PEXIDARTINIB HYDROCHLORIDE - Generic Drug Details

What are the generic sources for pexidartinib hydrochloride and what is the scope of patent protection?

Pexidartinib hydrochloride is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pexidartinib hydrochloride has one hundred and thirty-six patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for PEXIDARTINIB HYDROCHLORIDE

International Patents:	136
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	17
Patent Applications:	28
What excipients (inactive ingredients) are in PEXIDARTINIB HYDROCHLORIDE?	PEXIDARTINIB HYDROCHLORIDE excipients list
DailyMed Link:	PEXIDARTINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PEXIDARTINIB HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

10,435,404

Dosage:

CAPSULE;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 PEXIDARTINIB HYDROCHLORIDE

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

Sponsor	Phase
Daiichi Sankyo Co., Ltd.	Phase 2
Daiichi Sankyo, Inc.	Phase 4
Daiichi Sankyo Co., Ltd.	Phase 3

See all PEXIDARTINIB HYDROCHLORIDE clinical trials

Pharmacology for PEXIDARTINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 3A Inducers Kinase Inhibitors Tyrosine Kinase Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PEXIDARTINIB HYDROCHLORIDE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PEXIDARTINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	9,358,235
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	10,961,240
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	9,802,932			Y

International Patents for PEXIDARTINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
New Zealand	577011	COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR
Colombia	2017011534	Formas sólidas de quinasas que modulan un compuesto
Canada	2867918	COMPOSES ET PROCEDES POUR UNE MODULATION DE LA KINASE, ET INDICATIONS CORRESPONDANTES (COMPOUNDS AND METHODS FOR KINASE MODULATION, AND INDICATIONS THEREFOR)
China	107548394

PEXIDARTINIB HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pexidartinib Hydrochloride

Introduction

Pexidartinib hydrochloride, marketed under the name TURALIO, is a first-in-class small molecule tyrosine kinase inhibitor developed by Daiichi Sankyo. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its key indications, market performance, and future projections.

Indications and Approvals

Pexidartinib is primarily approved for the treatment of tenosynovial giant cell tumor (TGCT), a rare and often debilitating condition. It has also been investigated in various other indications, including acral lentiginous melanoma, glioblastoma, malignant melanoma, prostate cancer, and several types of leukemia and solid tumors[5].

Market Performance

Sales and Revenue

Since its approval, pexidartinib has shown a steady increase in sales. While specific financial figures for pexidartinib alone are not detailed in the sources, the drug's performance can be inferred from the broader context of Daiichi Sankyo's financial reports.

For instance, Daiichi Sankyo's overall oncology portfolio, which includes other successful drugs like ENHERTU®, has seen significant growth. However, pexidartinib's market penetration, though smaller in scale compared to ENHERTU®, still contributes to the company's revenue growth[1].

Market Share and Uptake

Pexidartinib has gained traction in the market for TGCT, which is a niche but significant area. The drug's approval and subsequent marketing efforts have led to a positive uptake in the patient population. Clinical trials and real-world evidence have supported its efficacy and safety, contributing to its market share[4].

Clinical Trials and Development Phases

Ongoing and Completed Trials

Pexidartinib has undergone several clinical trials across various phases. A notable multicenter, single-arm study evaluated its efficacy and safety in adult subjects with TGCT, showing positive results[2].

The drug is also in Phase II trials for acral lentiginous melanoma, glioblastoma, and malignant melanoma, among other indications. Phase I/II trials are ongoing for acute myeloid leukemia, breast cancer, and gastrointestinal stromal tumors[5].

Discontinued Indications

Despite its promise, pexidartinib has been discontinued for certain indications such as Alzheimer's disease, Hodgkin's disease, neurological disorders, and rheumatoid arthritis due to lack of efficacy or other strategic reasons[5].

Financial Projections

Revenue Growth

While specific revenue figures for pexidartinib are not provided, the overall trend for Daiichi Sankyo's oncology portfolio suggests continued growth. The success of other oncology drugs like ENHERTU® indicates a positive financial trajectory for the company's oncology segment, which includes pexidartinib.

Market Expansion

The drug's approval in various regions and its increasing market share in TGCT treatment are expected to drive revenue growth. As pexidartinib expands into new markets and gains approvals for additional indications, its financial performance is likely to improve[1].

Competitive Landscape

Market Competition

Pexidartinib operates in a competitive landscape dominated by other tyrosine kinase inhibitors and targeted therapies. However, its first-in-class status for TGCT treatment provides a unique market position. The drug's efficacy and safety profile, as demonstrated in clinical trials, help it maintain a competitive edge[4].

Regulatory and Clinical Milestones

FDA Approval

Pexidartinib received FDA approval in August 2019 for the treatment of TGCT. This approval was a significant milestone, marking the drug's entry into the market[4].

Ongoing Regulatory Activities

The drug continues to be under evaluation for various other indications, with ongoing clinical trials and regulatory submissions. These activities are crucial for expanding its market reach and increasing its revenue potential.

Patient and Market Impact

Patient Outcomes

Pexidartinib has shown significant improvements in patient outcomes for TGCT, offering a much-needed treatment option for this rare condition. The drug's efficacy in reducing tumor size and improving symptoms has been well-documented in clinical trials[2].

Market Penetration

The drug's market penetration is driven by its unique indication and the lack of alternative treatments for TGCT. As more patients and healthcare providers become aware of pexidartinib, its market share is expected to grow.

Future Outlook

Expansion into New Indications

Pexidartinib's future financial trajectory is closely tied to its potential approvals in new indications. Successful outcomes in ongoing clinical trials could significantly boost its revenue and market presence[5].

Global Market Expansion

As the drug gains approvals in more regions, its global market reach will expand, contributing to increased sales and revenue.

Key Takeaways

• Unique Indication: Pexidartinib is the first approved treatment for tenosynovial giant cell tumor (TGCT), providing a unique market position.
• Clinical Efficacy: The drug has shown positive results in clinical trials, supporting its safety and efficacy.
• Market Growth: Despite being a niche product, pexidartinib contributes to Daiichi Sankyo's overall revenue growth in the oncology segment.
• Future Potential: Ongoing clinical trials and potential approvals in new indications hold promise for future market expansion and revenue growth.

FAQs

1. What is pexidartinib hydrochloride used for? Pexidartinib hydrochloride, marketed as TURALIO, is primarily used for the treatment of tenosynovial giant cell tumor (TGCT).

2. Who developed pexidartinib? Pexidartinib was developed by Daiichi Sankyo.

3. What is the current market status of pexidartinib? Pexidartinib has been approved by the FDA for TGCT and is undergoing clinical trials for various other indications.

4. How does pexidartinib compare to other treatments in its class? Pexidartinib is a first-in-class tyrosine kinase inhibitor for TGCT, providing a unique treatment option where other alternatives are limited.

5. What are the future prospects for pexidartinib? The future prospects for pexidartinib include potential approvals in new indications and expansion into new markets, which could significantly boost its revenue and market presence.

Sources

1. FY2022 Financial Results Presentation - Daiichi Sankyo
2. Pexidartinib Hydrochloride - Drug Targets, Indications, Patents
3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee
4. Multi-Discipline Review - accessdata.fda.gov
5. Daiichi Sankyo - Pexidartinib - AdisInsight - Springer