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Last Updated: December 8, 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 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

SponsorPhase
University of ChicagoPhase 4
Myovant Sciences GmbHPhase 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
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 ⤷  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
>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; norethindrone acetate; relugolix

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 300814 Netherlands ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1380301 2009C/007 Belgium ⤷  Sign Up PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1591446 132021000000188 Italy ⤷  Sign Up PRODUCT NAME: RELUGOLIX O UN SUO SALE(RYEQO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1565, 20210720
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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