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Last Updated: November 19, 2019

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ESTRADIOL; PROGESTERONE - Generic Drug Details

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What are the generic drug sources for estradiol; progesterone and what is the scope of freedom to operate?

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 eight 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:108
US Patents:12
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 75
Suppliers / Packagers: 1
Clinical Trials: 208
DailyMed Link:ESTRADIOL; PROGESTERONE at DailyMed
Recent Clinical Trials for ESTRADIOL; PROGESTERONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Monash HealthPhase 4
Moustafa Mohammed AboueleaEarly Phase 1
Institut Universitari DexeusN/A

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   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
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial   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
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 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Boehringer Ingelheim
Colorcon
AstraZeneca
Moodys

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