Sandoz Generics Company Intelligence Report

Date: January 22, 2011
Pages: 30
Price:
US$ 340.00
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Publisher: Espicom Business Intelligence
Report type: Strategic Report
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ID: S6FECA7AD3CEN
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Sandoz Generics Company Intelligence Report
Sandoz is a subsidiary of Novartis, now headquartered in Germany. The subsidiary was formerly a collection of companies under the Novartis Generics umbrella name, but a major rebranding and reorganisation process began in 2002.

Sandoz is currently the second largest generic manufacturer in the world, behind Teva Pharmaceutical Industries. The company completed its acquisition of Hexal and Eon Labs in June 2005, in one of the generic industry’s largest mergers to date.

Major production sites are in Austria, the USA, Germany and Slovenia. Around two thirds of the company’s workforce is based in Europe. The US subsidiary was formerly known as Geneva Pharmaceuticals, owned by Novartis since 1979. Novartis purchased the major Slovenian producer, Lek, in 2002. Lek has a major presence in the CEE region.

Sandoz is a frontrunner in the development of biosimilar products. Its human growth hormone product, Omnitrope, was approved in 2006, and in April 2009 in Canada, and the company has followed this with European approval of EPO in 2007 and G-CSF in 2008. In October 2008, Sandoz' somatropin was launched in Japan, the first biosimilar to be approved there.

Sandoz had sales in 2009 worth US$7,493 million, representing a slight drop of 0.8% over 2008, when sales reached US$7,557 million. The year saw Sandoz' US business return to growth, improving by 4.6% over 2008 to US$1,847 million. However, sales in Europe fell by 4.7% to US$4,271 million.

In September 2009, Sandoz, through Novartis, completed its acquisition of the specialty generic injectables business of Ebewe Pharma. The deal cost Novartis 925 million euros (US$1,316 million). The acquisition has given Sandoz an oncology injectables division.

On 23rd July 2010, the FDA approved Sandoz' ANDA for enoxaparin sodium, which it developed in collaboration with Momenta Pharmaceuticals. The product is the first generic equivalent of sanofi-aventis' Lovenox to be approved by the FDA
EXECUTIVE SUMMARY

INTRODUCTION

PRODUCTS

Sandoz: Retail Generics division key marketed products
Sandoz: Anti-Infectives division key marketed products
Sandoz: Intermediates division key marketed products
Sandoz: Biopharmaceuticals division key marketed products
Sandoz: Oncology Injectables division key marketed products
Sandoz ANDA Approvals, January 2002 – September 2010
NICE guidance covers use of Sandoz' somatropin
Omnitrope gains new US indication
Recent product approvals
Piperacillin and tazobactam (US)
Lansoprazole (authorised generic) (US)
Pramipexole (US)
Losartan potassium (US)
Enoxaparin sodium (US)
Rivastigmine (US, authorised generic)
Naratriptan (US)
Anastrozole (US)
Rosuvastatin (Lek, Slovenia)
Valacyclovir (US)
Metaxalone (US)
Amoxicillin-clavulanate (US)
Vancomycin (US)
Tamsulosin (US)
Losartan (US, authorised generic)
Risperidone (US)
Oxcarbazepine (US, authorised generic)
Calcipotriene (US)
Metoprolol tartrate / hydrochlorothiazide (US, authorised generic)
Nicardipine (US)
Lansoprazole (US, authorised generic)
Calcium acetate (US) (authorised generic)
Topiramate
Somatropin (Japan)
Rivastigmine (EU)
Tacrolimus (US)
Bicalutamide (US)
Cefpodoxime (US)

FINANCIAL RESULTS

Latest Quarterly Results, Q310
Sandoz: quarterly results, in US$ millions
Latest Fiscal Year Results, 2009
Sandoz: full year results, fiscal years ended 31st December, in US$ millions

MAJOR DEVELOPMENTS

Sandoz opens new development centre in New Jersey
Sandoz opens new biopharmaceuticals facility in Slovenia
Sandoz opens extension to Aeropharm facility
Mergers, Acquisitions and Agreements
Sandoz acquires Oriel Therapeutics
Vectura revises VR315 agreement with Sandoz
BioVectra partners with Sandoz to market docetaxel in the US
Sandoz acquires Ebewe Pharma
Litigation
District Court denies sanofi-aventis request for preliminary injunction in enoxaparin case
Rosuvastatin patent upheld in court
sanofi-aventis enters series of oxaliplatin patent settlements
Eon Labs settles allegations of false claims to Medicaid
Shire/Sandoz settle all pending litigation concerning Adderall XR
AMRI files patent infringement lawsuits against Dr Reddy's and Sandoz
US Court of Appeals affirms summary judgement decision in Seroquel patent litigation
Orion and Hospira file dexmedetomidine lawsuit against Sandoz
Teva to file lawsuit against Momenta/Sandoz over generic glatiramer

CONTACT DETAILS
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