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-five 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
Japan	2001523722
Poland	193897
Canada	2306881	PROCEDES DE TRAITEMENT POSTMENOPAUSIQUE A DOSES D'OESTROGENES ULTRA-FAIBLES (METHODS FOR TREATING POSTMENOPAUSAL WOMEN USING ULTRA-LOW DOSES OF ESTROGEN)
Canada	1338819	SYSTEME D'ADMINISTRATION D'ESTRADIOL PAR VOIE TRANSDERMIQUE (TRANSDERMAL ESTRADIOL DELIVERY SYSTEM)
Iceland	2132
Australia	630347

Supplementary Protection Certificates for MENOSTAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211