VAGIFEM Drug Patent Profile

Which patents cover Vagifem, and what generic alternatives are available?

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 Minnesota	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
Portugal	1343508
Germany	10179223
Germany	69722203
Denmark	2366395

Supplementary Protection Certificates for VAGIFEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211