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

EU CEP holders (7)

Companies holding a valid EU Certificate of Suitability (CEP) for Buprenorphine, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (62 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