Rotigotine

Overview

Rotigotine is a non-ergoline, dopamine agonist used in the treatment of Parkinson’s disease and restless legs syndrome. It functions as a transdermal patch to deliver continuous stimulation to dopamine receptors.

API suppliers (8)

Suppliers of Rotigotine evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• TAPI NL BVNetherlands1 active DMF
• INTERQUIM SAPeru1 active DMF GMP on record
• WAVELENGTH ENTERPRISES LTDIsrael1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• Neuland Laboratories LimitedIndia1 active DMF
• SOLARA ACTIVE PHARMA SCIENCES LTDIndia1 active DMF GMP on record
• Sichuan Qingmu Pharmaceutical Co., Ltd.China1 active DMF
• OLON SPAItaly GMP on record

EU CEP holders (4)

Companies holding a valid EU Certificate of Suitability (CEP) for Rotigotine, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (6 approved US products), the latest listed US patent on Rotigotine expires 1 Mar 2032. Generic API sourcing typically opens up once these lapse.

Therapeutic areas