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Last Updated: June 24, 2021

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VAGIFEM Drug 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 MAYNE PHARMA on March 14th, 1996.

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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
University of Minnesota, MNPhase 4
Massachusetts General HospitalPhase 4

See all VAGIFEM clinical trials

Pharmacology for VAGIFEM
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for VAGIFEM
Tradename Dosage Ingredient NDA Submissiondate
VAGIFEM TABLET;VAGINAL estradiol 020908 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   Try Before You Buy   Try Before You Buy   Try Before You Buy
Novo Nordisk Inc VAGIFEM estradiol TABLET;VAGINAL 020908-001 Mar 26, 1999 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VAGIFEM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 C300221 Netherlands   Try Before You Buy PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301 CA 2009 00017 Denmark   Try Before You Buy PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076 49/2008 Austria   Try Before You Buy PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0402407 97C0005 Belgium   Try Before You Buy PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
0770388 9/2009 Austria   Try Before You Buy PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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