ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX - Generic Drug Details
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What are the generic sources for estradiol; norethindrone acetate; relugolix and what is the scope of freedom to operate?
Estradiol; norethindrone acetate; relugolix
is the generic ingredient in one branded drug marketed by Sumitomo Pharma and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Estradiol; norethindrone acetate; relugolix has one hundred and thirty-four patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
International Patents: | 134 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 12 |
DailyMed Link: | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Generic Entry Date for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Phase 4 |
Myovant Sciences GmbH | Phase 4 |
Myovant Sciences GmbH | Phase 1 |
See all ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX clinical trials
Pharmacology for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1591446 | ⤷ Sign Up | |
Israel | 265700 | שיטות לטיפול בפיברואידים של הרחם ובמחלת רירית הרחם (Methods of treating uterine fibroids and endometriosis) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2018060438 | ⤷ Sign Up | |
China | 100360538 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1591446 | C 2021 047 | Romania | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716 |
1453521 | C 2015 029 | Romania | ⤷ Sign Up | 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 |
1591446 | CA 2021 00048 | Denmark | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720 |
1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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