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Last Updated: November 21, 2024

LETROZOLE Drug Patent Profile


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Which patents cover Letrozole, and what generic alternatives are available?

Letrozole is a drug marketed by Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Natco Pharma Ltd, Norvium Bioscience, Ryan Labs, Strides Pharma, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms. and is included in twenty NDAs.

The generic ingredient in LETROZOLE is letrozole. There are twenty-four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Letrozole

A generic version of LETROZOLE was approved as letrozole by ACCORD HLTHCARE on June 3rd, 2011.

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Drug patent expirations by year for LETROZOLE
Drug Prices for LETROZOLE

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Drug Sales Revenue Trends for LETROZOLE

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Recent Clinical Trials for LETROZOLE

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SponsorPhase
Mridula George, MDPhase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4
Verastem, Inc.Phase 3

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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
Accord Hlthcare LETROZOLE letrozole TABLET;ORAL 090934-001 Jun 3, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd LETROZOLE letrozole TABLET;ORAL 091466-001 Jun 3, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa LETROZOLE letrozole TABLET;ORAL 090491-001 Jun 3, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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