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MYFEMBREE Drug Patent Profile

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When do Myfembree patents expire, and what generic alternatives are available?

Myfembree is a drug marketed by Myovant Sciences and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and thirty-four patent family members in thirty-four countries.

The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norethindrone acetate; relugolix profile page.

DrugPatentWatch^® Generic Entry Outlook for Myfembree

Myfembree will be eligible for patent challenges on December 18, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 27, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MYFEMBREE

International Patents:	134
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MYFEMBREE
What excipients (inactive ingredients) are in MYFEMBREE?	MYFEMBREE excipients list
DailyMed Link:	MYFEMBREE at DailyMed

Drug patent expirations by year for MYFEMBREE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYFEMBREE

Generic Entry Date for MYFEMBREE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 NDA: 214846 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 MYFEMBREE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Chicago	Phase 4
Myovant Sciences GmbH	Phase 4
Myovant Sciences GmbH	Phase 3

See all MYFEMBREE clinical trials

Pharmacology for MYFEMBREE

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 MYFEMBREE

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 MYFEMBREE

MYFEMBREE is protected by six US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MYFEMBREE is ⤷ Try a Trial.

This potential generic entry date is based on INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MYFEMBREE

Methods of treating uterine fibroids
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN

FDA Regulatory Exclusivity protecting MYFEMBREE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035
Exclusivity Expiration: ⤷ Try a Trial

FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
Exclusivity Expiration: ⤷ Try a Trial

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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	Y	Y		⤷ 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 MYFEMBREE

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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 MYFEMBREE

See the table below for patents covering MYFEMBREE around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2019529575	子宮筋腫及び子宮内膜症を治療する方法	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2014051164		⤷ Try a Trial
China	100360538		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MYFEMBREE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	51/2021	Austria	⤷ Try a Trial	PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 (MITTEILUNG) 20210720
1591446	2022C/501	Belgium	⤷ Try a Trial	PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1453521	C 2015 029	Romania	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description