Tofacitinib
Overview
Tofacitinib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL221959).
API suppliers (4)
Suppliers of Tofacitinib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
2 of 4 hold a GMP certificate on record in the EU or UK registers
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
- Shandong Anxin Pharmaceutical Co., Ltd.China1 active DMF GMP on record
- METROCHEM API PRIVATE LTDIndia1 active DMF
- YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDChina1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (43 approved US products), the latest listed US patent on Tofacitinib expires 14 Sept 2034 and exclusivity 21 Aug 2028. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- 3-[(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile
- Canonical SMILES
- C[C@@H]1CCN(C[C@@H]1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N
- InChIKey
- UJLAWZDWDVHWOW-YPMHNXCESA-N
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