Abstract
During the next ten years, at least 12 significant drugs in this sector will
lose patent protection in key markets - and this number could increase
depending on the outcome of patent challenges.
The inhalation and intranasal drugs discussed in detail in this report had
combined sales exceeding US$22 billion in 2007. These drugs are used in the
treatment of asthma, COPD, allergic rhinitis, influenza, migraine and
osteoporosis, and in general anaesthesia.
Successful IP challenges and regulatory approval will be critical
With major blockbusters in the Asthma/COPD sector, the generic industry is
keen to secure a slice of the action. However, they must overcome well
defended IP claims.
The biggest prize is GSK' s US$7 billion product Seretide/Advair. The patents
on the specific combination of fluticasone propionate and salmeterol xinafoate
are due to expire in 2010 in the US and in 2013 in Europe, including
Supplementary Protection Certificate extensions, after which generic companies
are expected to be able to enter the market.
Patent expiry in the US is not necessarily a gateway to generic competition,
however, due to the historic difficulty in gaining approval for inhalable
generics from the FDA. Flixotide/Flovent has been off patent for some time
and, while generic versions are available in Europe, generics have yet to be
approved in the US and the product remains a top seller for GSK.
As the generic industry matures companies are increasingly looking for higher
profit margins. From emerging specialist manufacturers to established
companies seeking new opportunities, new products plus novel drug delivery are
increasingly being seen as a route to a competitive edge in the generics
industry. That is why this report focuses on the opportunities for inhalation
and nasal spray generic drugs.
The report provides a complete review of the emerging opportunities and
operating environment for inhalation and nasal spray drugs. It reviews
products currently available generically and assesses the prospects for those
drugs losing patent protection over the next 10 years. The whole sector is put
in the context of the global generic market and the significant players are
assessed.
Profits through novel delivery
Drive for profit favours higher margin products
The generics market is undergoing radical restructuring, with much
rationalisation of the corporate landscape. In such a competitive environment
companies are now seeking not just new opportunities but opportunities which
combine good profit levels and a degree of product novelty - both of which are
available in the inhalation and nasal spray market.
Novel Drug Delivery is Critical
Inhalation and nasal spray drug delivery technologies are not an entirely
unknown concept for generics manufacturers; many have a presence in the
inhalation market, if only with one or two bronchodilators used in the
treatment of asthma and COPD.
Moving forward, however, a greater commitment to development will be required
for success in this market. By the end of 2008, asthma inhalers which use
ozone-depleting chlorofluorocarbon (CFC) propellants will have been entirely
phased-out of the US market. Only those companies that have successfully
developed more ozone-friendly hydrofluoroalkane (HFA) inhalers will be able to
compete for market share.
An eye on the future
The sector may currently be dominated by Asthma/COPD therapies, but novel
inhalation and intranasal drug candidates which are either in clinical
development or have been recently approved need to be built into business
plans. Conditions ranging from cystic fibrosis, osteoporosis, and erectile
dysfunction illustrate the potential for wider therapeutic portfolios of
inhalation and intranasal drugs in the future.
Questions, Questions
- What are the most promising future product opportunities and when do they
lose patent protection?
- What drug delivery challenges must companies overcome if they are to
really benefit in the marketplace?
- Why is Ranbaxy well placed to exploit opportunities going forwards in the
metered dose sector?
- What will be the effect on the value of GSK' s blockbusting Advair in 2013
assuming generic competition starts in 2010?
- What is the forecast value of Pulmicort to AstraZeneca assuming that it
successfully wins its litigation with Teva?
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