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Last Updated: February 22, 2024

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 Sumitomo Pharma and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Relugolix has one hundred and fifty-eight patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for relugolix
International Patents:158
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 26
Patent Applications: 225
What excipients (inactive ingredients) are in relugolix?relugolix excipients list
DailyMed Link:relugolix at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for relugolix
Generic Entry Date for 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.

Recent Clinical Trials for relugolix

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

SponsorPhase
PfizerPhase 2
Dana-Farber Cancer InstitutePhase 2
Myovant Sciences GmbHPhase 2

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
Sumitomo Pharma ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Sumitomo Pharma ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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

Supplementary Protection Certificates for relugolix

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591446 301158 Netherlands ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446 CA 2021 00048 Denmark ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446 CR 2021 00048 Denmark ⤷  Try a Trial PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446 132021000000188 Italy ⤷  Try a Trial PRODUCT NAME: RELUGOLIX O UN SUO SALE(RYEQO); AUTHORISATION NUMBER(S) AND DATE(S): 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

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.