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 (22)

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

• LUPIN MANUFACTURING SOLUTIONS LTD1 active DMF
• ZAKLADY FARMACEUTYCZNE POLPHARMA SA1 active DMF
• RAKS PHARMA PVT LTDIndia1 active DMF
• MSN LIFE SCIENCES PRIVATE LIMITEDIndia1 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Cipla USA, Inc.USA1 active DMF
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• Alkem Laboratories LimitedIndia1 active DMF GMP on record
• QUIMICA SINTETICA SASpain1 active DMF GMP on record
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• Unichem Laboratories Ltd.India1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• Neuland Laboratories LimitedIndia1 active DMF
• JUBILANT BIOSYS LTDIndia1 active DMF
• CHANGZHOU PHARMACEUTICAL FACTORYChina1 active DMF GMP on record
• ANHUI POLY PHARM CO LTDChina1 active DMF
• Zhejiang Huayi Pharmaceutical Co., Ltd.China1 active DMF
• LEK PHARMACEUTICALS DD1 active DMF GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (19 approved US products), the latest listed US patent on Apremilast expires 27 May 2042 and exclusivity 25 Oct 2027. Generic API sourcing typically opens up once these lapse.

Therapeutic areas