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-six 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
Mount Auburn Hospital	Phase 4
Beth Israel Deaconess Medical Center	Phase 4
Boston Urogynecology Associates	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
Sweden	8602666
Norway	872489
South Korea	920005824
Denmark	175529
Spain	2026481

Supplementary Protection Certificates for ESTRING

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305