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Last Updated: April 20, 2024

Estradiol; progesterone - Generic Drug Details


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What are the generic sources for estradiol; progesterone and what is the scope of freedom to operate?

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 sixty-nine patent family members in twenty-one countries.

Three suppliers are listed for this compound.

Summary for estradiol; progesterone
Recent Clinical Trials for estradiol; progesterone

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

SponsorPhase
Fundación Santiago Dexeus FontPhase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 4
El Shatby University Hospital for Obstetrics and GynecologyPhase 2/Phase 3

See all estradiol; progesterone clinical trials

Pharmacology for estradiol; progesterone
Drug ClassEstrogen
Progesterone
Mechanism of ActionEstrogen Receptor Agonists
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 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No ⤷  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 estradiol; progesterone

Country Patent Number Title Estimated Expiration
Australia 2021218231 Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods ⤷  Try a Trial
Croatia P20211377 ⤷  Try a Trial
European Patent Office 2861233 TRAITEMENT TRANSDERMIQUE DE SUBSTITUTION HORMONALE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES) ⤷  Try a Trial
Japan 2018024685 天然複合ホルモン補充製剤および療法 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Try a Trial
Russian Federation 2019115913 ПРИРОДНЫЕ КОМБИНИРОВАННЫЕ ГОРМОНОЗАМЕСТИТЕЛЬНЫЕ СОСТАВЫ И СПОСОБЫ ТЕРАПИИ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for estradiol; progesterone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2782584 2021C/558 Belgium ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584 LUC00245 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
1453521 15C0050 France ⤷  Try a Trial 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 C202130068 Spain ⤷  Try a Trial 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 C201630040 Spain ⤷  Try a Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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