TURALIO Drug Patent Profile

Which patents cover Turalio, and what generic alternatives are available?

Turalio is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and thirty-eight patent family members in forty-two countries.

The generic ingredient in TURALIO is pexidartinib hydrochloride. One supplier is listed for this compound. Additional details are available on the pexidartinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Turalio

Turalio was eligible for patent challenges on August 2, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 5, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TURALIO

International Patents:	138
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	1
Patent Applications:	1,603
Drug Prices:	Drug price information for TURALIO
What excipients (inactive ingredients) are in TURALIO?	TURALIO excipients list
DailyMed Link:	TURALIO at DailyMed

See drug prices for TURALIO

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

NDA:

211810

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 TURALIO

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2

See all TURALIO clinical trials

Pharmacology for TURALIO

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

US Patents and Regulatory Information for TURALIO

TURALIO is protected by twelve US patents and two FDA Regulatory Exclusivities.

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
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	Yes
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No				Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No				Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	Yes				Y

International Patents for TURALIO

When does loss-of-exclusivity occur for TURALIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Philippines

Portugal

Russian Federation

San Marino

Serbia

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 TURALIO around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016179415
Norway	342175
South Korea	102615829
Japan	6530826

Market Dynamics and Financial Trajectory for TURALIO (pexidartinib)

Last updated: February 20, 2026

What is TURALIO, and what is its approved use?

TURALIO (pexidartinib) is a selective colony-stimulating factor 1 receptor (CSF1R) inhibitor. Approved by the U.S. Food and Drug Administration (FDA) in August 2019, TURALIO targets tenosynovial giant cell tumor (TGCT), a rare, non-malignant joint disorder characterized by proliferative synovial tissue. Its approval was based on clinical trials demonstrating tumor reduction in symptomatic patients with unresectable or recurrent disease [1].

What is the current sales landscape for TURALIO?

As of 2022, TURALIO's global revenues primarily derive from the U.S. market. Novartis, the manufacturer, reported that sales exceeded $50 million for the year, with rapid growth in early regulatory years. However, due to the niche indication, total sales volumes remain constrained compared to blockbuster oncology and rare disease drugs.

Table 1. TURALIO (pexidartinib) 2022 Sales Breakdown

Region	Revenue (USD millions)	Market Share	Notes
U.S.	$45	90%	Main market, approved in 2019
Europe	$3	6%	Limited approval status, early access programs
Rest of World	$2	4%	Pending approvals, strategic partnerships in development

How does the competitive landscape shape TURALIO's market potential?

TURALIO's primary competitor in the TGCT space is surgical resection, which remains the standard of care. No other targeted systemic therapies have received regulatory approval for TGCT. Mirati Therapeutics is developing MRTX1719, an investigational CSF1R inhibitor, but it remains in early phases. As there are no direct approved treatments aside from surgery, TURALIO holds a first-mover advantage in systemic therapy.

However, its market penetration is limited by the rarity of TGCT, estimated at 50-70 cases per million population annually. Market growth depends on:

• Expansion of approved indications
• Off-label use in similar CSF1R-driven diseases
• Broader geographic approvals

What are the key factors influencing the financial trajectory?

1. Patent Status and Exclusivity

TURALIO’s patent coverage is expected to extend into 2030. Remaining data exclusivity spans until 2024-2025, with orphan drug designation providing seven years of market exclusivity in the U.S. [2]. This period buffers potential generic competition, supporting revenue stability.

2. Pricing Strategy

Per-label, initial wholesale acquisition cost (WAC) for TURALIO is approximately $30,000 per month. Estimated annual treatment costs for eligible patients approximate $360,000. Price negotiations, payor coverage, and patient assistance programs influence actual revenue realization.

3. Reimbursement and Market Access

Coverage for orphan drugs like TURALIO tends to be favorable, but reimbursement rates vary across health systems. Limited patient numbers reduce bargaining leverage, impacting net prices.

4. Clinical Trial Developments

Ongoing phase 2 and phase 3 trials aim to expand TURALIO’s indication to include other CSF1R-mediated disorders (e.g., diffuse pigmented villonodular synovitis). Positive trial results could broaden the market, possibly doubling or tripling revenues over five years [3].

5. Manufacturing and Supply Chain

As a small-molecule oral therapy, manufacturing costs are relatively contained. Supply chain disruptions could impact availability but are unlikely to impact revenue significantly in the current capacity.

What are the growth opportunities and risks?

Opportunities

• Expansion into larger markets with regulatory approvals in Europe, Asia, and other regions
• Label expansion for multiple CSF1R-driven diseases
• Strategic licensing agreements that could accelerate adoption and revenue

Risks

• Slow or limited uptake due to high cost and specialized patient population
• Competition from future pipeline drugs or biosimilars
• Potential adverse events affecting the safety profile, limiting indication expansion

How do financial forecasts project for TURALIO?

Analysts estimate that TURALIO could reach peak sales of approximately $150 million annually within five years, assuming successful geographic expansion and indication broadening. The current uptake rate suggests year-over-year growth of 20-30% during the initial three years post-approval.

Table 2. TURALIO Revenue Projection (USD millions)

Year	Estimated Revenue	Assumptions
2023	$60	Market expansion in the U.S., initial uptake
2024	$90	European approvals, reimbursement improvements
2025	$120	Indication expansion, increased off-label use
2026+	$150+	Broadened indications, new markets

Key market and financial milestones

• 2024: Expected European approvals, potential new indications
• 2025: First off-label use expansion, commercialization strategies
• 2027: ROI maximization with potential biosimilar entry in broader markets

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Key Takeaways

• TURALIO primarily generates revenue within the U.S. market; global expansion is critical for growth.
• No direct competitors currently exist for TGCT systemic therapy, but off-label surgical interventions dominate.
• Patent and exclusivity protections extend until approximately 2024-2030, supporting revenue stability.
• Market growth hinges on successful indication expansion, geographic approvals, and pricing negotiations.
• Financial estimates suggest $150 million peak annual sales within five years if key drivers are realized.

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FAQs

1. How does TURALIO's pricing compare to competing therapies?
TURALIO’s monthly WAC is about $30,000, placing it among high-cost orphan drugs. No direct therapies exist for TGCT, making competitive pricing less relevant but still impacting payor coverage.

2. When are European approvals expected?
European Medicines Agency (EMA) submissions are underway, with approvals anticipated by late 2023 or early 2024, subject to review outcomes.

3. What are the main challenges to increasing TURALIO sales?
Limited patient population, high treatment cost, and reliance on indication expansion pose challenges. Adoption depends on clinical validation and payer coverage.

4. Are there any notable development pipeline drugs that threaten TURALIO?
None approved, but early-stage pipeline drugs targeting CSF1R are in development, which could become future competitors.

5. What is the long-term outlook for TURALIO's patent protection?
Patent protection lasts until 2030. Orphan drug exclusivity and data exclusivity extend until at least 2024-2025, after which generic competition may enter.

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References

[1] U.S. Food and Drug Administration (2019). FDA approves TURALIO for tenosynovial giant cell tumor.
[2] Novartis AG. (2022). TURALIO patent and exclusivity details.
[3] Market research reports. (2022). Pipeline analysis of CSF1R inhibitors.