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Letrozole - Generic Drug Details

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Letrozole is the generic ingredient in two branded drugs marketed by Apotex Inc, Indicus Pharma, Jiangsu Hengrui Med, Novartis Pharms, Accord Hlthcare, Impax Labs, Roxane, 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. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for letrozole. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: letrozole

Tradenames:2
Patents:0
Applicants:19
NDAs:19
Drug Master File Entries: see list24
Suppliers / Packaging: see list20
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: letrozole

Drug ClassAromatase Inhibitor
Mechanism of ActionAromatase Inhibitors

Tentative approvals for LETROZOLE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL2.5MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd
LETROZOLE
letrozole
TABLET;ORAL091466-001Jun 3, 2011RXNo► subscribe► subscribe
Teva Pharms
LETROZOLE
letrozole
TABLET;ORAL090289-001Jun 3, 2011RXNo► subscribe► subscribe
Impax Labs
LETROZOLE
letrozole
TABLET;ORAL091638-001Jun 3, 2011DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: letrozole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms
FEMARA
letrozole
TABLET;ORAL020726-001Jul 25, 19974,978,672► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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