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Last Updated: September 25, 2022

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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in ten countries.

The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Thirty-eight 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 22nd, 1997.

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Drug patent expirations by year for VAGIFEM
Drug Prices for VAGIFEM

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Drug Sales Revenue Trends for VAGIFEM

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Recent Clinical Trials for VAGIFEM

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

SponsorPhase
University Hospitals Cleveland Medical CenterPhase 4
Massachusetts General HospitalPhase 3
Fred Hutchinson Cancer Research CenterPhase 3

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

VAGIFEM is protected by one US patents.

Patents protecting VAGIFEM

Hormone composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VAGIFEM estradiol TABLET;VAGINAL 020908-001 Mar 26, 1999 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

Country Patent Number Title Estimated Expiration
Japan 2010189409 USE OF OESTROGEN IN MANUFACTURE OF COMPOSITION CONTAINING OESTROGEN FOR TREATMENT OF ATROPHIC VAGINITIS See Plans and Pricing
Japan 4851057 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9801180 See Plans and Pricing
Portugal 1343508 See Plans and Pricing
Cyprus 1112542 See Plans and Pricing
European Patent Office 0910427 INSTRUMENT POUR L'INTRODUCTION D'UN SUPPOSITOIRE (INSTRUMENT FOR INSERTING A SUPPOSITORY) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VAGIFEM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 93156 Luxembourg See Plans and Pricing PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 300814 Netherlands See Plans and Pricing PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0285237 95C0008 Belgium See Plans and Pricing PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0584952 99C0004 Belgium See Plans and Pricing PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1453521 132016000025143 Italy See Plans and Pricing PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521 39/2015 Austria See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.