ELESTRIN Drug Patent Profile

When do Elestrin patents expire, and when can generic versions of Elestrin launch?

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-seven 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:	4,130
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

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
Portugal	1670433
European Patent Office	1323430	Composition pour l' administration percutanée et/ou par voie transmucosale de principes actifs assurant des niveaux d'efficacité thérapeutiques adéquats (Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels)
China	105853396
Australia	2004283431
World Intellectual Property Organization (WIPO)	2004080413
Japan	4864695

Supplementary Protection Certificates for ELESTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	2009/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0285237	95C0008	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406