Apremilast

Overview

Apremilast is an oral small molecule inhibitor of the enzyme phosphodiesterase 4 (PDE4), which is used for the treatment of certain types of psoriasis and psoriatic arthritis. By inhibiting PDE4, apremilast reduces inflammation by increasing intracellular cAMP levels.

API suppliers (3)

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

• Zhejiang Huahai Pharmaceutical Co., Ltd.China2 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF
• Unichem Laboratories Ltd.India1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (19 approved US products), the latest listed US patent on Apremilast expires 26 May 2042 and exclusivity 24 Oct 2027. Generic API sourcing typically opens up once these lapse.

Therapeutic areas