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Serving 500+ biopharmaceutical companies globally:

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Accenture
McKesson
Queensland Health
Julphar
Colorcon
Baxter
AstraZeneca
Covington
Mallinckrodt

Generated: June 26, 2017

DrugPatentWatch Database Preview

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 three 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, Kremers Urban Pharms, and Novartis Pharms Corp, and is included in twenty 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. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: letrozole

Tradenames:3
Patents:7
Applicants:20
NDAs:20
Drug Master File Entries: see list24
Suppliers / Packagers: see list21
Bulk Api Vendors: see list91
Clinical Trials: see list332
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. Strength Dosage Form
► Subscribe► Subscribe2.5MGTABLET;ORAL
► Subscribe► Subscribe2.5MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
KISQALI FEMARA CO-PACK (COPACKAGED)
letrozole; ribociclib succinate
TABLET, TABLET;ORAL209935-001May 4, 2017RXYesYes8,962,630► Subscribe ► Subscribe
Novartis Pharms Corp
KISQALI FEMARA CO-PACK (COPACKAGED)
letrozole; ribociclib succinate
TABLET, TABLET;ORAL209935-001May 4, 2017RXYesYes8,324,225► SubscribeYY ► Subscribe
Teva Pharms
LETROZOLE
letrozole
TABLET;ORAL090289-001Jun 3, 2011ABRXNoNo► Subscribe► Subscribe
Jiangsu Hengrui Med
LETROZOLE
letrozole
TABLET;ORAL202716-001May 16, 2013ABRXNoNo► Subscribe► Subscribe
Apotex Inc
LETROZOLE
letrozole
TABLET;ORAL091303-001Apr 19, 2012ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: letrozole

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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Queensland Health
Cantor Fitzgerald
Citi
Fish and Richardson
Merck
Dow
Deloitte
Cerilliant
Colorcon

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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