Tapentadol

Overview

Tapentadol is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1201776).

API suppliers (2)

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

• NORAMCO INCUnited States1 active DMF
• CURIA MISSOURI INC1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (12 approved US products), the latest listed US patent on Tapentadol expires 22 Mar 2029 and exclusivity 3 Jan 2027. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol

Canonical SMILES

CC[C@@H](C1=CC(=CC=C1)O)[C@@H](C)CN(C)C

InChIKey

KWTWDQCKEHXFFR-SMDDNHRTSA-N