EVAMIST Drug Patent Profile

When do Evamist patents expire, 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

International Patents for EVAMIST

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

Country	Patent Number	Title	Estimated Expiration
Australia	2005234689
European Patent Office	1345549
South Korea	100831386

Supplementary Protection Certificates for EVAMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
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
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