reimbursement

Drug Pricing

DLO, Federal Drug Supply System

Manufacturing

Akrikhin

Bryntsalov A

JSC Farmacon

Grindex Rus

KRKA

Makiz

Nizhpharm

Otechestvennye Lekarstva (Erka Farm)

Pharmstandard

Veropharm

Yugrafarm

ZiO Zdorovje



Spain

Introduction

Pharmaceutical Market

Generic Market

Size

Outlook & Projections

Biosimilars‟ Substitution, Not a Viable Option in Spain

Regional INN Prescribing

SWOT

Intellectual Property

European Supplementary Protection Certificate

Pricing & reimbursement

Co-Payments

RPS Analysis

Generic Pricing

Manufacturing

AESEG

Local Manufacturers

Adamed

Alter

Barr

Cantabria Pharma

Cinfa

Combino Pharm

DOMAC

Dr Reddy‟s

Kern Pharma

Mabo-Farma

Merck

Normon

Pharmagenus

Ranbaxy

ratiopharm

Sandoz

Stada

Teva

Switzerland

Introduction

Pharmaceutical Market

Generic Market

Size

OKP Market Data, 2006

Outlook & Projections

Intellectual Property

Pricing & reimbursement

Generic pricing

Generic pricing survey, 2006

Generic/Brand price comparisons, 2007

Generic reimbursement

Manufacturing

Cimex

Helvepharm

Mepha Pharma

Sandoz Pharmaceuticals

Spirig

Streuli Pharma



United Kingdom

Introduction

Pharmaceutical Market

Market Structure

NHS Prescription Medicines Market

Generic Market

Size

Generic Prescribing

Scotland

Wales

Outlook & Projections

Regulation

Marketing Authorisations in 2006

Intellectual Property

Supplementary Protection Certificates

Pricing & reimbursement

Pricing

Unbranded Generic Pricing

2005 generics reimbursement scheme

Generic price reductions for four major drugs

DOH Holds consultations regarding branded generics in the PPRS

Reimbursement

Investigations into price fixing

Department of Health

Goldshield, Ranbaxy and Merck settle DOH claims

Serious Fraud Office

Manufacturing

Actavis

Arrow Generics

Bristol Laboratories

Crescent Pharma

Dr Reddy‟s

Focus Pharmaceuticals

Generics (UK)

Genus Pharmaceuticals

Goldshield Pharmaceuticals

Kent Pharmaceuticals

Perrigo

Pliva Pharma (Barr Laboratories)

Ranbaxy

ratiopharm

Rosemont Pharmaceuticals

Sandoz

Teva Pharmaceuticals

Winthrop Pharmaceuticals

Wockhardt



USA

Introduction

Pharmaceutical Market

Generic Market

Size

Wal-Mart begins generic drug price war?

FTC reports summary of pharmaceutical company agreements filed in FY2006

Outlook & Projections

Intellectual Property

Hatch-Waxman

Hatch Waxman reform, 2003

Bolar Amendment

Patent Reform Act 2007

Wider patent reform?

Major Product Approvals

Generic Initiative for Value and Efficiency (GIVE)

ANDAs Approved in 2006

ANDAs Approved in 2007 (to September)

Forthcoming Patent Expiries

Atorvastatin

Clopidogrel

Pricing & reimbursement

Public Drug Procurement

Medicaid

Average Wholesale Price (AWP)

Medicare

H.R (Medicare Prescription Drug, Improvement, and Modernization Act of 2003)

State pricing/reimbursement moves

California drug plan signed into law

Manufacturing

Sources

Directory

Regulators

Industry Associations

Abstract

Key company, market and product information 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 2008. Packed with facts, figures, analysis and statistics, the new 700 page edition - now presented in 2 volumes - provides the most thorough analysis available on generic markets, products and companies and the issues they face.

The changing face of the generics industry The pace of corporate consolidation grows ever faster with, most notably this year, Mylan’s success in winning Merck Generics. But that was just one event in the ongoing global rationalisation of the generics industry.

Emerging European markets present good opportunities Generic companies and investors have spent much time in looking at new market opportunities often in emerging economies such as Brazil and Russia. However, France, Italy and Spain are all undergoing significant double digit growth with well organised and regulated operating environments.

Industry consolidation, emerging market opportunities, the latest on biosimilars plus much, much more! Published in December 2007, 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
  • Generic market growth - but where?
  • Biosimilars: more products and development in Europe and elsewhere
  • Authorised generics and other 180-day exclusivity issues in the US - a definite trend
  • Key legal challenges
  • The political and funding background
  • Intellectual property issues

This report will enable you to understand the threats and opportunities that are shaping this rapidly evolving marketplace.

This study is not presented with any quarterly updates. Please note, this file is delivered as a Zip file.



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