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Farmers Insurance
Express Scripts
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Chinese Patent Office
Johnson and Johnson
Boehringer Ingelheim
US Army

Generated: December 16, 2017

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VAGIFEM Drug 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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in eleven countries and twenty-seven 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-one suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Drug patent expirations by year for VAGIFEM

Pharmacology for VAGIFEM

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for VAGIFEM

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk IncVAGIFEMestradiolTABLET;VAGINAL020908-002Nov 25, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncVAGIFEMestradiolTABLET;VAGINAL020908-002Nov 25, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe
Novo Nordisk IncVAGIFEMestradiolTABLET;VAGINAL020908-001Mar 26, 1999DISCNYesNo► Subscribe► 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
Austria240764► Subscribe
World Intellectual Property Organization (WIPO)9801180► Subscribe
Australia3254397► Subscribe
Cyprus1112542► Subscribe
Canada2258310► Subscribe
Germany69722203► Subscribe
Germany20120246► Subscribe
Japan2004515531► Subscribe
Spain2376649► Subscribe
Portugal1343508► 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
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C0008Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Accenture
UBS
Moodys
Cipla
Harvard Business School
Healthtrust
Queensland Health
Fish and Richardson

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 verifification 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.

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