TheraRadar
Data updated: May 26, 2026

CAMCEVI KIT (leuprolide mesylate)

Oncology Approved 2021-05-25
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2021-05-25
Patent Cliff
2039

Pro Metrics

Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
EMULSION

Companies

ACCORD
Active Ingredient: LEUPROLIDE MESYLATE

CAMCEVI KIT Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2021 to 2026
Feb 2026 SUPPL
Label · Labeling
FDA Letter Label
Sep 2025 SUPPL
Label · Labeling
FDA Letter Label
Feb 2025 SUPPL
Label · Labeling
FDA Letter Label

What CAMCEVI KIT Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • 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 KIT FDA Label Details

View full patent landscape →
5 OB patents · 2 families · 63 international docs across 19 countries

CAMCEVI KIT Patents & Exclusivity

Latest Patent: Jan 2039

Patents (5 active)

US11717555 Expires Jan 1, 2039
US12133878 Expires Dec 18, 2037
US10646572 Expires Jan 16, 2027
US9744207 Expires Jan 16, 2027
US9572857 Expires Jan 16, 2027
Source: FDA Orange Book

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Deep insights for CAMCEVI KIT

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2039
  • • 5 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA211488 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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