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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

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, 2009RXYes7,018,992<disabled> <disabled>
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-002Nov 25, 2009RXYes5,860,946<disabled>Y <disabled>
Novo Nordisk Inc
VAGIFEM
estradiol
TABLET;VAGINAL020908-001Mar 26, 1999DISCNNo<disabled><disabled>
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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
Portugal1343508<disabled in preview>
World Intellectual Property Organization (WIPO)0247692<disabled in preview>
Austria532521<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
1214076/01Switzerland<disabled>PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C0018France<disabled>PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
C0004Belgium<disabled>PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
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