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Last Updated: November 5, 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-nine 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
>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 203752-002 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 203752-003 Oct 29, 2012 ⤷  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
Denmark 549489 ⤷  Sign Up
Mexico 9602656 DISPOSITIVO TRANSDERMICO QUE CONTIENE PIRROLIDONA POLIVINILICA COMO MEJORADOR DE SOLUBILIDAD. (TRANSDERMAL DEVICE CONTAINING POLYVINYLPYRROLIDONE AS SOLUBILITY ENHANCER.) ⤷  Sign Up
Chile 2009001556 Sistema de administración transdermica de fármacos que comprende una capa que contiene fármaco que comprende una matriz polimérica que contiene estradiol como unico fármaco; método de elaboración; útil para administrar estradiol. ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MINIVELLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 300814 Netherlands ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0398460 12/2004 Austria ⤷  Sign Up PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
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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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.