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Last Updated: November 21, 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-nine 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-007 Jan 8, 1999 AB1 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-005 Jan 8, 1999 AB1 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 AB1 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-008 Jan 8, 1999 AB1 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-007 Jan 8, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-009 May 3, 2002 ⤷  Sign Up ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-008 Jan 8, 1999 ⤷  Sign Up ⤷  Sign Up
>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
Hungary 227497 PRESS-SENSITIVE TRANSDERMAL DRUG DELIVERY SYSTEM AND METHOD FOR MODULATING THE DELIVERY RATE OF THE SAID SYSTEM ⤷  Sign Up
Japan H09511987 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9007940 ⤷  Sign Up
South Africa 9500108 ⤷  Sign Up
Australia 1521295 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIVELLE-DOT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 C01214076/01 Switzerland ⤷  Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0285237 95C0008 Belgium ⤷  Sign Up PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0398460 04C0022 France ⤷  Sign Up PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0334429 97C0002 Belgium ⤷  Sign Up PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0136011 2000C/027 Belgium ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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