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Last Updated: March 28, 2024

VIVELLE-DOT Drug Patent 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 Sandoz 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. 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-dot

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

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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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Early Phase 1
University of VirginiaEarly Phase 1
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 Strength NDA ANDAs Submitted Submissiondate
VIVELLE-DOT Transdermal System estradiol 0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day 020538 1 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
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-009 May 3, 2002 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-007 Jan 8, 1999 AB1 RX Yes 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-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-008 Jan 8, 1999 AB1 RX Yes Yes ⤷  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-DOT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-007 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-009 May 3, 2002 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-007 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-008 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-005 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VIVELLE-DOT

See the table below for patents covering VIVELLE-DOT 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
Singapore 77626 Compositions and methods for topical administration of pharmaceutically active agents ⤷  Try a Trial
Australia 700429 ⤷  Try a Trial
Denmark 0737066 ⤷  Try a Trial
Singapore 49331 Solubility parameter based pvp drug delivery system and methods therefor ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIVELLE-DOT

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
0771217 CA 2006 00038 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0398460 04C0022 France ⤷  Try a Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0771217 07C0001 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>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.