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Market Research Report
The World Generic Market Report 2009 - 7th EDition
| Published by |
Espicom Business Intelligence |
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| Published |
2009/01 |
Content info |
714 Pages |
| Product code |
ES80835 |
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From US $ 1130  |
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Table of Contents
VOLUME 01: Global Overview and Company Profiles
FOREWORD
Current Issues in the USA
- Authorised generics
- FTC investigation
- FDA issues direct final rule regarding listing of authorised generics
- FTC study finds increase in ‘reverse payments'
- Moves in Congress
- PhRMA responds
- GPhA responds
- More studies, more arguments
- Shared exclusivity
Industry consolidation
- Where next in the USA?
- Where next in Europe?
Biosimilars
- In the USA
- In Europe
- Elsewhere
- Market acceptance
- Who will the developers be?
Access to Generic Drugs in the Developing World: WTO Agreement
- 2003 Agreement
- TRIPS patent ruling on least-developed countries, 2002
- Canada
- Apotex uses the law
- Apotex awarded ApoTriavir tender from Rwandan Government
- European Union
- European Parliament pushes for greater access to generic drugs
- European patent rules streamlined
- EGA claims WTO compulsory licence system is unworkable
- Thailand
- Thai government issues further compulsory licences, reaches imatinib
deal with Novartis
- Brazil
- 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
- EC publishes preliminary report into competition in the pharmaceutical
sector
The widening influence of Indian companies
Prospects for Future Growth
- Relative strength of intellectual property laws
- Pricing/reimbursement regimes
- Prescriber/patient habits
Major Generic Manufacturersv
Actavis
- Executive Summary
- Background
- Financials
- Major developments
- Actavis to restructure manufacturing operations in Bulgaria
- Actavis opens R&D laboratories in Florida
- Congressional Committee turns attention to Actavis recall
- Keri Pharma rebranded as Actavis Hungary
- Actavis opens new offices, commences branded sales in Italy
- Actavis opens Albania office
- Mergers, acquisitions and agreements
- LPA to distribute Actavis' generic products in Algeria
- ASKA Pharmaceutical and Actavis enter alliance and joint venture in Japan
- Actavis expands presence in India
- Actavis formally launches in France
- Actavis signs distribution agreement with J&M Pharma
- Actavis divests Polish products to Glenmark
- Actavis signs distribution agreement with Generic Health in Australia
- Actavis acquires API manufacturing company in China
- Actavis acquires Italian manufacturing site from Pfizer
- Litigation
- Justice Department seeks permanent injunction against Actavis
- Endo and Penwest file oxymorphone suit against Actavis
Apotex
- Introduction
- Background
- Products
- Apotex awarded tender from Rwandan Government for ApoTriavir
- Apotex to develop biosimilar G-CSF with IBP
- Plavix (clopidogrel)
- sanofi-aventis and Bristol-Myers Squibb win US clopidogrel court action
- sanofi-aventis wins Canadian clopidogrel patent case against Apotex
- Financials
- Cangene
- Major developments
- Mergers, acquisitions and agreements
- BMP Sunstone launches Ferriprox in China
- Apotex acquires Lareq Pharma
- Topgen
- Beijing Med-Pharm
- Litigation
- Apotex prohibited from marketing generic Fortical under Unigene
injunction
- Apotex gains UK damages in perindopril case
- US Federal Court affirms omeprazole ruling
- Sanofi-aventis sues Apotex over docetaxel
- Pfizer enters settlement agreement with Apotex over atorvastatin
- Apotex loses ketorolac appeal
- Meda and Apotex settle azelastine dispute
- Apotex and GSK win pre-emption case
- Pfizer to appeal Federal Court ruling on atorvastatin patent
- AstraZeneca files patent infringement actions in response to
rosuvastatin ANDAs
- Merck & Co
- Abbott
- Acorda
- Pfizer
- Teva Pharmaceutical Industries
- Perindopril
Aspen Pharmacare
- Introduction
- Background
- Products
- HIV/AIDS drugs
- Tenofovir-based ARVs
- Efavirenz
- South African government ARV tender
- PEPFAR
- Other Antiretrovirals
- Financials
- Major developments
- Mergers, acquisitions and agreements
- Aspen and Matrix end joint venture
- Aspen and Strides revise Latin America terms
- GSK, Aspen, and Strides Arcolab announce tie-up
- Shelys Africa
- GSK to sell four products to Aspen
- Aspen Australia and Teva enter distribution agreement
Barr Pharmaceuticals
- Introduction
- Background
- Products
- Duramed' s BLA for Ad Type 4 and 7 vaccines accepted by FDA
- Financials
- Major developments
- Mergers, acquisitions and agreements
- Teva to acquire Barr
- Barr successfully acquires Pliva
- Litigation
- Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr
over generic Amrix
- sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US
patent litigations
- Barr initiates oxybutynin transdermal system patent challenge
- Barr confirms patent challenge of Opana ER
- Court of Appeals upholds 1997 Cipro settlement
- Court favours Barr and Mylan in galantamine case
- Barr initiates clozapine patent challenge
- Barr enters agreement to settle Aggrenox patent challenge
- Texas AG pursues generic manufacturers over false prices
- Barr challenges cinacalcet patents
- Barr launches levocetirizine challenge
- Barr confirms fentanyl challenge
- Barr receives favourable ruling in Mirapex patent challenge
- Barr challenges patents related to Prevacid SoluTab
- Barr initiates patent challenge relating to AstraZeneca' s Entocort EC
- Bayer appeals invalidity ruling on Yasmin patent
- Watson launches Seasonique patent challenge
- Barr challenges dutasteride patent
- Barr to pay states US$6 million in Ovcon settlement
- FTC files complaint against Cephalon charging unlawful blockage of
generic modafinil
- Barr and Ortho to settle contraceptive drug patent litigation
- Forest and Merz file lawsuits for memantine patent infringement
- Barr initiates US oxaliplatin patent challenge
- Encysive files argatroban lawsuit against Barr
- Barr sues Watson and Sandoz over oral contraceptive
- Barr initiates dexmethylphenidate patent challenge
- Novartis sues Barr over methylphenidate patent challenge
- Barr challenges Alcon' s olopatadine patents
- Barr and Par settle diazepam patent challenge with Valeant
- Warner Chilcott sues Barr and Watson over chewable contraceptive
- sanofi-aventis commences litigation over alfuzosin
Cipla
- Introduction
- Background
- Cipla planning Rs 9,500 million expansion
- 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
- Mergers, acquisitions and agreements
- Akorn
- Avesthagen/Cipla acquires Siegfried
- Litigation
- Interim Court order favours Cipla over generic Tarceva
Dr Reddy' s Laboratories
- Introduction
- Background
- Dr Reddy' s launches US Specialty Business
- Products
- Financials
- Segment Data
- Branded Formulations
- Active Pharmaceutical Ingredients and Intermediates
- Generics
- Custom Pharmaceutical Services (CPS)
- Major developments
- Mergers, acquisitions & agreements
- Dr Reddy' s makes dermatology product advances
- TMH/Dr Reddy' s sign agreement to create self-injectable product
- Dr Reddy' s and Albemarle sign ibuprofen API deal
- Aquapharm signs new agreement and extends R&D licence with Dr Reddy' s
- Dr Reddy' s to buy BASF contract manufacturing operations
- Dowpharma' s UK Small Molecules business sold to Dr Reddy' s
- Dr Reddy' s acquires Jet Generici
- 7TM/Dr Reddy' s enter drug-discovery collaboration
- Dr Reddy' s/SkyePharma collaborate on feasibility study
- Sygnis
- Argenta Discovery
- Ceragenix
- Litigation
- Teva and Dr Reddy' s settle carvedilol suit
- AstraZeneca sues Dr Reddy' s over generic zafirlukast
- US court affirms that Eisai' s Aciphex patent is valid and enforceable
- Dr Reddy' s and Novartis settle rivastigmine litigation
- Forest and Merz file additional lawsuit for Namenda patent infringement
- Moxifloxacin
- Levetiracetam
- Sertraline action
Egis
- Introduction
- Background
- Products
- Financials
- Major developments
- Mergers, acquisitions and agreements
- Egis and Gedeon Richter divest Medimpex
- Serdix
Hospira
- Introduction
- Background
- Manufacturing facilities
- Products
- Product Development
- Financials
- Major Developments
- Mergers, acquisitions and agreements
- HGS to manufacture biopharmaceuticals for Hospira
- Altea and Hospira enter deal for transdermal product
- Hospira agrees further contract with HealthTrust
- Hospira to distribute Orexo' s Rapinyl in Asia Pacific
- Mayne Pharma
KRKA
- Introduction
- Background
- Key strategic objectives and strategies to 2012
- Products
- Financials
- Results by Regions
- Slovenia
- South-Eastern Europe
- Eastern Europe
- Central Europe
- Western Europe and Overseas Market
- Product and Service Groups
- Major developments
- Mergers, acquisitions and agreements
- Krka acquires Alternova AT
- Krka purchases shares in Zhejiang and Anhui
- TAD Pharma GmbH
- Facilities
- Macedonia
- Slovenia
- Krka opens new chemical development laboratories
- Krka completes the construction of a new injection plant
- Sinteza 4
- Litigation
- Eli Lilly
- Merck Frosst Canada
Lannett
- Introduction
- Background
- Products
- Financial
- Major developments
- Lannett to enter pain management market
- Litigation
- Lannett files lawsuit against KV
Mylan
- Introduction
- Background
- Mylan to retain Dey subsidiary
- Products
- Mylan and Matrix ANDA Approvals
- Merck Generics subsidiary ANDA Approvals
- Financials
- Segment Data
- Geographic Information
- Sales by Therapy
- Major developments
- Mylan downsizes Puerto Rico facility
- Mergers, acquisitions and agreements
- Mylan signs OC agreement with Famy Care
- Forest Laboratories
- Merck Generics
- Litigation
- US Federal Court upholds decision in favour of Takeda in Actos patent
case
- Mylan/Novartis enter agreement to settle Femara patent challenge
- Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr
over generic Amrix
- Court favours Barr and Mylan in galantamine case
- Daiichi Sankyo sues Matrix for Azor patent infringement
- FTC files complaint against Cephalon charging unlawful blockage of
generic modafinil
- Forest and Merz file second suit against memantine challengers
- Mylan to appeal latest lorazepam and clorazepate ruling
- AstraZeneca files patent infringement actions in response to
rosuvastatin ANDAs
- Mylan and GSK settle generic Paxil dispute
- UCB settles levetiracetam patent litigation
Par Pharmaceuticals
- Introduction
- Background
- Products
- Financial
- Major Developments
- Mergers, acquisitions and agreements
- MonoSolRx licenses thin film formulation of ondansetron to Strativa
- Par acquires Spectrum' s interest in sumatriptan injection
- Litigation
- Santarus makes gains against Par in Markman hearing
- Texas AG pursues generic manufacturers over false prices
- AstraZeneca files patent infringement actions in response to
rosuvastatin ANDAs
- Federal Circuit affirms invalidity of Par' s megestrol patents
- Barr and Par settle diazepam patent challenge with Valeant
- Santarus commences Zegerid patent litigation against Par
Perrigo
- Introduction
- Background
- Products
- Financials
- Segment Sales
- Consumer Healthcare
- Rx Pharmaceuticals
- API
- Other
- Major developments
- Perrigo to expand operations in Michigan
- Mergers, acquisitions and agreements
- Perrigo acquires Unico Holdings
- Perrigo licenses dermatologicals to Medimetriks
- Perrigo acquires Mexico' s Laboratorios Diba
- Perrigo acquires exclusive US rights to generic levocetirizine
- Perrigo purchases JB Laboratories
- NeutraHealth purchases Perrigo UK
- Perrigo collaborates with Cobrek for generic topical products
- Perrigo acquires Galpharm Healthcare
- Litigation
- Perrigo dismissed from miconazole patent litigation
- Perrigo files ANDA for generic Vanos; Medicis files suit
Pliva
- Introduction
- Background
- Pliva delists from London Stock Exchange
- Products
- Financials
- Major developments
- Mergers, acquisitions and agreements
- Pliva divests Spanish operations
- Pliva divests Italian operations to Biomedica
- Pliva to acquire ORCApharm
- Barr successfully acquires Pliva
- Litigation
- California court rules branded firms can be liable for generics
- Barr confirms patent challenge regarding UCB' s Xyzal
Ranbaxy
- Introduction
- Background
- Ranbaxy to be acquired by Daiichi Sankyo
- Products
- Financials
- Results by Geography
- North America
- European Union
- UK
- Germany
- France
- Romania
- India
- Asia Pacific
- Results by Therapy
- Major developments
- FDA issues Warning Letters, blocks imports from two Ranbaxy facilities
- Congressional Committee expands Ranbaxy probe to include PEPFAR programme
- Daiichi acquires Ranbaxy
- Ranbaxy launches business operation in Yemen
- Ranbaxy clears NDDR de-merger
- Mergers, acquisitions and agreements
- Ranbaxy to market Gliadel for gliomas in India
- Cipher / Ranbaxy enter agreement for CIP-Isoptretinoin acne treatment
- Ranbaxy/Merck enter anti-infective drug-discovery and -development
collaboration
- Ranbaxy and Orchid enter long-term strategic alliance
- Ranbaxy/DBT collaborate to develop TB therapeutics
- Ranbaxy increases Zenotech stake
- Litigation
- Danish Court upholds two atorvastatin patents
- Ranbaxy, Goldshield win SFO cases
- Ranbaxy comes under fire from US Justice Department
- Pfizer and Ranbaxy settle majority of worldwide atorvastatin litigations
- AstraZeneca settles esomeprazole patent litigation with Ranbaxy; enters
further agreements
- Forest and Merz file second suit against memantine challengers
- Ranbaxy settles possible litigation with GSK over sumatriptan
- Ranbaxy, Astellas and Boehringer resolve tamsulosin US patent litigation
- Novartis sues Ranbaxy over valsartan
ratiopharm
- Introduction
- Background
- BioGeneriX
- Merckle Biotec
- Merckle
- PulmoTec
- ratiopharm direct
- Products
- BioGeneriX/Neose initiate Phase II trial for GlycoPEG-GCSF
- Financials
- Major developments
- Mergers, acquisitions and agreements
- Neose sells assets to Novo Nordisk and BioGeneriX as first step in
liquidation
- Litigation
- sanofi-aventis to appeal German generic clopidogrel marketing
authorisations
Gedeon Richter
- Introduction
- Background
- Products
- Financials
- Markets
- Exports
- CIS
- EU
- USA and Other Countries
- Products
- Major developments
- Mergers, acquisitions and agreements
- Gedeon Richter licenses DSM/Crucell' s PER.C6 cell line
- Richter to build biopharmaceutical plant in Debrecen
- Polpharma
- Akrihin
- Pharmafarm
- Egis and Gedeon Richter divest Medimpex
- Litigation
- Gedeon Richter and Merck settle alendronate lawsuit
Sandoz
- Introduction
- Background
- Production Facilities
- Sandoz Canada to invest C$80 million in Boucherville facilities
- Products
- Major New Products Launched in 2007
- Financials
- Major developments
- WHO issues Notice of Concern to Sandoz South Africa
- FDA sends Sandoz warning letter over metoprolol
- Mergers, Acquisitions and Agreements
- Sandoz enters into LNK cetirizine agreement
- Sandoz discloses link-up with Vectura on generic asthma drugs
- Sandoz and Gambro form strategic alliance
- Sandoz receives not approvable letter for enoxaparin
- Litigation
- Teva to file lawsuit against Momenta/Sandoz over generic glatiramer
- Summary judgement granted for Seroquel patent litigation
- Wyeth sues Sandoz over pantoprazole
- Abbot sues Zydus and Sandoz over divalproex
- AstraZeneca files patent infringement actions in response to
rosuvastatin ANDAs
- Barr sues Watson and Sandoz over oral contraceptive
- Spanish Appellate Court upholds atorvastatin patent
- Atomoxetine patent litigations launched
Sawai Pharmaceutical
- Introduction
- Background
- Products
- Leading Sawai Generics, 2002-07
- New government supply rules, 2006
- Heparin calcium, flutazolam, biperiden hydrochloride
- Synthetic penicillin
- Financials
- Major developments
- Mergers, acquisitions and agreements
- Towa, Sawai and Nichi-iko sign agreement for stable supply of generic
products
- Medisa Shinyaku
- Nihon Schering' s Mobara factory
- Litigation
- Eisai' s lawsuit against manufacturers/distributors of generic Selbex
dismissed
Stada Arzneimittel
- Introduction
- Background
- Teva ‘in talks' to buy Stada?
- Products
- Refusal of marketing approval confirmed by CHMP for Stada' s fentanyl
patches
- Financial
- Segment Data
- Segment Results, 2005 - 2007
- Stada' s top-five APIs, 2007
- Geographic Segment Data
- Major developments
- Stada opens Vietnam plant with EU approval
- Stada restructures its sales division
- Stada confirms product deal with German insurer
- Mergers, acquisitions and agreements
- Eisai China signs licence agreement for Alpha-Lipon 300 Stada
- Stada to acquire Forum Bioscience
- Litigation
- Court favours Stada over Merck in losartan case
Teva Pharmaceutical Industries
- Introduction
- Background
- Products
- Antares/Teva file sNDA for needlefree injector for HGH product
- Financial
- Pharmaceutical Sales
- North America
- Europe
- International
- Animal Health
- Innovative Products
- Specialty Products
- Active Pharmaceutical Ingredients Sales
- Major developments
- Mergers, acquisitions and agreements
- Jexys enters R&D collaboration with Teva
- Indevus/Teva enter deal to develop pagoclone for stuttering
- Teva to acquire Barr
- Teva and Kowa form strategic partnership to dominate Japanese generic
market
- Teva and Proteologics extend anticancer collaboration
- Consortium acquires Teva' s controlling stake in IVAX Diagnostics
- Teva to market CEL-SCI' s Multikine in Israel and Turkey
- Teva signs agreement for Capricorn' s Korkoat technology platform
- Teva acquires Bentley Pharmaceuticals
- Czech expansion
- Irish expansion
- Hungarian expansion
- CoGenesys acquisition
- UCB
- UK expansion
- Litigation
- Gilead files emtricitabine patent infringement lawsuit against Teva
- Teva loses lansoprazole litigation
- California court rules branded firms can be liable for generics
- sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US
patent litigations
- Appeals court rules against Teva in generic Prevacid litigation
- Teva gains budesonide approval, flurry of activity results
- Appellate court reverses generic risperidone exclusivity decision
- Teva and Dr Reddy' s settle carvedilol suit
- Appeals Court favours Eisai in rabeprazole judgement
- FDA review of generic Copaxone prompts lawsuit from Teva
- Summary judgement granted for Seroquel patent litigation
- Enoxaparin
- Escitalopram (UK)
- Brussels court revokes MSD' s European alendronate patent
- Depomed enters deal to settle patent litigation against IVAX
- Quetiapine
- Celecoxib
- Solvay subsidiaries file fenofibrate suits against Teva
- Forest and Merz file lawsuits for memantine patent infringement
- AstraZeneca files patent infringement actions in response to
rosuvastatin ANDAs
- Pfizer' s quinapril patent upheld
- Teva finalises adenosine settlement with Astellas, King and Item
- Teva wins Appeal Court ruling concerning cyclosporine
- GlaxoSmithKline and Teva settle rosiglitazone suit
- Novartis' famciclovir motion denied; Teva recommences sales
- Teva sues Apotex over carvedilol
- Appeals court favours Pfizer over Teva in gabapentin case
- Dr Reddy' s and Teva settle sertraline action
- Roche files complaint over Teva' s ibandronate
- Court favours Teva/Sun in pantoprazole motion
- Appeals court upholds escitalopram decision
Towa Pharmaceutical
- Introduction
- Background
- Products
- Financials
- Major developments
- Mergers and Agreements
- Towa, Sawai and Nichi-iko reach supply agreement
- Japanese Generic companies form agreement for stable generic supply
- Litigation
- Eisai' s lawsuit against manufacturers/distributors of generic Selbex
dismissed
Watson Pharmaceuticals
- Introduction
- Background
- Products
- Generics
- Brand Products
- Distribution
- Financials
- Segment Results
- Generics segment
- Brand segment
- Distribution segment
- Major developments
- Mergers, acquisitions and agreements
- Watson to acquire products related to Teva' s proposed acquisition of Barr
- Mylan buys out Watson' s Somerset Pharma stake
- Watson to distribute generic Fosamax Tablets under agreement with Merck
- Recordati licenses European rights to Kentera from Watson
- Litigation
- Watson enters lawsuit with Barr over Oxytrol system
- Barr initiates oxybutynin transdermal system patent challenge
- Watson loses naproxen patent dispute
- Texas AG pursues generic manufacturers over false prices
- Cephalon files patent infringement lawsuit against Watson over generic
Fentora
- Watson files ANDA for generic Yasmin; Bayer seeks to halt launch
- Watson challenges Lybrel patent
- Duramed sues Watson for Seasonique patent infringement
- Barr sues Watson and Sandoz over oral contraceptive
- Biovail and Watson reach settlement agreement regarding diltiazem
- Bayer sues Watson over drosperinone and ethinyloestradiol ANDA
- Warner Chilcott files lawsuit against Watson for infringement of Femcon
Fe patent
Winthrop Pharmaceuticals
- Introduction
- Background
- France
- Germany
- Portugal
- United Kingdom
- Products
- Financials
Wockhardt
- Introduction
- Background
- Products
- Financials
- Major developments
- Wockhardt to restructure its R&D business
- Mergers, acquisitions and agreements
- Sinclair Pharma
- IDC and Wockhardt co-develop insulin pens for Indian market
- Morton Grove
- Litigation
- Orion comments on Wockhardt' s carbidopa / entacapone / levodopa ANDA
- Forest and Merz file lawsuits for memantine patent infringement
- Orion files lawsuit against Wockhardt to enforce entacapone patents
Zentiva
- Introduction
- Background
- Products
- Financials
- Sales by segment
- Prescription Pharmaceutical Products
- Consumer Healthcare (CHC) Pharmaceutical Products
- APIs
- Pharmaceutical Sales by Region
- Czech Republic
- Turkey
- Romania
- Poland
- Slovakia
- Russia
- Major developments
- Mergers, acquisitions and agreements
- Anthiarose and sanofi-aventis bid for Zentiva; sanofi-aventis wins
through
- Zentiva completes purchase of Eczacibasi' s generic pharmaceuticals
business
Zydus Cadila
- Introduction
- Background
- Products
- Zydus to expand range of generics in Japan
- Zydus collaborates with WHO to develop MAb cocktail for rabies
- Financials
- Fiscal 2006/07 (year ended March 2007)
- Major Developments
- Mergers, acquisitions and agreements
- Zydus acquires Etna Biotech
- Zydus acquires majority stake in Simayla Pharmaceuticals
- Zydus acquires Laboratorios Combix
- Nycomed to move chemical production to India
- Karo Bio/Zydus Cadila sign research agreement for novel GR modulators
- Litigation
- Abbot sues Zydus and Sandoz over divalproex
VOLUME 02: National Markets
Overview
- Population
- GDP per capita
- Health Expenditure
- Total Pharmaceutical Expenditure
- Generic Pharmaceutical Expenditure
- Generic Market Projections
Australia
- Introduction
- Pharmaceutical Market
- Generic Market
- Summary Outlook
- Regulation
- International harmonisation
- 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
- Apotex (formerly GenRx)
- Arrow Pharmaceuticals Pty
- Ascent Pharmahealth Pty Ltd (formerly Genepharm)
- Aspen Australia
- Generic Health/Bellwether Pharma
- Mayne Pharma (Hospira)
- Ranbaxy Australia
- Sandoz Pty Ltd
- Sigma Pharmaceuticals (Australia) Pty Ltd
- Winthrop Pharmaceuticals
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
- Patent rejection of tenofovir
- National production of efavirenz
- Price negotiation of lopinavir+ritonavir
- Intellectual Property
- Pricing & reimbursement
- Price Rises From 1st April 2008
- 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 Quimica
- Multinational Producers of Generic Medicines In Brazil
- Apotex
- Mepha - ratiopharm
- Merck KGaA
- Ranbaxy
- Sandoz
- Zydus Cadila
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
- CGPA issues legal challenge
- Canadian government proposes new rules to confirm 2006 evergreening changes
- Canada" s Access to Medicine Regime
- Pricing & reimbursement
- PMPRB issues 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 Reduced Health Expenditure by 912 Million Euros in 2006
- France Transposes EU Pharmaceutical Directive
- Pharmacists Associations Agree 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
- Mylan (formerly Merck Génériques)
- Ranbaxy
- ratiopharm
- Sandoz
- Teva
- Winthrop
- Wockhardt
- Zydus France
Germany
- Introduction
- Pharmaceutical Market
- Generic Market
- Size
- Outlook & Projections
- Intellectual Property
- Pricing & Reimbursement
- Pricing
- Reimbursement
- GKV Negotiates Pharmaceutical Discount Contracts
- Generic Substitution Policies
- Compulsory Manufacturer Rebates
- AVWG, 2006
- Manufacturing
- Accedo Arzneimittel GmbH
- Actavis Deutschland
- betapharm
- CT-Arzneimittel
- Heumann Pharma Generics/Torrent Pharmaceuticals
- Hexal
- Hospira Deutschland GmbH
- Mylan Dura (formerly Merck Dura)
- Neuraxpharm
- ratiopharm
- Ribosepharm
- Sandoz
- Stada Arzneimittel
- 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 (Stada Arzneimittel)
- Hexan
- Merck Generics Italia (Mylan)
- Pliva Pharma
- Ranbaxy
- ratiopharm Italia
- Sandoz
- Teva Pharma Italia
Japan
- Introduction
- Pharmaceutical Market
- Generic Market
- Size
- Generic substitution plans
- Outlook & Projections
- Regulations
- 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 - 2009
- 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
- Pricing & Reimbursement
- Drug Pricing
- DLO, Federal Drug Supply System
- Manufacturing
- Government Programme for the Development of the Pharmaceutical Industry
- Purchasing of Licences
- Funding of R&D
- Trade Associations
- Manufacturers
- Akrikhin
- Bryntsalov A
- JSC Farmacon
- Grindex Rus
- KRKA
- Makiz
- Nizhpharm
- Otechestvennye Lekarstva (Erka Farm)
- Pharmstandard
- Acquisitions & Agreements
- Veropharm
- Yugrafarm
- ZiO Zdorovje
Spain
- Introduction
- Pharmaceutical Market
- Generic Market
- Size
- Outlook & Projections
- Spain rules to prevent biosimilar subsititution
- Regional INN Prescribing
- SWOT
- Intellectual Property
- European Supplementary Protection Certificate
- Pricing & Reimbursement
- RPS Analysis
- Generic Pricing
- Manufacturing
- 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
- Zydus Cadila
Switzerland
- Introduction
- Pharmaceutical Market
- Generic Market
- Size
- OKP Generic Market Data, 2006
- Outlook & Projections
- Intellectual Property
- Pricing & reimbursement
- Generic pricing
- Generic pricing survey, 2006
- Generic/Brand price comparisons, 2007
- Generic reimbursement
- Manufacturing
- Acino Pharma (formerly Cimex)
- Helvepharm
- 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 2007
- Marketing Authorisations in 2008
- Intellectual Property
- Supplementary Protection Certificates
- Pricing & Reimbursement
- Pricing
- PPRS Reforms, 2008
- Unbranded Generic Pricing
- 2005 generics reimbursement scheme
- Reimbursement
- Investigations into price fixing
- 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
- Pliva Pharma (Barr Laboratories)
- Ranbaxy
- ratiopharm
- Rosemont Pharmaceuticals
- Sandoz
- Teva Pharmaceuticals
- Winthrop Pharmaceuticals
- Wockhardt
USA
- Introduction
- Pharmaceutical Market
- Generic Market
- Size
- Outlook & Projections
- Market Developments
- Congress approves increased funding for FDA" s Office of Generic Drugs
- HHS Inspector General releases study on FDA review times
- Wal-Mart expands generic prescription programme
- FTC study finds increase in reverse payments"
- Medicare pays too much for new generics, HHS report argues
- PCMA report slams proposals restricting access to generics
- Intellectual Property
- Hatch-Waxman
- Hatch Waxman reform, 2003
- Bolar Amendment
- Patent Reform Act 2007
- Major Product Approvals
- Generic Initiative for Value and Efficiency (GIVE)
- ANDAs Approved in 2007
- ANDAs Approved in 2008 (to October)
- Forthcoming Patent Expiries
- Nexium
- Pricing & Reimbursement
- Public Drug Procurement
- Medicaid
- Average Wholesale Price (AWP)/ Average Sales Price (ASP)
- Medicare
- H.R.1 (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
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