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Last Updated: January 21, 2020

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LETROZOLE - Generic Drug Details

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What are the generic sources for letrozole and what is the scope of patent protection?

Letrozole is the generic ingredient in three branded drugs marketed by Novartis Pharms, Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Dr Reddys Labs Ltd, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Jiangsu Hengrui Med, Lannett Co Inc, Mylan, Natco Pharma Ltd, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Vintage Pharms Llc, and Novartis, and is included in twenty-two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for letrozole. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for LETROZOLE

See drug prices for LETROZOLE

Drug Sales Revenue Trends for LETROZOLE

See drug sales revenues for LETROZOLE

Recent Clinical Trials for LETROZOLE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Illinois at ChicagoPhase 1
Yale UniversityPhase 1
Johns Hopkins UniversityPhase 1

See all LETROZOLE clinical trials

Generic filers with tentative approvals for LETROZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MGTABLET;ORAL
  Start Trial  Start Trial2.5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LETROZOLE
Drug ClassAromatase Inhibitor
Mechanism of ActionAromatase Inhibitors
Synonyms for LETROZOLE
1-[Bis-(4-cyanophenyl)methyl]-1,2,4-triazole
1-[bis(4-cyanophenyl)methyl]-1,2,4-triazole
1-Bis(4-cyanophenyl)methyl-1,2,4-triazole
112809-51-5
4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile
4-[(4-CYANOPHENYL)(1H-1,2,4-TRIAZOL-1-YL)METHYL]BENZONITRILE
4-[1-(4-CYANOPHENYL)-1-(1,2,4-TRIAZOL-1-YL)METHYL]BENZONITRILE
4,2,4-Triazol-1-ylmethylene)dibenzonitrile
4,4 -(1H-1,2,4-triazol-1-ylmethanediyl)dibenzonitrile
4,4 inverted exclamation marka-(1H-1,2,4-Triazol-1-ylmethylene)bisbenzonitrile
4,4'-((1h-1,2,4-triazol-1-yl)methylene)dibenzonitrile
4,4'-(1,2,4-Triazol-1-ylmethylene)dibenzonitrile
4,4'-(1H-1,2,4-triazol-1-ylmethanediyl)dibenzonitrile
4,4'-(1h-1,2,4-triazol-1-ylmethylene) bis-benzonitrile
4,4'-(1h-1,2,4-triazol-1-ylmethylene)-bisbenzonitrile
4,4'-(1h-1,2,4-triazol-1-ylmethylene)bis-benzonitrile
4,4'-(1H-1,2,4-triazol-1-ylmethylene)bis-Benzonitrile Letrozole
4,4'-(1h-1,2,4-triazol-1-ylmethylene)bisbenzonitrile
4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile
4CA-0737
7LKK855W8I
809L515
A25380
AB0012832
AB00514009
AB00514009_10
AB00514009_11
AB00514009-05
AB00514009-07
AB00514009-08
AB00514009-09
AB07525
AB1009309
ABP001083
AC-1193
AC1L1GYT
AJ-45577
AKOS005145822
AN-6525
ANW-48664
API0024524
AX8041188
BC205693
BCP0726000213
BCP23354
BCP9000848
BDBM13061
Benzonitrile, 4,4'-(1H-1,2,4-triazol-1-ylmethylene)bis-
BG0620
BIDD:GT0015
BIDD:PXR0130
BPBio1_001331
BR-59607
BRD-K88789588-001-03-2
BSPBio_001209
C08163
C17H11N5
CAS-112809-51-5
CCG-100849
CCRIS 8822
CGS 20267
CGS-20267
CGS-20267 pound>>LETROZOLE
CGS20267
CHEBI:6413
CHEMBL1444
CPD000466343
CS-1776
CTK8B5413
D00964
DB01006
DSSTox_CID_3202
DSSTox_GSID_23202
DSSTox_RID_76924
DTXSID4023202
EN300-264820
EX-A965
F2173-0288
FEM-345
Femara
Femara (TN)
Femara (TN) (Novartis)
Femara, Letrozole
Femera
FT-0627797
GTPL5209
HMS1571M11
HMS2051E08
HMS2089L22
HMS2098M11
HMS2233C23
HMS3369E11
HMS3393E08
HMS3651K05
HMS3715M11
HPJKCIUCZWXJDR-UHFFFAOYSA-N
HSDB 7461
HY-14248
I06-0022
J10423
KB-187805
KS-00000XA8
KS-1269
L0248
Letoval
LETRAZOLE
Letrozol
Letrozole (JAN/USP/INN)
Letrozole [USAN:INN]
Letrozole [USAN:USP:INN:BAN]
Letrozole, >=98% (HPLC)
Letrozole, European Pharmacopoeia (EP) Reference Standard
Letrozole, Pharmaceutical Secondary Standard; Certified Reference Material
Letrozole, United States Pharmacopeia (USP) Reference Standard
LS-38788
MFCD00866241
MLS000759455
MLS001424038
MLS002584991
MLS006010040
NC00099
NCGC00016973-01
NCGC00016973-02
NCGC00016973-03
NCGC00016973-06
NCGC00257460-01
NSC-719345
NSC-759652
NSC719345
NSC759652
Pharmakon1600-01502354
Prestwick0_001025
Prestwick1_001025
Prestwick2_001025
Prestwick3_001025
Q-201291
QCR-225
RP29922
RTC-070977
S-4137
s1235
SAM001246649
SC-00402
SCHEMBL4331
SMR000466343
SPBio_003070
SR-01000759382
SR-01000759382-4
SR-01000759382-5
ST2405214
STL451047
SW197294-4
TL8000371
Tox21_110719
Tox21_303572
UNII-7LKK855W8I
W-60273
Z1741968261
ZINC3778874
Paragraph IV (Patent) Challenges for LETROZOLE
Tradename Dosage Ingredient NDA Submissiondate
FEMARA TABLET;ORAL letrozole 020726 2006-03-02

US Patents and Regulatory Information for LETROZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Synthon Pharms LETROZOLE letrozole TABLET;ORAL 090196-001 Jun 3, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Indicus Pharma LETROZOLE letrozole TABLET;ORAL 201804-001 Jun 3, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hikma LETROZOLE letrozole TABLET;ORAL 090838-001 Jun 3, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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