Sirolimus

Overview

Sirolimus, also known as rapamycin, is an immunosuppressive drug commonly used to prevent organ transplant rejection. It works by inhibiting the mammalian target of rapamycin (mTOR), which plays a crucial role in cell growth and proliferation.

API suppliers (12)

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

• FUJIAN KERUI PHARMACEUTICAL CO LTDChina1 active DMF
• CURIA ITALY SRLItaly1 active DMF GMP on record
• YANGZHOU LIANAO BIOPHARMACEUTICAL CO LTD1 active DMF
• Lonza Group AGSwitzerland1 active DMF
• CONCORD BIOTECH LTDIndia1 active DMF GMP on record
• HISUN PHARMACEUTICAL HANGZHOU CO LTD1 active DMF
• Chongqing Daxin Pharmaceutical Co., Ltd.China1 active DMF
• HEILONGJIANG WEIKAIER BIOTECHNOLOGY CO LTD1 active DMF
• BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDChina1 active DMF
• LUNAN NEW TIME BIO-TECH CO LTD1 active DMF
• HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDChina
• Zhejiang Hisun Pharmaceutical Co., Ltd.China GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (23 approved US products), the latest listed US patent on Sirolimus expires 28 Oct 2040 and exclusivity 22 Mar 2029. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

1,18-dihydroxy-12-[1-(4-hydroxy-3-methoxycyclohexyl)propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone

Canonical SMILES

CC1CCC2CC(C(=CC=CC=CC(CC(C(=O)C(C(C(=CC(C(=O)CC(OC(=O)C3CCCCN3C(=O)C(=O)C1(O2)O)C(C)CC4CCC(C(C4)OC)O)C)C)O)OC)C)C)C)OC

InChIKey

QFJCIRLUMZQUOT-UHFFFAOYSA-N

Therapeutic areas