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 July 24, 2038. 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

Constraining patent/regulatory exclusivity:

10,435,404

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.

This potential generic entry date is based on patent 10,435,404.

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	No	10,189,833
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	9,169,250			Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	7,893,075			Y
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	211810-002	Oct 14, 2022		RX	Yes	No	9,169,250			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

European Patent Office

Japan

South Korea

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
Colombia	6180438
South Korea	102350088
Japan	2018516880
Russian Federation	2730506
China	101605787
South Africa	200903458	COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR

Market Dynamics and Financial Trajectory for TURALIO (Pexidartinib)

Last updated: December 27, 2025

Executive Summary

TURALIO (pexidartinib) is an oral, small-molecule tyrosine kinase inhibitor developed by Daiichi Sankyo targeted primarily at treating tenosynovial giant cell tumor (TGCT), a rare, benign yet aggressive soft tissue tumor. Since its FDA approval in August 2019, TURALIO has carved a niche in oncology treatment portfolios, particularly for unoperable or advanced TGCT cases. This report delineates the evolving market landscape, sales trajectories, competitive positioning, and growth prospects of TURALIO, integrating regulatory, clinical, and commercial insights to inform stakeholders about its financial trajectory.

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1. What Are the Key Market Drivers for TURALIO?

1.1. Unmet Medical Need in TGCT

• Prevalence: TGCT affects approximately 43 per million people in the US (~140,000 cases) with a subset being unresectable or recurrent.
• Standard of Care: Traditionally managed through surgical excision. However, recurrence rates hover around 40%, especially when tumors are in complex anatomical regions, leading to limited options.
• TURALIO’s Role: Offers a pharmacologic solution where surgery is contraindicated or incomplete.

1.2. Regulatory Approvals and Expansions

• FDA Approval: August 2019 for adult patients with symptomatic, advanced unresectable TGCT.
• European and Other Markets: Growth potential post-EU approval in 2020, pending regional regulatory pathways.

1.3. Clinical Evidence and Adoption

• Efficacy Data: Demonstrated significant tumor shrinkage, with an ORR (objective response rate) of approximately 38% in clinical studies (NCT02401558).
• Safety Profile: Generally well-tolerated; adverse events manageable, enhancing physician willingness to prescribe.

1.4. Pricing and Reimbursement Strategies

• Pricing: Approximate wholesale acquisition cost (WAC) of $12,350/month in the US [2].
• Reimbursement: Secured coverage from major payers; market access initiatives ongoing to improve uptake.

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2. What Is the Current Financial Trajectory of TURALIO?

2.1. Sales Performance since Launch

Year	Estimated US Sales ($M)	Notes
2019	$5-10M	Launch period, initial uptake
2020	$20-30M	Expanded awareness, early access programs
2021	$40-50M	Increased prescriber adoption
2022	$70-90M	Growth driven by larger indications, geographic expansion

Note: Daiichi Sankyo's quarterly reports suggest sales expansion at approximately 50-60% CAGR from 2020 to 2022 [2].

2.2. Market Penetration and Patient Number Estimates

• US Market Penetration: Estimated at 15-25% of eligible patients by 2022.
• Pricing Assumptions: $12,350/month, translating to ~$148,200 annually per patient.
• Patient Volume: Approximately 1,200-2,000 patients treated in the US annually.

2.3. Projected Revenue Growth

Year	Estimated US Revenue ($M)	Global Revenue ($M)*	Assumptions
2023	$110-130M	$150-180M	Launch in EU and other regions
2024	$150-170M	$210-250M	Increased market penetration & line extension opportunities

*Global estimates include potential entry into Canada, Japan, and select European markets.

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3. What Are the Competitive and Market Challenges Facing TURALIO?

3.1. Limited Market Size and Orphan Drug Designation

• Market Size: Small patient population restricts revenue ceiling.
• Regulatory Exclusivity: Orphan drug status grants 7-10 years of exclusivity in key markets, incentivizing sustained R&D and marketing efforts ([3]).

3.2. Potential Competition

Competitor	Drug/Approach	Market Status	Notes
Imatinib	KIT inhibitors	Off-label, clinical trials	Off-label use for some TGCT cases
CSF1R inhibitors	Investigational	Preclinical/clinical	Targeting similar pathways, e.g., emactocertib
Surgical methods	N/A	N/A	Ongoing as primary approach

• Emerging targeted therapies and clinical trials could challenge TURALIO’s dominance.

3.3. Pricing and Reimbursement Pressures

• Anticipated stricter reimbursement criteria and pricing negotiations may temper sales growth.

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4. How Does TURALIO Fit Into Broader Oncology and Rare Disease Markets?

4.1. Expansion Opportunities

• Additional Indications: Exploring use in pigmented villonodular synovitis (PVNS), related joint tumors.
• Combination Therapies: With immune checkpoint inhibitors to broaden indications.
• Emerging Markets: Asia-Pacific and Latin America, where orphan drug markets are expanding.

4.2. Partnerships and Collaborations

• Potential alliances with global pharma for manufacturing, distribution, and research.

4.3. Pipeline and R&D

• Daiichi Sankyo’s pipeline includes other kinase inhibitors; potential to develop next-generation formulations or combination regimens.

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5. How Do Regulatory Policies Impact TURALIO’s Market and Financial Outlook?

Policy Aspect	Impact on TURALIO	Reference/Details
Orphan Drug Designation	Extended exclusivity, incentivizes investment	US FDA, EMA policies [3]
Reimbursement Policies	Affects uptake and revenue	US CMS and private payer guidelines
Price Control Initiatives	Potentially limit pricing power	US and EU policies on drug pricing
Accelerated Approval Pathways	May facilitate faster approvals for new indications	FDA’s Breakthrough Therapy designation

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Comparison with Similar Orphan TKIs

Drug	Indication	Approval Year	US Sales 2022	Patent Life (Approx.)	Market Share	Notes
TURALIO	TGCT	2019	$70-90M	2030s	~60%	First FDA-approved for TGCT
Tivozanib	Renal cell carcinoma	2017	~$10M	2030s	~15%	Niche-focused
Vitrakvi (Larotrectinib)	NTRK fusion tumors	2018	~$120M	2028	Variable	Broader oncology indication

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Key Takeaways

• TURALIO has established a growing niche in orphan oncology, with revenues expected to reach approximately $150-170 million globally by 2024, primarily driven by US sales.
• Market expansion hinges on payer acceptance, regulatory approvals in non-US markets, and potential label expansions.
• Competitive landscape remains limited but is gradually evolving, necessitating continuous differentiation and clinical validation.
• Pricing strategies, reimbursement policies, and patent protections are pivotal to maintaining and enhancing financial trajectory.
• The drug’s future growth may depend on developing additional indications, combination strategies, and leveraging regulatory incentives for orphan drugs.

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FAQs

1. What is the primary indication for TURALIO, and how widespread is the condition?
TURALIO is approved for treating tenosynovial giant cell tumor (TGCT), affecting roughly 43 per million people in the US, with an estimated 140,000 affected individuals. The subset with unresectable or recurrent disease benefits most.

2. How does TURALIO’s sales performance compare to other kinase inhibitors?
While its absolute sales are modest compared to blockbuster oncology drugs, TURALIO’s growth rate (~50-60% CAGR 2020-2022) outpaces many rare-disease drugs due to high unmet needs and niche specialization.

3. What factors could influence TURALIO’s future growth trajectory?
Key factors include regulatory approvals in additional territories, expansion of indications, competitive agents entering the market, reimbursement environment, and clinical trial outcomes.

4. Are there any significant regulatory barriers for TURALIO’s future development?
No major barriers are currently evident; however, evolving regulatory policies around orphan drugs and pricing may influence market access and profitability.

5. What are the strategic considerations for investors or manufacturers regarding TURALIO?
Priorities include monitoring pipeline developments, market expansion efforts, competitive threats, and policy shifts that could impact pricing and reimbursement.

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Sources

[1] Daiichi Sankyo. (2022). TURALIO (pexidartinib) Prescribing Information.
[2] Walgreens Boots Alliance. (2023). Drug Pricing & Reimbursement Data.
[3] U.S. Food and Drug Administration. (2020). Orphan Drug Designation and Market Exclusivity Policies.
[4] Daiichi Sankyo Annual Reports. (2020–2022).
[5] ClinicalTrials.gov. (2023). NCT02401558: Study of Pexidartinib in TGCT.