Viewing data from:

LUPRON DEPOT

NDA

LEUPROLIDE ACETATE | N020011 | ABBVIE ENDOCRINE INC

2 strengths0 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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3 - Draft Package Insert Proposed for Leuprolide acetate injection... FDA-2023-P-4357 · 8 docket documents Orbical Pharmaceutical Technologies Private Limited filed a citizen petition requesting FDA approval of additional strengths for leuprolide acetate injection, 1 mg/0.2 mL, with a draft package insert provided for the proposed formulation. The petition seeks regulatory suitability determination for t	Suitability	2023-10-05	Granted	Orbical Pharmaceutical Technologies Private Limited
Attachment III Draft Package Insert Proposed for Leuprolide acetate injection... FDA-2023-P-0609 · 6 docket documents Orbical Pharmaceutical Technologies Private Limited filed a citizen petition regarding leuprolide acetate injection, proposing a draft package insert as part of a suitability petition to establish specifications and standards for this generic drug product under the ANDA regulatory pathway.	Suitability	2023-02-24	Withdrawn	Orbical Pharmaceutical Technologies Private Limited
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-1609 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine whether the two-vial container closure system previously used for Lupron Depot (Leuprolide Acetate for Depot Suspension) Injection products under NDAs 19732, 20011, and	505(q)	2013-12-30	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

205 trials from ClinicalTrials.gov — 3 recruiting, 17 active, 129 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer NCT03902951	Phase 2	Active	Jonsson Comprehensive Cancer Center	28	2021-03-17 → 2028-01-01
Management of Castration-Resistant Prostate Cancer with Oligometastases NCT02685397	Phase 2/3	Active	Sir Mortimer B. Davis - Jewish General Hospital	102	2016-10 → 2041-08
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer NCT00430183	Phase 3	Active	Alliance for Clinical Trials in Oncology	788	2007-05-08 → 2030-10
A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer NCT04194554	Phase 1/2	Active	University of Michigan Rogel Cancer Center	102	2020-11-06 → 2029-05
FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer NCT03944434	Phase 2	Active	Fondazione Sandro Pitigliani	116	2018-12-27 → 2025-11-27
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)NCT02319837	Phase 3	Active	Pfizer	1,068	2014-12-17 → 2026-09-19
REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer NCT03951831	Phase 2	Active	Mark Stein	26	2019-05-16 → 2028-04
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer NCT01786265	Phase 2	Active	M.D. Anderson Cancer Center	310	2013-02-05 → 2027-02-01
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer NCT00544830	Phase 2	Active	City of Hope Medical Center	29	2006-07-18 → 2027-02-15
Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer NCT02023463	Phase 1	Active	Thomas Jefferson University	25	2014-04-02 → 2040-01-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1826.71

per ea

Lowest NADAC/Unit

$1826.71

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00074364103LUPRON DEPOT 3.75 MG KIT	$1826.71	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$995.59

Highest Price

$995.59

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-3641-03LUPRON DEPOT 3.75MG KIT	$995.59	FSS	Abbvie US LLC	07/31/2030
00074-3641-03LUPRON DEPOT 3.75MG KIT	$995.59	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

17 letters from Drugs@FDA

Date	Submission	Document
Sep 11, 2025	SUPPL -47	View Letter (PDF)
Sep 11, 2025	SUPPL -48	View Letter (PDF)
Jan 30, 2023	SUPPL -46	View Letter (PDF)
Feb 16, 2021	SUPPL -42	View Letter (PDF)
Oct 31, 2013	SUPPL -41	View Letter (PDF)
Apr 2, 2012	SUPPL -38	View Letter (PDF)
Jan 25, 2012	SUPPL -40	View Letter (PDF)
Jun 16, 2011	SUPPL -39	View Letter (PDF)
Nov 2, 2010	SUPPL -37	View Letter (PDF)
Jun 8, 2009	SUPPL -36	View Letter (PDF)
Nov 8, 2007	SUPPL -33	View Letter (PDF)
Oct 20, 2005	SUPPL -31	View Letter (PDF)
Oct 20, 2005	SUPPL -29	View Letter (PDF)
Jan 22, 2004	SUPPL -25	View Letter (PDF)
Jan 14, 2004	SUPPL -28	View Letter (PDF)
Sep 21, 2001	SUPPL -21	View Letter (PDF)
Apr 9, 1998	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 22, 1990

No patent or exclusivity listings for this strength.

#002 — 3.75MG

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 26, 1995