Fingolimod

Overview

Fingolimod is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL314854).

API suppliers (13)

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

• MSN Laboratories Private LimitedIndia2 active DMF GMP on record
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• RUYUAN HEC PHARM CO LTD1 active DMF
• Emcure Pharmaceuticals LimitedIndia1 active DMF GMP on record
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• MAPRIMED SAArgentina1 active DMF GMP on record
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Intas Pharmaceuticals Ltd.India1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• NOVUGEN PHARMA MALAYSIA SDN BHD1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (17 approved US products), the latest listed US patent on Fingolimod expires 30 Sept 2032. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol

Canonical SMILES

CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)N

InChIKey

KKGQTZUTZRNORY-UHFFFAOYSA-N