FEMARA Drug Patent 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. Sixteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Femara

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

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Summary for FEMARA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	196
Patent Applications:	2,594
Drug Prices:	Drug price information for FEMARA
What excipients (inactive ingredients) are in FEMARA?	FEMARA excipients list
DailyMed Link:	FEMARA at DailyMed

Drug patent expirations by year for FEMARA

Recent Clinical Trials for FEMARA

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

Sponsor	Phase
Verastem, Inc.	Phase 3
GOG Foundation	Phase 3
European Network of Gynaecological Oncological Trial Groups (ENGOT)	Phase 3

See all FEMARA clinical trials

Pharmacology for FEMARA

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Paragraph IV (Patent) Challenges for FEMARA

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 FEMARA

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Glossary

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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	⤷ 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

Expired US Patents for FEMARA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms	FEMARA	letrozole	TABLET;ORAL	020726-001	Jul 25, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FEMARA

See the table below for patents covering FEMARA around the world.

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Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	8707367	METHOD OF TOLUNITRILES PRODUCTION SUBSTITUTED BY HETEROCYCLIC RESIDUE	⤷ Sign Up
Latvia	5769	Tolunitrili ar heterociklisku aizvietotaju alfa-stavokli	⤷ Sign Up
Luxembourg	90128		⤷ Sign Up
Czechoslovakia	8701512	METHOD OF TOLUNITRILES PRODUCTION SUBSTITUTED BY HETEROCYCLIC RESIDUE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FEMARA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236940	97C0053	Belgium	⤷ Sign Up	PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072
0236940	C970011	Netherlands	⤷ Sign Up	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
0236940	SPC/GB97/013	United Kingdom	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description