Buprenorphine

Overview

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

API suppliers (15)

Suppliers of Buprenorphine backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• SIEGFRIED USA LLC5 active DMF
• NORAMCO INC3 active DMF
• Arevipharma GmbHGermany3 active DMF
• TAPI NL BV2 active DMF
• MACFARLAN SMITH LTD1 active DMF
• SPECGX LLCUnited States1 active DMF
• Unichem Laboratories Ltd.India1 active DMF
• ASPEN OSS BV1 active DMF
• Unichem Laboratories Ltd.India1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF
• SPECGX LLCUnited States1 active DMF
• SALARS SPA
• DIOSYNTH BV
• RESONANCE LABORATORIES PVT LTDIndia

Patent & exclusivity (US)

Per the FDA Orange Book (60 approved US products), the latest listed US patent on Buprenorphine expires 21 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