FEMARA Drug Patent Profile

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. Fifteen 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.

Summary for FEMARA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	194
Patent Applications:	4,355
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FEMARA
What excipients (inactive ingredients) are in FEMARA?	FEMARA excipients list
DailyMed Link:	FEMARA at DailyMed

See drug prices for FEMARA

Recent Clinical Trials for FEMARA

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

Sponsor	Phase
Universitaire Ziekenhuizen KU Leuven	Phase 2
Kom Op Tegen Kanker	Phase 2
GOG Foundation	Phase 2

See all FEMARA clinical trials

Pharmacology for FEMARA

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FEMARA

L02BG	Aromatase inhibitors
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

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

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

Expired US Patents for FEMARA

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

International Patents for FEMARA

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

Country	Patent Number	Title	Estimated Expiration
Slovakia	279102
Netherlands	970011
U.S.S.R.	1577695	CПOCOБ ПOЛУЧEHИЯ ГETEPOЦИKЛOЗAMEЩEHHЫX TOЛУHИTPИЛOB ИЛИ ИX ФAPMAЦEBTИЧECKИ ПPИEMЛEMЫX COЛEЙ (METHOD OF OBTAINING HETEROCYCLOSUBSTITUTED TIOLUNITRILES OF PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF)
Spain	2059317
South Africa	8701637
Japan	S62212369	TRINITRILE COMPOUND, MANUFACTURE AND USE
Morocco	20888

Supplementary Protection Certificates for FEMARA

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