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

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	No
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	No				Y
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				Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No				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
Japan	2020528884	キナーゼを調節する化合物の製剤
Argentina	063878
China	110944670
Japan	2021185163
Slovenia	3292123
Russian Federation	2730506	ТВЕРДЫЕ ФОРМЫ СОЕДИНЕНИЯ, МОДУЛИРУЮЩЕГО КИНАЗЫ (SOLID FORMS OF THE COMPOUND MODULATING THE KINASES)
World Intellectual Property Organization (WIPO)	2016179415

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TURALIO

Last updated: July 27, 2025

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Introduction

TURALIO (pexidartinib) is a targeted kinase inhibitor developed by Daiichi Sankyo for the treatment of tenosynovial giant cell tumor (TGCT), a rare, debilitating musculoskeletal disorder characterized by proliferative synovial-like tissue growth. As a pioneering treatment for this niche indication, TURALIO’s market dynamics are influenced by regulatory approvals, competitive landscape, unmet medical needs, and evolving healthcare policies. This analysis explores the current market landscape, demand drivers, revenue projections, and strategic factors shaping TURALIO’s financial trajectory.

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Regulatory Milestones and Market Entry

TURALIO received FDA approval in August 2019 under priority review for adults with symptomatic, locally advanced, or metastatic TGCT not amenable to surgery. The drug's approval was supported by robust clinical data demonstrating significant tumor reduction and symptom alleviation, notably in patients with unresectable cases [1].

Regulatory acceptance across other regions remains evolving. The European Medicines Agency (EMA) granted orphan designation and approval processes are ongoing in select markets, potentially expanding the geographic reach. The approval pathway, combined with rapid adoption owing to limited alternatives, positions TURALIO as a first-in-class therapy for its indication.

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Market Size and Patient Demographics

TGCT, also known as pigmented villonodular synovitis, typically affects patients aged 20-50, with prevalence estimated at approximately 43 cases per million globally [2]. The disease, although rare, leads to joint destruction, pain, and functional impairment.

Estimates suggest that about 250,000 to 300,000 individuals worldwide may be at risk across various markets. Due to the rarity (orphan disease status), the treatment market remains niche but with high per-patient revenue potential, driven by the severity and lack of existing effective therapies.

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Market Dynamics Influencing TURALIO

1. Therapeutic Landscape and Competition

Prior to TURALIO, treatment options were predominantly surgical, with recurrence rates as high as 44%. No approved medical therapies existed until TURALIO's approval, giving it a significant first-mover advantage.

Emerging therapies include other kinase inhibitors under investigation, but none have attained commercial approval for TGCT. The absence of direct competitors enhances TURALIO's market dominance, though potential pipeline therapies could emerge, impacting future dynamics.

2. Pricing, Reimbursement, and Patient Access

TURALIO is positioned as a high-cost dedicated therapy, with list prices approximating $15,000-20,000 per month in the U.S. (based on analogous targeted therapies). Reimbursement pathways are generally favorable under orphan drug programs, with payers recognizing the unmet needs and cost-benefit ratio driven by improved quality of life and reduced surgical interventions.

Patient access hinges on local healthcare policies, inclusion in clinical guidelines, and insurance coverage. As awareness grows, market penetration is likely to deepen, especially with indications for inoperable or recurrent cases.

3. Clinical Adoption and Physician Awareness

Education campaigns and inclusion in clinical guidelines by rheumatology and orthopedic societies bolster physician confidence. Demonstrated clinical benefits support rapid adoption, especially in surgical-ineligible cases. Post-marketing studies confirming long-term safety and efficacy will further drive prescription behaviors.

4. Regulatory Approvals and Orphan Status

Orphan drug designation confers benefits such as market exclusivity and potential tax incentives, facilitating a favorable economic environment. Regulatory approval in additional markets (e.g., the EU, Japan) could significantly extend TURALIO’s commercial reach.

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Financial Trajectory and Revenue Projections

1. Revenue Growth Drivers

• Market Penetration: Initial uptake in U.S. specialty centers, expanding through awareness and formulary inclusion.
• Geographic Expansion: Regulatory approvals in Europe and Asia will diversify revenue streams.
• Indication Expansion: Potential research into off-label uses or broader indications could increase forecasts if supportive clinical data emerge.

2. Short to Medium-Term Outlook (Next 3–5 Years)

Sales are expected to grow steadily, with initial revenues in the low hundreds of millions USD. According to industry analysts, peak sales could reach between $500 million and $1 billion globally, contingent upon market acceptance and competitive developments [3].

3. Market Challenges and Risks

• Pricing pressures due to healthcare cost containment policies.
• Limited patient populations, constraining the total addressable market.
• Potential emergence of competitors or alternative therapies.
• Long-term safety concerns affecting formulary access and physician prescribing patterns.

4. Strategic Growth Opportunities

• Combination therapies: Could enhance clinical benefits and expand indications.
• Market expansion: Entry into Asian and European markets, supported by regulatory approvals.
• Patient advocacy and clinical engagement: Strengthening awareness among clinicians and patients to accelerate adoption.

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Impact of External Factors

Healthcare policies aimed at controlling drug costs may tighten reimbursement landscapes, impacting TURALIO’s market penetration. Advances in surgical techniques and minimally invasive procedures also influence demand. Furthermore, increased awareness and diagnostic capabilities facilitate earlier intervention, possibly altering utilization rates.

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Conclusion

TURALIO's market dynamics are characterized by its status as a first-in-class, orphan-designated therapy targeting an unmet need in TGCT. Its financial trajectory hinges on successful global regulatory approvals, clinician adoption, and favorable health economics. While short-term revenues are promising, long-term success depends on expanded indications, strategic market entry, and maintaining a competitive edge amidst evolving therapeutic options.

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Key Takeaways

• First-mover advantage in the niche TGCT market positions TURALIO as a significant revenue generator within targeted indications.
• Market expansion across Europe, Asia, and other regions could substantially increase sales, contingent upon regulatory success.
• Pricing strategy and reimbursement policies are crucial for optimizing patient access and revenue realization.
• Emerging competitors or alternative treatments could impact future growth, emphasizing the need for ongoing clinical development and brand positioning.
• Strategic partnerships, advocacy, and education will be vital to accelerate adoption and maximize commercial potential.

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FAQs

1. What is TURALIO’s primary indication?
   TURALIO is indicated for adults with symptomatic, inoperable, or recurrent tenosynovial giant cell tumor (TGCT).

2. Are there any approved alternatives to TURALIO for TGCT?
   No, prior to TURALIO, management was mainly surgical, with no approved pharmacological treatments.

3. What are the key factors influencing TURALIO’s market penetration?
   Regulatory approvals, clinician awareness, reimbursement policies, and healthcare system acceptance.

4. What is the expected peak sales potential for TURALIO?
   Industry projections estimate between $500 million to $1 billion globally, depending on market expansion and adoption rates.

5. What risks could affect TURALIO's financial growth?
   Pricing pressures, emerging competitors, safety concerns, and limited patient population size.

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References

[1] Food and Drug Administration. FDA approves pexidartinib for tenosynovial giant cell tumor. 2019.
[2] Doll, H., et al. (2016). Epidemiology of tenosynovial giant cell tumor. Orphanet Journal of Rare Diseases.
[3] MarketLine. (2022). Global drugs market analysis.

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This comprehensive assessment aims to support strategic decision-making for stakeholders involved in TURALIO’s market development, investment, and broader pharmaceutical innovation strategies.