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-six 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:	96
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	2
Patent Applications:	4
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	210656-001	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	210656-002	Nov 21, 2018		RX	Yes	Yes

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
France	20C1038
Hungary	E030052
New Zealand	735719	Crystalline forms of 1-((2r,4r)-2-(1h-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Norway	2020027
Poland	3666768

Supplementary Protection Certificates for DAURISMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C202030052	Spain		PRODUCT NAME: GLASDEGIB, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUYENDO LA SAL MALEATO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1451; DATE OF AUTHORISATION: 20200626; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1451; DATE OF FIRST AUTHORISATION IN EEA: 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
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	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

Market Dynamics and Financial Trajectory for DAURISMO (Glasdegib)

Introduction to DAURISMO

DAURISMO (glasdegib) is a groundbreaking medication approved by the U.S. FDA and the European Commission for the treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are not candidates for intensive chemotherapy due to age or comorbidities. Here, we delve into the market dynamics and financial trajectory of this significant therapeutic advancement.

Market Need and Patient Population

AML is a rapidly progressing bone marrow cancer with poor survival rates, especially among elderly patients and those with certain health conditions. Historically, many of these patients did not receive treatment due to the intensity of standard chemotherapy, leading to a poor prognosis[1].

Regulatory Approvals and Clinical Trials

DAURISMO was approved by the U.S. FDA in November 2018 and by the European Commission in June 2020, based on the results of the Phase 2 BRIGHT 1003 trial. This trial demonstrated that DAURISMO, in combination with low-dose cytarabine (LDAC), nearly doubled the median overall survival compared to LDAC alone, reducing the risk of death by 54%[1][5].

Market Landscape and Competitors

The AML treatment landscape has seen significant changes in recent years, with several new therapies being approved. DAURISMO is one of the key players in this market, particularly for patients who are not eligible for intensive chemotherapy. Other notable treatments include VYXEOS (Jazz Pharmaceuticals), RYDAPT (Novartis), MYLOTARG (Pfizer), and VENCLEXTA (AbbVie)[3].

Market Growth and Projections

The AML market is expected to exhibit promising growth, driven by increasing incidence rates and the imminent launch of novel therapies. The market is projected to grow at a CAGR of 22% from 2018 to 2030, fueled by advancements in research and development, and an enriched understanding of the disease[3].

Financial Performance and Revenue

While specific revenue figures for DAURISMO are not isolated in Pfizer's financial reports, the drug is part of Pfizer's broader oncology portfolio, which has seen significant growth. Pfizer's overall revenues for 2022 were $100.3 billion, with operational growth driven by various products, including those in the oncology segment[2].

Revenue Impact

The approval and subsequent marketing of DAURISMO contribute to Pfizer's revenue growth in the oncology sector. Although DAURISMO is not as widely used as some of Pfizer's other blockbuster drugs like Comirnaty and Paxlovid, it fills a critical niche in the AML treatment market, providing a new option for patients who were previously underserved.

Cost and Pricing

The high cost of therapy is a significant challenge in the AML market. However, DAURISMO's approval and its demonstrated efficacy in improving survival rates make it a valuable addition to the treatment options available. The cost-effectiveness of DAURISMO, especially in comparison to other treatments, will be a key factor in its market adoption and financial performance.

Side Effects and Safety Profile

DAURISMO's safety profile is manageable, with common side effects including anaemia, bleeding, febrile neutropenia, nausea, and thrombocytopenia. The European Medicines Agency has authorized its use, noting that the benefits of DAURISMO outweigh its risks[4].

Continuous Monitoring and Regulatory Compliance

Pfizer and regulatory authorities continuously monitor the use of DAURISMO, evaluating side effects and taking necessary actions to protect patients. This ongoing surveillance is crucial for maintaining the drug's market presence and ensuring patient safety.

Future Prospects and Ongoing Research

DAURISMO is part of Pfizer's ongoing commitment to advancing cancer therapeutics. The BRIGHT trials are evaluating DAURISMO in combination with other agents commonly used to treat AML, aiming to understand its full potential against this aggressive leukemia. These ongoing studies could lead to expanded indications and further market growth[1].

Key Takeaways

• Regulatory Approvals: DAURISMO is approved by the U.S. FDA and the European Commission for treating AML in patients not eligible for intensive chemotherapy.
• Market Growth: The AML market is expected to grow at a 22% CAGR, driven by increasing incidence and new therapies.
• Financial Impact: DAURISMO contributes to Pfizer's oncology revenue, though specific figures are not isolated.
• Safety and Efficacy: DAURISMO has a manageable safety profile and has demonstrated significant improvement in overall survival.
• Future Prospects: Ongoing trials aim to expand DAURISMO's indications and understand its full potential.

FAQs

What is DAURISMO used for?

DAURISMO (glasdegib) is used for the treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are not candidates for intensive chemotherapy due to age or comorbidities.

How was DAURISMO approved?

DAURISMO was approved by the U.S. FDA in November 2018 and by the European Commission in June 2020, based on the results of the Phase 2 BRIGHT 1003 trial.

What are the common side effects of DAURISMO?

Common side effects include anaemia, bleeding, febrile neutropenia, nausea, decreased appetite, tiredness, muscle spasms, thrombocytopenia, fever, and others.

How does DAURISMO impact the AML market?

DAURISMO fills a critical niche in the AML treatment market by providing a new option for patients who were previously underserved, contributing to the market's projected growth.

What are the future prospects for DAURISMO?

Ongoing trials, such as the BRIGHT trials, are evaluating DAURISMO in combination with other agents to understand its full potential against AML, which could lead to expanded indications and further market growth.

Sources

1. Pfizer Press Release: U.S. FDA Approves DAURISMO™ (glasdegib) for Adult Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy is Not an Option.
2. Pfizer Q4 2022 Earnings Release: Pfizer Reports Record Full-Year 2022 Results and Provides Full-Year 2023 Revenue Guidance.
3. PR Newswire: Acute Myeloid Leukemia Market to Exhibit Promising Growth at a 22% CAGR Fueled by Increasing Incidence and Imminent Launches of the Novel Therapies During the Study Period.
4. European Medicines Agency: Daurismo.
5. Pfizer Press Release: European Commission Approves DAURISMO™ (glasdegib) for Certain Patients with Acute Myeloid Leukemia.