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Generated: October 23, 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 six 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. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: letrozole

US Patents:6
Tradenames:3
Applicants:20
NDAs:20
Drug Master File Entries: see list24
Suppliers / Packagers: see list19
Bulk Api Vendors: see list91
Clinical Trials: see list343
Patent Applications: see list6,263
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
u► Subscribe2.5MGTABLET;ORAL
u► 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, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
KISQALI FEMARA CO-PACK (COPACKAGED)
letrozole; ribociclib succinate
TABLET, TABLET;ORAL209935-001May 4, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
West-ward Pharms Int
LETROZOLE
letrozole
TABLET;ORAL090838-001Jun 3, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Jiangsu Hengrui Med
LETROZOLE
letrozole
TABLET;ORAL202716-001May 16, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
KISQALI FEMARA CO-PACK (COPACKAGED)
letrozole; ribociclib succinate
TABLET, TABLET;ORAL209935-001May 4, 2017RXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms
LETROZOLE
letrozole
TABLET;ORAL090289-001Jun 3, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Lannett Holdings Inc
LETROZOLE
letrozole
TABLET;ORAL202048-001Oct 29, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Oncol
LETROZOLE
letrozole
TABLET;ORAL090491-001Jun 3, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Hikma Pharms
LETROZOLE
letrozole
TABLET;ORAL203796-001Jun 3, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
KISQALI FEMARA CO-PACK (COPACKAGED)
letrozole; ribociclib succinate
TABLET, TABLET;ORAL209935-001May 4, 2017RXYesYes► Subscribe► SubscribeYY ► 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, 1997► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Fish and Richardson
Farmers Insurance
Healthtrust
Fuji
Dow
Chinese Patent Office
Federal Trade Commission
Chubb
Novartis

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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