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 (1)

Suppliers of Roflumilast backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• APITORIA PHARMA PRIVATE LTDIndia1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (23 approved US products), the latest listed US patent on Roflumilast expires 18 Aug 2042 and exclusivity 3 Oct 2028. Generic API sourcing typically opens up once these lapse.

Therapeutic areas