The Indian Pharmaceutical Industry 2009

Diversification, Expansion & Ambitions

Publication Date	May 2009
Publisher	Espicom
Product Type	Report
Pages	250
ISBN Number	978-1-85822-348-3
Product Code	ESP00613

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Summary

The USA - Still The Market of Choice for The Indian Industry

Patent Expiry: Rich Pickings Ahead

A boost for the Indian generic industry will come from the significant number of blockbuster branded products - many of them first-line therapies - that will lose patent protection in the next 5 years in the US. over 49 such products will be affected by the end of 2013, including Topamax, Effexor XR, Lipitor, Plavix and Cymbalta.

US Regulatory Encouragement

The availability of a significant number of high value products has to be seen in the context of the US market. Indian companies are becoming increasingly active in the US market. in the years 2002, 2003 and 2004, the FDA approved 21, 26 and 25 ANDAs respectively for Indian pharmaceutical companies and their US subsidiaries. However, in 2005, the number increased to 52 and has been increasing year-on-year since, to reach 134 in 2008. in the first quarter of 2009, Indian companies had achieved 50 ANDA approvals, suggesting the pace is still increasing.

50 Authorised Generics: Threat Or Opportunity?

over the last few years, a growing number of 'authorised generic' agreements have been evident in the US and most branded companies have issued them in order to take sales and profits away from 'hostile' generic competition. While there is currently nothing to stop a branded company from issuing a licensed generic during the period of 180 days exclusivity, it has been argued that authorised generics are counter to the spirit of Hatch-Waxman, and devalue the 180-day exclusivity period by destroying the incentive for generic companies to challenge patents. Certainly some Indian companies such as Ranbaxy and Dr. Reddy's have been quick to exploit this opportunity, and the new products coming up, combined with their experience, will make them well placed to develop this area further.

Opinion Driven Analysis - Available Now!

The Indian Pharmaceutical Industry: Diversification, Expansion & Ambitions is a new, insightful and data-rich management report packed with facts, maps and statistics. Published in May 2009 and extending to 250 pages, the report provides a complete and detailed review of the Indian market and the 18 companies that are leading the way.

about The Author

The report has been researched and written by Espicom's Senior Analyst, Karen Holmes. Karen has over 12 years pharmaceutical and healthcare market analysis experience. Her recent studies include Injectable Generic Drugs: Prospects and Opportunities, Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs, Diabetes Drug Discoveries: what the future holds and The Pharmaceutical Market: India, Challenges and Opportunities.

Content

Foreword
The Indian Pharmaceutical Industry
Introduction
Indian Bases
Sales Revenue
The Advent of The Product Patent Regime in India
Background
The Patents (Amendments) Bill, 2005
Mashelkar Committee Report, December 2006
What Effect Has The Advent of The Product Patent Regime Had on The Indian Pharmaceutical Industry?
Looking beyond Reverse-Engineering
in-Licensing and Custom Manufacturing
Key Markets Now and in The Future
Established and Emerging Generic Markets
The United States
Authorised Generics Threat or Opportunity?
Europe
South Africa
Brazil
Australia
Biosimilars
India's Competitive Advantage
Foreign Acquisitions
Exports
Company Profiles
Alembic
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Dabur Pharma Acquisition
Products
Domestic Formulations
Apis
International Formulations
Generics
Financials
Aurobindo Pharma
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Licensing and Supply Agreements with Pfizer
Tad Italy Acquisition
Pharmacin Acquisition
Acquisition of US Facility
Milpharm: Aurobindo's First Acquisition in Europe
Products
Apis
Domestic Formulations
International Generics
US and Canada
CNS
Antibacterials
Antiretrovirals
Cardiovascular
European Union
South Africa
Australia
Financials
Biocon
Company Strategy
Manufacturing
R&d
Major Developments
Acquisitions
Biocon Buys Majority Stake in German Marketing Company
Acquisition of Asset of Nobex Corporation
Agreements
Abraxis and Biocon Announce G-Csf Partnership
Invitrogen/Biocon Sign Agreement to Market Insulin to Cell Culture Market
Biocon/Vaccinex Partner to Discover and Develop Therapeutic Abs
Products
Apis
Domestic Formulations
International Formulations
Insugen
Financials
Cipla
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Strategic Alliances & Agreements
Drug Development Agreements with Akorn
Malaria Agreement with Dndi
Akorn
Divestiture of Cipla Medpro
Compulsory Licensing in Malaysia
Products
Apis
Domestic Formulations
International Generics
US
Europe
Financials
Claris Lifesciences
Company Strategy
Manufacturing
R&d
Key Markets
Products
Domestic Formulations
International Generics
Dr. Reddy's
Company Strategy
Manufacturing
Usp's Pharmaceutical Ingredient Verification Programme
R&d
Perlecan
Cancer
Diabetes
Key Markets
Major Developments
Mergers & Acquisitions
Basf Contract Manufacturing Operations
Dowpharma's UK Small Molecules Business
Jet Generici
Betapharm
Roche's Mexico Api Facility
Trigenesis Therapeutics
Bms Laboratories and Meridian Health Care
American Remedies and Cheminor Drugs
Joint Ventures
China - Kunshan Rotam Reddy Pharmaceutical Co., Ltd
South Africa - Dr. Reddy's Laboratories (Proprietary) Ltd
Agreements
Dr. Reddy's Files Fondaparinux Anda under Alchemia Agreement
Dr Reddy's Makes Dermatology Product Advances
Tmh/Dr Reddy's Sign Agreement to Create Self-Injectable Product
Aquapharm Signs New Agreement and Extends R&d Licence with Dr Reddy's
7tm/Dr. Reddy's Enter Drug-Discovery Collaboration
Dr. Reddy's and Torrent Sign Russian Lisinopril Agreement
Dr. Reddy's and Clintec Co-Development Agreement
Dr. Reddy's and Argenta Announce R&d Collaboration
Dr. Reddy's and Rheoscience R&d Collaboration
Dr. Reddy's/Pharmascience Sign Multi-Product Agreement
Litigation
Clarinex-D Settlement with Schering-Plough and Sepracor
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
Products
Apis
Domestic Formulations
International Generics
US
Europe
Financials
Glenmark Pharmaceuticals
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Mergers & Acquisitions
Glenmark Begins Polish Venture
Glenmark Purchases Rights to Chr-1103 and Chr-1201 from Chromos
Medicamenta, Czech Republic
Bouwer Bartlett, South Africa
Agreements
Lilly/Glenmark Form Trpv1 Partnership
R&d Agreement with Dyax for Therapeutic Antibodies
Merck Kgaa
Royalty Deal with Paul Capital Partners
Lehigh Valley Technologies
Aspen USA
Generics Agreement with Invagen for US Market
Litigation
Glenmark Launches Fluticasone Patent Challenge; Nycomed Files Lawsuit
Abbott's Trandolapril/Verapamil Product
Products
Apis
Domestic Formulations
International Generics
US
Europe
Brazil
Financials
Jubilant Organosys
Company Strategy
Manufacturing
R&d
Acquisitions
Draxis Health
Speciality Molecules Pvt. Ltd
Hollister-Stier Laboratories
Trinity Laboratories/Trigen Laboratories
Agreements
Distribution Agreement with Guerbet
Jubilant and Bioleap Enter Drug-Discovery Alliance
Jv Agreement with Eli Lilly
Jubilant in Drug Discovery Partnership with Amgen
Neoprobe Signs Non-Binding Loi with Draximage for Lymphoseek Distribution
Products
Apis
International Generics
US
Canada
Europe
Financials
Lupin
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Acquisitions
Multicare Pharmaceuticals Philippines
Pharma Dynamics
Generic Health
Hormosan Pharma Gmbh
Kyowa Pharmaceutical Industry
Rubamin Laboratories
Agreements
Lupin/Forest Agree US Marketing Pact for Aerochamber plus
Gsk Philippines
Allergan
Baxter
Watson Pharmaceuticals
Litigation
Oscient and Ethypharm Fenofibrate Lawsuit
Lupin/Schering-Plough Settle Desloratadine Litigation
Products
Apis
Domestic Formulations
International Generics
US
Europe
Financials
Matrix Laboratories
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Mergers, Acquisitions & Divestitures
Aspen and Matrix End Joint Venture
Acquisition of Residual Holding in Mchem
Mylan Acquires Matrix
Matrix Gains 43% Stake in Explora
Matrix Acquires Docpharma
Matrix Purchases Finished Dosage Facility
Agreements
Clinton Hiv/Aids Initiative
Litigation
Daiichi Sankyo Sues Matrix for Azor Patent Infringement
Products
Apis
International Generics
Financials
Orchid Chemicals & Pharmaceuticals
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Agreements
Ranbaxy
Actavis
Alpharma (Now Actavis)
Apotex
Par Pharmaceuticals
Acquisitions & Joint Ventures
Bexel Pharmaceuticals Inc
Biotechnological Chemical Development Ltd
Mano Pharmaceuticals & Sali Healthcare
Ncpc Orchid Pharmaceuticals Ltd
Products
Apis
Domestic Formulations
International Generics
US
Canada
Europe
Financials
Piramal Healthcare
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Mergers & Acquisitions
Minrad International
Rxelite's Inhalation Anaesthetic Gas Distribution Business
Haemaccel Brands Group of Plasmaselect Ag, Germany
Pharmaceuticals Business of Healthline Private Limited, Bangalore
Boots Piramal Healthcare
Pfizer's Morpeth Facility
Rhodia's Inhalation Anaesthetics Business
Canere
Sarabhai Piramal
Ici Pharmaceutical
Agreements & Joint Ventures
Eli Lilly
Napo Pharmaceuticals
Biosyntech
Astrazeneca
Allergan
Ethypharm
Products
Apis
Domestic Formulations
International Formulations
Financials
Ranbaxy
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Daiichi Sankyo Acquires Ranbaxy
Industry Comment
Fda Takes Regulatory Action against Ranbaxy
Congressional Committee Expands Ranbaxy Probe to Include Pepfar Programme
Mergers & Acquisitions
Ranbaxy Acquires Dermatology Brands from Bristol-Myers Squibb
Ranbaxy Acquires Be-Tabs for US$71 Million
Ranbaxy Acquires Gsk's Mundogen Generic Business in Spain
Ranbaxy Acquires Terapia
Ranbaxy Acquires Generic Product Portfolio from Efarmes
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 Signs First Biosimilars Agreement
R&d Agreement with Glaxosmithkline
Ipca and Ranbaxy Sign Deal for US Market
Ranbaxy Signs Canadian Licensing and Supply Agreements with Janssen-Ortho
Ranbaxy to Market Lupin's Tb Brands in Africa
Litigation
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
Ranbaxy and Goldshield Win Sfo Cases
UK Department of Health Legal Action Settled
Products
Apis
Domestic Formulations
International Generics
US
Canada
Europe
Australia
Japan
Brazil
Financials
Strides Arcolab200
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Acquisitions, Agreements & Joint Ventures
Ascent Pharmahealth
Glaxosmithkline
Sagent
Grandix
Joint Venture Relationship for Spain and Portugal
Akorn-Strides
Products
Domestic Formulations
International Generics
US
Financials
Sun Pharma
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Mergers & Acquisitions
Taro Pharmaceutical Industries
Chattem Chemicals
Able Laboratories
Valeant
Women's First Healthcare Brands
Phlox Pharma
Litigation
Orion Sues Sun Pharma to Enforce Patent Covering Comtan
Products
Apis
Domestic Formulations
International Generics
US
Europe
Financials
Torrent Pharmaceuticals
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Mergers & Acquisitions
Heumann Pharma Generics
Agreements
Dr Reddy's and Torrent Sign Russian Lisinopril Agreement
Torrent Pharma Licenses Age Compound to Novartis
Products
Domestic Formulations
International Generics
Financials
Wockhardt
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Acquisitions
Morton Grove
Negma Laboratories
Pinewood Laboratories
Cp Pharmaceuticals Ltd
Agreements & Joint Ventures
Wockhardt and Sinclair Pharma Reach in-Licensing and Collaborative Agreements
Idc and Wockhardt Co-Develop Insulin Pens for Indian Market
Li-Taka Pharmaceuticals
Wockhardt Mexico
Wockhardt South Africa
Litigation
Orion Files Carbidopa/Entacapone/Levodopa Lawsuit against Wockhardt
Products
Apis
Domestic Formulations
International Generics
US
Europe
Financials
Zydus Cadila
Company Strategy
Manufacturing
R&d
Key Markets
Major Developments
Mergers & Acquisitions
Etna Biotech
Majority Stake in Simayla Pharmaceuticals
Laboratorios Combix
Quimica E Farmaceutica Nikkho Do Brasil
Nippon Universal Pharmaceutical
Liva Healthcare
Alpharma France
Merger into Cadila Healthcare
Agreements & Joint Ventures
Zydus Collaborates with Who to Develop Mab Cocktail for Rabies
Nycomed Chemical Production Moved to Zydus Nycomed
Karo Bio/Zydus Cadila Sign Research Agreement for Novel Gr Modulators
Evolupharn and Aerocid
Bharat Serums and Vaccines
Venus Remedies
Mallinckrodt
Mayne Group
Zambon Group
Litigation
Three Rivers Sues Zydus Cadila for Ribavirin Patent Infringement
Products
Apis
Domestic Formulations
International Generics
US
Europe
Japan
Financials
Sources
- Espicom Sources
- Others
List of Tables
- Indian Company Sales, 2008
- Fda Anda Approvals, 2002-2009 (Number)
- Indian Pharmaceutical Companies' US Subsidiaries
- Fda Anda Approvals, January 2007 March 2009
- Indian Pharmaceutical Companies' Eu Subsidiaries
- UK Marketing Authorisations, 2007-2009
- Indian Company Registrations of Generic Medicines in Brazil, November 2008
- Indian Companies' Foreign Acquisitions
- Export Summary, 1998-2007 (US$000)
- Finished Medicament Exports, 1998-2007 (US$000)
- Alembic's Manufacturing Facilities
- Alembic: Top 8 Brands
- Alembic: Fda Anda Approvals, 2009
- Alembic: Financial Results 2004-2008
- Aurobindo Pharma: Manufacturing Facilities
- Aurobindo Pharma: Key Subsidiaries
- Aurobindo Pharma: Anda Approvals, 2004-2009
- Cephazone Pharma: Fda Anda Approval, 2007
- Aurobindo UK Mhra Authorisations, 2006-2009
- Milpharm UK Mhra Authorisations, 2006-2009
- Aurobindo Pharma: Financial Results, 2004-2008
- Biocon: Financial Results, 2004-2008
- Cipla: Manufacturing Facilities
- Cipla: Fda Anda Approvals
- Cipla: Tentative Fda Anda Approvals
- Cipla: Tentative Fda Nda Approvals
- Cipla: Financial Results, 2004-2008
- Claris Lifesciences: Key Subsidiaries
- Claris Lifesciences: Fda Anda Approvals, 2008
- Dr. Reddy's: Manufacturing Facilities
- Dr. Reddy's: Regional Headquarters and Key Subsidiaries
- Dr. Reddy's: Key Api Products by Sales, 2007-2008
- Dr. Reddy's: Top 10 Brands in India, 2005-2008
- Dr. Reddy's: Fda Anda Approvals, 2002-2009
- Dr. Reddy's: UK Mhra Marketing Authorisations, 2006-2009
- Dr. Reddy's: Financial Summary, 2004-2008
- Glenmark Pharmaceuticals: Manufacturing Facilities
- Glenmark Generics: Manufacturing Facilities
- Glenmark: Key Subsidiaries
- Glenmark: Fda Anda Approvals, 2006-2009
- Glenmark: UK Mhra Authorisations, 2008-2009
- Glenmark: Anvisa Registered Generics, 2008
- Glenmark: Financial Results, 2004-2008
- Jubilant Organosys: Manufacturing Facilities
- Jubilant Organosys: Fda Anda Approvals, 2004-2009
- Pharmaceutical Services Incorporated (Psi): Mhra Authorisations, 2007-2009
- Jublilant Organosys: Financial Results, 2004-2008
- Lupin: Manufacturing Facilities
- Lupin: Leading Brands in India, 2008
- Lupin: Fda Anda Approvals, 2003-2009
- Lupin: Tentative Fda Approvals
- Lupin: UK Mhra Authorisations, 2007-2008
- Lupin: Financial Results, 2004-2008
- Matrix: Manufacturing Facilities
- Matrix: Fda Anda Approvals, 2008-2009
- Matrix: Tentative Anda Approvals
- Matrix: Financial Results, 2004-2008
- Orchid: Manufacturing Facilities
- Orchid: Key Subsidiaries and Joint Ventures
- Orchid: Top Ten Brands
- Orchid: Fda Anda Approvals, 2005-2009
- Orchid: UK Mhra Authorisations, 2008
- Orchid: Financial Results, 2004-2008
- Piramal Healthcare: Manufacturing Facilities
- Piramal Healthcare: Financial Results, 2004-2008
- Piramal Healthcare Solutions: Formulations Sales by Therapeutic Area, 2007-2008 (Rs. Million)
- Ranbaxy: Manufacturing Facilities
- Ranbaxy: Regional Headquarters & Key Subsidiaries
- Ranbaxy Laboratories: Fda Anda Approvals, 2002-2009
- Ohm Laboratories: Fda Anda Approvals, 2006-2008
- UK Mhra Marketing Authorisations, 2006-2009
- Ranbaxy: Anvisa Registered Generics, 2008
- Ranbaxy: Financial Results, 2004-2008
- Ranbaxy: Sales by Region, 2008
- Strides Arcolab: Manufacturing Facilities
- Strides Arcolab: Key Subsidiaries
- Akorn Strides: Fda Anda Approvals, 2007-2009
- Sagent Strides: Fda Anda Approvals
- Strides: Financial Results, 2005-2008
- Sun Pharma: Manufacturing Facilities
- Sun Pharma: Key Subsidiaries
- Sun Pharma: Fda Anda Approvals, 2006-2009
- Caraco Pharmaceutical: Anda Approvals, 2002-2008
- Sun Pharma UK Marketing Authorisations
- Sun Pharma: Financial Results, 2004-2008
- Torrent Pharma: Manufacturing Facilities
- Torrent Pharma: Key Subsidiaries
- Torrent Pharma: Fda Anda Approvals, 2007-2009
- Torrent Pharma: Financial Results, 2004-2008
- International Sales by Region, 2008
- Wockhardt Manufacturing Facilities
- Wockhardt: Key Subsidiaries
- Wockhardt: Fda Anda Approvals, 2003-2009
- Wockhardt UK Marketing Authorisations, 2006-2009
- Pinewood Laboratories UK Marketing Authorisations, 2006-2009
- Wockhardt: Financial Results, 2004-2008
- Wockhardt Sales by Region, 2007
- Zydus Cadila: Manufacturing Facilities
- Zydus Cadila: Key Subsidiaries
- Zydus: Anda Approvals, 2005-2009
- Zydus: Tentative Fda Anda Approvals
- Zydus Cadila: Financial Results, 2004-2008
List of Figures
- Map: Indian Pharmaceutical Company Headquarters
- Map: Manufacturing Locations in India
- Map: Indian Companies in The US
- Map: Indian Companies in The UK and Ireland
- Map: Indian Companies in Continental Europe
- Map: Indian Companies in Brazil
- Map: Indian Companies in China
- Exports of Raw Materials & Finished Medicaments, 1998-2007 (US$000)
- Pharmaceutical Exports by Category, 1998 & 2007 (%)
- Pharmaceutical Export Growth, 1999-2007 (%)
- Cipla: Exports by Region, 2008 (%)
- Dr. Reddy's: Api Sales by Region, 2008 (%)
- Dr. Reddy's: Formulations Sales by Region, 2008 (%)
- Glenmark: Formulations Sales by Region, 2008 (%)
- Matrix: Sales by Region, 2008 (%)
- Piramal Formulations Revenue by Therapeutic Area, 2008 (%)
- Ranbaxy: Sales by Region, 2008 (%)
- Strides: Revenue by Region, 2008
- Sun Pharma: Formulations Sales, 2006-2008
- Torrent Pharma: International Sales by Region, 2008 (%)224
- Wockhardt: Sales by Region, 2007 (%)
- Zydus Cadila: Formulation Sales by Region, 2008 (%)
- Zydus Cadila: Domestic Formulations Sales by Therapy Area, 2008 (%)