Last Updated: September 24, 2026

ESTRADIOL; PROGESTERONE - Generic Drug Details

Name: ESTRADIOL; PROGESTERONE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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.

Summary for ESTRADIOL; PROGESTERONE

International Patents:	175
US Patents:	24
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	290
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESTRADIOL; PROGESTERONE
DailyMed Link:	ESTRADIOL; PROGESTERONE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ESTRADIOL; PROGESTERONE

Generic Entry Date for ESTRADIOL; PROGESTERONE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial Dosage: CAPSULE;ORAL

^*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 ESTRADIOL; PROGESTERONE

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

Sponsor	Phase
University of British Columbia	NA
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	PHASE4
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE4

See all ESTRADIOL; PROGESTERONE clinical trials

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

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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	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start 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 ESTRADIOL; PROGESTERONE

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Country	Patent Number	Title	Estimated Expiration
Argentina	095619	FORMULACIÓN Y TERAPIAS PARA SUSTITUCIÓN HORMONAL DE COMBINACIÓN NATURAL	⤷ Start Trial
Argentina	098160	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS	⤷ Start Trial
Argentina	099872	FORMULACIONES DE PROGESTERONA	⤷ Start Trial
Argentina	107022	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS POR VÍA VAGINAL Y MÉTODOS	⤷ Start Trial
Argentina	127914	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS EN LA VAGINA Y PROCEDIMIENTOS	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ESTRADIOL; PROGESTERONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium	⤷ Start Trial	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	300814	Netherlands	⤷ Start Trial	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2782584	132021000000197	Italy	⤷ Start Trial	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
2782584	301153	Netherlands	⤷ Start Trial	PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0334429	97C0002	Belgium	⤷ Start Trial	PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.