Sofosbuvir

Overview

Sofosbuvir is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1259059).

API suppliers (6)

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

• BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDChina1 active DMF
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• Laurus Labs LimitedIndia1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• FUXIN LONG RUI PHARMACEUTICAL CO LTD1 active DMF
• SUZHOU RYWAY BIOTECH CO LTD1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (4 approved US products), the latest listed US patent on Sofosbuvir expires 11 Jun 2031 and exclusivity 28 Aug 2026. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

propan-2-yl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-phenoxyphosphoryl]amino]propanoate

Canonical SMILES

C[C@@H](C(=O)OC(C)C)N[P@](=O)(OC[C@@H]1[C@H]([C@@]([C@@H](O1)N2C=CC(=O)NC2=O)(C)F)O)OC3=CC=CC=C3

InChIKey

TTZHDVOVKQGIBA-IQWMDFIBSA-N