estradiol; norethindrone acetate; relugolix - Profile
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What are the generic drug sources for estradiol; norethindrone acetate; relugolix and what is the scope of patent protection?
Estradiol; norethindrone acetate; relugolix
is the generic ingredient in one branded drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Estradiol; norethindrone acetate; relugolix has one hundred and seventy-three patent family members in forty countries.
Summary for estradiol; norethindrone acetate; relugolix
| International Patents: | 173 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for estradiol; norethindrone acetate; relugolix |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for estradiol; norethindrone acetate; relugolix
Generic Entry Date for estradiol; norethindrone acetate; relugolix*:
Constraining patent/regulatory exclusivity:
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.
Paragraph IV (Patent) Challenges for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MYFEMBREE | Tablets | estradiol; norethindrone acetate; relugolix | 1 mg/0.5 mg/40 mg | 214846 | 1 | 2024-12-18 |
US Patents and Regulatory Information for estradiol; norethindrone acetate; relugolix
Expired US Patents for estradiol; norethindrone acetate; relugolix
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sumitomo Pharma Am | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | 8,058,280 | ⤷ Start Trial |
| Sumitomo Pharma Am | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | 9,346,822 | ⤷ Start 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 |
|---|---|---|---|
| Australia | 2017336338 | ⤷ Start Trial | |
| Taiwan | 201906847 | ⤷ Start Trial | |
| Croatia | P20190729 | ⤷ Start Trial | |
| Norway | 20053974 | ⤷ Start Trial | |
| European Patent Office | 1591446 | Composés de thienopyrimidine et utilisation (Thienopyrimidine compounds and use thereof) | ⤷ Start 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 |
|---|---|---|---|---|
| 1453521 | CA 2016 00016 | Denmark | ⤷ Start Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1453521 | 93156 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1591446 | 2022C/501 | Belgium | ⤷ Start Trial | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
| 1591446 | 301158 | Netherlands | ⤷ Start Trial | PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720 |
| 1453521 | C201630040 | Spain | ⤷ Start Trial | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
