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 Sumitomo Pharma and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and thirty-nine patent family members in thirty-five 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 was eligible for patent challenges on December 18, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 28, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for MYFEMBREE?
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Summary for MYFEMBREE
International Patents: | 139 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 3 |
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
Generic Entry Date for MYFEMBREE*:
Constraining patent/regulatory exclusivity:
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 |
---|---|
University of Chicago | Phase 4 |
Myovant Sciences GmbH | 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 ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Expired US Patents for MYFEMBREE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | ⤷ Try for Free | ⤷ Try for Free |
>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 |
---|---|---|---|
Morocco | 46361 | ⤷ Try for Free | |
Spain | 2913753 | ⤷ Try for Free | |
Eurasian Patent Organization | 201990857 | СПОСОБЫ ЛЕЧЕНИЯ МИОМЫ МАТКИ И ЭНДОМЕТРИОЗА | ⤷ Try for Free |
Japan | 2023029608 | 女性不妊の治療方法 | ⤷ Try for Free |
Canada | 2514407 | COMPOSES DE THIENOPYRIMIDINE ET UTILISATION (THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF) | ⤷ Try for Free |
Canada | 3038875 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYFEMBREE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1591446 | 2022C/501 | Belgium | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
1591446 | CA 2021 00048 | Denmark | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720 |
1453521 | CA 2016 00016 | Denmark | ⤷ Try for Free | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
0334429 | 97C0002 | Belgium | ⤷ Try for Free | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
1591446 | 122022000002 | Germany | ⤷ Try for Free | PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716 |
1453521 | 300814 | Netherlands | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for MYFEMBREE
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