Relugolix - Generic Drug Details

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

Relugolix has one hundred and ninety patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for relugolix

International Patents:	190
US Patents:	11
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for relugolix

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

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

See all relugolix clinical trials

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

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			Y	Y
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes			Y	Y
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes			Y
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes

Expired US Patents for relugolix

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

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/005353Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.	Authorised	no	no	no	2022-04-29

International Patents for relugolix

Country	Patent Number	Title	Estimated Expiration
Portugal	1591446
Australia	2017336338
Taiwan	I602819
Hungary	E062269
Israel	300071	טיפול בסרטן הערמונית (Treatment of prostate cancer)

Supplementary Protection Certificates for relugolix

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	132021000000188	Italy		PRODUCT NAME: RELUGOLIX O UN SUO SALE(RYEQO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1565, 20210720
1591446	CA 2021 00048	Denmark		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446	21C1056	France		PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	51/2021	Austria		PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 (MITTEILUNG) 20210720
1591446	2190051-9	Sweden		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720

Market Dynamics and Financial Trajectory for RELUGOLIX

Last updated: February 25, 2026

Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist developed by Takeda Pharmaceuticals. Approved for certain gynecological conditions, it targets hormone-dependent diseases such as uterine fibroids and prostate cancer. Its market prospects depend on competitive positioning, indications, regulatory status, and reimbursement frameworks.

Market Entry and Regulatory Status

Relugolix received U.S. Food and Drug Administration (FDA) approval in 2020 for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The European Medicines Agency (EMA) approved the drug in 2021 for similar indications. Additional approvals are pending or sought in markets like Japan, China, and other regions.

Market Size and Growth Drivers

Uterine Fibroids

The global uterine fibroids market was valued at approximately USD 1.1 billion in 2021. It is forecasted to reach USD 1.7 billion by 2028, with a compounded annual growth rate (CAGR) of 6.1%. The increasing prevalence of fibroids—affecting an estimated 20-80% of women by age 50—and a limited number of effective non-surgical therapies support organic growth.

Prostate Cancer

Relugolix’s approval for advanced prostate cancer in 2022 positions it as a competitor to established GnRH agonists. The prostate cancer therapeutics market exceeds USD 9 billion globally, with GnRH antagonists capturing a significant share. The rapid adoption of oral therapies over injectables favors relugolix.

Market Drivers

• Preference for oral medications over injectables.
• Patient compliance improvements.
• Reduced need for surgical interventions.
• Expanding indications and pipeline drugs.

Market Barriers

• Competition from established GnRH antagonists such as relugolix’s rivals, including degarelix.
• Reimbursement and insurance coverage barriers.
• Limited long-term safety data compared to existing standards.

Competitive Landscape

Major competitors include:

• AbbVie’s Orilissa (elagolix): Primarily for endometriosis and fibroids.
• Pfizer’s Lutropin (for other indications).
• Debilitating price competition and entry of generics post-patent expiry.

Takeda’s strategic advantage hinges on oral administration, a critical differentiator from injectable competitors.

Revenue Projections and Financial Trajectory

2022–2028 Revenue Estimates

Year	Estimated Revenue (USD Million)	Key Assumptions
2022	300	Initial commercialization, early adoption in fibroid market.
2023	450	Broader regional uptake, expanding prostate cancer indications.
2024	600	Growing market awareness and pipeline expansion.
2025	900	Increased adoption, potential multiple indications approval.
2026	1,200	Market penetration stabilizes; competition influences growth.
2027	1,400	New formulations or combination therapies introduced.
2028	1,700	Peak revenue within forecast window, moderated by competition.

Profitability Factors

• Launch costs and sales and marketing expenses affect margins initially.
• Patent expiration anticipated around 2030, risking generic competition.
• Pricing strategies and reimbursement negotiations will impact revenue per unit.

Risks Impacting Financial Trajectory

• Regulatory Risks: Approval delays or denials in key markets.
• Competitive Risks: Entry of new oral GnRH antagonists or biosimilars.
• Market Adoption: Physician and patient acceptance slowdowns.
• Pricing Pressures: Payers demanding discounts, affecting margins.

Strategic Opportunities

• Expanding indications to hormone-dependent cancers.
• Developing combination therapies with other hormonal agents.
• Geographic expansion into emerging markets with rising healthcare access.

Key Takeaways

• Relugolix’s market potential focuses on multiple hormone-dependent conditions.
• The drug benefits from the shift toward oral therapies against injectables.
• Revenue growth is forecasted at approximately 22% CAGR from 2022–2028.
• Competitive pressures and patent cliffs pose significant risks.
• Opportunities exist in expanding indications and geographies.

FAQs

1. What are the primary indications for relugolix?

Relugolix is approved for heavy menstrual bleeding associated with uterine fibroids and advanced prostate cancer.

2. How does relugolix compare to competitors in the GnRH antagonist market?

Relugolix offers oral administration, which provides a convenience advantage over injectable competitors like degarelix, potentially enhancing patient adherence.

3. What is the competitive outlook for relugolix’s revenue?

Forecasted to reach USD 1.7 billion by 2028 assuming steady adoption and approval for additional indications with a 22% CAGR.

4. What risks could impact relugolix’s market success?

Regulatory delays, competitive biosimilar entries, pricing pressures, and limited long-term safety data are primary risks.

5. What are the key growth opportunities for relugolix?

Expanding into additional hormone-dependent diseases, developing combination therapies, and entering emerging markets.

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Sources

[1] MarketWatch. (2022). Uterine Fibroids Market Size & Forecast.
[2] GlobalData. (2022). Prostate Cancer Therapeutics Market Analysis.
[3] U.S. Food and Drug Administration. (2020). FDA Approval Announcement for Relugolix.
[4] European Medicines Agency. (2021). EMA Approval for Relugolix.