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Last Updated: April 25, 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-five 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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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Transdermal estrogen device and delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Transdermal estrogen device and delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  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
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-005 Sep 23, 2014 AB3 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-001 Oct 29, 2012 AB3 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-005 Sep 23, 2014 AB3 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012 AB3 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-003 Oct 29, 2012 AB3 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-004 Oct 29, 2012 AB3 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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 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 ⤷  Try a Trial ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012 ⤷  Try a Trial ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-001 Oct 29, 2012 ⤷  Try a Trial ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012 ⤷  Try a Trial ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-003 Oct 29, 2012 ⤷  Try a Trial ⤷  Try a Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-005 Sep 23, 2014 ⤷  Try a Trial ⤷  Try a Trial
>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) 9114463 ⤷  Try a Trial
South Korea 20110039331 TRANSDERMAL ESTROGEN DEVICE AND DELIVERY ⤷  Try a Trial
South Africa 9500108 ⤷  Try a Trial
Portugal 2310001 ⤷  Try a Trial
Australia 632534 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9606602 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MINIVELLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 12/2004 Austria ⤷  Try a Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
0770388 09C0018 France ⤷  Try a Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388 PA2009004 Lithuania ⤷  Try a Trial PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2782584 132021000000197 Italy ⤷  Try a Trial PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
0398460 SPC/GB04/032 United Kingdom ⤷  Try a Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
1453521 132016000025143 Italy ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
>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.