ESTRADIOL; PROGESTERONE - Generic Drug Details
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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.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
International Patents: | 169 |
US Patents: | 24 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 264 |
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 |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 4 |
Fundación Santiago Dexeus Font | Phase 3 |
El Shatby University Hospital for Obstetrics and Gynecology | Phase 2/Phase 3 |
Pharmacology for ESTRADIOL; PROGESTERONE
Drug Class | Estrogen Progesterone |
Mechanism of Action | Estrogen 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 | ⤷ Try a Trial | ||||
Amneal Pharms | ESTRADIOL AND PROGESTERONE | estradiol; progesterone | CAPSULE;ORAL | 214293-001 | May 16, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-002 | Dec 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | 210132-001 | 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 | 2782584 | PRÉPARATIONS ET THÉRAPIES DE SUBSTITUTION POUR HORMONOTHÉRAPIE NATURELLE COMBINÉE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) | ⤷ Try a Trial |
Brazil | 112019025914 | composições farmacêuticas de estradiol para inserção vaginal e métodos | ⤷ Try a Trial |
Russian Federation | 2016136666 | СОСТАВЫ НА ОСНОВЕ ПРОГЕСТЕРОНА | ⤷ Try a Trial |
European Patent Office | 2861072 | FORMULATIONS ET THÉRAPIES DE REMPLACEMENT D'HORMONES DE COMBINAISON NATURELLE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) | ⤷ 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 |
---|---|---|---|---|
0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
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 |
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 |
2782584 | 301153 | Netherlands | ⤷ Try a 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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