Exciting opportunities in this high growth area can be expected over the next 10 years. At least nine significant products 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 this report from Espicom had combined sales exceeding US$18 billion in 2006. These drugs are used in the treatment of asthma, COPD, allergic rhinitis, influenza, migraine and osteoporosis, and in general anaesthesia.

In the longer term, novel inhalation and intranasal drug candidates which are being developed now could greatly expand the therapeutic coverage of these drug delivery technologies and potentially provide a lucrative future for the generic industry.

The generics market is undergoing radical restructuring, with much rationalisation of the corporate landscape. In such a competitive cauldron 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.

This new report from Espicom 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.
The traditional view of generic drugs is that they offer a cheap alternative to their branded equivalents. Cost has been an important factor in their development, particularly for oral drugs that are relatively cheap to produce and can be introduced to the market at a fraction of the price of the original drug.

As the generic industry matures, however, companies are increasingly looking for higher profit margins. From emerging specialist manufacturers to established companies seeking new opportunities, alternative drug delivery technologies 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.

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 chronic obstructive pulmonary disease (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.

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?

What will be the effect on the value of GSK's blockbusting Advair in 2011 assuming generic competition starts in 2008?

Which therapy areas offer the best potential for ANDA development?
THERAPY AREAS AND PRODUCTS ASSESSED
Asthma & COPD
Flixotide/Flovent (fluticasone propionate)
Serevent (salmeterol xinafoate)
Seretide/Advair (salmeterol xinafoate+fluticasone propionate)
Pulmicort (budesonide)
Combivent (ipratropium bromide+salbutamol)
Xopenex (levalbuterol)

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

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
Merck Generics
Morton Grove Pharmaceuticals
Nephron Pharmaceuticals
Ranbaxy Laboratories
Roxane Laboratories
RxElite
Sandoz
Teva Pharmaceutical Industries
Watson Pharmaceuticals