The patent on Glaxo’s Flonase expired in November 2005, allowing Roxane, a subsidiary of Boehringer Ingelheim, to apply for approval of its generic product containing the same active ingredient fluticasone propionate.
US sales of Flonase reached $881.7 million last year; 2.3% of Glaxo’s total revenues. Although the company had expected the arrival of generic competition, the FDA decision has come sooner than anticipated, leading some analysts to revise their 2006 profit forecasts for Glaxo. However, a spokesman for GSK said the company was sticking to its original financial projections, expecting to gain earnings of around 10% per share in 2006.
Roxane’s product, Fluticasone Propionate Nasal Spray 50mcg, will be available in a 16 gram bottle containing 120 metered sprays. It has been approved for the relief of stuffy nose and other nasal symptoms linked to allergic or non-allergic rhinitis in adults and children over 4 years of age.
Glaxo has already announced plans to sue US regulators to block the sale of the generic. Any legal action may question whether the copycat product is absorbed into the body as effectively as Flonase. However, this is not the first time Glaxo has tried to stop the introduction of the generic, having already filed petitions to block Roxane’s application during the approval process.