Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2008

Espicom Healthcare Intelligence

- Pub ID: ESPI1935235

Providing…
Product forecasts by value 2007/2013 for 20 leading therapies
Patent expiry opportunities to 2018
Inhalable and nasal spray generics in market context
A review of pipeline developments which will affect the sector going forward
Competitive evaluation for 17 significant companies

Use this report...
To identify product and market opportunities
Understand the patent status and current challenges
Assess the longer term potential of the sector
Evaluate the competitive environment
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.

Additional Information

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. 9
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?

THERAPY AREAS AND PRODUCTS ASSESSED
Asthma & COPD
Flixotide/Flovent (fluticasone propionate)
Serevent (salmeterol xinafoate)
Seretide/Advair (salmeterol xinafoate+fluticasone propionate)
Pulmicort (budesonide)
Symbicort (budesonide+formoterol)
Combivent (ipratropium bromide+salbutamol)
Xopenex (levalbuterol)

Allergic rhinitis
Flixonase (fluticasone propionate)
Rhinocort (budesonide)
Nasonex (mometasone furoate)
Nasacort (triamcinolone acetonide)
Astelin (azelastine hydrochloride)

Influenza
Relenza (zanamivir)

Migraine
Imigran (sumatriptan)
Zomig (zolmitriptan)

Osteoporosis
Miacalcin (calcitonin-salmon)
Fortical (calcitonin-salmon [rDNA origin])

Anaesthesia
Ultane (sevoflurane)
Suprane (desflurane)

COMPANIES EVALUATED
Amphastar Pharmaceuticals
Apotex
Barr Pharmaceuticals
Baxter Healthcare
Beximco Pharmaceuticals
Cipla
Hi-Tech Pharmacal
Hovione FarmaCiencia
Mylan
Nephron Pharmaceuticals
Ranbaxy Laboratories
Roxane Laboratories
RxElite
Sandoz
Teva Pharmaceutical Industries
Watson Pharmaceuticals

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