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 seven 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MYFEMBREE?
- What are the global sales for MYFEMBREE?
- What is Average Wholesale Price for MYFEMBREE?
Summary for MYFEMBREE
International Patents: | 134 |
US Patents: | 7 |
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 |
![MYFEMBREE drug patent expirations Drug patent expirations by year for MYFEMBREE](/p/graph/s/t/MYFEMBREE-patent-expirations.png)
![Drug Prices for MYFEMBREE](/p/graph/drug-price/MYFEMBREE.png)
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
Sponsor | Phase |
---|---|
Myovant Sciences GmbH | Phase 4 |
University of Chicago | Phase 4 |
Myovant Sciences GmbH | Phase 3 |
Pharmacology for MYFEMBREE
US Patents and Regulatory Information for MYFEMBREE
MYFEMBREE is protected by seven 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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
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 | 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 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 |
---|---|---|---|
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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYFEMBREE
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |