NDAORALTABLET
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
FEMARA (letrozole) by Novartis is aromatase inhibitors [moa]. First approved in 1997.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FEMARA (letrozole) is an oral aromatase inhibitor approved in 1997 for hormone receptor-positive breast cancer in postmenopausal women. It works by blocking aromatase, an enzyme that converts androgens to estrogen in peripheral tissues, thereby reducing circulating estrogen levels. The drug is used for both early-stage adjuvant therapy and metastatic disease management.
$0.001BPart D
LOE ApproachingDeclining
As LOE approaches, the brand team is likely contracting; career focus shifts from growth to maximizing remaining exclusivity and preparing for generic competition.
Mechanism of Action
Aromatase Inhibitors
Pharmacologic Class:
Aromatase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
Started May 2026
1,056 enrolled
HR+/HER2- Breast Cancer
A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor
Started Jul 2025
5 enrolled
Ovarian Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Started Apr 2025
450 enrolled
Breast Cancer
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Started Jan 2025
1,035 enrolled
Breast Cancer
ALPINE: Maintenance Letrozole/Abemaciclib
Started Sep 2024
32 enrolled
Endometrial CancerRecurrent Endometrial CancerTP53
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.