MENOSTAR Drug Patent Profile

Which patents cover Menostar, and what generic alternatives are available?

Menostar is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in MENOSTAR is estradiol. There are seventy-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Menostar

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

Summary for MENOSTAR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	5,456
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MENOSTAR
What excipients (inactive ingredients) are in MENOSTAR?	MENOSTAR excipients list
DailyMed Link:	MENOSTAR at DailyMed

See drug prices for MENOSTAR

Recent Clinical Trials for MENOSTAR

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

Sponsor	Phase
Bayer	Phase 3

See all MENOSTAR clinical trials

Pharmacology for MENOSTAR

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for MENOSTAR

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 MENOSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004	AB	RX	Yes	Yes

Expired US Patents for MENOSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004

International Patents for MENOSTAR

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	004573	СПОСОБЫ ЛЕЧЕНИЯ ЖЕНЩИН В ПОСТКЛИМАКТЕРИЧЕСКОМ СОСТОЯНИИ С ПРИМЕНЕНИЕМ УЛЬТРАНИЗКИХ ДОЗ ЭСТРОГЕНА (METHOD FOR TREATING POSTMENOPAUSAL WOMEN USING ULTRA-LOW DOSES OF ESTROGEN)
Australia	3280989
China	100398110
Australia	1591499

Supplementary Protection Certificates for MENOSTAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211