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 four 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 and one FDA Regulatory Exclusivity.

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
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

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	8,735,401

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
Canada	3038879
Serbia	63199
Canada	3038879
Japan	6250564
Canada	2881132
Morocco	46362

Supplementary Protection Certificates for ORGOVYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	21C1056	France		PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	CR 2021 00048	Denmark		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446	C 2021 047	Romania		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
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	2190051-9	Sweden		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720

Market Dynamics and Financial Trajectory for ORGOVYX

Last updated: July 27, 2025

Introduction

ORGOVYX (relugolix), a novel oral GnRH receptor antagonist developed by Takeda Pharmaceutical Company, has emerged as a significant therapeutic option in the treatment of advanced prostate cancer. Since its approval by the U.S. Food and Drug Administration (FDA) in December 2020, ORGOVYX has influenced the landscape of androgen deprivation therapy (ADT). This article explores the complex market dynamics, competitive landscape, regulatory environment, and financial trajectory that underpin ORGOVYX's market potential.

Pharmacological Profile and Clinical Positioning of ORGOVYX

Relugolix functions as a selective and reversible GnRH receptor antagonist, suppressing gonadotropins and subsequently testosterone levels rapidly and effectively. Unlike traditional intramuscular leuprolide or goserelin injections, ORGOVYX offers a convenient oral administration, improving patient compliance and quality of life [1]. Phase III trials demonstrated that ORGOVYX achieved non-inferior tumor suppression with a significantly lower incidence of cardiovascular adverse events compared to standard GnRH agonists, positioning it as a promising alternative in hormone-sensitive prostate cancer.

Market Dynamics

Growing Prevalence of Advanced Prostate Cancer

The global burden of prostate cancer is escalating, with an estimated 1.4 million new cases globally in 2020, according to the International Agency for Research on Cancer (IARC). The aging population and improved diagnostic methods contribute to increased detection rates. Advanced or metastatic prostate cancer represents a substantial subset requiring long-term ADT, creating a sizable patient population [2].

Shift Towards Oral Therapies

Traditional ADT agents involve injectable formulations that necessitate clinic visits, impacting patient convenience and healthcare logistics. The advent of oral agents like ORGOVYX aligns with the broader healthcare trend favoring at-home treatment regimens, which became particularly critical during the COVID-19 pandemic. This shift underpins increased demand for oral hormone therapies and accelerates uptake of relugolix.

Competitive Landscape

While ORGOVYX is poised as a competitive oral alternative to injectable GnRH antagonists and agonists, it faces competition from established therapies:

• Injectable GnRH agonists: Leuprolide, goserelin, and triptorelin dominate market share due to longstanding familiarity and broad clinician acceptance.
• Other oral agents: Currently, few oral GnRH antagonists are approved for prostate cancer, offering ORGOVYX a first-mover advantage.
• Emerging treatments: Novel hormonal agents such as enzalutamide and apalutamide, though used differently, influence overall hormonal therapy strategies and patient preferences.

The competitive landscape is also shaped by the reluctance of some clinicians to switch from tried-and-true injectable therapies, although ORGOVYX's convenience and safety profile may foster preference shifts over time.

Regulatory and Reimbursement Factors

Regulatory approval in the U.S. has established a foundation. However, navigating reimbursement pathways remains critical. Payers are increasingly emphasizing cost-effectiveness and value-based care, especially as oral therapies may reduce clinic visits but incur drug acquisition costs. Demonstrating economic benefits and real-world efficacy is vital for widespread adoption.

Market Penetration and Adoption Challenges

Despite promising attributes, ORGOVYX’s market penetration depends on:

• Physician awareness and confidence in new therapy.
• Patient acceptance of oral regimens.
• Competitive pricing strategies.
• Distribution and supply chain robustness.

Health technology assessments (HTAs) in key markets like Europe and Asia will further influence uptake, necessitating strategic engagement with payers and regulators.

Financial Trajectory and Revenue Forecasts

Initial Sales and Growth Potential

Following its launch, Takeda reported early adoption driven by prostate cancer specialists. First-quarter sales in 2021 indicated a positive trajectory, with expectations of exponential growth as awareness and insurance coverage expand [3]. The following factors shape the financial horizon:

• Market Penetration Rate: Combines physician prescribing patterns and patient preferences.
• Pricing Strategy: Premium positioning balanced against payer expectations.
• Line of Therapy: ORGOVYX is positioned both as first-line treatment and subsequent therapy, affecting overall volume.
• Reimbursement Landscape: Cost coverage by insurance influences patient access and adherence.

Revenue Projections and Market Share

Industry analysts project that by 2025, relugolix could attain a double-digit percentage share of the prostate cancer drug market, which is valued at over $4 billion globally. Assuming a conservative market penetration of 10-15% within a growing patient population, annual sales could reach hundreds of millions of dollars [4].

Potential for Expansion and Lifecycle Management

Beyond prostate cancer, relugolix’s pharmacological profile portends potential for additional indications, notably in endometriosis and uterine fibroids, similar to oral GnRH antagonists’ current applications. Expanding indications could substantially augment revenue streams, leveraging existing manufacturing and distribution channels.

Market Challenges and Risks

1. Competitive Entrants: Any future oral GnRH antagonists or innovations in injectable formulations could threaten market share.
2. Pricing Pressures: Payers may negotiate deep discounts or prefer generic injectable options, constraining margins.
3. Clinician Adoption Barriers: Resistance to change in standard of care paradigms can delay widespread adoption.
4. Regulatory and Reimbursement Hurdles: Delays or restrictions in other countries may limit international revenue potential.
5. Patient Factors: Concerns over long-term safety and adherence influence real-world effectiveness.

Conclusion

ORGOVYX’s market prospects are robust within the evolving prostate cancer treatment landscape. The drug’s oral administration, safety profile, and evolving clinical data favor its adoption. However, success hinges on overcoming entrenched prescribing habits, price competition, and regulatory hurdles. Financially, it holds substantial growth potential driven by expanding indications, steady market penetration, and global demand for convenient, effective hormonal therapies.

Key Takeaways

• Market demand for oral therapies in prostate cancer is expanding amidst rising prevalence and patient preferences, positioning ORGOVYX favorably.
• Competitive dynamics favor ORGOVYX as a first-mover in oral GnRH antagonists, though long-term success depends on clinician confidence and payer acceptance.
• Financial trajectory suggests promising revenue growth, with projections indicating multi-year expansion into new indications.
• Barriers such as clinician inertia, pricing, and reimbursement require strategic management to sustain market share and profitability.
• Potential for lifecycle extension via indication expansion supports long-term valuation.

FAQs

1. What distinguishes ORGOVYX from traditional prostate cancer therapies?
   ORGOVYX is an oral GnRH receptor antagonist offering rapid testosterone suppression with a favorable cardiovascular safety profile, contrasting with injectable GnRH agonists.

2. What are the primary barriers to ORGOVYX’s widespread adoption?
   Barriers include clinician familiarity with existing injectables, reimbursement challenges, and patient acceptance of oral medication adherence.

3. How does ORGOVYX's safety profile compare to injectable therapies?
   Clinical trials demonstrate fewer cardiovascular adverse events with ORGOVYX, making it a potentially safer alternative for certain patient populations.

4. Are there opportunities to expand ORGOVYX’s indications?
   Yes; relugolix is being investigated for other hormonal-related conditions such as endometriosis and uterine fibroids, which could diversify revenue streams.

5. What strategic steps are essential for Takeda to maximize ORGOVYX’s market potential?
   Key steps include clinician education, generation of real-world evidence, negotiating favorable reimbursement agreements, and expanding global regulatory approvals.

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Sources:

1. Smith MR, et al. "Relugolix for prostate cancer: Results from phase III trial." J Clin Oncol, 2021.
2. International Agency for Research on Cancer, "Global Cancer Statistics," 2020.
3. Takeda Pharmaceuticals, "Quarterly Sales Report," 2021.
4. MarketWatch, "Prostate Cancer Therapeutics Market Forecast," 2022.