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^: ⤷ Sign Up* 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
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				⤷ 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
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

Expired US Patents for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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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

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Country	Patent Number	Title	Estimated Expiration
Canada	2514407	COMPOSES DE THIENOPYRIMIDINE ET UTILISATION (THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF)	⤷ Sign Up
Australia	2023200731	Methods of treating female infertility	⤷ Sign Up
Japan	2022020827	女性不妊の治療方法	⤷ Sign Up
Hungary	E044048		⤷ Sign Up
Norway	20053974		⤷ Sign Up
Taiwan	202300169	Methods of treating female infertility	⤷ Sign Up
>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	15C0050	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1591446	CR 2021 00048	Denmark	⤷ Sign Up	PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446	SPC/GB21/065	United Kingdom	⤷ Sign Up	PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REGISTERED: UK EU/1/21/1565(NI) 20210720; UK FURTHER MA ON IPSUM 20210720
1591446	301158	Netherlands	⤷ Sign Up	PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	2022C/501	Belgium	⤷ Sign Up	PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1453521	122015000093	Germany	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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