ESTRING Drug Patent Profile

Which patents cover Estring, and when can generic versions of Estring launch?

Estring is a drug marketed by Pfizer and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Estring

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

Summary for ESTRING

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	4
Patent Applications:	4,059
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ESTRING
Drug Sales Revenues:	Drug sales revenues for ESTRING
What excipients (inactive ingredients) are in ESTRING?	ESTRING excipients list
DailyMed Link:	ESTRING at DailyMed

See drug prices for ESTRING

See drug sales revenues for ESTRING

Recent Clinical Trials for ESTRING

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 4
Boston Urogynecology Associates	Phase 4
Mount Auburn Hospital	Phase 4

See all ESTRING clinical trials

Pharmacology for ESTRING

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ESTRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ESTRING	estradiol	INSERT, EXTENDED RELEASE;VAGINAL	020472-001	Apr 26, 1996		RX	Yes	Yes

Expired US Patents for ESTRING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ESTRING	estradiol	INSERT, EXTENDED RELEASE;VAGINAL	020472-001	Apr 26, 1996
Pfizer	ESTRING	estradiol	INSERT, EXTENDED RELEASE;VAGINAL	020472-001	Apr 26, 1996

International Patents for ESTRING

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

Country	Patent Number	Title	Estimated Expiration
Finland	872629
Finland	91709
Japan	2671953
Canada	1314482	DISPOSITIF INTRA-VAGINALS (INTRAVAGINAL DEVICES)
European Patent Office	0253109	INTRAVAGINAL DEVICE AND METHOD OF PREPARING THE SAME
China	87104229
Ireland	60654	Intravaginal devices

Supplementary Protection Certificates for ESTRING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004,C0770388	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
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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
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