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Last Updated: August 13, 2020

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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, Dr Reddys Labs Ltd, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Jiangsu Hengrui Med, Lannett Co Inc, Mylan, Natco Pharma Ltd, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Vintage Pharms Llc, and Novartis, and is included in twenty-two 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. Fourteen suppliers are listed for this compound. There are two 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

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SponsorPhase
Assiut UniversityEarly Phase 1
Queen Mary Hospital, Hong KongPhase 3
Medical College of WisconsinPhase 1

See all LETROZOLE clinical trials

Generic filers with tentative approvals for LETROZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MGTABLET;ORAL
  Start Trial  Start Trial2.5MGTABLET; 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 NDA Submissiondate
FEMARA TABLET;ORAL letrozole 020726 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
Teva Pharms LETROZOLE letrozole TABLET;ORAL 090289-001 Jun 3, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare LETROZOLE letrozole TABLET;ORAL 090934-001 Jun 3, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Eugia Pharma LETROZOLE letrozole TABLET;ORAL 211717-001 Jan 11, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc LETROZOLE letrozole TABLET;ORAL 091303-001 Apr 19, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa LETROZOLE letrozole TABLET;ORAL 090491-001 Jun 3, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes   Start Trial   Start Trial   Start 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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