Estradiol; progesterone - Generic Drug Details
✉ Email this page to a colleague
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
International Patents: | 168 |
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 | 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.