Treprostinil

Overview

Treprostinil is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1237119).

API suppliers (6)

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

• CHIROGATE INTERNATIONAL INCTaiwan1 active DMF
• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• Emcure Pharmaceuticals LimitedIndia1 active DMF GMP on record
• SHANGHAI FOREFRONT PHARMACEUTICAL CO LTD1 active DMF
• TIEN (Tianjin) Pharmaceutical Co. LtdChina1 active DMF
• DR REDDYS LABORATORIES LTD1 active DMF GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (31 approved US products), the latest listed US patent on Treprostinil expires 3 Feb 2042 and exclusivity 23 May 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]acetic acid

Canonical SMILES

CCCCC[C@@H](CC[C@H]1[C@@H](C[C@H]2[C@@H]1CC3=C(C2)C(=CC=C3)OCC(=O)O)O)O

InChIKey

PAJMKGZZBBTTOY-ZFORQUDYSA-N