DAURISMO Drug Patent Profile

When do Daurismo patents expire, 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

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
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	210656-002	Nov 21, 2018		RX	Yes	Yes	11,168,066

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
Canada	2983387
China	107531667
Cyprus	1124056

Supplementary Protection Certificates for DAURISMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2170860	36/2020	Austria		PRODUCT NAME: GLASDEGIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES MALEATSALZES; REGISTRATION NO/DATE: EU/1/20/1451/001 (MITTEILUNG) 20200629
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	CR 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
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	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	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	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 and Fundamentals Analysis for Daurismo (Glasdegib)

Last updated: February 21, 2026

What is Daurismo (Glasdegib)?

Daurismo (brand name for glasdegib) is an oral hedgehog pathway inhibitor approved by the U.S. Food and Drug Administration (FDA) for treating newly diagnosed acute myeloid leukemia (AML) in adults who are unfit for intensive chemotherapy. It is developed by Pfizer, entering the market in January 2020. The drug acts by blocking the hedgehog signaling pathway, which is implicated in the growth of certain cancers, including AML. The drug is used in combination with low-dose cytarabine (LDAC).

Market Potential and Commercial Feasibility

Target Patient Population

• AML patients aged 55 and above with comorbidities preventing intensive chemotherapy.
• Estimated annual incidence of AML in the U.S.: approximately 20,000 cases.
• AML accounts for approximately 1% of all adult cancers.
• Unmet needs exist among unfit patients who cannot tolerate standard intensive therapy.

Market Size and Penetration

Metric	Data	Source
U.S. AML incidence	20,000/year	[1]
Unfit for intensive chemotherapy	65%	[2]
Addressable patient base	13,000/year	Calculated (20,000 x 0.65)
Current market share (initial 3 years)	10%	Analyst estimates
Estimated revenue per patient	$35,000	Based on drug pricing (~$29,000/year + administration)

Year	Potential Patients	Market Penetration	Estimated Sales	Notes
Year 1	1,300	10%	~$45.5 million	Launch year
Year 3	2,600	20%	~$91 million	Growth in patient base

Competitive Landscape

• Other approved drugs: Vyxeos (CPX-351), venetoclax + azacitidine.
• Daurismo’s niche: Unfit AML patients unsuitable for intensive chemotherapy.
• Market entry barriers: Moderate, limited by clinical adoption and drug pricing negotiations.

Clinical and Regulatory Fundamentals

Efficacy Data

• Clinical trials: Phase 2 (BRIGHT AML 1003) trial demonstrated an overall response rate (ORR) of approximately 30% in combination with LDAC.
• Median overall survival (OS): 8.3 months versus 4.3 months with LDAC alone.
• Side effects: Common include fatigue, dizziness, nausea, muscle pain. Serious adverse events are infrequent.

Regulatory Status

• FDA approval received January 2020 under accelerated approval pathway.
• Fast-track designation granted due to unmet medical need.
• Confirmatory trials required post-approval for full approval.

Patent and Exclusivity

• Patent rights extend to approximately 2030 in key markets.
• Exclusivity aligned with patent protection; potential for extension via supplementary patents.

Financial and Investment Considerations

Revenue Projections

• Market share assumption: Steady growth reaching 20% within 3 years.
• Peak revenue: Estimated at ~$91 million annually initially, growing with market penetration.
• Pricing strategies: Price adjustments based on reimbursement negotiations, inflation, and competitive dynamics.

Cost Structure and R&D

• Development costs largely sunk; ongoing costs involve manufacturing, sales, and marketing.
• No recent significant patent challenges, supporting pricing and market entry.

Risks

• Clinical: Efficacy and safety profile must sustain; emergence of resistance.
• Regulatory: Evolving standards, need for confirmatory trials.
• Commercial: Market penetration may be limited by competition and physician acceptance.

Key Investment Indicators

Indicator	Data	Commentary
Market size	~13,000 patients/year in U.S.	Solid niche, limited to unfit AML population
Revenue potential	~$91 million/year initially	Moderate, limited by market size
Patent life	Expiring ~2030	Long-term exclusivity allows amortization of development costs
Competitive edge	First approved hedgehog inhibitor for AML	Differentiates within targeted patient subset

Conclusion

Daurismo presents a niche yet significant market opportunity within AML treatment for unfit patients. Limited but growing sales potential is supported by clinical efficacy and regulatory approval. Investment considerations include moderate revenue, patent longevity, and competitive positioning. Risks focus on clinical durability and reimbursement dynamics.

Key Takeaways

• Daurismo targets a specific AML patient subset with unmet needs.

• Market size is approximately 13,000 potential U.S. patients annually.

• Estimated initial revenue of $45.5 million, reaching ~$91 million within three years.

• The drug benefits from FDA accelerated approval; full approval depends on confirmatory trial outcomes.

• Long patent life supports potential profitability despite moderate market size.

FAQs

1. What is the current market for Daurismo?

The U.S. AML unfit patient segment is approximately 13,000 annually, with initial sales projections of around $45.5 million, reaching near $91 million within three years post-launch.

2. How does Daurismo compare to competitive treatments?

Daurismo offers a targeted mechanism (hedgehog pathway inhibition) with a favorable safety profile, filling a niche where patients are ineligible for intensive chemotherapy. Other options like venetoclax combinations are used for similar populations but differ in mechanism and cost.

3. What are the main regulatory challenges?

The FDA approved Daurismo via accelerated review, requiring confirmatory studies. Clinical durability of efficacy and safety remains under surveillance, which could impact full approval and formulary inclusion.

4. What is the patent outlook?

Patent protections extend to approximately 2030, providing market exclusivity during this period, barring patent challenges or generic entry.

5. What are risks to investment?

Key risks include the drug’s clinical efficacy being insufficient for sustained market share, reimbursement hurdles, or stronger competition from emerging therapies.

References

1. American Cancer Society. (2022). Cancer Facts & Figures 2022.

2. National Cancer Institute. (2021). Acute Myeloid Leukemia Treatment & Support.