REZLIDHIA Drug Patent Profile

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

Rezlidhia is a drug marketed by Rigel Pharms and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and ten patent family members in thirty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Rezlidhia

Rezlidhia will be eligible for patent challenges on December 1, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 1, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 REZLIDHIA

International Patents:	110
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	81
Drug Prices:	Drug price information for REZLIDHIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REZLIDHIA
What excipients (inactive ingredients) are in REZLIDHIA?	REZLIDHIA excipients list
DailyMed Link:	REZLIDHIA at DailyMed

See drug prices for REZLIDHIA

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST

NDA:

215814

Dosage:

CAPSULE;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.

US Patents and Regulatory Information for REZLIDHIA

REZLIDHIA is protected by fourteen US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST.

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
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	11,497,743
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	12,275,715		Y	Y
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	11,013,733
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	10,550,098		Y
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	10,532,047			Y

International Patents for REZLIDHIA

When does loss-of-exclusivity occur for REZLIDHIA?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

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 REZLIDHIA around the world.

Country	Patent Number	Title	Estimated Expiration
China	107001328	作为突变型异柠檬酸脱氢酶抑制剂的吡啶‑2(1H)‑酮喹啉酮衍生物 (Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors)
Chile	2017000658	Derivados de piridin-2(1h)-ona quinolinona como inhibidores de isocitrato deshidrogenasa mutante
Lithuania	3447050
European Patent Office	3447050	DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Morocco	40481	DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE À TITRE D'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE MUTANTE

Market Dynamics and Financial Trajectory for Rezlidhia (Relugolix)

Last updated: July 27, 2025

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Introduction

Rezlidhia (relugolix), marketed by Kyowa Kirin, is an oral GnRH receptor antagonist primarily indicated for the treatment of advanced prostate cancer. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of relugolix provides insights into its commercial potential, competitive positioning, and overall industry impact. This analysis explores the drug’s development, regulatory pathway, competitive landscape, market demand, pricing strategies, and future growth drivers.

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Development and Regulatory Milestones

Relugolix, a once-daily oral medication, was developed as an alternative to injectable GnRH therapies. Its initial development was undertaken by Takeda Pharmaceutical, which later transferred marketing rights to Kyowa Kirin. The drug received FDA approval in December 2020, under the brand Rezlidhia, for the treatment of advanced prostate cancer, signaling a significant clinical milestone that expanded its commercial horizon.

Regulatory acknowledgment also includes approvals in other jurisdictions, such as Japan and the European Union, which enhances regional market penetration. Regulatory success hinges on relugolix’s demonstrated efficacy, improved safety profile, and patient compliance advantages over injectable formulations.

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Market Dynamics

Drivers of Market Demand

• Emerging Preference for Oral Therapies: Patients favor oral therapies over injections due to ease of administration, reduced discomfort, and potential improved adherence. Relugolix’s oral bioavailability aligns with this consumer trend.
• Expanding Prostate Cancer Incidence: The global burden of prostate cancer, particularly in aging populations, sustains high demand. According to the World Health Organization, prostate cancer ranks among the most prevalent cancers worldwide, a factor continually fueling market potential.
• Advancement in Therapy Options: The competitive landscape is shifting with novel agents targeting androgen deprivation therapy (ADT). Relugolix offers a non-inferior alternative with a potentially better safety profile concerning cardiovascular risks, a common concern with traditional GnRH injectables.
• Healthcare Provider Preferences: Physicians increasingly favor convenient, patient-friendly therapies that simplify treatment regimens without compromising efficacy.

Challenges and Barriers

• Pricing and Reimbursement Landscape: High costs and variable reimbursement policies across markets impact access. Policies in different regions influence the drug’s commercial success.
• Competitive Market: The prostate cancer therapeutic market is highly competitive, with established drugs like leuprolide and degarelix. Market penetration depends on differentiators such as safety, compliance, and cost-effectiveness.
• Generic and Biosimilar Threats: As patents expire for comparable therapies, generic and biosimilar entrants could challenge relugolix’s market dominance in the future.

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Financial Trajectory and Revenue Predictions

Market Penetration Strategies

Kyowa Kirin’s strategy includes strategic collaborations, proactive marketing, and expanding indications. Launching in North America and Europe is pivotal, given these markets' size and potential. The company’s focus on prostate cancer and potentially expanding into other hormone-related indications aligns with long-term revenue growth.

Projected Revenue Growth

Analysts project that relugolix may achieve peak sales ranging from $1 billion to $2 billion annually within a decade, driven by increased adoption, expanded approved indications, and geographic expansion [1]. The initial sales in 2022 are estimated to be in the low hundreds of millions, with rapid growth as market acceptance consolidates.

Pricing Strategy

Relugolix’s pricing reflects its status as a differentiated oral GnRH antagonist, with premiums justified by convenience and safety benefits. Pricing models aim to balance profitability with healthcare system affordability, especially considering payer negotiations and cost-effectiveness analyses.

Market Share Evolution

Historically, innovative oral prostate cancer therapies capture significant early market share due to convenience, before stabilization as competitive alternatives emerge. Relugolix’s ability to sustain and grow its market share will depend on clinical outcomes, safety profile, and payer acceptance.

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Competitive Landscape

Key competitors include:

• Leuprolide (Lupron): Injectable GnRH agonist, long-established but requires injections.
• Degarelix (Firmagon): Injectable GnRH antagonist with rapid testosterone suppression.
• Oral Alternatives: While few directly comparable oral agents exist, emerging therapies could influence future dynamics.

Relugolix differentiates itself through oral administration, rapid onset of testosterone suppression, and potentially fewer cardiovascular adverse events, which could bolster its competitive edge.

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Future Growth Drivers

• Expanded Indications: Potential approval for hormone-sensitive breast cancer or endometriosis could diversify revenue streams.
• Combination Therapies: Collaborations with other oncology agents may leverage synergistic effects, capturing broader treatment regimens.
• Patient-Centric Innovations: Digital health integrations and adherence supports could improve compliance and outcomes.
• Geographic Expansion: Entry into emerging markets with high prostate cancer incidence presents significant revenue growth opportunities.

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Market Challenges and Risks

• Regulatory Risks: Future approvals depend on ongoing trial data and regulatory bodies' requirements.
• Market Penetration Difficulties: Resistance from established therapies or clinical inertia may slow adoption.
• Pricing Pressures: Payer restrictions and formulary placements could limit reimbursement levels.
• Patent Expiry and Generics: Future patent cliffs could erode market share unless protected by secondary patents or brand loyalty.

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Conclusion

Rezlidhia (relugolix) stands at a promising threshold, leveraging the shift toward oral, patient-friendly therapies for prostate cancer. Its market dynamics are shaped by evolving clinical preferences, regulatory approvals, and competitive pressures. Financially, its growth potential is substantial but contingent on strategic market entry, payer acceptance, and potential indication expansion. As the therapeutic landscape advances, relugolix’s ability to sustain competitive differentiation and deliver value will be critical to its long-term financial trajectory.

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Key Takeaways

• Relugolix is positioned as a convenient, oral alternative to injectable prostate cancer therapies with significant market potential.
• The drug benefits from increasing demand for oral, outpatient treatment options and expanding prostate cancer incidence.
• Market success relies on strategic pricing, regulatory approvals in key regions, and positioning against entrenched competitors.
• Projected peak sales could reach up to $2 billion annually, driven by geographic expansion and indication growth.
• Future growth hinges on clinical differentiation, payer engagement, and expansion into related indications or markets.

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FAQs

1. What are the primary advantages of relugolix over traditional prostate cancer treatments?
Relugolix offers oral administration, rapid testosterone suppression, and a potentially better safety profile, especially regarding cardiovascular risks, compared to injectable GnRH therapies.

2. How does the regulatory landscape influence relugolix’s market prospects?
Global approvals in key markets such as the U.S., Japan, and Europe facilitate widespread adoption. Regulatory hurdles, however, remain contingent on ongoing clinical data and compliance with regional standards.

3. What factors could limit relugolix’s market growth?
Pricing and reimbursement barriers, fierce competition from established injectables, patent expiries, and the emergence of biosimilars could restrict long-term market expansion.

4. Are there any upcoming indications for relugolix?
Potential expansion into other hormone-sensitive cancers or conditions, such as breast cancer or endometriosis, is under investigation, which could broaden its therapeutic footprint.

5. How does relugolix perform in the competitive landscape?
Its oral formulation and safety profile provide a competitive edge, but long-term market share will depend on ongoing efficacy data, safety outcomes, and payer strategy adaptations.

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References

1. Market forecasts and sales estimates based on industry analyst reports and company disclosures (2022-2023).