Duloxetine Hydrochloride

Dolder announces cooperation with Chongqing Shenghuaxi Pharmaceutical Co. Ltd.

Dolder AG has gained a strong partner in the Chinese active pharmaceutical ingredient manufacturer, Chongqing Shenghuaxi Pharmaceutical Co. Ltd. Transferring the exclusive European distribution rights for the active pharmaceutical ingredient duloxetine emphasises Dolder’s strategic shift to antidepressants. Chongqing Shenhuaxi has recently been successfully inspected by the USFDA health authority and has also submitted a US DMF for duloxetine hydrochloride (# 21801).

Duloxetine Hydrochloride (Yentreve^®/Cymbalta^®) is a serotonin and noradrenaline (norepinephrine) reuptake inhibitor (SNRI). It is used in the treatment of depression, generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and moderate to severe stress urinary incontinence in women. Please refer to our Fact Sheet (PDF) for details.

Market performance
The global market volume of Yentreve^®/Cymbalta^® is currently about USD 2.9 billion.

Patent
The basic patent EP273658 expired in December 2007. The SPC (Supplementary Protection Certificate) and data exclusivity ensure that Yentreve^® is protected in EU countries against competition from generics.

Your benefits
Advantages for the general medicinal product manufacturer include the availability of an active substance from an emerging Chinese API manufacturer with strong growth, an attractive cost structure and exceptional scientific know-how.

Dolder is proud to be the technical support and regulatory affairs partner in this collaboration and the planned registration of this antidepressant. As a result, finished product manufacturers finally gain access to a competitively priced alternative to established providers.