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TMCNet:  Research and Markets: Inhalation & Nasal Spray Generic Drugs 2013

[December 19, 2013]

Research and Markets: Inhalation & Nasal Spray Generic Drugs 2013

DUBLIN --(Business Wire)--

Research and Markets ( has announced the addition of the "Inhalation & Nasal Spray Generic Drugs 2013" report to their offering.

Around three quarters of the US$36.4 billion respiratory prescription drugs market comprises drugs that are delivered using inhalation or nasal spray technologies. The top five drugs used in the treatment of asthma and chronic obstructive pulmonary disease (COPD) attracted combined revenues of around US$18.0 billion in 2012. All five are blockbuster drugs. The current market leader overall is GlaxoSmithKline's Seretide/Advair (fluticasone propionate+salmeterol xianfoate), with sales of US$8.0 billion. Boehringer Ingelheim's leading COPD therapy, Spiriva (tiotropium bromide) achieved sales of US$4.6 billion. In third place was AstraZeneca's Symbicort (budesonide+formoterol), with sales of US$3.2 billion. I the allergy segment, the leading nasal spray therapy used in the treatment of allergic rhinitis is Merck & Co's Nasonex (mometasone furoate), with sales of US$1.3 billion in 2012.

High revenue originator drugs undoubtedly attract interest from prospective generic competitors. Unlike the oral generics market, however, where numerous companies typically compete for a revenue share, relatively few companies have the technology and expertise to compete in the market for generic inhalation and nasal spray products.

While there have been some generic approvals in Europe, the US market for generic MDIs has been virtually non-existent since the CFC ban was enforced at the end of December 2008. However, this may be about to change. In April 2013, the FDA posted its first individual product guidance for an MDI (News - Alert), for albuterol sulphate. This was followed in September 2013 by product guidance for fluticasone+salmeterol combination. Not only has the FDA's Office of Generic Drugs produced guidance that outlines the process by which a bioequivalent generic version of GSK's Advair may be developed for the US market; it has also made it possible for companies to hold pre-ANDA meetings, to help to resolve complex issues prior to submission. While significant technological barriers remain, with positive backing from the FDA, it may at last be possible for companies to demonstrate bioequivalence in hand-held, metered dose inhalers.

Key Topics Covered

  1. Foreword
  2. Executive Summary
  3. Respiratory Drugs Market
  4. Allergic Rhinitis
  5. Generic Competitors

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