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-five 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:	4,225
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

Anatomical Therapeutic Chemical (ATC) Classes for ESTRING

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 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
Norway	172784
New Zealand	220616	INTRAVAGINAL DEVICE CONTAINING 17B-ESTRADIOL AND SUPPORTING MATRIX; METHOD OF PREPARATION
European Patent Office	0253109	INTRAVAGINAL DEVICE AND METHOD OF PREPARING THE SAME
South Korea	920005824
Israel	82769	DEVICE FOR TREATING HYPOESTROGENIC WOMEN

Supplementary Protection Certificates for ESTRING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
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
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: 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