Buprenorphine

Overview

Buprenorphine is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL511142).

API suppliers (13)

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

• Siegfried LTDUnited Kingdom3 active DMF
• NORAMCO INCUnited States3 active DMF
• Unichem Laboratories Ltd.India1 active DMF GMP on record
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• SPECGX LLCUnited States1 active DMF
• MACFARLAN SMITH LTD A JOHNSON MATTHEY CO1 active DMF
• Arevipharma GmbHGermany1 active DMF GMP on record
• CHATTEM CHEMICALS INCUnited States1 active DMF
• TAPI NL BVNetherlands1 active DMF
• CHR OLESEN SYNTHESIS AS1 active DMF
• DIOSYNTH BV
• RESONANCE LABORATORIES PVT LTDIndia GMP on record
• RUSAN PHARMA LTDIndiaCEP GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (60 approved US products), the latest listed US patent on Buprenorphine expires 22 Jun 2038 and exclusivity 21 Feb 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

(1S,2S,6R,14R,15S,16R)-5-(cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-trien-11-ol

Canonical SMILES

C[C@]([C@H]1C[C@@]23CC[C@]1([C@H]4[C@@]25CCN([C@@H]3CC6=C5C(=C(C=C6)O)O4)CC7CC7)OC)(C(C)(C)C)O

InChIKey

RMRJXGBAOAMLHD-CTAPUXPBSA-N