MINIVELLE Drug Patent Profile

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 22^nd, 1997.

Summary for MINIVELLE

International Patents:	23
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Formulation / Manufacturing:	see details
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

See drug prices for MINIVELLE

See drug sales revenues for MINIVELLE

Pharmacology for MINIVELLE

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for MINIVELLE

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

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			Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	AB3	RX	Yes	No			Y	Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	AB3	RX	Yes	No			Y	Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	AB3	RX	Yes	No			Y
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	AB3	RX	Yes	No
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	AB3	RX	Yes	Yes			Y	Y

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
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014

International Patents for MINIVELLE

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

Country	Patent Number	Title	Estimated Expiration
Austria	144704
Austria	223185
Canada	2170505
World Intellectual Property Organization (WIPO)	9007939
World Intellectual Property Organization (WIPO)	0069422
Spain	2548457

Supplementary Protection Certificates for MINIVELLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0770388	SPC/GB09/026	United Kingdom		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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
2782584	122021000080	Germany		PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804