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Last Updated: July 26, 2024

MINIVELLE Drug Patent Profile


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When do Minivelle patents expire, and when can generic versions of Minivelle launch?

Minivelle is a drug marketed by Noven and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-three patent family members in fifteen countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Minivelle

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

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Drug patent expirations by year for MINIVELLE
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Pharmacology for MINIVELLE
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for MINIVELLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MINIVELLE Transdermal System estradiol 0.025 mg/day 203752 1 2015-05-08
MINIVELLE Transdermal System estradiol 0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day 203752 1 2014-08-18

US Patents and Regulatory Information for MINIVELLE

MINIVELLE is protected by four US patents.

Patents protecting MINIVELLE

Transdermal estrogen device and delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Transdermal estrogen device and delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Transdermal estrogen device and delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900

Transdermal estrogen device and delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-005 Sep 23, 2014 AB3 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-001 Oct 29, 2012 AB3 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-005 Sep 23, 2014 AB3 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012 AB3 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-003 Oct 29, 2012 AB3 RX Yes No ⤷  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 MINIVELLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-001 Oct 29, 2012 ⤷  Sign Up ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-004 Oct 29, 2012 ⤷  Sign Up ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-004 Oct 29, 2012 ⤷  Sign Up ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012 ⤷  Sign Up ⤷  Sign Up
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-005 Sep 23, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MINIVELLE

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9640086 ⤷  Sign Up
Israel 112269 Adhesive compositions for use in transdermal drug delivery systems and method of their preparation ⤷  Sign Up
New Zealand 243200 TRANSDERMAL DRUG DELIVERY SYSTEMS WHEREIN A BLEND OF POLYMERS IS UTILISED TO AFFECT THE RATE OF DRUG DELIVERY ⤷  Sign Up
European Patent Office 0592481 ⤷  Sign Up
Australia 1521295 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MINIVELLE

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
1380301 CA 2009 00017 Denmark ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584 301153 Netherlands ⤷  Sign Up PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0770388 2009/012 Ireland ⤷  Sign Up PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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