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Last Updated: March 28, 2024

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.

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
Generic Entry Date for ETHINYL ESTRADIOL; SEGESTERONE ACETATE*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
TherapeuticsMDPhase 1

See all ETHINYL ESTRADIOL; SEGESTERONE ACETATE clinical trials

Pharmacology for ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

Country Patent Number Title Estimated Expiration
China 114364369 用于提供节育的系统 (System for providing birth control) ⤷  Try a Trial
Brazil 112021025853 Sistema para fornecimento de controle de natalidade ⤷  Try a Trial
Australia 2020294780 System for providing birth control ⤷  Try a Trial
Chile 2021003410 Sistema para proporcionar control de la natalidad ⤷  Try a Trial
European Patent Office 3986375 SYSTÈME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL) ⤷  Try a Trial
Colombia 2021017509 Sistema para proporcionar control de la natalidad ⤷  Try a Trial
Canada 3141077 SYSTEME DE FOURNITURE DE CONTRACEPTION (SYSTEM FOR PROVIDING BIRTH CONTROL) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 CA 2006 00038 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076 C01214076/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0398460 C300221 Netherlands ⤷  Try a Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521 122015000093 Germany ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0771217 07C0001 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1380301 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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