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Last Updated: March 29, 2024

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 patent protection?

Estradiol; norethindrone acetate; relugolix is the generic ingredient in one branded drug marketed by Myovant Sciences and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol; norethindrone acetate; relugolix has one hundred and thirty-one patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for estradiol; norethindrone acetate; relugolix
International Patents:131
US Patents:6
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

SponsorPhase
Myovant Sciences GmbHPhase 4
University of ChicagoPhase 4
Myovant Sciences GmbHPhase 1

See all estradiol; norethindrone acetate; relugolix clinical trials

US Patents and Regulatory Information 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
Myovant Sciences MYFEMBREE estradiol; norethindrone acetate; relugolix TABLET;ORAL 214846-001 May 26, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Myovant Sciences MYFEMBREE estradiol; norethindrone acetate; relugolix TABLET;ORAL 214846-001 May 26, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Myovant Sciences MYFEMBREE estradiol; norethindrone acetate; relugolix TABLET;ORAL 214846-001 May 26, 2021 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; norethindrone acetate; relugolix

Country Patent Number Title Estimated Expiration
Brazil 112019006228 tratamento de câncer de próstata ⤷  Try a Trial
Israel 265696 שיטות לטיפול באי-פוריות של אשה (Methods of treating female infertility) ⤷  Try a Trial
Serbia 63199 KRISTALNI OBLIK 1-(4-1-(2,6-DIFLUOROBENZIL)-5-DIMETILAMINOMETIL-3-(6-METOKSIPIRIDAZIN-3-IL)-2,4-DIOKSO-1,2,3,4-TETRAHIDROTIENO(2,3-D)-PIRIMIDIN-6IL)FENIL)-3-METOKSIUREA (CRYSTALLINE FORM OF 1-(4-1-(2,6-DIFLUOROBENZYL)-5-DIMETHYLAMINOMETHYL-3-(6-METHOXYPYRIDAZIN-3-YL)-2,4-DIOXO-1,2,3,4-TETRAHYDROTHIENO(2,3-D)-PYRIMIDIN-6YL)PHENYL)-3-METHOXYUREA) ⤷  Try a Trial
>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 CA 2021 00048 Denmark ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446 122022000002 Germany ⤷  Try a Trial PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716
1591446 SPC/GB21/065 United Kingdom ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REGISTERED: UK EU/1/21/1565(NI) 20210720; UK FURTHER MA ON IPSUM 20210720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.