Last Updated: November 4, 2026

Relugolix - Generic Drug Details

Name: Relugolix Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for relugolix and what is the scope of freedom to operate?

Relugolix is the generic ingredient in one branded drug marketed by Sumitomo Pharma Am and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Relugolix

International Patents:	190
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	48
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Relugolix
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

Sponsor	Phase
University of Michigan	PHASE3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE3
University of Utah	PHASE2

See all Relugolix clinical trials

Generic filers with tentative approvals for RELUGOLIX

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	120MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for Relugolix

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

Anatomical Therapeutic Chemical (ATC) Classes for Relugolix

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for RELUGOLIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORGOVYX	Tablets	relugolix	120 mg	214621	6	2024-12-18

US Patents and Regulatory Information for Relugolix

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial		Y		⤷ Start Trial
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for Relugolix

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020	⤷ Start Trial	⤷ Start Trial
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for Relugolix

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Orgovyx	relugolix	EMEA/H/C/005353Orgovyx 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

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Country	Patent Number	Title	Estimated Expiration
Australia	2016224503		⤷ Start Trial
Brazil	112017018173		⤷ Start Trial
Canada	2978223		⤷ Start Trial
China	107249590		⤷ Start Trial
Cyprus	1126118		⤷ Start Trial
Denmark	3263110		⤷ Start Trial
Denmark	4233847		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for Relugolix

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	SPC/GB21/065	United Kingdom	⤷ Start Trial	PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REGISTERED: UK EU/1/21/1565(NI) 20210720; UK FURTHER MA ON IPSUM 20210720
1591446	LUC00240	Luxembourg	⤷ Start Trial	PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720
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	132021000000188	Italy	⤷ Start Trial	PRODUCT NAME: RELUGOLIX O UN SUO SALE(RYEQO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1565, 20210720
1591446	21C1056	France	⤷ Start Trial	PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	2190051-9	Sweden	⤷ Start Trial	PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446	C 2021 047	Romania	⤷ Start Trial	PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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