TheraRadar
Data updated: May 26, 2026

CAMCEVI ETM (leuprolide mesylate)

Oncology Approved 2025-08-25
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-08-25
Patent Cliff
2028

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Routes
SUBCUTANEOUS
Dosage Forms
EMULSION

Companies

ACCORD
Active Ingredient: LEUPROLIDE MESYLATE

CAMCEVI ETM Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Aug 2025 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What CAMCEVI ETM Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT03261999 results posted FP01C-17-001 2017-001333-88 Ph 3 completed Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
NCT02234115 results posted FP01C-13-001 2013-001790-25 Ph 3 completed Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CAMCEVI ETM FDA Label Details

CAMCEVI ETM Patents & Exclusivity

Exclusivity: Aug 2028

Exclusivity

NS Until Aug 2028
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA219745 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.