Hovione developed its own innovative synthetic process for Fluticasone propionate and patented it – patent number WO 2002/100878, filed with priority date of 12 of June 2001. The process validation campaign was carried out during 2002 and the Drug Master File was filed with the FDA in December 2002.

In December 2006, the European Directorate for the Quality of Medicines & HealthCare (EDQM) granted to Hovione the Certificate of Suitability no. R0-CEP 2005-160 Rev00 for Fluticasone Propionate drug substance.

Fluticasone propionate drug substance is manufactured by Hovione according to the latest cGMP requirements at a FDA/European inspected plant and fully complies with the European and U.S. Pharmacopoeia monographs. Special control requirements like microbial controls are handled case by case depending on Customers request.

Fluticasone propionate is an anti-allergic and anti-inflammatory corticosteroid. The drug substance was discovered and patented by Glaxo in 1981 and is now marketed by GlaxoSmithKline (GSK). It is approved worldwide for respiratory use through a Dry Powder Inhaler (Rotadisk®), a Metered Dose Inhaler (Flovent®) and a nasal spray (Flonase®).

Flonase® and Flovent® are the proprietary names in United States and Canada and known in Europe as Flixonase® and Flixotide®. These products are used to reduce inflammation in airways. The nasal spray (Flonase®) is used for rhinites or inflammation of the nose. The inhaler (Flovent®) is used for respiratory problems like asthma.

Also, it is approved since 1990 as a cream and ointment for topical application (Cutivate®). GSK has received the approval for a dry powder inhaler with a combination a Fluticasone propionate and Salmeterol xinafoate (Advair®). The original patent expired in the United States in November 2003 and in the majority of the European countries between 2005 and 2006.

In the table below are listed the Innovators drug products containing Fluticasone propionate and respective strengths available in the United States.