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Last Updated: August 13, 2020

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VIVELLE-DOT Drug Profile

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Which patents cover Vivelle-dot, and when can generic versions of Vivelle-dot launch?

Vivelle-dot is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in VIVELLE-DOT is estradiol. There are seventy-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

US ANDA Litigation and Generic Entry Outlook for Vivelle-dot

A generic version of VIVELLE-DOT was approved as estradiol by MAYNE PHARMA on March 14th, 1996.

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Drug patent expirations by year for VIVELLE-DOT
Drug Prices for VIVELLE-DOT

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Drug Sales Revenue Trends for VIVELLE-DOT

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Recent Clinical Trials for VIVELLE-DOT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of VirginiaEarly Phase 1
Nemours Children's ClinicPhase 4
Genentech, Inc.Phase 4

See all VIVELLE-DOT clinical trials

Pharmacology for VIVELLE-DOT
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for VIVELLE-DOT
Tradename Dosage Ingredient NDA Submissiondate
VIVELLE-DOT FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 020538 2010-04-27

US Patents and Regulatory Information for VIVELLE-DOT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-009 May 3, 2002 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-007 Jan 8, 1999 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-005 Jan 8, 1999 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-006 Jan 8, 1999 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VIVELLE-DOT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-005 Jan 8, 1999   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-008 Jan 8, 1999   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-007 Jan 8, 1999   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-009 May 3, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for VIVELLE-DOT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0136011 2000C/027 Belgium   Start Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521 C201630040 Spain   Start Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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