DAURISMO Drug Patent Profile

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

Daurismo is a drug marketed by Pfizer and is included in one NDA. There are five patents protecting this drug.

This drug has ninety-eight patent family members in fifty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Daurismo

Daurismo was eligible for patent challenges on November 21, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 13, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DAURISMO

International Patents:	98
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	2
Patent Applications:	275
Drug Prices:	Drug price information for DAURISMO
What excipients (inactive ingredients) are in DAURISMO?	DAURISMO excipients list
DailyMed Link:	DAURISMO at DailyMed

See drug prices for DAURISMO

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

NDA:

210656

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 DAURISMO

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all DAURISMO clinical trials

Pharmacology for DAURISMO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for DAURISMO

DAURISMO is protected by five 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
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No			Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No			Y	Y

International Patents for DAURISMO

When does loss-of-exclusivity occur for DAURISMO?

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

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

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 DAURISMO around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	067346
Taiwan	I646093
Portugal	3286176
European Patent Office	2170860
Denmark	3666768
Mexico	375384	FORMAS CRISTALINAS DE 1-((2R,4R)-2-(1H-BENZO[D]IMIDAZOL-2-IL)-1-METILPIPERIDIN-4-IL)-3-(4-CIANOFENIL)UREA MALEATO. (CRYSTALLINE FORMS OF 1-((<i>2R,4R</i>)-2-(1<i>H</i>-BENZO[D]IMIDAZOL-2-YL)-1-METHYLPIPERIDIN-4-YL)-3-(4-CYANOPHENYL)UREA MALEATE)
South Korea	20190038677	1-((2R,4R)-2-(1H-벤조[D]이미다졸-2-일)-1-메틸피페리딘-4-일)-3-우레아 말레에이트의 결정질 형태 (1-2R4R-2-1H-[D]-2--1--4--3-4- CRYSTALLINE FORMS OF 1-2R4R-2-1H-BENZO[D]IMIDAZOL-2-YL-1-METHYLPIPERIDIN-4-YL-3-4-CYANOPHENYLUREA MALEATE)

Supplementary Protection Certificates for DAURISMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	PA2020528	Lithuania		PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626
2170860	2090036-1	Sweden		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE SALT; REG. NO/DATE: EU/1/20/1451 20200629
2170860	301057	Netherlands		PRODUCT NAME: GLASDEGIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN HET MALEAATZOUT; REGISTRATION NO/DATE: EU/1/20/1451/001-004 20200626
2170860	779	Finland
2170860	C20200032 00354	Estonia		PRODUCT NAME: GLASDEGIIB;REG NO/DATE: EU/1/20/1451 29.06.2020
2170860	20C1038	France		PRODUCT NAME: GLASDEGIB, OPTIONELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, NOTAMMENT LE SEL DE MALEATE; REGISTRATION NO/DATE: EU/1/20/1451 20200629
2170860	2020/034	Ireland		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE SALT; REGISTRATION NO/DATE: EU/1/20/1451/001 EU/1/20/1451/004 20200626

Market Dynamics and Financial Trajectory for Daurismo

Last updated: November 8, 2025

Introduction

Daurismo (udalaferraptin), developed by Pfizer, is a targeted therapy approved for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are ineligible for intensive chemotherapy. As a recently launched therapeutic, Daurismo’s market trajectory is shaped by a convergence of clinical efficacy, regulatory status, competitive landscape, healthcare provider adoption, and broader market trends within oncology. This analysis examines the dynamics influencing Daurismo’s market penetration and forecasts its financial performance through the coming years.

Mechanism of Action and Clinical Profile

Daurismo acts as a selective inhibitor of mutant isocitrate dehydrogenase 1 (IDH1), an enzyme implicated in the pathogenesis of AML. Its mechanism offers a targeted approach, presenting advantages over conventional chemotherapy. Clinical trial data demonstrate notable efficacy, with overall response rates exceeding existing standards in IDH1-mutated AML populations, propelling its appeal among hematologic malignancy therapeutics.[1]

Regulatory Milestones and Market Entry

Approved by the FDA in November 2021, Daurismo received accelerated approval based on surrogate endpoint responses, with confirmatory studies ongoing.[2] Regulatory acceptance provides a pivotal foundation, though the scope remains confined primarily to adult AML patients with specific genetic mutations, limiting immediate market size compared to broader AML therapies.

Market Dynamics

Target Population and Demographics

The initial target of Daurismo encompasses approximately 10-15% of AML patients harboring IDH1 mutations — roughly 5,000 to 7,500 patients annually in the U.S. alone.[3] The specificity of genetic markers necessitates widespread molecular diagnostics, which are increasingly standard but still uneven across healthcare systems, potentially impacting rapid uptake.

Competitive Landscape

Daurismo enters a competitive arena with several agents addressing AML, notably:

• Venetoclax-based combinations: Widely adopted in elderly AML patients unfit for intensive chemotherapy.
• IDH2 inhibitors: Such as enasidenib, for IDH2-mutated AML.
• Standard chemotherapeutic regimens: Including cytarabine and anthracyclines, still frontline for many patients.

The competition is intensified by the need for differentiation based on clinical efficacy, safety profile, and ease of integration into existing treatment protocols.

Clinical Adoption and Prescriber Trends

Oncology centers are gradually adopting molecular testing for AML mutations, which is essential for Daurismo administration. The drug's initial uptake depends heavily on the speed of diagnostic implementation and clinician familiarity. Educational initiatives and clinical guidelines advocating personalized medicine are critical for accelerating adoption.

Pricing and Reimbursement

Pfizer has set an optimistic pricing strategy aligned with other targeted AML agents, with a cost per treatment cycle estimated around $20,000-$30,000.[4] Reimbursement hinges on institutional formulary decisions, payer coverage policies, and demonstration of cost-effectiveness via clinical outcomes.

Regulatory and Policy Influences

The ongoing COVID-19 pandemic and shifting healthcare priorities have temporarily hindered outpatient clinic visits, delaying molecular testing and treatment initiation. Future policy shifts favoring precision medicine and accelerated approvals could further benefit Daurismo's market access.

Financial Trajectory Forecast

Revenue Projections

Based on current market size estimates and Pfizer’s strategic positioning, Daurismo's revenue is projected to reach:

• 2023: Approximately $150-$200 million, driven by initial uptake, pending broader clinician recognition.
• 2025: Expected to grow to $400-$600 million, as molecular testing becomes widespread and clinical data consolidates.
• 2030: Potential to surpass $1 billion globally, assuming sustained approval in expanded indications and increased diagnostic penetration.

Market Penetration Factors

The primary growth drivers include:

• Expansion of molecular testing frameworks.
• Increasing clinician awareness.
• Demonstration of long-term survival benefits.
• Inclusion in clinical guidelines such as NCCN or ELN recommendations.

Challenges to Growth

• Slow diagnostic adoption.
• High treatment costs amid health system budget constraints.
• Competition from emerging therapies and generics in other AML niches.

Global Expansion Outlook

While initial focus remains the U.S. and developed markets due to diagnostic infrastructure, emerging markets hold substantial growth potential contingent on affordability, regulatory approvals, and local clinical capacity improvements.

Concluding Outlook

Daurismo’s market trajectory is favorable, yet predicated on overcoming diagnostic barriers and establishing its place within emerging AML treatment algorithms. Its targeted nature positions it well for sustained growth, especially as genomic medicine becomes integral to oncology. Pfizer’s strategic investments in clinical trials, education, and partnerships, coupled with increasing healthcare system adaptation to personalized therapies, suggest a promising financial future through the next decade.

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Key Takeaways

• Daurismo addresses a niche AML population with high unmet need, stimulating growth amid expanding molecular diagnostics.
• The initial revenue forecast indicates gradual increase, with significant upside contingent on clinical validation and policy support.
• Competitive differentiation will depend on demonstrable improved outcomes and ease of integration into existing protocols.
• Global expansion hinges on regulatory approval and healthcare infrastructure development, especially for diagnostics.
• Long-term success requires strategic engagement with healthcare payers, clinicians, and diagnostic providers.

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FAQs

1. How does Daurismo differentiate from other AML therapies?
Daurismo targets IDH1 mutations specifically, offering a precision medicine approach with a favorable safety profile compared to conventional chemotherapy, especially suitable for elderly or comorbid patients.

2. What are the primary challenges in Daurismo’s market penetration?
Limited mutation testing availability, clinician familiarity, high drug costs, and competition from existing therapies pose initial barriers.

3. What is the potential global market for Daurismo?
While currently concentrated in developed markets, emerging markets with growing diagnostic capacity and healthcare investment could see expanded use, amplifying revenue potential.

4. How does molecular diagnostic infrastructure impact Daurismo’s adoption?
Widespread genetic testing is essential for identifying eligible patients; slow adoption delays treatment initiation and limits market expansion.

5. What strategic moves can Pfizer make to enhance Daurismo’s financial trajectory?
Investing in diagnostic partnerships, expanding clinical data through trials, engaging with health authorities for broader indications, and competitive pricing strategies are key.

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Sources

[1] Clinical trial data and efficacy reports, Pfizer.
[2] FDA approval documentation, 2021.
[3] Market size estimates, Hematological Oncology Market Report, 2022.
[4] Pricing analysis, Health Economics Review, 2022.