EVAMIST Drug Patent Profile

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

Evamist is a drug marketed by Padagis Us and is included in one NDA.

The generic ingredient in EVAMIST 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 Evamist

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

Summary for EVAMIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	1
Patent Applications:	4,323
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EVAMIST
Drug Sales Revenues:	Drug sales revenues for EVAMIST
What excipients (inactive ingredients) are in EVAMIST?	EVAMIST excipients list
DailyMed Link:	EVAMIST at DailyMed

See drug prices for EVAMIST

See drug sales revenues for EVAMIST

Recent Clinical Trials for EVAMIST

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

Sponsor	Phase
Lumara Health, Inc.	Phase 3

See all EVAMIST clinical trials

Pharmacology for EVAMIST

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for EVAMIST

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 EVAMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007		RX	Yes	Yes

Expired US Patents for EVAMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007

International Patents for EVAMIST

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1769785
European Patent Office	1769785	Promoteurs de pénétration dermique et systèmes d'administration de médicaments comprenant ces promoteurs (Dermal penetration enhancers and drug delivery systems involving same)
World Intellectual Property Organization (WIPO)	9729735
Hong Kong	1018884
Australia	1713497
European Patent Office	0901368	PROMOTEURS DE PENETRATION DERMIQUE ET SYSTEME D'ADMINISTRATION DE MEDICAMENTS COMPRENANT CES PROMOTEURS (DERMAL PENETRATION ENHANCERS AND DRUG DELIVERY SYSTEMS INVOLVING SAME)
Hong Kong	1087355

Supplementary Protection Certificates for EVAMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306