Viewing data from:

CAMCEVI ETM

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Camcevi (2023)

Total Spending

$27.5M

Total Claims

8,051

Beneficiaries

6,318

ASP Price

—

HCPCS: J1952 — Leuprolide injectable, camcevi, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

Change History (5)

Recent changes detected for this application.

ADDED7/1/2026

Accord added United States Patent 12,133,878 to the Orange Book listing for Camcevi (leuprolide mesylate).

New: New record

ADDED7/1/2026

Accord added U.S. Patent 10,646,572 to the Orange Book for Camcevi (leuprolide mesylate), listing patent protection for this subcutaneous leuprolide formulation.

New: New record

ADDED7/1/2026

Accord added U.S. Patent 11,717,555 to the Orange Book for Camcevi (leuprolide mesylate), NDA 219745, formulation 001.

New: New record

ADDED7/1/2026

Accord added U.S. Patent 9,744,207 to the Orange Book listing for Camcevi (leuprolide mesylate) under NDA 219745.

New: New record

ADDED7/1/2026

Accord added U.S. Patent 9,572,857 to the Orange Book for Camcevi (leuprolide mesylate) NDA 219745.

New: New record