VAGIFEM Drug Patent Profile

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When do Vagifem patents expire, 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-nine 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.

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Summary for VAGIFEM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	14
Patent Applications:	4,098
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

Drug patent expirations by year for VAGIFEM

Recent Clinical Trials for VAGIFEM

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

Sponsor	Phase
University of Washington	Phase 2
Breast Cancer Research Foundation	Phase 2
Koru Health Groups	N/A

See all VAGIFEM clinical trials

Pharmacology for VAGIFEM

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

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

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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
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-001	Mar 26, 1999		DISCN	Yes	No	⤷ 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 VAGIFEM

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

International Patents for VAGIFEM

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

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Country	Patent Number	Title	Estimated Expiration
Austria	532521		⤷ Sign Up
World Intellectual Property Organization (WIPO)	9801180		⤷ Sign Up
Australia	3254397		⤷ Sign Up
Spain	2725774		⤷ Sign Up
Canada	2258310	INSTRUMENT POUR L'INTRODUCTION D'UN SUPPOSITOIRE (INSTRUMENT FOR INSERTING A SUPPOSITORY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VAGIFEM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0285237	95C0008	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0398460	04C0022	France	⤷ Sign Up	PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0334429	97C0002	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0136011	2000C/027	Belgium	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description