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 seventy patent family members in twenty-one countries.
Three suppliers are listed for this compound.
Summary for estradiol; progesterone
International Patents: | 170 |
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 |
---|---|
Fundación Santiago Dexeus Font | Phase 3 |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 4 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for estradiol; progesterone
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 | 210132-002 | 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 | ⤷ 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 | ||||
>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 | 2019204658 | Vaginal Inserted Estradiol Pharmaceutical Compositions And Methods | ⤷ Try a Trial |
European Patent Office | 2861233 | TRAITEMENT TRANSDERMIQUE DE SUBSTITUTION HORMONALE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES) | ⤷ Try a Trial |
Australia | 2018222947 | Progesterone Formulations | ⤷ Try a Trial |
Mexico | 2014015898 | FORMULACIONES Y TERAPIAS DE REEMPLAZO DE COMBINACION DE HORMONAS NATURALES. (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES.) | ⤷ Try a Trial |
Brazil | 112018011483 | métodos e composições farmacêuticas com estradiol vaginalmente inserido | ⤷ Try a Trial |
European Patent Office | 3386514 | COMPOSITIONS PHARMACEUTIQUES À BASE D' STRADIOL INTRODUITES PAR VOIE VAGINALE ET PROCÉDÉS ASSOCIÉS (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS) | ⤷ 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 |
---|---|---|---|---|
1453521 | C 2015 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
1380301 | 2009C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
2782584 | 122021000080 | Germany | ⤷ Try a Trial | PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406 |
0334429 | 97C0002 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
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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