ORGOVYX Drug Patent Profile

When do Orgovyx patents expire, and when can generic versions of Orgovyx launch?

Orgovyx is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ORGOVYX is relugolix. One supplier is listed for this compound. Additional details are available on the relugolix profile page.

DrugPatentWatch^® Generic Entry Outlook for Orgovyx

Orgovyx was eligible for patent challenges on December 18, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2036. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ORGOVYX

International Patents:	190
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	10
Patent Applications:	410
Drug Prices:	Drug price information for ORGOVYX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORGOVYX
What excipients (inactive ingredients) are in ORGOVYX?	ORGOVYX excipients list
DailyMed Link:	ORGOVYX at DailyMed

See drug prices for ORGOVYX

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

Constraining patent/regulatory exclusivity:

10,350,170

NDA:

214621

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 ORGOVYX

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

Sponsor	Phase
Pfizer	PHASE2
Ohio State University Comprehensive Cancer Center	PHASE2
Myovant Sciences GmbH	PHASE2

See all ORGOVYX clinical trials

Pharmacology for ORGOVYX

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

Paragraph IV (Patent) Challenges for ORGOVYX

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

US Patents and Regulatory Information for ORGOVYX

ORGOVYX is protected by eleven US patents.

This potential generic entry date is based on patent 10,350,170.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	12,144,809
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	7,300,935			Y
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	12,097,198
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	11,795,178		Y	Y
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	11,583,526
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	12,336,990
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	10,786,501

Expired US Patents for ORGOVYX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020	8,058,280
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020	8,735,401

EU/EMA Drug Approvals for ORGOVYX

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 ORGOVYX

When does loss-of-exclusivity occur for ORGOVYX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

San Marino

Serbia

Slovenia

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORGOVYX around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1591446
Australia	2017336338
Taiwan	I602819
Hungary	E062269
Israel	300071	טיפול בסרטן הערמונית (Treatment of prostate cancer)
Cyprus	1121641
Canada	3038875

Supplementary Protection Certificates for ORGOVYX

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
1591446	301158	Netherlands		PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	C202130069	Spain		PRODUCT NAME: RELUGOLIX O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716

Market Dynamics and Financial Trajectory for ORGOVYX

Last updated: February 19, 2026

What Is the Current Market Position of ORGOVYX?

ORGOVYX (relugolix), developed by Astellas Pharma, was approved by the FDA in December 2020 for the treatment of advanced prostate cancer. It is a hormone therapy that acts as a GnRH receptor antagonist, offering an oral alternative to injectable therapies.

As of early 2023, ORGOVYX's global sales reach approximately $400 million, with the US accounting for 85% of revenue. The drug faces competition mainly from injectable GnRH antagonists such as degarelix, which held a dominant market share before oral options entered.

How Does ORGOVYX Fit Into the Urological Market?

The prostate cancer drug market is valued at around $3 billion globally (ICR, 2022). ORGOVYX operates within this segment by targeting hormone-sensitive advanced prostate cancer, which accounts for roughly 70% of prostate cancer cases worldwide (WHO, 2021).

The drug's advantages include oral administration, reduced injection site reactions, and fewer cardiovascular side effects compared to GnRH agonists. These factors improve patient adherence and quality of life, influencing prescribing behaviors.

What Are the Growth Drivers and Barriers?

Drivers:

• Competitive Edge: Oral administration increases patient compliance, favored over injectables.
• Label Expansion: Clinical trials are exploring ORGOVYX's application in other indications, including premenopausal women with endometriosis.
• Market Penetration: Increasing adoption driven by urologists' and oncologists’ acceptance.

Barriers:

• Established Competitors: Injectable GnRH antagonists like degarelix have a longstanding market presence.
• Pricing and Reimbursement: Cost-effectiveness and insurance coverage influence uptake.
• Physician Familiarity: Preference for proven injectable therapies may slow adoption.

What Are the Sales Projections?

Astellas projects ORGOVYX will generate sales exceeding $500 million annually by 2025, assuming a compound annual growth rate (CAGR) of 20% from 2022.

Yearly sales estimates:

Year	Projected Revenue	CAGR
2023	$480 million	20%
2024	$576 million	20%
2025	$691 million	20%

Initial growth in 2022-2023 benefits from increased physician awareness and expanded formulary access. Post-2024, growth is expected to slow amid market saturation and competition.

What Are the R&D and Regulatory Future Plans?

Astellas is pursuing clinical development to expand ORGOVYX’s indications:

• Preliminary trials in combination therapies for prostate cancer.
• Investigational use for endometriosis and other hormone-dependent conditions in women.

Regulatory filings for these indications could occur by 2024-2025, potentially broadening the market.

How Does Pricing Impact Revenue?

ORGOVYX is priced at approximately $17 per daily dose in the US, with annual treatment costs around $6,200. This pricing aligns with oral prostate cancer therapies but remains competitive relative to injectable options, which can cost over $12,000 annually.

Insurance coverage is robust, supported by CMS and major payers, facilitating rapid adoption among eligible patients.

What Are the Competitive and Market Risks?

• Entrance of biosimilars or generic hormone therapies could pressure prices.
• Price sensitivity among payers may limit reimbursement.
• Potential regulatory delays in expanding indications could slow revenue growth.
• Clinical trial failure in projected indications could reduce future market potential.

Key Market and Financial Insights Summary

• Market size: ~$3 billion global prostate cancer drug market.
• Current sales: ~$400 million (2022), with a growth trajectory toward $500 million+ by 2025.
• Market share: Predominantly US-based; expanding globally.
• Growth Drivers: Oral administration, label expansion.
• Barriers: Established injectable competitors, reimbursement policies, physician resistance.

Key Takeaways

• ORGOVYX has established a significant foothold in the advanced prostate cancer market, with high growth potential driven by patient preference and expanded label indications.
• Its revenue trajectory hinges on successful market penetration, competitive positioning, and regulatory approvals.
• Market risks include competitive pressures and reimbursement challenges, which could influence sales margins.

FAQs

1. What distinguishes ORGOVYX from injectable GnRH antagonists?
   ORGOVYX is an oral therapy offering similar efficacy with improved patient convenience and fewer side effects.

2. What is the primary market for ORGOVYX?
   US remains the main market, with increasing adoption expected in Europe and Japan.

3. Are there ongoing clinical trials for ORGOVYX in other indications?
   Yes, studies are exploring its use in breast cancer, endometriosis, and premenopausal hormone regulation.

4. How does pricing affect its market competitiveness?
   Its price (~$17/day) positions it favorably against injectables (~$30+/day), facilitating reimbursement.

5. What is the potential impact of biosimilars?
   Biosimilars could erode market share if priced aggressively and approved for indication overlap.

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References

[1] ICR. (2022). Global prostate cancer therapeutics market size, trends, and forecast.
[2] WHO. (2021). Global Cancer Observatory: Prostate Cancer Statistics.
[3] Astellas Pharma. (2022). ORGOVYX drug profile and sales forecast. [4] CMS. (2023). Reimbursement policies for prostate cancer therapies.