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Last Updated: March 28, 2024

Estradiol; progesterone - Generic Drug Details


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What are the generic 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 sixty-eight 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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 4
Fundación Santiago Dexeus FontPhase 3
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 ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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
European Patent Office 4309646 FORMULATIONS ET THÉRAPIES DE REMPLACEMENT D'HORMONES COMBINÉES NATURELLES (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Try a Trial
Russian Federation 2740059 КАПСУЛЫ С РАСТВОРИМЫМ ЭСТРАДИОЛОМ ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ (CAPSULES WITH SOLUBLE OESTRADIOL FOR INTRAVAGINAL INTRODUCTION) ⤷  Try a Trial
Japan 2017516768 天然の併用ホルモン補充療法剤及び療法 ⤷  Try a Trial
Australia 2018280270 Vaginal inserted estradiol pharmaceutical compositions and methods ⤷  Try a Trial
European Patent Office 3936133 PRÉPARATIONS ET THÉRAPIES DE SUBSTITUTION POUR HORMONOTHÉRAPIE NATURELLE COMBINÉE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  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 21C1058 France ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
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
1214076 C01214076/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0334429 97C0002 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0398460 12/2004 Austria ⤷  Try a Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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. 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.