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Last Updated: March 29, 2024

VAGIFEM Drug Patent Profile


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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-four 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
Angelica Lindén HirschbergPhase 4
University Hospitals Cleveland Medical CenterPhase 4
Fred Hutchinson Cancer Research CenterPhase 3

See all VAGIFEM clinical trials

Pharmacology for VAGIFEM
Drug ClassEstrogen
Mechanism of ActionEstrogen 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

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 a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc VAGIFEM estradiol TABLET;VAGINAL 020908-001 Mar 26, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VAGIFEM

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

Country Patent Number Title Estimated Expiration
Germany 20120246 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 0247692 ⤷  Try a Trial
Australia 2156702 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9801180 ⤷  Try a Trial
Japan 2010189409 USE OF OESTROGEN IN MANUFACTURE OF COMPOSITION CONTAINING OESTROGEN FOR TREATMENT OF ATROPHIC VAGINITIS ⤷  Try a Trial
Austria 240764 ⤷  Try a Trial
Japan 4851057 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VAGIFEM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 PA2009004,C0770388 Lithuania ⤷  Try a Trial 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
1453521 C 2015 029 Romania ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0402407 97C0005 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
1214076 SZ 49/2008 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1380301 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584 21C1058 France ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
0285237 95C0008 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
>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.