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Last Updated: February 16, 2020

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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 one branded drug marketed by Therapeuticsmd Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol; progesterone has one hundred and twelve patent family members in twelve countries.

There are seventy-five drug master file entries for estradiol; progesterone. One supplier is listed for this compound.

Summary for estradiol; progesterone
International Patents:112
US Patents:12
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 75
Suppliers / Packagers: 1
Clinical Trials: 210
DailyMed Link:estradiol; progesterone at DailyMed
Recent Clinical Trials for estradiol; progesterone

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SponsorPhase
Cairo UniversityPhase 2
Assistance Publique - Hôpitaux de ParisN/A
Monash HealthPhase 4

See all estradiol; progesterone clinical trials

Pharmacology for estradiol; progesterone

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
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for estradiol; progesterone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521 C201630040 Spain   Start 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Express Scripts
AstraZeneca
Baxter
Johnson and Johnson

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