Leuprolide

Overview

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

API suppliers (11)

Suppliers of Leuprolide backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• POLYPEPTIDE LABORATORIES INCUnited States1 active DMF
• ASPEN OSS BV1 active DMF
• POLYPEPTIDE LABORATORIES INCUnited States1 active DMF
• ASPEN OSS BV1 active DMF
• ASPEN OSS BV1 active DMF
• ANYGEN CO LTD1 active DMF
• POLYPEPTIDE LABORATORIES INCUnited States1 active DMF
• ASPEN OSS BV1 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 24 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