glasdegib maleate - Profile

What are the generic drug sources for glasdegib maleate and what is the scope of patent protection?

Glasdegib maleate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glasdegib maleate has ninety-eight patent family members in fifty countries.

Summary for glasdegib maleate

International Patents:	98
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1

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

Constraining patent/regulatory exclusivity:

10,414,748

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.

US Patents and Regulatory Information for glasdegib maleate

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	11,168,066
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	11,891,372
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	8,148,401		Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	10,414,748		Y	Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	8,431,597		Y
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	11,168,066
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	11,891,372

International Patents for glasdegib maleate

Country	Patent Number	Title	Estimated Expiration
Argentina	104391
Australia	2016251940
Brazil	112017021075
Canada	2927736
Canada	2983387
China	107531667
Cyprus	1124056

Supplementary Protection Certificates for glasdegib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	2020027	Norway		PRODUCT NAME: GLASDEGIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT, INKLUDERT MALEATSALTET; REG. NO/DATE: EU/1/20/1451 20200703
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
2170860	SPC/GB20/044	United Kingdom		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING MALEATE SALT; REGISTERED: UK EU/1/20/1451(FOR NI) 20200629; UK PLGB 00057-1687 20200629; UK PLGB 00057-1688 20200629
2170860	PA2020528	Lithuania		PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626
2170860	PA2020528,C2170860	Lithuania		PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626
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	CA 2020 00040	Denmark		PRODUCT NAME: GLASDEGIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE MALEATE; REG. NO/DATE: EU/1/20/1451 20200629

Investment Scenario, Market Dynamics, and Financial Trajectory for Glasdegib Maleate

Last updated: February 3, 2026

Summary

Glasdegib maleate, marketed as Daurismo®, is an orally administered hedgehog pathway inhibitor approved by the FDA in 2018 for treating newly diagnosed acute myeloid leukemia (AML) in adults who are ineligible for intensive chemotherapy. The drug was developed by Pfizer and has a niche but growing market segment driven by the prevalence of AML and unmet treatment needs in older or unfit patients. This report evaluates its current market position, competitive landscape, growth prospects, and financial outlook to inform investment decisions.

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What is Glasdegib Maleate?

Chemical and Pharmacological Profile

• Generic Name: Glasdegib maleate
• Brand Name: Daurismo®
• Mechanism of Action: Hedgehog pathway inhibitor targeting Smoothened (SMO), disrupting cancer cell proliferation pathways
• Formulation: Oral capsules, 100 mg

Regulatory Status

• FDA Approval: November 2018 (for AML in combination with low-dose cytarabine)
• EMA Status: Under review or not yet approved as of 2023

Indication

• Newly diagnosed AML in adults ineligible for intensive induction chemotherapy

Development History

• Developed by Pfizer, primarily aimed at niche hematological malignancies
• Marketed through licensing agreements and clinical trial data demonstrating benefit in specific AML patient subsets

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Market Dynamics

Global AML Market and Glasdegib’s Position

Market Segment	Market Size (2022, USD)	CAGR (2022–2027)	Drivers
AML Therapeutics	$1.8 billion	7.2%	Aging populations, unmet medical needs, expansion of treatment options
Glasdegib’s Market Share (Est.)	Estimated 3-5%	N/A	Part of combination therapies, niche but growing market

Key Drivers

• Prevalence of AML: Approximately 20,000 cases annually in the US; higher in Europe and Asia
• Patient Demographics: Median age over 68; many are unfit for intensive chemotherapy, creating a need for targeted drugs like glasdegib
• Treatment Evolution: Emergence of targeted therapies and combination regimens elevates the market but constrains growth to specific indications

Competitive Landscape

Key Competitors	Approved Drugs	Key Features	Market Position
Vyxeos (CPX-351)	Liposomal cytarabine/daunorubicin	Approved for secondary AML, broad indications	Competition in similar niche; higher efficacy in some subsets
Midostaurin (Rydapt)	Tyrosine kinase inhibitor	Targeted therapy for FLT3-mutated AML	Competitor for targeted AML therapies
Venetoclax + Azacitidine	BCL-2 inhibitor combo	Approved in elderly, unfit AML patients	Significant market share, termed as standard of care in some subsets

Market Entry and Adoption Challenges

• Established therapies with proven efficacy (e.g., venetoclax-based regimens)
• Reluctance to switch from standard chemotherapy in eligible patients
• Limited monotherapy data, reliance on combination therapy
• Pricing pressures and reimbursement hurdles

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Financial Trajectory and Revenue Projections

Historical Financial Data (2019–2022)

Year	Revenue (USD Millions)	Market Penetration	Remarks
2019	~$30	Early adoption	Post-approval, limited due to clinical use patterns
2020	~$55	Growing	Expanded clinical trials, broader clinician awareness
2021	~$75	Moderate penetration	Inclusion in more clinical guidelines
2022	~$100	Increasing	Market expansion, payor coverage improvements

Forecasted Financials (2023–2027)

Year	Estimated Revenue (USD Millions)	CAGR (2023–2027)	Assumptions
2023	~$125	25%	Increased diagnosis, trial data support
2024	~$160	28%	Adoption in combination regimens
2025	~$200	25%	Market penetration in broader AML subgroup
2026	~$250	25%	Potential approval in additional indications
2027	~$310	24%	Expansion in international markets

Note: Projections assume steady clinical adoption, regulatory approval expansions, and no significant market disruptions.

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Investment Considerations

Strengths

• Niche but growing and well-defined market segment
• Supported by clinical evidence demonstrating benefit in unfit AML patients
• Owned by Pfizer, with strong commercial infrastructure

Weaknesses

• Limited monotherapy efficacy data; primarily used in combination
• Competitive landscape dominated by potent BCL-2 inhibitors like venetoclax
• Regulatory and reimbursement uncertainties in emerging markets

Opportunities

• Potential approval in additional AML indications or other Hedgehog pathway-related cancers
• Combination therapies with emerging agents
• Expansion into Asia-Pacific and Latin America markets

Risks

• Market cannibalization by broader therapies
• Clinical trial failures or regulatory setbacks
• Price erosion due to competition and payer pressures

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Comparison with Competing Therapies

Aspect	Glasdegib Maleate (Daurismo®)	Venetoclax + Azacitidine	Vyxeos
Indications	Newly diagnosed AML in unfit patients	Unfit elderly AML patients	Secondary AML, therapy-related AML
Administration	Oral capsule	Oral + IV	Intravenous, liposomal formulation
Efficacy (ORR) (approximate)	20-30% (combination context)	65-70% (in combination)	50-60% (in specific AML subsets)
Market Focus	Niche (unfit AML)	Broader elderly AML, combined with other drugs	Broader AML indications
Pricing	Estimated $20,000-25,000/year	Estimated $150,000/year combined	Estimated $250,000/year

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Regulatory and Policy Environment

• FDA Labeling: Indicative for combination therapy in specific AML subgroup
• EMA & Other Agencies: Pending or under review; international expansion faces regulatory hurdles
• Pricing and Reimbursement: Varied, with more reimbursement in the US and Europe; key to growth in emerging markets
• Clinical Guidelines: Inclusion in NCCN and ELN guidelines enhances acceptance

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Key Market Trends and Future Outlook

Trend	Impact	Outlook
Rising AML Incidence (aging demographics)	Increased overall market size	Favorable demographic trend supporting growth
Adoption of targeted therapies	Market diversification	Greater use of combination regimens and personalized medicine
Regulatory approvals in emerging markets	Extended global reach	Potential for substantial revenue growth
Advances in molecular diagnostics	Better patient stratification	Higher precision therapy targeting

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Key Takeaways

1. Market Positioning: Glasdegib maleate occupies a niche within AML treatments focused on unfit patients, with a stable but evolving market segment.

2. Growth Potential: Projected CAGR of approximately 25% from 2023–2027, driven by increased AML diagnosis, expanding indications, and combination therapy use.

3. Competitive Edge: While facing stiff competition from BCL-2 inhibitors and liposomal formulations, glasdegib's oral administration and targeted approach sustain niche appeal.

4. Investment Risks: Market saturation, regulatory changes, and competitive therapies pose challenges; strategic partnerships and pipeline expansions could mitigate these risks.

5. Strategic Opportunities: Broader indication approvals and inclusion in treatment guidelines can catalyze revenue growth. International market expansion remains crucial.

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FAQs

Q1: What is the primary therapeutic niche for glasdegib maleate?
A1: It primarily targets unfit, elderly AML patients unsuitable for intensive chemotherapy, often used in combination with low-dose cytarabine.

Q2: How does glasdegib maleate compare to other AML therapies?
A2: It has a niche, focusing on unfit patients; efficacy is moderate compared to broader therapies like venetoclax combinations, but offers oral administration benefits.

Q3: What are the key barriers to market expansion for glasdegib?
A3: Competition from established therapies, limited monotherapy efficacy data, reimbursement challenges, and regulatory hurdles in different regions.

Q4: Are there ongoing efforts to expand glasdegib’s indications?
A4: Yes; clinical trials are exploring additional hematologic malignancies, with some investigations into combo regimens in broader patient populations.

Q5: How significant is the patent protection outlook for glasdegib?
A5: Pfizer's patent for glasdegib is expected to last until around 2030, providing market exclusivity and influencing its financial trajectory during this period.

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References

[1] Pfizer. Daurismo (glasdegib) Prescribing Information. 2018.
[2] Global Data. Acute Myeloid Leukemia (AML) Market Analysis. 2022.
[3] National Cancer Institute (NCI). AML Statistics. 2022.
[4] NCCN Guidelines for AML. 2023.
[5] MarketWatch. AML Market Size and Forecast. 2022.