Ethinyl estradiol; segesterone acetate - Generic Drug Details

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What are the generic drug sources for ethinyl estradiol; segesterone acetate and what is the scope of freedom to operate?

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.

Two suppliers are 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:	2
Clinical Trials:	2
DailyMed Link:	ethinyl estradiol; segesterone acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ethinyl estradiol; segesterone acetate

Generic Entry Date for ethinyl estradiol; segesterone acetate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; segesterone acetate

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 ethinyl estradiol; segesterone acetate

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Glossary

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

International Patents for ethinyl estradiol; segesterone acetate

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Country	Patent Number	Title	Estimated Expiration
Canada	3141077	SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020257544		⤷ Sign Up
Japan	2022536836	受胎調節を提供するためのシステム	⤷ Sign Up
Colombia	2021017509	Sistema para proporcionar control de la natalidad	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ethinyl estradiol; segesterone acetate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	49/2008	Austria	⤷ Sign Up	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	300814	Netherlands	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	07C0001	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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