VAGIFEM Drug Patent Profile

When do Vagifem patents expire, and when can generic versions of Vagifem launch?

Vagifem is a drug marketed by Novo Nordisk Inc and is included in one NDA.

The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vagifem

A generic version of VAGIFEM was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for VAGIFEM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	12
Patent Applications:	6,715
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VAGIFEM
Drug Sales Revenues:	Drug sales revenues for VAGIFEM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VAGIFEM
What excipients (inactive ingredients) are in VAGIFEM?	VAGIFEM excipients list
DailyMed Link:	VAGIFEM at DailyMed

See drug prices for VAGIFEM

See drug sales revenues for VAGIFEM

Recent Clinical Trials for VAGIFEM

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

Sponsor	Phase
Angelica Lindén Hirschberg	Phase 4
University Hospitals Cleveland Medical Center	Phase 4
University of California, San Diego	Phase 3

See all VAGIFEM clinical trials

Pharmacology for VAGIFEM

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for VAGIFEM

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for VAGIFEM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VAGIFEM	Vaginal Tablets	estradiol	10 mcg	020908	1	2013-01-02

US Patents and Regulatory Information for VAGIFEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009	AB	RX	Yes	Yes
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-001	Mar 26, 1999		DISCN	Yes	No

Expired US Patents for VAGIFEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009

International Patents for VAGIFEM

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

Country	Patent Number	Title	Estimated Expiration
Japan	4851057
Germany	10179223
Canada	2258310	INSTRUMENT POUR L'INTRODUCTION D'UN SUPPOSITOIRE (INSTRUMENT FOR INSERTING A SUPPOSITORY)
Japan	2010189409	USE OF OESTROGEN IN MANUFACTURE OF COMPOSITION CONTAINING OESTROGEN FOR TREATMENT OF ATROPHIC VAGINITIS
World Intellectual Property Organization (WIPO)	0247692
Japan	2004515531

Supplementary Protection Certificates for VAGIFEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612