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Last Updated: January 30, 2023

Relugolix - Generic Drug Details


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What are the generic sources for relugolix and what is the scope of patent protection?

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.

Relugolix has one hundred patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for relugolix
International Patents:100
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 46
Clinical Trials: 23
Patent Applications: 225
What excipients (inactive ingredients) are in relugolix?relugolix excipients list
DailyMed Link:relugolix at DailyMed
Recent Clinical Trials for relugolix

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ChicagoPhase 4
Myovant Sciences GmbHPhase 4
Emory UniversityPhase 4

See all relugolix clinical trials

US Patents and Regulatory Information for relugolix

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Myovant Sciences ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Myovant Sciences ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Myovant Sciences ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for relugolix

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Accord Healthcare S.L.U. Orgovyx relugolix EMEA/H/C/005353
Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.,
Authorised no no no 2022-04-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for relugolix

Country Patent Number Title Estimated Expiration
Japan 4039574 See Plans and Pricing
Russian Federation 2331648 СОЕДИНЕНИЯ ТИЕНОПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ (THIENOPYRIMIDINE COMPOUNDS AND THEIR APPLICATION) See Plans and Pricing
Argentina 109759 MÉTODOS PARA TRATAR FIBROIDES UTERINOS Y ENDOMETRIOSIS Y USO See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for relugolix

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591446 21C1056 France See Plans and Pricing PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446 LUC00240 Luxembourg See Plans and Pricing PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
1591446 CR 2021 00048 Denmark See Plans and Pricing PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Merck
Mallinckrodt
Express Scripts
Dow

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.