VIVELLE Drug Patent Profile

When do Vivelle patents expire, and what generic alternatives are available?

Vivelle is a drug marketed by Sandoz and is included in two NDAs.

The generic ingredient in VIVELLE 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 Vivelle

A generic version of VIVELLE was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for VIVELLE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	4
Patent Applications:	5,371
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIVELLE
Drug Sales Revenues:	Drug sales revenues for VIVELLE
DailyMed Link:	VIVELLE at DailyMed

See drug prices for VIVELLE

Recent Clinical Trials for VIVELLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1
University of Virginia	Early Phase 1
Nemours Children's Clinic	Phase 4

See all VIVELLE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VIVELLE

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

US Patents and Regulatory Information for VIVELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-002	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-009	May 3, 2002	AB1	RX	Yes	No

Expired US Patents for VIVELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-002	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-004	Oct 28, 1994

International Patents for VIVELLE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9114463
South Africa	9500108
Australia	632534
World Intellectual Property Organization (WIPO)	9606602
Australia	5093790
European Patent Office	0453505
Australia	2699895

Supplementary Protection Certificates for VIVELLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	12/2004	Austria		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		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388	PA2009004	Lithuania		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		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		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		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306