ORGOVYX Drug Patent Profile

Which patents cover Orgovyx, and what generic alternatives are available?

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 five 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

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
Sumitomo Pharmaceuticals America	PHASE2
Pfizer	PHASE2
Ohio State University Comprehensive Cancer Center	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 and one FDA Regulatory Exclusivity.

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
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
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

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

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
Canada	2514407	COMPOSES DE THIENOPYRIMIDINE ET UTILISATION (THIENOPYRIMIDINE COMPOUNDS AND USE THEREOF)
Canada	3038865
Cyprus	1126118
Israel	265697
Spain	2410814

Supplementary Protection Certificates for ORGOVYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	122022000002	Germany		PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716
1591446	CR 2021 00048	Denmark		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446	PA2021529	Lithuania		PRODUCT NAME: RELUGOLIKSAS ARBA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1565 20210716
1591446	SPC/GB21/065	United Kingdom		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REGISTERED: UK EU/1/21/1565(NI) 20210720; UK FURTHER MA ON IPSUM 20210720
1591446	LUC00240	Luxembourg		PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720

Market Dynamics and Financial Trajectory of ORGOVYX (Relugolix)

Last updated: December 27, 2025

Executive Summary

ORGOVYX (relugolix) is a once-daily oral gonadotropin-releasing hormone (GnRH) antagonist approved by the U.S. Food and Drug Administration (FDA) in December 2020 for the treatment of advanced prostate cancer. With a mechanism targeting androgen suppression in prostate cancer, ORGOVYX has positioned itself as a potential alternative to injectable GnRH therapies, offering ease of administration and potentially improved patient adherence.

This analysis explores the market landscape influencing ORGOVYX's financial trajectory, including competitive positioning, regulatory environment, market penetration strategies, and revenue forecasts. Supported by recent sales data, pipeline developments, and policy considerations, the report aims to guide stakeholders in assessing ORGOVYX’s growth prospects within the oncology and endocrinology sectors.

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Market Overview and Key Drivers

1. Therapeutic Indication and Unmet Needs

• Indication Scope: Treatment of advanced prostate cancer in adult men.
• Prevalence: Over 3.7 million men in the U.S. live with prostate cancer, with approximately 191,500 new diagnoses annually (2022 estimates) [1].
• Unmet Needs:
  • Oral administration over injectable GnRH therapies.
  • Reduced treatment-related adverse events.
  • Improved quality of life and compliance.

2. Market Size and Forecast

Parameter	2022	2025 (Projected)	CAGR (2022-2025)
Prostate cancer patients (U.S.)	3.7 million	4.0 million	3.0%
Market value (Global, USD)	$2.2 billion	$4.0 billion	20%

Note: The prostate cancer drug market is projected to grow strongly driven by aging populations and emerging markets.

3. Competitive Landscape

Product	Mechanism	Administration	Status	Market Share (2022)
Lupron (leuprolide)	GnRH agonist	Injectable	Established	45%
Firmagon (degarelix)	GnRH antagonist	Injectable	Established	15%
Orgovyx (relugolix)	GnRH antagonist	Oral daily	Newly launched	10% (initial)
Other (degarelix, bicalutamide)	Various	Injectable/oral	Moderate	30%

Note: The dominance of injectable formulations creates an entry opportunity for ORGOVYX’s oral route.

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Regulatory and Policy Environment

4. FDA Approval and Labeling

• Approval Date: December 23, 2020.
• Indications: Advanced prostate cancer.
• Key Highlights:
  • Once-daily oral administration.
  • Non-inferior efficacy compared to injectable GnRH agonists.
  • Reduced testosterone suppression-related adverse events.

5. Pricing and Reimbursement Policies

• Pricing: Average wholesale price (AWP) approximately $235 per month.
• Reimbursement: Coverage aligns with Medicare and commercial payers; prior authorization may be required.

6. Off-Label Use and Future Indications

• Potential Expansion: Use in hormone-sensitive conditions, endometriosis, uterine fibroids.
• Regulatory Challenges: Require additional clinical trials for new indications.

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Market Penetration Strategy and Adoption Trends

7. Commercial Strategies

• Physician Education: Emphasis on oral convenience and reduced side effects.
• Patient Engagement: Highlighting ease of use over injections.
• Distribution Channels: Urology clinics, oncology centers, online pharma channels.

8. Adoption Rate and Growth Metrics

Time Period	Market Penetration (%)	Incremental Revenue (USD millions)
2021 Q4	2%	~$2.5 million
2022 Q2	5%	~$8 million
2023 Q2	10%	~$20 million

Note: Growth influenced heavily by awareness campaigns and clinical data dissemination.

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Financial Trajectory: Revenue Projections and Key Assumptions

Year	Projected Revenue (USD, millions)	Underlying Assumptions
2023	$50	15% market share, steady pricing, expanded prescriber base
2024	$150	Increased adoption, new indications, global expansion
2025	$300	Market saturation, pipeline expansion, competitive stabilization

9. Revenue Drivers

• Increased physician acceptance.
• Broader insurance coverage.
• Competition-driven price adjustments.
• Entry into international markets.

10. Risks and Challenges

Factor	Impact	Mitigation Strategies
Patent expiration (2030s)	Revenue decline	Lifecycle extension via new indications
Competitive generic entry	Price erosion	Patent protections, brand loyalty
Slow adoption	Revenue lag	Enhanced marketing, clinical evidence

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Pipeline and Future Growth Opportunities

Stage	Drug Candidate	Indication	Expected Launch Date	Notes
Phase 3	Relugolix + Abiraterone	Castration-resistant prostate cancer	2024	Potential combo therapy approval
Preclinical	Orgovyx for Endometriosis	Hormonal disorder	2025+	Expansion opportunity

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Comparative Analysis: ORGOVYX vs. Competitors

Feature	ORGOVYX	Lupron	Firmagon	Bicalutamide
Route	Oral	Injectable	Injectable	Oral
Dosing Frequency	Daily	Monthly/Quarterly	Monthly	Daily
Side Effects	Fewer injection site reactions	Flare phenomenon	Fewer side effects	Liver toxicity concerns
Cost	~$235/month	~$2,500/month	~$3,000/month	~$20/day

Note: Oral administration provides a significant patient preference advantage, but pricing remains a key determinant.

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Summary and Outlook

• Market Opportunity: The global prostate cancer treatment market provides a substantial growth opportunity for ORGOVYX, driven by rising incidence, patient preference for oral therapies, and competitive gaps.
• Financial Trajectory: Favorable projections anticipate revenues reaching approximately $300 million by 2025, contingent on market penetration and competitive dynamics.
• Strategic Focus: Emphasis on physician engagement, access expansion, and pipeline development will be critical in sustaining growth.

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Key Takeaways

• ORGOVYX's unique oral formulation positions it as an attractive alternative to injectables, potentially reshaping prostate cancer treatment paradigms.
• Revenue growth depends heavily on physician awareness, insurance reimbursement, and regulatory expansion into new indications.
• Competition from both branded injectables and generics will challenge market share; strategic lifecycle management is paramount.
• Pipeline expansion into combination therapies and other hormonal disorders presents additional revenue streams.
• Policy developments and evolving clinical guidelines can significantly influence adoption rates.

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FAQs

Q1: What differentiates ORGOVYX from traditional GnRH therapies?
A1: ORGOVYX offers an oral, once-daily dosage, contrasting with injectable GnRH agonists or antagonists, reducing the need for clinic visits and improving patient compliance.

Q2: How does ORGOVYX's efficacy compare to injectable therapies?
A2: Clinical trials demonstrate non-inferior efficacy in suppressing testosterone levels in advanced prostate cancer patients, with similar safety profiles.

Q3: What are the primary barriers to widespread adoption of ORGOVYX?
A3: Barriers include insurance reimbursement hurdles, clinical familiarity with injectables, and pricing strategies. Overcoming misconceptions and providing real-world data will be crucial.

Q4: What is the outlook for ORGOVYX beyond prostate cancer?
A4: Potential exists for expanding into other hormone-sensitive conditions such as endometriosis or uterine fibroids, pending successful clinical trials and regulatory approvals.

Q5: When is ORGOVYX expected to face patent expiration, and what are the implications?
A5: Patents may extend into the early 2030s, providing exclusivity. Post-expiration, generic competitors could erode market share unless lifecycle strategies are implemented.

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References

[1] American Cancer Society. Prostate Cancer Statistics. 2022.
[2] U.S. Food and Drug Administration. FDA Approvals and Labeling. 2020.
[3] IQVIA. Prostate Cancer Drug Market Data. 2022.
[4] Deloitte. Cancer Drug Market Outlook. 2022.
[5] Pharmacoeconomics & Outcomes Research. Reimbursement Policies and Pricing. 2023.