MINIVELLE Drug Patent Profile

Name: MINIVELLE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 22^nd, 1997.

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Summary for MINIVELLE

International Patents:	23
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	102
Drug Prices:	Drug price information for MINIVELLE
Drug Sales Revenues:	Drug sales revenues for MINIVELLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MINIVELLE
What excipients (inactive ingredients) are in MINIVELLE?	MINIVELLE excipients list
DailyMed Link:	MINIVELLE at DailyMed

Drug patent expirations by year for MINIVELLE

Pharmacology for MINIVELLE

Drug Class	Estrogen
Mechanism of Action	Estrogen 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.

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Glossary

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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	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	AB3	RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	AB3	RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	AB3	RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	AB3	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	⤷ Start Trial	⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	⤷ Start Trial	⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	⤷ Start Trial	⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	⤷ Start Trial	⤷ Start Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	⤷ Start Trial	⤷ Start 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.

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Country	Patent Number	Title	Estimated Expiration
Argentina	002355	COMPOSICIONES Y METODOS PARA ADMINISTRACION LOCAL DE AGENTES FARMACEUTICAMENTE ACTIVOS.	⤷ Start Trial
Austria	122240		⤷ Start Trial
Austria	144704		⤷ Start Trial
Austria	148633		⤷ Start Trial
Austria	223185		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MINIVELLE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	C00136011/03	Switzerland	⤷ Start Trial	PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
0136011	2000C/027	Belgium	⤷ Start Trial	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0136011	99C0003	Belgium	⤷ Start Trial	PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0584952	99C0004	Belgium	⤷ Start Trial	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0398460	SPC/GB04/032	United Kingdom	⤷ Start Trial	PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

DrugChatter Q&A for MINIVELLE

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