Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013

1. The market for injectable generics has been through a period of consolidation over the last few years as the leading companies have increased their presence through acq
This is hardly surprising with a global injectables market in the region of US$144 billion. While the lion’s share remains with the innovative industry for the time
chemical generics and will involve costly clinical trials. To date, only a handful of companies have gained regulatory approval for biosimilars in Europe, and the US is lik
This report features in-depth reviews of 35 major products within specific therapy areas. Each product review examines mode of action, market approvals, competition,
What this report covers:
Executive Summary Injectable Drugs Market – Market Size and Opportunities Cancer – Hormonal Therapies, Chemotherapy, Monoclonal Antibodies, S
The Injectable Generic and Biosimilar Drugs Report is the foolproof business resource for any industry executive that needs to fully understand the current products and
table Of Content
foreword
executive Summary
injectable Drugs Market
market Size
generic And Biosimilar Opportunities
cancer
hormonal Therapies
faslodex (fulvestrant)
mode Of Action
approvals
lifecycle Development
competition Within The Marketplace
patents
market Outlook
generic Company Activity
zoladex (goserelin)
mode Of Action
approvals
competition Within The Marketplace
breast Cancer
prostate Cancer
patents
market Outlook
generic Company Activity
europe
north America
chemotherapy
eloxatin (oxaliplatin)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
the ‘874 Patent Litigation: At Risk Launches And Subsequent Withdrawals
europe
taxotere (docetaxel)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
europe
us
abraxane (paclitaxel Protein-bound Particles For Injectable Suspension; Albumin-bound)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
alimta (pemetrexed)
mode Of Action
approvals
lifecycle Development
competition Within The Marketplace
patents
Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013

2. approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
monoclonal Antibodies
rituxan/mabthera (rituximab)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Rituximab
herceptin (trastuzumab)
mode Of Action
approvals
competition Within The Marketplace
breast Cancer
gastric Cancer
patents
market Outlook
biosimilar Trastuzumab
avastin (bevacizumab)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Bevacizumab
erbitux (cetuximab)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Cetuximab
supportive Therapies
g-csf
neupogen (filgrastim)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Filgrastim
europe
usa
rest Of The World
neulasta (pegfilgrastim)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Pegfilgrastim
diabetes
humulin (insulin [rdna Origin])
mode Of Action
approvals
competition Within The Marketplace
market Outlook
humalog (insulin Lispro)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
lantus (insulin Glargine)
mode Of Action
approvals
competition Within The Marketplace
patents
Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013

3. competition Within The Marketplace
patents
market Outlook
levemir (insulin Detemir)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
novorapid & Novomix (insulin Aspart)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Human Insulin
europe And Usa
rest Of The World
haematology
epogen/eprex/procrit (epoetin Alfa)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Epoetin
eu
us
aranesp (darbepoetin Alfa)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilars In Development
lovenox/clexane (enoxaparin)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
court Of Appeals Decision In Enoxaparin Suit
immunology
multiple Sclerosis
copaxone (glatiramer Acetate)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generics In Development
sandoz And Momenta
mylan And Natco Pharma
avonex (interferon Beta-1a)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
rebif (interferon Beta-1a)
mode Of Action
approvals
competition Within The Marketplace
market Outlook
betaferon/betaseron & Extavia (interferon Beta-1b)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Interferon Beta
Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013

4. competition Within The Marketplace
patents
market Outlook
biosimilar Etanercept
humira (adalimumab)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Adalimumab
remicade (infliximab)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Infliximab
infection
cubicin (daptomycin)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
invanz (ertapenem)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
tygacil (tygecycline)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
generic Company Activity
synagis (palivizumab)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Development
pegintron (peginterferon Alfa-2b)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
pegasys (pegylated-40k Interferon Alfa-2a)
mode Of Action
approvals
competition Within The Marketplace
patents
market Outlook
biosimilar Interferon Alfa
major Competitors
actavis
products
major Developments
acquisitions & Agreements
actavis Completes Acquisition Of Warner Chilcott
litigation
generic Diprivan Patent Challenge
generic Velcade Patent Challenge
akorn
products
acquisitions & Agreements
Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013

5. american Regent
products
amphastar Pharmaceuticals
products
apotex
products
agreements
stada Arzneimittel In-licenses Grastofil
aurobindo Pharma
products
claris Lifesciences
products
recent Developments
claris Lifesciences Completes Transfer Of Its Infusion Business For India And Emerging Markets
to The Joint Venture With Otsuka Pharmaceutical And Mitsui
claris Lifesciences To Sell On Its Own In The Us
dr Reddy’s Laboratories
products
fresenius Kabi
products
product Recalls
fresenius Kabi Recalls Benztropine Mesylate Injection
fresenius Kabi Recalls Single Lot Of Magnesium Sulphate
acquisitions
app Acquires Three Products From Nexus
agreements
fresenius Kabi Begins Joint Venture On Iv Generics In Indonesia
app And Teva Enter Gemcitabine Agreement
litigation
app Settles With The Medicines Company On Angiomax Patent Litigation
hikma Pharmaceuticals
products
acquisitions & Agreements
commercial Supply Contract With Unilife Medical Solutions
hikma Enters Ethiopian Pharmaceutical Market Through Joint Venture With Midroc Group
hospira
products
biosimilars
acquisitions & Agreements
hospira Signs Agreement With Q Core Medical For International Distribution Of Sapphire Infusion System
hospira Acquires Api Manufacturing And R&d Facilities From Orchid
litigation
cubicin Patent Infringement Lawsuit
mylan
products
acquisitions
mylan’s Acquires Agila From Strides Arcolab
litigation
mylan And Teva Settle Copaxone Patent Litigation
sagent Pharmaceuticals
products
product Recalls
sagent Pharmaceuticals Announces Expanded Recall Of Vecuronium Bromide
acquisitions And Agreements
sagent Pharmaceuticals Announces Agreement To Acquire Remaining 50% Interest In Chinese
manufacturing Joint Venture
sagent Announces Amendment To Supply Agreement With Actavis
sandoz
Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013

6. litigation
sandoz’s Generic Copaxone Does Not Infringe Teva’s Patent
strides Arcolab
products
agreements
pfenex And Agila Biotech In Joint Venture To Develop Biosimilars For Global Market
sale Of Agila Specialties Division To Mylan
strides And Eli Lilly Strategic Partnership To Deliver Generic Cancer Medicines In Emerging Markets
strides Arcolab Sells Generic Pharmaceutical Operations In Australia And Southeast Asia To Watson
pharmaceuticals
sun Pharma
products
acquisitions & Agreements
sun Pharma And Intrexon Joint Venture To Develop New Class Of Therapeutics For Ocular Diseases
sun Pharma And Taro Announce Termination Of Proposed Merger
sun Pharma To Acquire Url Generic From Takeda
teva Pharmaceutical Industries
products
biopharmaceuticals And Biosimilars
litigation
teva And Mylan Settle Patent Dispute
agreements
teva And Lonza Discontinue Biologics Joint Venture
teva Terminates Agreements With Curetech
teva Enters Agreement With Handok
wockhardt
products
appendix: Fda Anda Approvals
sources
index
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Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013