Viewing data from:

CAMCEVI KIT

NDA

LEUPROLIDE MESYLATE | N211488 | ACCORD BIOPHARMA INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

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

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

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 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

6 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2026	SUPPL -11	View Letter (PDF)
Sep 25, 2025	SUPPL -10	View Letter (PDF)
Feb 12, 2025	SUPPL -6	View Letter (PDF)
Feb 12, 2025	SUPPL -6	View Letter (PDF)
Mar 14, 2024	SUPPL -4	View Letter (PDF)
May 26, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 42MG BASE

RLD

5 patents0 exclusivities▴

EMULSION;SUBCUTANEOUS | Approved: May 25, 2021

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	—	—

Change History (1)

Recent changes detected for this application.

MODIFIEDPatent Expiration7/1/2026

Accord updated the patent expiration date for leuprolide mesylate (Camcevi Kit) from Jan 2027 to Aug 2029, extending the listed patent term for NDA 211488 by approximately 2.5 years.

Old: Jan 16, 2027

New: Aug 2, 2029