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
Germany	69839026
Spain	2299912
Australia	3280989
Estonia	04221	Östrogeeni kasutamine ravimi valmistamiseks füüsiliste seisundite raviks menopausijärgsetel isikutel

Supplementary Protection Certificates for MENOSTAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C201630040	Spain		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
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
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
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414