EVAMIST Drug Patent Profile

When do Evamist patents expire, and what generic alternatives are available?

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-five 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
Japan	2000504697
Russian Federation	2270701	ДОЗИРУЮЩЕЕ УСТРОЙСТВО (ВАРИАНТЫ) (DOZER (VERSIONS))
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)
New Zealand	330942	Dermal penetration enhancers and drug delivery systems involving same
Germany	69739037

Supplementary Protection Certificates for EVAMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 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
1769785	CA 2012 00011	Denmark
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