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NDA

LEUPROLIDE ACETATE | N213225 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain15 active DMFs9 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

TAKEDA PHARMACEUTICAL CO LTDLEUPROLIDE ACETATE

DMF 104161993

POLYPEPTIDE LABORATORIES INCLEUPROLIDE

DMF 131501998

BACHEM AGLEUPROLIDE ACETATE

DMF 138221998

CHEMI SPALEUPROLIDE ACETATE

DMF 147632000

PIRAMAL PHARMA LTDLEUPROLIDE ACETATE

DMF 251282011

BCN PEPTIDES SALEUPROLIDE (LEUPRORELIN)

DMF 267162012

POLYPEPTIDE LABORATORIES SWEDEN ABLEUPROLIDE ACETATE

DMF 268322013

SUN PHARMACEUTICAL INDUSTRIES LTDLEUPROLIDE ACETATE USP

DMF 278322014

AURO PEPTIDES LTDLEUPROLIDE ACETATE USP

DMF 311702016

MATRIX PHARMACORP PRIVATE LTDLEUPROLIDE ACETATE USP

DMF 322952017

REALI TIDE BIOLOGICAL TECHNOLOGY (WEIHAI) CO LTDLEUPROLIDE ACETATE

DMF 337652019

ALP PHARM BEIJING CO LTDLEUPROLIDE ACETATE

DMF 348472020

ZHEJIANG PEPTITES BIOTECH CO LTDLEUPROLIDE ACETATE

DMF 350712020

SHANXI TONGDA PHARMACEUTICAL CO LTDLEUPROLIDE ACETATE

DMF 405562024

ALEMBIC PHARMACEUTICALS LTDLEUPROLIDE ACETATE USP

DMF 412602025

BACHEM AMERICAS INCInactiveLEUPROLIDE ACETATE

DMF 112361994

SPECGX LLCInactiveLEUPROLIDE ACETATE

DMF 120521996

PENINSULA LABS INCInactiveLEUPROLIDE

DMF 139221998

GENZYME CORPInactiveLEUPROLIDE ACETATE

DMF 144401999

LIPOTEC SAInactiveLEUPROLIDE ACETATE NON-STERILE BULK DRUG SUBSTANCE

DMF 151642000

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLEUPROLIDE ACETATE

DMF 151892000

SPECGX LLCInactiveLEUPROLIDE ACETATE (SPECIAL)

DMF 248452013

AMBIOPHARM INCInactiveLEUPROLIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 263802012

CHINESE PEPTIDE COInactiveLEUPROLIDE ACETATE

DMF 293552015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 28, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 28MG/2.8ML (10MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Aug 26, 2026

No patent or exclusivity listings for this strength.