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VAGIFEM Drug Profile

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Which patents cover Vagifem, and what substitute generic drugs are available?

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 seventeen patent family members in eleven countries.

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

Summary for Tradename: VAGIFEM

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list63
Clinical Trials: see list3
Patent Applications: see list4,896
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009RXYesYes7,018,992► Subscribe ► Subscribe
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009RXYesYes5,860,946► SubscribeY ► Subscribe
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-001Mar 26, 1999DISCNYesNo► Subscribe► Subscribe
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Paragraph IV activity for: VAGIFEM

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

International Patent Family for Tradename: VAGIFEM

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9801180► Subscribe
Japan2010189409► Subscribe
Germany69722203► Subscribe
European Patent Office1343508► 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
C0008Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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
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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 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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