MYFEMBREE Drug Patent Profile
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Which patents cover Myfembree, and when can generic versions of Myfembree launch?
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
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MYFEMBREE
*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 |
Pharmacology for MYFEMBREE
Anatomical Therapeutic Chemical (ATC) Classes for MYFEMBREE
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 ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035
Exclusivity Expiration: ⤷ Sign Up
FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
Exclusivity Expiration: ⤷ 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 | 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 | ||||
| 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 | |||
| >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
| 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 MYFEMBREE
See the table below for patents covering MYFEMBREE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2331648 | СОЕДИНЕНИЯ ТИЕНОПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ (THIENOPYRIMIDINE COMPOUNDS AND THEIR APPLICATION) | ⤷ Sign Up |
| Lithuania | 2900675 | ⤷ Sign Up | |
| Canada | 3038875 | TRAITEMENT DU CANCER DE LA PROSTATE (TREATMENT OF PROSTATE CANCER) | ⤷ Sign Up |
| Portugal | 1591446 | ⤷ Sign Up | |
| Japan | 2019529573 | 女性不妊の治療方法 | ⤷ Sign Up |
| Australia | 2022241582 | Methods of treating uterine fibroids and endometriosis | ⤷ Sign Up |
| Taiwan | 202300169 | Methods of treating female infertility | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYFEMBREE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1591446 | LUC00240 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
| 1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1214076 | C01214076/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 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 |
| 1591446 | C 2021 047 | Romania | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716 |
| 0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1453521 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| >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.
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