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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Accenture
Chubb
Colorcon
Julphar
Moodys
Novartis
Queensland Health
Merck

Generated: October 18, 2017

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VAGIFEM Drug Profile

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What is the patent landscape for Vagifem, and when can generic versions of Vagifem launch?

Vagifem is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in eleven countries and twenty-six supplementary protection certificates in eleven countries.

The generic ingredient in VAGIFEM is estradiol. There are seventy-five drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for Tradename: VAGIFEM

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list63
Clinical Trials: see list11
Patent Applications: see list6,461
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VAGIFEM at DailyMed

Pharmacology for Tradename: VAGIFEM

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
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;VAGINAL020908-002Nov 25, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-001Mar 26, 1999DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: VAGIFEM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for VAGIFEM

Drugname Dosage Strength RLD Submissiondate
estradiolVaginal Tablets10 mcgVagifem1/2/2013

International Patent Family for Tradename: VAGIFEM

Country Document Number Estimated Expiration
Austria532521► Subscribe
European Patent Office1343508► Subscribe
European Patent Office2366395► Subscribe
Japan2010189409► Subscribe
Australia3254397► Subscribe
Japan2004515531► Subscribe
Portugal1343508► Subscribe
Denmark1343508► Subscribe
Cyprus1112542► Subscribe
Japan4851057► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VAGIFEM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C/GB09/026United Kingdom► SubscribePRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
2009004,C0770388Lithuania► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Accenture
Dow
Mallinckrodt
Novartis
Teva
Cantor Fitzgerald
Cerilliant
Farmers Insurance
Julphar

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