ETHINYL ESTRADIOL; SEGESTERONE ACETATE - Generic Drug Details

What are the generic sources for ethinyl estradiol; segesterone acetate and what is the scope of patent protection?

Ethinyl estradiol; segesterone acetate is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; segesterone acetate has fourteen patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

International Patents:	14
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	ETHINYL ESTRADIOL; SEGESTERONE ACETATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Dosage:

RING;VAGINAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

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

Sponsor	Phase
TherapeuticsMD	Phase 1

See all ETHINYL ESTRADIOL; SEGESTERONE ACETATE clinical trials

Pharmacology for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes			Y

International Patents for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020257544
Chile	2021003410	Sistema para proporcionar control de la natalidad
Canada	3141077	SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)
Japan	2022536836	受胎調節を提供するためのシステム
China	114364369	用于提供节育的系统 (System for providing birth control)

Supplementary Protection Certificates for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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