ESTRADIOL; PROGESTERONE - Generic Drug Details

What are the generic drug sources for estradiol; progesterone and what is the scope of patent protection?

Estradiol; progesterone is the generic ingredient in two branded drugs marketed by Mayne Pharma and Amneal Pharms, and is included in two NDAs. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol; progesterone has one hundred and seventy-one patent family members in twenty-one countries.

Three suppliers are listed for this compound.

Summary for ESTRADIOL; PROGESTERONE

International Patents:	171
US Patents:	24
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	267
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESTRADIOL; PROGESTERONE
DailyMed Link:	ESTRADIOL; PROGESTERONE at DailyMed

Recent Clinical Trials for ESTRADIOL; PROGESTERONE

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 2
Lauren Whitehurst	Phase 3
Ohio State University	Phase 3

See all ESTRADIOL; PROGESTERONE clinical trials

Pharmacology for ESTRADIOL; PROGESTERONE

Drug Class	Estrogen Progesterone
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL; PROGESTERONE

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for ESTRADIOL; PROGESTERONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BIJUVA	Capsules	estradiol; progesterone	1 mg/100 mg	210132	1	2020-01-06

US Patents and Regulatory Information for ESTRADIOL; PROGESTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No			Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No			Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes

International Patents for ESTRADIOL; PROGESTERONE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3548036
Japan	2019214598	天然の併用ホルモン補充療法剤及び治療 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
South Korea	20210107915	천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Russian Federation	2015100531	КАПСУЛЫ С РАСТВОРИМЫМ ЭСТРАДИОЛОМ ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ
Russian Federation	2019142696	ЕСТЕСТВЕННАЯ КОМБИНАЦИЯ СОСТАВОВ И СПОСОБОВ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ
World Intellectual Property Organization (WIPO)	2015073177
Australia	2017206262

Supplementary Protection Certificates for ESTRADIOL; PROGESTERONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008