Dexlansoprazole

Overview

Dexlansoprazole is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1201863).

API suppliers (14)

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

• METROCHEM API PRIVATE LTDIndia3 active DMF
• MSN Laboratories Private LimitedIndia2 active DMF GMP on record
• Hetero Drugs LimitedIndia2 active DMF GMP on record
• Orchid Pharma LimitedIndia1 active DMF GMP on record
• JUBILANT BIOSYS LTDIndia1 active DMF
• Piramal Pharma LimitedIndia1 active DMF GMP on record
• LEE PHARMA LTDIndia1 active DMF GMP on record
• Dipharma Francis SrlItaly1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• CHROMO LABORATORIES INDIA PRIVATE LTDIndia1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• OPTIMUS DRUGS PRIVATE LTDIndia1 active DMF
• WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDChina
• Lupin LimitedIndia GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (10 approved US products), the latest listed US patent on Dexlansoprazole expires 5 Mar 2032. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylsulfinyl]-1H-benzimidazole

Canonical SMILES

CC1=C(C=CN=C1C[S@@](=O)C2=NC3=CC=CC=C3N2)OCC(F)(F)F

InChIKey

MJIHNNLFOKEZEW-RUZDIDTESA-N