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NDA

LEUPROLIDE MESYLATE | N219745 | ACCORD BIOPHARMA INC

1 strength5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (2)Active (3)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Aug. 2, 2029

Jan. 16, 2027

Jan. 16, 2027

Jan. 1, 2039

Dec. 18, 2037

Aug. 25, 2028

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

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.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SCINOPHARM TAIWAN LTDLEUPROLIDE MESYLATE

DMF 267702012

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 26, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 21MG BASE

RLD

5 patents1 exclusivity▴

EMULSION;SUBCUTANEOUS | Approved: Aug 25, 2025

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9572857	Aug 2, 2029	—	—	Yes	—	—
9744207	Jan 16, 2027	—	—	Yes	—	—
10646572	Jan 16, 2027	—	—	Yes	—	—
11717555	Jan 1, 2039	—	—	Yes	—	—
12133878	Dec 18, 2037	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NS	Aug 25, 2028	Active