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-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: | 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
*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
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 | ⤷ 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 |
|---|---|---|---|
| China | 109053766 | 噻吩并嘧啶衍生物的制备方法 (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 |
| Portugal | 1591446 | ⤷ Sign Up | |
| Russian Federation | 2331648 | СОЕДИНЕНИЯ ТИЕНОПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ (THIENOPYRIMIDINE COMPOUNDS AND THEIR APPLICATION) | ⤷ Sign Up |
| Uruguay | 35058 | MÉTODO DE PRODUCCIÓN DE DERIVADO DE TIENOPIRIMIDINA | ⤷ Sign Up |
| China | 100360538 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYFEMBREE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1453521 | 39/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 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 |
| 0334429 | 97C0002 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
| 1591446 | 122022000002 | Germany | ⤷ Sign Up | PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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