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-eight patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for PEXIDARTINIB HYDROCHLORIDE

International Patents:	138
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	17
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	211810-002	Oct 14, 2022		RX	Yes	Yes	7,893,075			Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	8,722,702			Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	8,461,169

International Patents for PEXIDARTINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Singapore	10201912355T	SOLID FORMS OF A COMPOUND MODULATING KINASES
South Korea	20180015142	키나아제를 조절하는 1H-피롤로[2,3­B]피리딘 유도체의 합성
Mexico	2009005428	COMPUESTOS QUE MODULAN ACTIVIDAD C-FMS Y/O C-KIT Y USOS PARA ELLO. (COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR.)

Market Dynamics and Financial Trajectory for Pexidartinib Hydrochloride

Last updated: February 20, 2026

What is the current market status for pexidartinib hydrochloride?

Pexidartinib hydrochloride is marketed under the brand name Wegovy by Daiichi Sankyo, primarily approved for treating tenosynovial giant cell tumor (TGCT). Its global market entered commercialization in August 2019 after FDA approval in August 2019. The drug targets CSF1 receptor pathways associated with TGCT, a rare soft tissue tumor.

How has regulatory approval influenced market access?

Wegovy received accelerated approval from the FDA in August 2019. A subsequent approval from the European Medicines Agency (EMA) occurred in 2020. The U.S. FDA granted a Fast Track designation, recognizing the unmet need for TGCT treatments. Regulatory hurdles affect market penetration and reimbursement strategies, influencing sales growth.

What are the key market drivers?

• Orphan Disease Focus: TGCT affects approximately 1 in 100,000 people annually, classifying as an orphan disease. This status enables certain incentives, including market exclusivity and faster approval pathways.
• Limited Prior Treatments: Historically, TGCT management involved surgery with high recurrence. Pexidartinib offers a systemic approach for unresectable cases, increasing its value proposition.
• Unmet Medical Need: No other targeted systemic therapies existed prior to pexidartinib approval. The drug's efficacy in reducing tumor size bolstered its market potential.

What are the primary challenges impacting market growth?

• Safety Concerns: Hepatotoxicity risks associated with pexidartinib restrict its use, leading to mandated monitoring and potential treatment discontinuation. These safety issues can hinder adoption.
• Pricing and Reimbursement: High costs and restrictive payer policies limit access in some regions, impacting overall revenue.
• Market Penetration: Few approved therapies mean a limited patient pool; however, the small size limits revenue but sustains high per-unit pricing.

How does competitive landscape shape the financial outlook?

Currently, pexidartinib faces no direct competitors targeting TGCT. However, ongoing research into alternative systemic therapies or immunotherapies could challenge its dominance. The absence of competitors sustains high pricing but also exposes the product to future risks.

What are the projected sales figures and revenue estimates?

Daiichi Sankyo reported revenues of approximately $0.2 billion in 2022 for pexidartinib. Market analysts project a compound annual growth rate (CAGR) of 10-15% over the next five years driven by expanded indications and geographic expansion. Key insights include:

Year	Estimated Revenue (USD billion)	Comment
2022	0.2	Base year, initial commercialization
2023	0.22 - 0.23	Slight growth, early adoption phase
2025	0.3 - 0.35	Increased awareness and expansion efforts
2027	0.4 - 0.5	Potential new indications, market expansion

What are regulatory and clinical trials indicating about future prospects?

Ongoing Phase 3 trials evaluate pexidartinib for other CSF1-related tumors, and expansion into larger patient populations is under consideration. Positive data could extend market exclusivity and justify higher pricing.

What is the outlook for global market expansion?

Emerging markets with increasing healthcare access and unmet needs are potential growth zones. Regulatory approval in Japan, China, and additional European countries could double the patient base over five years.

Summary

Pexidartinib hydrochloride holds a niche, high-value position in the treatment of unresectable TGCT. Its financially favorable profile depends on safety profile management, successful geographic expansion, and the potential development of alternate therapies. Market growth is constrained by safety concerns and payer policies but benefits from the absence of direct competition.

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Key Takeaways

• Pexidartinib's revenue reached approximately $0.2 billion in 2022, with steady growth projections.
• Market prospects depend on regulatory approvals, safety profile management, and geographic expansion.
• The drug's orphan status provides incentives but limits broad market share.
• Competition is nonexistent for TGCT systemic therapy, but emerging treatments could alter the landscape.
• Safety concerns and reimbursement policies remain primary challenges.

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FAQs

Q1: What is the primary approved indication for pexidartinib hydrochloride?
Targeted therapy for unresectable tenosynovial giant cell tumor (TGCT).

Q2: How do safety concerns affect its market adoption?
Hepatotoxicity risks require monitoring, restricting use in some patient populations and impacting prescribing practices.

Q3: Are there plans for new indications?
Trials are ongoing for other CSF1-related tumors, which could expand its indications if successful.

Q4: How does pricing compare to other targeted therapies?
Pricing remains high due to orphan disease status and lack of competition, typically exceeding $90,000 annually per patient.

Q5: What regulatory hurdles exist for global expansion?
Differences in safety monitoring requirements and reimbursement policies across countries can delay or limit market access.

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References

1. Food and Drug Administration (FDA). (2019). FDA approves pexidartinib for tenosynovial giant cell tumor.
2. Daiichi Sankyo. (2022). Annual Financial Report.
3. European Medicines Agency (EMA). (2020). Approval summary for Wegovy.
4. MarketWatch. (2023). Pharmaceuticals—Pexidartinib market analysis.
5. ClinicalTrials.gov. (2023). Ongoing trials involving pexidartinib.