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Last Updated: March 28, 2024

VIVELLE Drug Patent Profile


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

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Vivelle

A generic version of VIVELLE was approved as estradiol by BARR LABS INC on October 22nd, 1997.

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Drug patent expirations by year for VIVELLE
Drug Prices for VIVELLE

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Recent Clinical Trials for VIVELLE

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

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
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-005 Aug 16, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-005 Jan 8, 1999 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-003 Oct 28, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-003 Oct 28, 1994 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-002 Oct 28, 1994 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-005 Aug 16, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VIVELLE

See the table below for patents covering VIVELLE around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0591432 SYSTEME D'APPORT DE MEDICAMENTS FONDE SUR UN PARAMETRE DE SOLUBILITE ET PROCEDE MODIFIANT LA CONCENTRATION DE SATURATION D'UN MEDICAMENT (SOLUBILITY PARAMETER BASED DRUG DELIVERY SYSTEM AND METHOD FOR ALTERING DRUG SATURATION CONCENTRATION) ⤷  Try a Trial
Brazil 9008012 ⤷  Try a Trial
European Patent Office 0379044 Couche de support perméable à l'air. (Breathable backing.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIVELLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 15C0050 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 39/2015 Austria ⤷  Try a 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
1214076 49/2008 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.