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VAGIFEM Drug Profile

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Vagifem is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from two suppliers. 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-four drug master file entries for this compound. Forty-two 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 list2
Drug Prices: :see details

Pharmacology for Tradename: VAGIFEM

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: VAGIFEM

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009RXYes7,018,992Sep 17, 2022
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009RXYes5,860,946Jul 1, 2017Y
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-001Mar 26, 1999DISCNNo
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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
European Patent Office2366395<disabled in preview>
Japan2004515531<disabled in preview>
Canada2258310<disabled in preview>
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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
2009Austria<disabled>PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
2009004,C0770388Lithuania<disabled>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
C/GB04/032United Kingdom<disabled>PRODUCT 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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