Letrozole
Femara, Letrozole (letrozole) is a small molecule pharmaceutical. Letrozole was first approved as Femara on 1997-07-25. It is used to treat breast neoplasms in the USA. The pharmaceutical is active against aromatase.
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Trends
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Events Timeline
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YTD
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2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Femara, Letrozole (discontinued: Letrozole)
CombinationsKisqali femara co-pack
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| femara | New Drug Application | 2025-08-21 |
| kisqali femara co-pack | New Drug Application | 2025-09-16 |
| letrozole | ANDA | 2025-12-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LETROZOLE / RIBOCICLIB SUCCINATE, KISQALI FEMARA CO-PACK (COPACKAGED), NOVARTIS | |||
| 2024-12-10 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Letrozole / Ribociclib Succinate, Kisqali Femara Co-Pack (Copackaged), Novartis | |||
| 10799506 | 2036-04-14 | DP | |
| 9193732 | 2031-11-09 | DS, DP | |
| 9868739 | 2031-11-09 | U-2505, U-3264 | |
| 8415355 | 2031-03-13 | DS, DP | |
| 8685980 | 2030-05-25 | DS, DP | |
| 8962630 | 2029-12-09 | U-2505, U-3264 | |
| 9416136 | 2029-08-20 | U-2505, U-3264 | |
| 8324225 | 2028-06-17 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
840 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | — | — | 1 | — | — | 1 |
| Anovulation | D000858 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Letrozole |
| INN | letrozole |
| Description | Letrozole is a member of triazoles and a nitrile. It has a role as an antineoplastic agent and an EC 1.14.14.14 (aromatase) inhibitor. |
| Classification | Small molecule |
| Drug class | aromatase inhibitors (imidazole/triazole derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 112809-51-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1444 |
| ChEBI ID | 6413 |
| PubChem CID | 3902 |
| DrugBank | DB01006 |
| UNII ID | 7LKK855W8I (ChemIDplus, GSRS) |
Target
Agency Approved
CYP19A1
CYP19A1
Organism
Homo sapiens
Gene name
CYP19A1
Gene synonyms
ARO1, CYAR, CYP19
NCBI Gene ID
Protein name
aromatase
Protein synonyms
CYPXIX, Cytochrome P-450AROM, Cytochrome P450 19A1, cytochrome P450, family 19, subfamily A, polypeptide 1, cytochrome P450, subfamily XIX (aromatization of androgens), Estrogen synthase, estrogen synthetase, flavoprotein-linked monooxygenase, microsomal monooxygenase
Uniprot ID
Mouse ortholog
Cyp19a1 (13075)
aromatase (P28649)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Letrozole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 19,870 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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40,566 adverse events reported
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