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:	1,384
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
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	Yes

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
Australia	2016258027
Brazil	112017023490
Brazil	112017023540
Canada	2984899
Canada	2984910

Turalio (pexidartinib) Market Dynamics and Financial Trajectory: Pricing, Sales Drivers, Exclusivity, and Competitive Pressure

Last updated: July 23, 2026

Turalio (pexidartinib) entered the US market through a narrow, high-unmet-need oncology indication and remains a single-product commercial story. Sales momentum has been constrained by payer friction, limited addressable use in tenosynovial giant cell tumor (TGCT), and an adverse competitive setup from alternative TKIs and off-label options. Financial trajectory through 2024 is tied to (1) enrollment and conversion in TGCT treatment pathways, (2) manufacturing availability after launch execution, and (3) payer-specific access rules for a costly daily oral cancer drug.

What is Turalio (pexidartinib) and what indication drives its US revenue?

Turalio is pexidartinib, an oral kinase inhibitor developed for tenosynovial giant cell tumor (TGCT). In the US, it is used for adult patients with symptomatic, tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Why the TGCT population limits sales ceiling

Key commercial realities for Turalio:

• TGCT incidence is low relative to mainstream oncology markets. That shrinks the addressable base.
• The indication is surgery-resistant and severity-defined. Many patients remain managed through surgery or observation depending on lesion location and functional impact.
• The therapy is typically chronic or long-duration in practice when disease control needs persist, but the patient pool remains constrained.

Commercial implication: revenue depends on patient flow, not broad label expansion

Without a large epidemiology tail or multiple lines of use, Turalio revenue is driven by:

• Referral velocity to specialty centers
• Rapid identification of “not amenable to surgery” eligibility
• End-to-end access from diagnostic confirmation to payer approval

How does Turalio pricing and reimbursement affect market adoption?

Turalio’s pricing is structured like a specialized oncology oral. Its market dynamics are dominated by payer reimbursement behavior rather than consumer uptake.

Payer friction points that reduce conversion

Common barriers for high-cost oncology drugs in rare tumor labels:

• Prior authorization requirements for surgery-ineligible TGCT
• Evidence documentation demands around morbidity and functional limitation
• Treatment monitoring burden, including liver-related safety management typical for kinase inhibitors and reflected in prescribing requirements

Net pricing sensitivity

With a small addressable population, even a modest rate of denials, slow approvals, or restrictive coverage policies can materially affect monthly prescriptions and pull-through.

What sales performance trajectory does Turalio show through 2024?

Turalio’s financial trajectory is typically reported in quarterly company segment/product lines as a late-stage commercial product under an orphan/rare oncology umbrella. The revenue path has been shaped by:

• Launch ramp and center buildout after FDA approval
• Fluctuations in reimbursement speed by payer
• Patient identification cycles for surgery-resistant TGCT

Typical trajectory pattern for a niche rare-oncology oral

• Initial uptake driven by early adopters at academic/specialty centers
• Slowdown when coverage constraints and eligibility verification lengthen time-to-treatment
• Stabilization as approved networks mature, with upside dependent on incremental payer wins and sustained patient flow

What patents protect Turalio (pexidartinib) and how strong is the patent estate?

Turalio’s exclusivity and patent protection define the commercial risk window for generics and other competing therapies with similar kinase targeting.

How to think about the protection stack

For a small-molecule oncology drug, the relevant protection layers generally include:

• Compound and analog patents covering pexidartinib
• Composition-of-matter and formulation patents (if any) for oral drug form
• Method-of-treatment patents tied to TGCT dosing regimens and patient selection criteria
• Orphan-drug exclusivity (if applicable) that can block approval of competing generics in the US even when some patents expire

Enforceable protection drives competitor timing

Competitor entry timing usually aligns with:

• Patent expiration dates that eliminate legal barriers
• Regulatory exclusivity that delays approval even if patents expire
• Litigation outcomes that can shift launch timing by years

When does Turalio lose exclusivity in the US?

The US loss-of-exclusivity timeline is controlled by the later of:

• Patent expiration for the relevant Orange Book-listed patents
• Regulatory exclusivity periods triggered by FDA orphan drug designation and approval (if applicable)
• Any periods stayed by patent litigation outcomes or settlement-triggered “no generic” agreements

What is the Orange Book status of Turalio (pexidartinib)?

Orange Book status determines:

• Which specific patents are listed for approval blocking
• Whether there are multiple expiration dates across compound, composition, and method patents
• Which patent numbers would be challenged under Paragraph IV (if ANDA applicants seek a carveout)

Orange Book-driven risk for generics

In practice, the market impact is concentrated in:

• Patents with the latest expiration date
• Listed method-of-use patents that can sustain litigation even if compound patents expire earlier

Have there been Paragraph IV challenges to Turalio?

Paragraph IV filings indicate generic challengers are seeking FDA approval before patent expiry. Their timing, whether they lead to litigation, and whether they settle determine:

• Potential generic launch windows
• Likely settlement “carveouts” that cap downside risk for brand sponsors
• Whether multiple ANDA filings create competitive pressure

What Turalio patent litigation affects generic entry risks?

Patent litigation typically impacts the commercial trajectory through:

• Automatic stays or litigation-triggered injunction risk
• Settlement agreements that delay launches
• Narrow carveouts that allow limited launch earlier than full replacement

Key outcomes market participants model

• Whether Turalio’s strongest listed patents are upheld
• Whether any challenged patents are found invalid or not infringed
• Whether a settlement sets a date for the first-to-file generic to launch

Which companies are challenging Turalio and what is their likely launch strategy?

ANDA applicants and authorized generics (if any) tend to align launch plans with:

• The latest patent expiration
• Settlement dates
• Practical manufacturing readiness for a daily oral oncology drug

Competitive set for “near entry”

Even without generic launch, competition includes:

• Alternative TKIs used off-label in TGCT management pathways
• Surgical alternatives and procedural management that reduce medical drug use
• Other clinical agents under development with overlapping target profiles

How does Turalio’s competitive landscape compare with alternative TGCT therapies?

Turalio competes in a narrow therapeutic niche. The competitive “substitutes” are not always direct label competitors but often determine whether patients accept systemic therapy.

Primary comparison axes that influence prescribing

• Efficacy in shrinking lesions or reducing functional limitation
• Dosing convenience and monitoring requirements
• Safety profile severity and the willingness of centers to manage toxicity
• Payer willingness to approve surgery-ineligible TGCT patients

Practical impact on volume

If physicians perceive similar benefit with lower monitoring burdens from other options, Turalio adoption can slow even if label exclusivity remains intact.

What manufacturing and supply factors affect Turalio revenue?

For niche oncology oral therapies, revenue can be sensitive to:

• Batch release timelines and stability
• Raw material procurement
• Contract manufacturing capacity during demand spikes from early ramp centers

When supply constraints occur, it can cause missed refill cycles and delayed treatment starts, affecting prescription counts.

How do safety and monitoring requirements drive real-world discontinuation risk?

Turalio is a kinase inhibitor and is expected to require ongoing clinical monitoring. The commercial effect:

• Discontinuation and dose interruption can reduce treatment duration per patient
• Monitoring visit frequency can affect prescribing workflows in community settings versus academic centers

Revenue consequence

Lower persistence shortens the “lifetime value” of each treated patient, which matters in low-incidence indications.

How does Turalio’s pipeline and label expansion (or lack of it) shape financial trajectory?

In rare oncology, financial trajectory depends on:

• Whether the company expands into new TGCT subgroups or earlier lines
• Whether trials support new dosing regimens or combination strategies
• Whether competitor agents enter the same treatment pathway before generic erosion

If the label remains narrow and pipeline updates do not create meaningful expansion, revenue depends mostly on repeat treatment and retention rather than new patient volumes.

What generic entry risks exist for Turalio and how would they play out financially?

Generic erosion in a niche oncology label depends on:

• Whether biosimilar-like substitution dynamics are plausible for small molecules (typically yes at the payer level, not always clinically)
• Payer incentives and formulary tiering
• Patient and physician substitution norms

Financial modeling lens

• If Turalio loses patent/exclusivity and generics enter, price typically declines quickly, but volume may not fully compensate because TGCT remains narrow.
• Generic entry also depends on the litigation outcome and the number of ANDA filers ready to launch.

Key Takeaways

• Turalio’s financial trajectory is driven by a narrow TGCT patient pool, payer access friction, and sustained patient identification through specialty referral networks.
• Market dynamics remain sensitive to payer approval speed, eligibility verification, and real-world persistence given safety monitoring needs.
• Exclusivity and Orange Book-listed patents define the generic entry clock; litigation outcomes and any settlements are the critical determinants of launch timing and revenue loss.
• Competitive pressure comes less from broad oncology substitution and more from surgical management preference and alternative systemic strategies in overlapping TGCT pathways.

FAQs

1. What are the main reimbursement and prior authorization requirements that limit Turalio uptake?
2. How do Turalio’s safety monitoring requirements affect treatment duration and payer approvals?
3. Which Orange Book patents typically block ANDA approvals for pexidartinib, and what matters most for expiration timing?
4. What Paragraph IV and patent litigation milestones would indicate a realistic generic launch window for Turalio?
5. How would a generic entry in TGCT affect net revenue if the addressable patient population remains small?

References

1. FDA Orange Book. “Turalio (pexidartinib).” US Food and Drug Administration.
2. FDA Label. “Turalio (pexidartinib) Prescribing Information.” US Food and Drug Administration.

DrugChatter Q&A for TURALIO

Turalio+mechanism+of+action?
Turalio prescribing information?
Turalio specialty pharmacy?