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Last Updated: May 7, 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		Y		⤷ 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	Y	Y		⤷ 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
Russian Federation	2005127052	СОЕДИНЕНИЯ ТИЕНОПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ	⤷ Try a Trial
Spain	2912929		⤷ Try a Trial
New Zealand	752916	Methods of treating uterine fibroids and endometriosis	⤷ Try a Trial
Lithuania	3415517		⤷ Try a Trial
Serbia	58703	METODA PROIZVODNJE DERIVATA TIENOPIRIMIDINA (PRODUCTION METHOD OF THIENOPYRIMIDINE DERIVATIVE)	⤷ Try a Trial
Slovenia	2900675		⤷ Try a Trial
China	104703992	Production method of thienopyrimidine derivative	⤷ 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
1591446	672	Finland	⤷ Try a Trial
1453521	CA 2016 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1591446	LUC00240	Luxembourg	⤷ Try a Trial	PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1453521	39/2015	Austria	⤷ Try a 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
1453521	93156	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	122015000093	Germany	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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.