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Product
API
Class
Description
Delivery route
Development stage
Generics
Fluticasone propionate
ICS
Directly substitutable generic monotherapy for asthma and COPD
pMDI (multi-dose)
Preparation underway for 2014 submission in EU via IVE-only route
Fluticasone propionate
ICS
Directly substitutable generic monotherapy for asthma and COPD
pMDI (multi-dose with counter)
US development strategy underway, targeting ANDA submission
Not disclosed
ICS / LABA
Directly substitutable generic combination therapy for asthma and COPD
pMDI (multi-dose)
Development underway towards submission in EU via IVE-only route
'Super-generics'
Glycopyrronium bromide
LAMA
Novel, potentially ‘best-in-class’ once-daily monotherapy for COPD
pMDI (multi-dose)
Phase 2a clinical trials to commence in 2013
Novel MCP™ combinations
Multiple undisclosed programmes
ICS / LABA
LABA / LAMA
ICS / LAMA / LABA
LABA / LAMA
ICS / LAMA / LABA
Multi-component Particle™ (MCP™) combination therapies for respiratory diseases
pMDI / DPI
Preclinical development underway for selected MCP™ combinations
Co-development programmes
Undisclosed
LAMA
Directly substitutable generic monotherapy for COPD
cDPI
Development underway towards submission in EU via IVE-only route; US development strategy underway, targeting ANDA submission
Undisclosed
LABA
Directly substitutable generic monotherapy for asthma and COPD
pMDI
Development underway towards submission in EU via IVE-only route
Abbreviations: ANDA – Abbreviated new drug application; DPI – dry powder inhaler; cDPI – capsule-based DPI; ICS – Inhaled corticosteroid; IVE – in vitro equivalence; LABA – long-acting β2 agonist; LAMA – long-acting muscarinic antagonist; pMDI – pressurised metered dose inhaler