ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX - Generic Drug Details

✉ Email this page to a colleague

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 Myovant Sciences 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
Myovant Sciences GmbH	Phase 4
University of Chicago	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Myovant Sciences	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Myovant Sciences	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Myovant Sciences	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Myovant Sciences	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Myovant Sciences	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Myovant Sciences	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

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Lithuania	3518933		⤷ Sign Up
Argentina	109762	TRATAMIENTO DE CÁNCER DE PRÓSTATA, FORMULACIÓN ORAL	⤷ Sign Up
Canada	2881132	PROCEDE DE PRODUCTION D'UN DERIVE DE THIENOPYRIMIDINE (PRODUCTION METHOD OF THIENOPYRIMIDINE DERIVATIVE)	⤷ Sign Up
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)	⤷ Sign Up
Israel	265696	שיטות לטיפול באי-פוריות של אשה (Methods of treating female infertility)	⤷ Sign Up
Russian Federation	2331648	СОЕДИНЕНИЯ ТИЕНОПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ (THIENOPYRIMIDINE COMPOUNDS AND THEIR APPLICATION)	⤷ Sign Up
Slovenia	1591446		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	97C0002	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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	2022C/501	Belgium	⤷ Sign Up	PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1453521	93156	Luxembourg	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0398460	12/2004	Austria	⤷ Sign Up	PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1591446	122022000002	Germany	⤷ Sign Up	PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716
1591446	C202130069	Spain	⤷ Sign Up	PRODUCT NAME: RELUGOLIX O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF 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

Make Better Decisions: Try a trial or see plans & pricing

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.