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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-one 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
Austria240764<disabled in preview>
European Patent Office0910427<disabled in preview>
Germany69722203<disabled in preview>
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Supplementary Protection Certificates for Tradename: VAGIFEM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
00221Netherlands<disabled>PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
00C/027Belgium<disabled>PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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