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			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			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
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

International Patents for ESTRADIOL; PROGESTERONE

Country	Patent Number	Title	Estimated Expiration
Japan	2018024688	天然の併用ホルモン補充療法剤及び治療 (NATURAL COMBINATION HORMONE REPLACEMENT THERAPY AGENTS AND THERAPIES)
Canada	2856520	PREPARATIONS ET THERAPIES DE SUBSTITUTION POUR HORMONOTHERAPIE NATURELLE COMBINEE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Argentina	098160	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS
South Korea	20210107915	천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Russian Federation	2016136666	СОСТАВЫ НА ОСНОВЕ ПРОГЕСТЕРОНА
Japan	2020504093	天然配合ホルモン補充製剤及び治療法
European Patent Office	2861073	CAPSULE D'ESTRADIOL SOLUBLE POUR INSERTION VAGINALE (SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION)

Supplementary Protection Certificates for ESTRADIOL; PROGESTERONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
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
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