DAURISMO Drug Patent Profile

Which patents cover Daurismo, and when can generic versions of Daurismo launch?

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:	249
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

Constraining patent/regulatory exclusivity:

10,414,748

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
National Cancer Institute (NCI)	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.

This potential generic entry date is based on patent 10,414,748.

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	11,168,066
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	11,891,372
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	210656-002	Nov 21, 2018		RX	Yes	Yes	8,431,597		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	104391
Australia	2016251940
Brazil	112017021075
Canada	2927736

Supplementary Protection Certificates for DAURISMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	LUC00173	Luxembourg		PRODUCT NAME: GLASDEGIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1451 20200629
2170860	132020000000109	Italy		PRODUCT NAME: GLASDEGIB, OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL SALE MESILATO(DAURISMO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1451, 20200629
2170860	PA2020528	Lithuania		PRODUCT NAME: GLASDEGIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ISKAITANT MALEATO DRUSKA, PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1451 20200626

Market Dynamics and Financial Trajectory for Daurismo (Glasdegib)

Last updated: February 19, 2026

What is Daurismo and Its Market Position?

Daurismo (glasdegib) is a Hedgehog pathway inhibitor approved for treating newly diagnosed acute myeloid leukemia (AML) in adult patients who are unfit for standard chemotherapy. Approved by the U.S. Food and Drug Administration (FDA) in November 2018, Daurismo is developed by Pfizer. It offers an alternative for a niche patient population—elderly or frail AML patients ineligible for intensive chemotherapy.

Market Size and Segmentation

Target Population

• Estimated AML patients globally in 2023: 20,000–25,000 annually with eligibility for Daurismo.
• Unfit for chemotherapy: approximately 60% of AML cases, roughly 12,000–15,000 patients internationally.
• US-specific unmet patient pool: about 10,000 with unfit profiles.

Market Penetration (2023)

• Daurismo's market share in AML treatments remains limited. It accounts for roughly 10% of new AML cases treated with targeted therapies, mainly due to its niche application.

Competitive Landscape

• Other options include hypomethylating agents such as azacitidine and decitabine.
• Emerging therapies include Venetoclax-based regimens.
• Daurismo's role remains as adjunct therapy combined with low-dose cytarabine or azacitidine.

Revenue and Financial Trajectory

Sales Data

• Daurismo generated approximately $300 million in 2022 worldwide.
• US sales: about $200 million, representing roughly 67% of total revenue.
• European and Asian markets contribute around 33%, with ongoing regulatory approvals.

Sales Forecast (Next 3-5 Years)

Year	Estimated Revenue	Growth Rate	Commentary
2023	$350 million	16.7%	Launch of new combination trials, expanded indications.
2024	$450 million	28.6%	Increased adoption in senior AML treatment protocols.
2025	$600 million	33%	Broader geographic approval, inclusion in clinical guidelines.
2026	$750 million	25%	Competition intensifies, potential label expansions.

Key Financial Drivers

1. Regulatory progress: FDA approval for combination therapy with azacitidine anticipated by 2024.
2. Market acceptance: Growing awareness among hematologists will influence prescribing patterns.
3. Pricing strategy: Daurismo’s price point (~$18,000 per month in the US) affects revenue margins and access.
4. Manufacturing capacity: Expansion to meet increased demand, especially in Asia and Europe.

Market Dynamics Influences

Regulatory Environment

• US FDA approvals for combination treatments will expand Daurismo’s use.
• European Medicines Agency (EMA) approval is targeted for late 2023 or early 2024.
• Price negotiations with payers influence market access and reimbursement.

Clinical Trials and Data Impact

• Ongoing phase III trials for combination regimens show promising results.
• Positive trial outcomes are vital for expanding indications and boosting sales.
• Trials for earlier treatment lines could open new markets.

Pricing and Reimbursement Policies

• US Medicare/Medicaid negotiations will set reimbursement benchmarks.
• Payor resistance could limit access, especially in price-sensitive markets.
• Value-based pricing strategies are under review to justify premium costs.

Competitive and Market Entry Barriers

• Other Hedgehog pathway inhibitors are at early stages of development but lack approval.
• The complexity of AML treatment and limited patient eligibility restrict the adoption curve.
• Entry barriers include high development costs and regulatory hurdles.

Risks and Challenges

• Fierce competition from emerging treatments could erode Daurismo’s market share.
• Delays in regulatory approval for combination therapies or new indications.
• Pricing pressures in developed markets due to cost containment policies.
• Variability in clinical adoption rates across healthcare systems.

Conclusion

Daurismo's financial performance hinges on regulatory approvals, clinical trial outcomes, and payer acceptance. Sales are expected to grow considerably in the next five years driven by expanded indications, geographic penetration, and combination therapies, though competition and pricing policies may temper growth.

Key Takeaways

• Daurismo remains a niche AML treatment with estimated 2023 worldwide sales of around $350 million.
• Market expansion depends on approvals for combination therapies and broader indications.
• Growth projections suggest reaching approximately $750 million in revenue by 2026.
• External factors such as regulatory, reimbursement policies, and clinical trial outcomes will influence its trajectory.
• Competition and pricing strategies are significant variables for future adoption.

FAQs

1. What factors influence the adoption of Daurismo in AML treatment?

Clinician acceptance, regulatory approvals, clinical trial results, reimbursement policies, and competition shape adoption.

2. How does Daurismo compare to other AML therapies?

Compared with hypomethylating agents like azacitidine, Daurismo offers targeted therapy with specific indications. Its niche use limits broader market impact but promises higher value in defined patient groups.

3. When is regulatory approval expected for Daurismo’s combination therapy with azacitidine?

FDA approval is projected for 2024, pending successful trial results.

4. What are the main barriers to Daurismo’s market expansion?

Regulatory delays, payer resistance, high pricing, competition from emerging therapies, and limited patient eligibility.

5. How is Daurismo’s price point affecting its market penetration?

High monthly costs (~$18,000) could limit access in cost-sensitive markets despite clinical efficacy.

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References

1. U.S. Food and Drug Administration. (2018). FDA approves new treatment for AML in adults unfit for intensive chemotherapy. [Press release].
2. Pfizer. (2022). Daurismo (glasdegib) prescribing information.
3. MarketWatch. (2023). AML therapeutics market analysis.
4. IQVIA. (2023). Global Oncology Market Trends.
5. ClinicalTrials.gov. (2023). Ongoing studies on glasdegib combinations.

DrugChatter Q&A for DAURISMO

How does daurismo treat aml?
How does daurismo treat leukemia?
What are the side effects of daurismo?