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Last Updated: March 2, 2021

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VIVELLE Drug Profile

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When do Vivelle patents expire, and what generic alternatives are available?

Vivelle is a drug marketed by Novartis and is included in two NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Vivelle

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

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Drug patent expirations by year for VIVELLE
Drug Prices for VIVELLE

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Recent Clinical Trials for VIVELLE

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SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Early Phase 1
University of VirginiaEarly Phase 1
Nemours Children's ClinicPhase 4

See all VIVELLE clinical trials

US Patents and Regulatory Information for VIVELLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-005 Aug 16, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-005 Jan 8, 1999 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-003 Oct 28, 1994 DISCN No 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-004 Oct 28, 1994   Start Trial   Start Trial
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-003 Oct 28, 1994   Start Trial   Start Trial
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-001 Oct 28, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for VIVELLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
0770388 9/2009 Austria   Start Trial PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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