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Last Updated: May 1, 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
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-004 Oct 29, 2012 AB3 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 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 ⤷  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 203752-003 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 203752-005 Sep 23, 2014 ⤷  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
>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
Australia 7672294 ⤷  Try a Trial
Spain 2094906 ⤷  Try a Trial
Finland 121527 ⤷  Try a Trial
Israel 102277 Dermal composition comprising a plurality of polymers and which modulates the permeation rate of a drug contained therein ⤷  Try a Trial
Brazil 9206208 ⤷  Try a Trial
European Patent Office 0592481 ⤷  Try a Trial
European Patent Office 1181930 BANDE ⤷  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
1214076 SZ 49/2008 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521 C201630040 Spain ⤷  Try a Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1380301 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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
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
0402407 97C0005 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
0770388 SPC/GB09/026 United Kingdom ⤷  Try a Trial PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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