June 2007

SPECIAL REPORT: How Will the Withdrawal of Generic Albuterol Change the U.S. Respiratory Disease Market?

Report Authors
Peter Norman, M.B.A., Ph.D.


The albuterol inhaler market in the United States will soon change from low-value to significant. The only MDIs sold will be branded HFA formulations; CFC propellants will be eliminated. Because the new HFA formulations are not bioequivalent, companies will compete for market leadership by convincing physicians and patients of their product’s superiority and by making strategic pricing decisions.

Questions Answered in This Report:

  *   The imminent discontinuation of many generic formulations of albuterol in the United States will be the most significant change in the respiratory disease market in some time. Will today’s sales leaders weather the change and continue to enjoy market dominance? How will the change affect generics manufacturers? What marketing strategies will be key elements in development of the market between 2006 and 2011? What are the market leaders doing now?

  *   As production of albuterol CFC ends, patients will have to switch from familiar generics to more-expensive, branded HFA formulations that are not interchangeable despite having the same active ingredient. How can companies differentiate their products to win patient and physician allegiance? How will higher costs affect patients and reimbursement providers? How will they react?

  *   By the beginning of 2009, the U.S. market for inhaled albuterol MDIs will comprise branded products exclusively. Which products will drive the market at least until 2011? Which company is likely to own the biggest market share in 2011? Which companies will lose market share? Are new companies with new formulations likely to impact the market by 2011?


Respiratory disease market: asthma and chronic obstructive pulmonary disease prevalence and treatment; albuterol agents and manufacturers.

Montreal Protocol: ban on CFC propellants; impact on the albuterol market and on brand and generic manufacturers, consumers, and payers.

From CFC to HFA: supply and demand challenges; manufacturer compliance; non-bioequivalence of HFAs; reimbursement issues.

Market outlook: continuing demand for albuterol products; DPI formulations; pricing and product differentiation; U.S. market forecast; winners and losers.

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Mentioned in this report:

  • Companies:
  • 3M
  • Amphastar
  • Andrx
  • Armstrong
  • AstraZeneca
  • Boehringer Ingelheim
  • Critical Therapeutics
  • Dava
  • Dey
  • GenPharm
  • GlaxoSmithKline
  • Ivax
  • Key Pharmaceutical
  • Merck
  • Novartis
  • Ono
  • Otsuka
  • Pliva
  • Schering-Plough
  • Sepracor
  • Teva
  • Warrick
Decision Resources Group brands include: