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Last Updated: February 26, 2024

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-one 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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  Try a Trial

Summary for MYFEMBREE
International Patents:131
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
Drug Prices for MYFEMBREE

See drug prices for MYFEMBREE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MYFEMBREE
Generic Entry Date for MYFEMBREE*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035
NDA:
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

SponsorPhase
University of ChicagoPhase 4
Myovant Sciences GmbHPhase 4
Myovant Sciences GmbHPhase 3

See all MYFEMBREE clinical trials

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

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
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 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

International Patents for MYFEMBREE

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

Country Patent Number Title Estimated Expiration
Israel 300071 טיפול בסרטן הערמונית (Treatment of prostate cancer) ⤷  Try a Trial
Lithuania PA2021529 ⤷  Try a Trial
Colombia 5590921 COMPUESTOS DE TIENOPIRIMIDINA Y USOS DE LOS MISMOS ⤷  Try a Trial
Hungary S2100052 ⤷  Try a Trial
Taiwan 201815409 Methods of treating female infertility ⤷  Try a Trial
Portugal 2900675 ⤷  Try a Trial
Japan 2019529575 子宮筋腫及び子宮内膜症を治療する方法 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MYFEMBREE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 21C1056 France ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446 122022000002 Germany ⤷  Try a Trial PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716
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
1453521 15C0050 France ⤷  Try a Trial 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 LUC00240 Luxembourg ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1591446 301158 Netherlands ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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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.