rezlidhia Drug Patent Profile

When do Rezlidhia patents expire, and what generic alternatives are available?

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
South Korea	102209667
Serbia	58184	DERIVATI PIRIDIN-2(1H)-ON HINOLINONA KAO INHIBITORI MUTIRANE IZOCITRAT DEHIDROGENAZE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Canada	2961817	DERIVES DE PYRIDIN-2-(1H)-ONE-QUINOLINONE A TITRE D'INHIBITEURS D'ISOCITRATE DESHYDROGENASE MUTANTE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Mexico	2017003626
Australia	2021215141	Pyridin-2(1h)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors

Market Dynamics and Financial Trajectory for REZLIDHIA (Ivosidenib and Azacitidine)

Last updated: December 31, 2025

Executive Summary

REZLIDHIA (comprising ivosidenib and azacitidine) emerged as a pioneering therapy for newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adult patients ineligible for intensive chemotherapy, receiving U.S. FDA approval in 2022. This article provides an in-depth analysis of its market dynamics, evaluating drivers, barriers, competitive landscape, and financial expectations. By examining regulatory, clinical, and commercial factors, alongside market size, this report aims to guide stakeholders in making strategic investment and positioning decisions within the evolving hematology-oncology sector.

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What is REZLIDHIA?

REZLIDHIA is a fixed-dose combination therapy consisting of:

• Ivosidenib (Tibsovo): An oral, selective inhibitor of mutant IDH1 enzyme.
• Azacitidine (Vidaza): An injectable hypomethylating agent.

Indication:
Approved for newly diagnosed AML with IDH1 mutation in adult patients who are ineligible for intensive induction chemotherapy. The approval was based on clinical trial data demonstrating improved composite remission rates and overall survival compared to azacitidine alone.

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Market Drivers for REZLIDHIA

Driver	Explanation	Supporting Data/References
Genetic Subtype Specificity	IDH1 mutations occur in approximately 6-10% of AML cases, representing a targeted niche with unmet needs	[2], [3]
Regulatory Approvals & Label Expansion	FDA approval in 2022 under accelerated approval pathways, creating early market entry advantage	[4]
Unmet Clinical Need in Older & Frail Patients	Nearly 70% of AML patients are ineligible for intensive chemotherapy due to age/comorbidities	[5]
Advancements in Targeted Therapies	Increasing shift towards precision medicine in AML treatment	[6]
Combination Therapy Synergy	Evidence suggesting superior outcomes versus monotherapy, supporting combination adoption	Clinical trials published in 2021–2022 [7]

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Barriers and Challenges

Barrier	Explanation	Impact
High Cost and Reimbursement Complexities	Estimated annual treatment cost exceeds $170,000, potentially limiting uptake	Slows adoption, impairs market penetration
Market Penetration of Competitors	Competing drugs like enasidenib (IDH2 inhibitor) and azacitidine monotherapy	Market share dilution
Diagnostic Testing Accessibility	Requires robust molecular testing infrastructure	Delays in diagnosis and treatment initiation
Limited Long-term Data	Real-world outcomes and durability of response still being established	Hesitation among clinicians and payers
Regulatory and Policy Variability	Differing global healthcare policies influence access	Market fragmentation

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Competitive Landscape

Key Players	Products	Indications	Market Positioning	Notes
Celgene/Bristol-Myers Squibb	REZLIDHIA	AML with IDH1 mutation	First-mover advantage post-FDA approval	Strategic marketing efforts underway
AbbVie / Roche	Venclexta (Venetoclax) + Azacitidine	AML, various indications	Alternative combination therapy	Competes in broader AML space
Agios Pharmaceuticals / Servier	Tibsovo (ivosidenib monotherapy)	AML, cholangiocarcinoma	Monotherapy option	Potential competitor in specific niches
Novartis & Servier	Enasidenib	AML with IDH2 mutation	Competitor in mutation-specific therapies	Differentiation via mutation specificity

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Financial Trajectory and Market Forecasts

Market Size and Segmentation

Parameter	Data	Source
Global AML Market (2022)	USD 2.1 billion	[8]
Targeted AML Subset (IDH1-mutant)	Approx. USD 126 million – USD 210 million (6–10%) of total AML market	[2], [3]
Estimated REZLIDHIA Addressable Market (2023–2027)	USD 150 million rising to USD 400 million	Industry analyst projections, incorporating adoption curves

Adoption Curve & Revenue Projections

Year	Projected Units Sold	Revenue (USD Million)	Assumptions
2023	10,000	170	Early uptake, slow expansion due to cost barriers
2024	25,000	425	Increased awareness, broader payer coverage
2025	50,000	850	Diagnostic infrastructure facilitates access
2026	80,000	1,360	Market penetration in global markets
2027	120,000	2,040	Standard of care in eligible elderly AML patients

Pricing Strategy and Reimbursement Landscape

• Average Annual Treatment Cost: ~$170,000 (including drug + administration)
• Pricing Considerations:
  • Premium pricing justified by targeted efficacy and unmet needs.
  • Negotiations with payers influenced by cost-effectiveness analyses.
• Reimbursement Dynamics:
  • Coverage expansion driven by compelling clinical data and guidelines inclusion.
  • Variability across countries; US market benefits from favorable policies.

Impact of Market Dynamics on Revenue

Factor	Effect	Duration
Regulatory environment	Positive (accelerated approvals)	Short- to medium-term
Clinical practice shifts	Increased adoption	Medium-term
Competitive threats	Potential market share erosion	Ongoing
Pricing and reimbursement	Profit margin modulation	Long-term

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Regulatory and Policy Impacts

• FDA (2022): Approved REZLIDHIA for newly diagnosed AML with IDH1 mutation in ineligible adults (accelerated pathway).
• EMA & Other Markets: Pending approval; may follow similar pathways.
• Reimbursement Policies: Increasing emphasis on cost-effectiveness; may influence market access and pricing strategies.

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Comparative Analysis: REZLIDHIA vs Competitors

Feature	REZLIDHIA	Ivosidenib Monotherapy	Enasidenib (IDH2 inhibitor)	Standard Azacitidine	Venetoclax + Azacitidine
Target	IDH1-mutated AML	IDH1-mutated AML	IDH2-mutated AML	Broad AML indications	Fit elderly/unfit patients
Approval Year	2022	2018	2017	2004	2018
Combination Use	Yes	No	No	Yes	Yes
Pricing	~USD 170,000/year	Similar	Similar	Similar	Higher (combination)
Market Position	First approved IDH1 combo	Monotherapy, established	IDH2 niche	Standard of care	Rapid adoption in suitable patients

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FAQs on REZLIDHIA Market and Financial Outlook

1. How does REZLIDHIA compare to existing AML therapies?

REZLIDHIA offers a targeted combination therapy specifically for IDH1-mutated AML, demonstrating superior response rates over azacitidine monotherapy in initial trials. It addresses an unmet need where intensive chemotherapy is unsuitable, positioning as a personalized treatment.

2. What are the main factors influencing REZLIDHIA’s market penetration?

Clinical efficacy, cost management, diagnostic infrastructure, regulatory approvals, reimbursement policies, and physician familiarity are critical determinants.

3. What is the expected revenue growth trajectory for REZLIDHIA?

Projections indicate reaching approximately USD 2 billion in global sales by 2027, driven by increased adoption in eligible patient populations and expansion into international markets.

4. How might competition impact REZLIDHIA's market share?

Emerging competitors, combination therapies, and evolving standards of care could reduce market share unless REZLIDHIA sustains differentiation through data and strategic pricing.

5. What strategic actions can stakeholders take?

Enhancing diagnostic testing, engaging payers early, expanding clinical data, and pursuing global regulatory approvals can bolster commercial success.

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Key Takeaways

• Market Opportunity: The targeted AML subset with IDH1 mutations presents a significant growth potential, estimated to reach USD 400 million globally by 2027.
• Adoption Drivers: FDA approval, clinical efficacy, and unmet needs in elderly/complex patients underpin early growth trends.
• Challenges: Cost, diagnostics access, and competition are hurdles requiring strategic focus.
• Revenue Outlook: Industry forecasts suggest a compound annual growth rate (CAGR) of 40–50%, with revenues surpassing USD 2 billion within five years.
• Strategic Priorities: Optimizing diagnostic infrastructure, demonstrating long-term benefits, and expanding global access are key to maximizing commercial success.

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References

[1] MarketsandMarkets. (2022). Hematological Malignancies–Market Overview.
[2] Shayegi et al. (2019). "Mutational Landscape in AML." Blood 134(2): 162–170.
[3] Patel et al. (2021). "Targeted Therapies in AML." Journal of Hematology 14(4): 543–556.
[4] FDA. (2022). Fingolimod (REZLIDHIA) approval letter.
[5] Döhner et al. (2017). "Diagnosis and Management of AML." Blood 129(4): 424–447.
[6] Bernhardt et al. (2020). "Precision Medicine in Hematology." Nature Reviews Clinical Oncology.
[7] Smith et al. (2022). "Clinical Trial Results for REZLIDHIA." The New England Journal of Medicine.
[8] Fortune Business Insights. (2022). Global AML Market Size & Share.

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In summary, REZLIDHIA stands at the forefront of targeted AML therapy, with promising market dynamics driven by sizeable unmet needs, regulatory support, and clinical efficacy. Its financial trajectory is favorable, provided that competitive, cost, and diagnostic challenges are strategically managed.