Glenmark Pharmaceuticals Europe Ltd has launched a generic version of Seretide Accuhaler, used to treat asthma, in Denmark.
The product was developed by Celon Pharma and Glenmark has marketing and distribution rights for the product across 15 European countries.
“This is Glenmark’s first inhaled respiratory product launch in Europe. Glenmark is the first generic company to receive regulatory approval for substitution in Denmark for its generic of Seretide Accuhaler,” Glenmark Pharmaceuticals Ltd said in a BSE filing.
Glenmark had entered into a strategic development and licensing agreement with Celon Pharma S.A. to develop and market a generic version of GlaxoSmithKline’s Seretide Accuhaler product – Fluticasone/Salmeterol dry powder inhaler in 15 European countries.
Fluticasone/Salmeterol dry powder inhaler is a combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD), it added.
Glenmark said it has already received National Marketing Authorizations for the product in Sweden, Finland, Norway and Iceland.
Quotng IQVIA data, Glenmark Pharma said Fluticasone/Salmeterol dry powder Inhaler (DPI) had sales of USD 864 million in Europe in the 12 month period ending September 2017.