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Last Updated: March 28, 2024

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, Carnegie, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Mylan, Natco Pharma Ltd, Strides Pharma, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Novartis, and is included in twenty-two NDAs. There are eight 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. Fifteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for LETROZOLE

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Drug Sales Revenue Trends for LETROZOLE

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Recent Clinical Trials for LETROZOLE

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

SponsorPhase
Universitaire Ziekenhuizen KU LeuvenPhase 2
Kom Op Tegen KankerPhase 2
University of MiamiPhase 2

See all LETROZOLE clinical trials

Generic filers with tentative approvals for LETROZOLE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial2.5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial2.5MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial200MG;2.5MGTABLET;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
Paragraph IV (Patent) Challenges for LETROZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FEMARA Tablets letrozole 2.5 mg 020726 1 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
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Synthon Pharms LETROZOLE letrozole TABLET;ORAL 090196-001 Jun 3, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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