Lorlatinib
Overview
Lorlatinib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL3286830).
API suppliers (1)
Suppliers of Lorlatinib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
1 of 1 holds a GMP certificate on record in the EU or UK registers
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (2 approved US products), the latest listed US patent on Lorlatinib expires 4 Oct 2038 and exclusivity 3 Mar 2028. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- (16R)-19-amino-13-fluoro-4,8,16-trimethyl-9-oxo-17-oxa-4,5,8,20-tetrazatetracyclo[16.3.1.02,6.010,15]docosa-1(22),2,5,10(15),11,13,18,20-octaene-3-carbonitrile
- Canonical SMILES
- C[C@@H]1C2=C(C=CC(=C2)F)C(=O)N(CC3=NN(C(=C3C4=CC(=C(N=C4)N)O1)C#N)C)C
- InChIKey
- IIXWYSCJSQVBQM-LLVKDONJSA-N
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