ELESTRIN Drug Patent Profile

Which patents cover Elestrin, and what generic alternatives are available?

Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA.

The generic ingredient in ELESTRIN 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 Elestrin

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

Summary for ELESTRIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	1
Patent Applications:	4,193
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ELESTRIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELESTRIN
What excipients (inactive ingredients) are in ELESTRIN?	ELESTRIN excipients list
DailyMed Link:	ELESTRIN at DailyMed

See drug prices for ELESTRIN

See drug sales revenues for ELESTRIN

Recent Clinical Trials for ELESTRIN

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

Sponsor	Phase
University of Missouri-Columbia	N/A

See all ELESTRIN clinical trials

Pharmacology for ELESTRIN

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ELESTRIN

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 ELESTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006		RX	Yes	Yes

Expired US Patents for ELESTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006

International Patents for ELESTRIN

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA06003316	FORMULACION FARMACEUTICA TRANSDERMICA PARA MINIMIZAR LOS RESIDUOS EN LA PIEL. (TRANSDERMAL PHARMACEUTICAL FORMULATION FOR MINIMIZING SKIN RESIDUES.)
South Korea	20030031568
European Patent Office	1325752
Australia	2004220498

Supplementary Protection Certificates for ELESTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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