Roflumilast

Overview

Roflumilast is a selective phosphodiesterase 4 (PDE4) inhibitor that is used for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) to reduce the risk of exacerbations. It works by reducing inflammation in the lungs to improve breathing.

API suppliers (12)

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

• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• INTERQUIM SAPeru1 active DMF GMP on record
• ALP PHARM BEIJING CO LTD1 active DMF
• CHONGQING HUAPONT PHARMACEUTICAL CO LTD1 active DMF
• Hetero Drugs LimitedIndia1 active DMF GMP on record
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• VERANOVA LPUnited Kingdom1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Torrent PharmaceuticalsIndia1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• HEFEI TIANRUI PHARMACEUTICAL CHEMICAL CO LTDChina1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (23 approved US products), the latest listed US patent on Roflumilast expires 19 Aug 2042 and exclusivity 4 Oct 2028. Generic API sourcing typically opens up once these lapse.

Therapeutic areas