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Last Updated: April 27, 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-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:	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^: ⤷ Try a Trial* 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

Drug Class	Estrogen Gonadotropin Releasing Hormone Receptor Antagonist Progestin
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Estrogen Receptor Agonists Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

Anatomical Therapeutic Chemical (ATC) Classes for estradiol; norethindrone acetate; relugolix

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for estradiol; norethindrone acetate; relugolix

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Glossary

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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
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

Expired US Patents for estradiol; norethindrone acetate; relugolix

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Myovant Sciences	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for estradiol; norethindrone acetate; relugolix

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Country	Patent Number	Title	Estimated Expiration
Japan	2008094846	THIENOPYRIMIDINE COMPOUND AND APPLICATION THEREOF	⤷ Try a Trial
Australia	2023201047	Treatment of prostate cancer	⤷ Try a Trial
Israel	265696	שיטות לטיפול באי-פוריות של אשה (Methods of treating female infertility)	⤷ Try a Trial
New Zealand	541772	Thienopyrimidine compounds and use thereof	⤷ Try a Trial
Spain	2724206		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for estradiol; norethindrone acetate; relugolix

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C201630040	Spain	⤷ Try a 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
1591446	51/2021	Austria	⤷ Try a Trial	PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 (MITTEILUNG) 20210720
1453521	93156	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1591446	122022000002	Germany	⤷ Try a Trial	PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716
1591446	C 2021 047	Romania	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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