Glasdegib maleate - Generic Drug Details

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-six patent family members in fifty countries.

One supplier is listed for this compound.

Summary for glasdegib maleate

International Patents:	96
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	2
Patent Applications:	5
DailyMed Link:	glasdegib maleate at DailyMed

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

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 glasdegib maleate

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

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

See all glasdegib maleate clinical trials

Pharmacology for glasdegib maleate

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for glasdegib maleate

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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			Y	Y
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

International Patents for glasdegib maleate

Country	Patent Number	Title	Estimated Expiration
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
South Korea	20170129245	1-((2R,4R)-2-(1H-벤조[D]이미다졸-2-일)-1-메틸피페리딘-4-일)-3-우레아 말레에이트의 결정질 형태
Guatemala	200900328	DERIVADOS DE BENCIMIDAZOL
Taiwan	201702238	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[D]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate

Supplementary Protection Certificates for glasdegib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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,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	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 Glasdegib Maleate

Introduction to Glasdegib Maleate

Glasdegib maleate, developed by Pfizer Inc., is a small-molecule hedgehog signaling inhibitor used in the treatment of Acute Myeloid Leukemia (AML). It was approved by the FDA on November 21, 2018, and targets the sonic hedgehog receptor smoothened (SMO), a key component in the Hedgehog (Hh) signaling cascade, which is often aberrantly activated in AML[1][5].

Market Outlook for Acute Myeloid Leukemia

The AML market is poised for significant growth, driven by several key factors:

• Increasing Incidence: The incidence of AML is expected to rise, contributing to the growing demand for effective treatments[3].
• Emerging Therapies: The development and imminent launch of novel therapies, including glasdegib, are expected to drive market growth. These therapies aim to be less toxic and more effective, particularly for elderly patients who have higher relapse rates[3].
• Research and Development: There has been a substantial increase in research and development activities, leading to a better understanding of the disease and the development of more targeted therapies[3].

Current Treatment Landscape

The AML treatment landscape has seen recent approvals of several drugs, including VYXEOS, RYDAPT, MYLOTARG, and ONUREG for frontline intensive chemotherapy-eligible patients. For ineligible patients, drugs like Daurismo (also from Pfizer), TIBSOVO, and VENCLEXTA are approved. However, the current gold standard for older patients remains venetoclax with hypomethylation agents, with glasdegib being explored as a potential alternative due to its more favorable side effects profile[1][3].

Clinical Trials and Efficacy

Glasdegib has shown promising results in clinical trials, particularly when combined with other treatments. The Phase 2 Bright AML 1003 trial demonstrated superior overall survival and complete response rates when glasdegib was combined with low-dose cytarabine. This combination is being closely watched as a potential new standard of care[1].

Market Drivers

Several factors are driving the market for glasdegib maleate:

• Combination Therapies: The efficacy of glasdegib in combination with other treatments, such as cytarabine, is a significant market driver. These combinations are being tested in various clinical trials to optimize treatment outcomes[1][2].
• Favorable Side Effects Profile: Compared to other treatments like venetoclax, glasdegib has a more favorable side effects profile, which could make it a preferred option for patients and clinicians[1].
• Government and Industry Support: Support from both government and industry is crucial for the development and approval of new therapies. This support is expected to continue, driving further innovation in AML treatments[3].

Market Barriers

Despite the promising outlook, there are several barriers to the market growth of glasdegib maleate:

• High Cost of Therapy: The high cost of AML treatments, including glasdegib, can be a significant barrier to access. This cost can limit the adoption of these therapies, especially in regions with limited healthcare resources[3].
• Toxic Therapies: While glasdegib has a more favorable side effects profile compared to some other treatments, AML therapies in general can be toxic. This toxicity can lead to low survival rates and reduced quality of life for patients[3].
• Clinical Trial Limitations: Designing and conducting clinical trials for AML treatments can be challenging due to the heterogeneity of the disease and the limited number of patients available for trials[3].

Financial Trajectory

The financial trajectory for glasdegib maleate is closely tied to the overall growth of the AML market:

• Revenue Growth: With the increasing incidence of AML and the growing demand for effective treatments, the revenue from glasdegib maleate is expected to grow. The drug's approval and its potential to replace or complement existing treatments will contribute to this growth[3].
• Market Share: As glasdegib maleate gains traction, it is likely to capture a significant share of the AML market. This will be driven by its efficacy in combination therapies and its favorable side effects profile compared to other treatments[1][3].

Future Prospects

The future prospects for glasdegib maleate are promising, with several ongoing and planned clinical trials:

• Ongoing Clinical Trials: Studies are ongoing to explore the efficacy of glasdegib in various combinations and patient populations. For example, pilot/phase 1b studies are investigating glasdegib-based treatment combinations in adult patients with relapsed AML post allogeneic hematopoietic cell transplantation[2].
• Personalized Therapy: The development of personalized therapies based on genomic, proteomic, and metabolomic alterations of the disease is expected to improve clinical outcomes. Glasdegib, with its targeted mechanism of action, is well-positioned to benefit from these advancements[3].

Key Takeaways

• Growth Drivers: Increasing incidence of AML, emerging therapies, and research advancements are driving the market growth.
• Efficacy: Glasdegib shows superior outcomes when combined with other treatments like cytarabine.
• Market Barriers: High cost of therapy, toxic therapies, and limitations in clinical trial design are significant barriers.
• Financial Trajectory: Revenue growth is expected due to increasing demand and market share gains.
• Future Prospects: Ongoing clinical trials and the potential for personalized therapy are promising.

FAQs

Q: What is glasdegib maleate used for? A: Glasdegib maleate is used for the treatment of Acute Myeloid Leukemia (AML), specifically targeting the sonic hedgehog receptor smoothened (SMO)[1][5].

Q: When was glasdegib maleate approved by the FDA? A: Glasdegib maleate was approved by the FDA on November 21, 2018[1][5].

Q: What are the key market drivers for glasdegib maleate? A: The key market drivers include the increasing incidence of AML, emerging therapies, and the drug's favorable side effects profile when compared to other treatments[1][3].

Q: What are the main barriers to the market growth of glasdegib maleate? A: The main barriers include the high cost of therapy, toxic therapies, and limitations in designing clinical trials[3].

Q: What is the current gold standard for treating older AML patients? A: The current gold standard for older AML patients is venetoclax with hypomethylation agents, although glasdegib is being explored as a potential alternative[1][3].

Sources

1. DrugBank Online - Glasdegib maleate | DrugBank Online
2. Synapse - Glasdegib Maleate - Drug Targets, Indications, Patents - Synapse
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 2018-2030 States DelveInsight
4. European Medicines Agency - Assessment report - Daurismo - European Medicines Agency
5. PubChem - Glasdegib | C21H22N6O | CID 25166913 - PubChem

Last updated: 2024-12-19