ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX - Generic Drug Details
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What are the generic sources for estradiol; norethindrone acetate; relugolix and what is the scope of freedom to operate?
Estradiol; norethindrone acetate; relugolix
is the generic ingredient in one branded drug marketed by Myovant Sciences and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Estradiol; norethindrone acetate; relugolix has one hundred and thirty-four patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
| International Patents: | 134 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 12 |
| DailyMed Link: | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Generic Entry Date for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 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 ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Chicago | Phase 4 |
| Myovant Sciences GmbH | Phase 4 |
| Myovant Sciences GmbH | Phase 1 |
See all ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX clinical trials
Pharmacology for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | I602819 | ⤷ Try a Trial | |
| Israel | 265697 | טיפול בסרטן הערמונית (Treatment of prostate cancer) | ⤷ Try a Trial |
| Australia | 2022241582 | Methods of treating uterine fibroids and endometriosis | ⤷ Try a Trial |
| Argentina | 110636 | MÉTODOS PARA TRATAR LA INFERTILIDAD FEMENINA | ⤷ Try a Trial |
| Portugal | 1591446 | ⤷ Try a Trial | |
| Taiwan | I778979 | ⤷ Try a Trial | |
| Hungary | E044048 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1380301 | 2009C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 1591446 | C202130069 | Spain | ⤷ Try a Trial | 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 | 122022000002 | Germany | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716 |
| 1591446 | 2022C/501 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
| 0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1591446 | LUC00240 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
| >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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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