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Last Updated: August 9, 2020

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FEMARA Drug Profile

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When do Femara patents expire, and what generic alternatives are available?

Femara is a drug marketed by Novartis Pharms and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Femara

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

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Drug patent expirations by year for FEMARA
Drug Prices for FEMARA

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Recent Clinical Trials for FEMARA

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SponsorPhase
Medical College of WisconsinPhase 1
Spanish Breast Cancer Research GroupPhase 2
University of Illinois at ChicagoPhase 1

See all FEMARA clinical trials

Pharmacology for FEMARA
Drug ClassAromatase Inhibitor
Mechanism of ActionAromatase Inhibitors
Paragraph IV (Patent) Challenges for FEMARA
Tradename Dosage Ingredient NDA Submissiondate
FEMARA TABLET;ORAL letrozole 020726 2006-03-02

US Patents and Regulatory Information for FEMARA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms FEMARA letrozole TABLET;ORAL 020726-001 Jul 25, 1997 AB 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

Supplementary Protection Certificates for FEMARA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0236940 97C0053 Belgium   Start Trial PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072
0236940 SPC/GB97/013 United Kingdom   Start Trial PRODUCT NAME: LETROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: FR 341 474-2 19960724; FR 341 475-9 19960724; UK PL00001/0224 19961118
0236940 C970011 Netherlands   Start Trial PRODUCT NAME: LETROZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; NAT. REGISTRATION: RVG 20755 19970106; FIRST REGISTRATION: FR NL 21 881 19960724
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
McKesson
McKinsey
Dow
Medtronic
Harvard Business School

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