Leuprolide

Overview

Leuprolide is a protein active pharmaceutical ingredient (ChEMBL CHEMBL1201199).

API suppliers (10)

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

• ASPEN OSS BVNetherlands1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• POLYPEPTIDE LABORATORIES INCUnited States1 active DMF GMP on record
• ANYGEN CO LTDSouth Korea1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• AURO PEPTIDES LTD1 active DMF
• SPECGX LLCUnited States
• PENINSULA LABS INC
• LIPOTEC SA

Patent & exclusivity (US)

Per the FDA Orange Book (28 approved US products), the latest listed US patent on Leuprolide expires 22 Dec 2041 and exclusivity 25 Aug 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

(2S)-N-[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2R)-1-[[(2S)-1-[[(2S)-5-(diaminomethylideneamino)-1-[(2S)-2-(ethylcarbamoyl)pyrrolidin-1-yl]-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]-5-oxopyrrolidine-2-carboxamide

Canonical SMILES

CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](CC2=CC=C(C=C2)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC3=CNC4=CC=CC=C43)NC(=O)[C@H](CC5=CN=CN5)NC(=O)[C@@H]6CCC(=O)N6

InChIKey

GFIJNRVAKGFPGQ-LIJARHBVSA-N