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Generated: April 30, 2017

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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 letrozole freedom to operate?

Letrozole
is the generic ingredient in two branded drugs marketed by Apotex Inc, Indicus Pharma, Jiangsu Hengrui Med, Novartis Pharms, Accord Hlthcare, Impax Labs, West-ward Pharms Int, Lannett Holdings Inc, Natco Pharma Ltd, Sun Pharm Inds Ltd, Teva Pharms, Vintage Pharms Llc, Mylan, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Actavis Totowa, Hikma Pharms, Synthon Pharms, and Kremers Urban Pharms, and is included in nineteen NDAs. There is one patent 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. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: letrozole

Tradenames:2
Patents:1
Applicants:19
NDAs:19
Drug Master File Entries: see list24
Suppliers / Packagers: see list21
Bulk Api Vendors: see list91
Clinical Trials: see list124
Patent Applications: see list6,948
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:letrozole at DailyMed

Pharmacology for Ingredient: letrozole

Drug ClassAromatase Inhibitor
Mechanism of ActionAromatase Inhibitors

Tentative approvals for LETROZOLE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL2.5MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett Holdings Inc
LETROZOLE
letrozole
TABLET;ORAL202048-001Oct 29, 2014ABRXNoNo► Subscribe► Subscribe
Impax Labs
LETROZOLE
letrozole
TABLET;ORAL091638-001Jun 3, 2011DISCNNoNo► Subscribe► Subscribe
Novartis Pharms
FEMARA
letrozole
TABLET;ORAL020726-001Jul 25, 1997ABRXYesYes► Subscribe► Subscribe
Dr Reddys Labs Ltd
LETROZOLE
letrozole
TABLET;ORAL091191-001Jun 3, 2011ABRXNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
LETROZOLE
letrozole
TABLET;ORAL091466-001Jun 3, 2011ABRXNoNo► Subscribe► Subscribe
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