Details for Patent: 11,679,110

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Which drugs does patent 11,679,110 protect, and when does it expire?

Patent 11,679,110 protects ROMVIMZA and is included in one NDA.

This patent has fifty-three patent family members in twenty-seven countries.

Summary for Patent: 11,679,110

Title:	Methods of treating disorders using CSF1R inhibitors
Abstract:	Described herein are methods of treating cancers and other tumors related to the decreased proliferation, the depletion, or the repolarization of tumor-associated macrophages (TAMs) and treatment of associated disorders, including tenosynovial giant cell tumor (TGCT) and diffuse-type tenosynovial giant cell tumor (DTGCT).
Inventor(s):	Daniel L. Flynn, Bryan D. Smith, Rodrigo Ruiz Soto, Keisuke Kuida
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US17/358,137
Patent Claim Types: see list of patent claims	Use;

US Drug Patent 11,679,110: Scope, Claims, Expiration and Vimseltinib Patent Landscape

US Patent No. 11,679,110 protects specified dosing regimens of vimseltinib, a selective colony-stimulating factor 1 receptor (CSF1R) inhibitor, for tenosynovial giant cell tumor (TGCT) and other tumors associated with CSF1R, CSF1 or interleukin-34 biology. The core commercial relevance is the twice-weekly oral regimen, particularly 30 mg twice weekly, that corresponds to the FDA-approved dosing of Romvimza (vimseltinib).

The patent is method-of-use protection. It does not primarily claim the chemical compound, a tablet formulation, or a manufacturing process. Its enforceability therefore depends on whether a competing product is administered within the claimed dose, frequency, disease and biomarker parameters.

What drug and therapeutic use does US Patent 11,679,110 protect?

US 11,679,110 covers methods using the compound represented in the claims. The compound is vimseltinib, also known as DCC-3014, developed by Deciphera Pharmaceuticals.

Vimseltinib inhibits CSF1R signaling. CSF1R-dependent macrophages contribute to the growth and maintenance of TGCT, including diffuse-type TGCT, historically called pigmented villonodular synovitis in certain clinical contexts.

The patent’s principal therapeutic target is:

Attribute	Patent scope
Active compound	Vimseltinib or a pharmaceutically acceptable salt
Administration route	Oral administration for the TGCT claims
Core dose range	About 2 mg to about 50 mg twice weekly
Broader tumor claim dose range	About 2 mg to about 60 mg twice weekly
Key commercial dose	30 mg twice weekly
Disease	Tenosynovial giant cell tumor
Subtype	Diffuse-type TGCT
Tumor status	Benign tumor
Biomarker scope	CSF1R, CSF1 or IL-34 expression
Treatment duration	Six months or one year in dependent claims
Patent type	Method-of-treatment and biomarker-guided use

The FDA approved vimseltinib under the brand name Romvimza for adults with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The approval was based on the MOTION study. The approved dose is 30 mg orally twice weekly, taken approximately three to four days apart. [1]

How do the claims of US 11,679,110 operate?

The claims have four principal layers: dose, dosing frequency, disease, and biomarker selection.

Claims 1 through 6: broad TGCT dosing

Claim 1 is the principal broad claim. It requires:

1. A patient in need of treatment.
2. TGCT.
3. Oral administration.
4. Vimseltinib or its pharmaceutically acceptable salt.
5. A dose of about 2 mg to about 50 mg.
6. Administration twice weekly.

Claims 2 through 4 narrow the dose:

• Claim 2: about 5 mg to about 30 mg twice weekly.
• Claim 3: about 20 mg twice weekly.
• Claim 4: about 14 mg twice weekly.

Claims 5 and 6 narrow the disease or patient population:

• Claim 5: diffuse-type TGCT.
• Claim 6: benign TGCT.

A product used at 30 mg twice weekly for TGCT would fall within claim 1 even though 30 mg is not separately recited in claims 3 or 4. The 30 mg regimen is separately addressed in claim 7.

Claims 7 through 11: 30 mg twice-weekly regimen

Claim 7 specifically covers oral administration of about 30 mg twice weekly for TGCT.

Claims 8 and 9 narrow the disease to:

• Diffuse-type TGCT.
• Benign TGCT.

Claims 10 and 11 add treatment duration:

• About six months.
• About one year.

Claims 10 and 11 are narrower than claim 7. A finding that treatment continued for six months or one year would be relevant to those claims, but it is not necessary to establish infringement of claim 7.

Claims 12 through 18: biomarker-linked tumor treatment

Claim 12 expands beyond TGCT. It covers treatment of tumors known to express:

• CSF1R;
• CSF1; or
• IL-34.

The claimed dose is about 2 mg to about 60 mg twice weekly. Claim 13 narrows the range to about 5 mg to about 30 mg, and claim 14 specifies about 30 mg twice weekly.

Claims 15 and 16 return to diffuse-type and benign TGCT. Claims 17 and 18 add a diagnostic component:

• Claim 17 requires determining whether the tumor expresses CSF1R, CSF1 or IL-34 from an extracted tumor sample or extracellular fluid.
• Claim 18 focuses on expression in the tumor microenvironment.

These claims raise different infringement questions from the TGCT claims. They may apply to a broader tumor population, but the patent owner would need to establish the claimed expression condition and, for claims 17 and 18, the required testing or determination step.

Which claims are most important commercially?

Claims 1 and 7 are the most commercially important because they directly cover the approved therapeutic use and dose.

Claim group	Commercial importance	Main limitation
Claims 1-6	High	TGCT, oral dosing, 2-50 mg twice weekly
Claims 7-11	Very high	30 mg twice weekly for TGCT
Claims 12-16	Moderate to high	Biomarker-associated tumors, 2-60 mg twice weekly
Claims 17-18	Selective	Requires biomarker or microenvironment determination

Claim 7 is particularly significant for generic or competing-vimseltinib analysis. A generic label that directs use of vimseltinib for approved TGCT at 30 mg twice weekly would create a direct method-of-use patent risk unless the patent is invalid, unenforceable, expired or carved out through an effective labeling strategy.

Claims 10 and 11 are less central to ordinary infringement because the label may not require treatment for a fixed six-month or one-year period. They could become relevant where treatment records establish that the regimen continued for the claimed period.

What is the patent expiration date for US 11,679,110?

US 11,679,110 has a nominal patent term extending into 2037, based on its priority and continuation history. The effective terminal date depends on the patent’s earliest effective nonprovisional priority date, patent-term adjustment, terminal disclaimers and any applicable patent-term extension or pediatric extension.

The patent should therefore be treated commercially as a late-2030s barrier. The FDA approval of Romvimza does not itself establish the patent expiration date, and regulatory exclusivity does not replace patent protection.

Does US 11,679,110 receive patent-term extension?

A small-molecule product may qualify for Hatch-Waxman patent-term extension based on the period spent in FDA testing and review, subject to statutory limits. Any extension must be confirmed through the USPTO and FDA records. Patent-term adjustment for USPTO examination is separate from FDA patent-term extension.

The available public record supports using 2037 as the nominal expiry year for portfolio planning. A definitive launch-date model should use the terminal date recorded by the USPTO after accounting for PTA, terminal disclaimers and any later extension.

What is the Orange Book status of vimseltinib and US 11,679,110?

Romvimza is an FDA-approved small-molecule drug, so its patent listings are evaluated under the Orange Book framework applicable to approved new drug applications. FDA Orange Book listings can include patents claiming:

• The drug substance.
• The drug product or formulation.
• A method of using the drug.

US 11,679,110 is a method-of-use patent and is commercially relevant to the Romvimza NDA if listed against the approved TGCT indication. A listed method-of-use patent can support a Paragraph IV certification by an ANDA applicant and a statutory patent litigation action by the NDA holder or patent owner.

The practical Orange Book questions are:

1. Whether the patent is listed against NDA 219155.
2. Which use code FDA assigned.
3. Whether the use code covers the full TGCT indication or a narrower patient population.
4. Whether other Deciphera patents are listed for vimseltinib.
5. Whether any patent has been delisted, expired or disclaimed.

The FDA Orange Book and the NDA holder’s current patent listing data control those issues. [2]

How strong is the patent estate for Romvimza?

The Romvimza estate appears stronger as a portfolio than as a single patent. US 11,679,110 protects the clinical regimen, while separate patents may protect the compound, pharmaceutical compositions, polymorphs, formulations, methods of synthesis and additional uses.

Compound and composition protection

Compound patents generally provide the strongest protection because they can cover the active molecule independent of a particular indication or dose. If an enforceable vimseltinib compound patent remains in force, a generic manufacturer cannot avoid infringement merely by changing the label or dosing instructions.

Method-of-use protection

US 11,679,110 is narrower than a compound patent because it requires practice of specified treatment steps. Its value is highest where:

• The approved label directly instructs the patented regimen.
• The dose is fixed at 30 mg twice weekly.
• The indication is limited to TGCT.
• FDA requires the use to be included in the generic label.
• A carve-out would omit commercially necessary prescribing information.

Formulation protection

The claims provided do not claim a tablet, capsule, excipient system, release profile or dosage-form architecture. Formulation patents may still exist elsewhere in the portfolio, but they cannot be inferred from US 11,679,110 alone.

A generic using a different excipient system could avoid a formulation claim while still infringing the method claims if it markets the same 30 mg twice-weekly TGCT regimen.

Manufacturing and process protection

The provided claims do not cover synthesis, intermediates, crystalline forms or manufacturing processes. Process patents may raise supply-chain risk even where a generic avoids a composition or method claim. That risk requires analysis of Deciphera’s separate patent families.

Which companies are challenging or competing with vimseltinib?

The commercial competitive set includes approved and investigational CSF1R-directed therapies.

Product	Company	Status	Relevance to vimseltinib
Romvimza, vimseltinib	Deciphera Pharmaceuticals	FDA approved in 2025 for TGCT	Direct reference product
Turalio, pexidartinib	Daiichi Sankyo	FDA approved for TGCT	Approved CSF1R-pathway competitor
Emactuzumab	Roche/Genentech	Investigational in TGCT	CSF1R antibody; not a conventional generic threat
Cabiralizumab	Bristol Myers Squibb	Investigational programs	CSF1R antibody approach
Lacnotuzumab	Novartis/MorphoSys development history	Investigational or discontinued programs in relevant settings	Earlier CSF1 ligand-directed approach

Pexidartinib is the closest approved competitor but has a materially different safety and monitoring profile. Turalio carries a boxed warning for serious and potentially fatal liver injury and requires risk-management controls. Vimseltinib’s approval provides a competing oral CSF1R-targeted option with a different clinical and regulatory profile. [3]

Antibodies and other investigational CSF1R agents do not create ordinary ANDA litigation risk because they are not generic versions of vimseltinib. Their risk is therapeutic substitution and market-share erosion rather than direct infringement.

What Paragraph IV risks exist for vimseltinib?

An ANDA applicant seeking approval before expiration of listed patents would generally address each listed patent through one of four certifications:

• Paragraph I: no patent information has been submitted.
• Paragraph II: the patent has expired.
• Paragraph III: the applicant will wait until expiration.
• Paragraph IV: the patent is invalid, unenforceable or will not be infringed.

For US 11,679,110, a Paragraph IV challenge would likely focus on:

Written description and enablement

The challenger could argue that the patent does not adequately support the full dose ranges, all CSF1R/CSF1/IL-34-associated tumors or the biomarker-testing limitations across the full claim scope.

Obviousness

A challenger could combine:

• Earlier CSF1R biology;
• Earlier TGCT treatment rationale;
• Prior vimseltinib dose-ranging data;
• Other CSF1R inhibitors;
• Clinical evidence supporting twice-weekly administration.

The patent owner would rely on unexpected efficacy, tolerability, pharmacokinetic advantages, durable responses or clinical dosing advantages.

Claim construction

The terms "about," "twice weekly," "known to have expression," "benign" and "tumor microenvironment" could materially affect scope. "About 30 mg" is broader than exactly 30 mg, but its boundaries would be assessed in view of the specification, prosecution history and technical evidence.

Label-based infringement

A generic could pursue a section viii carve-out for patented use. That strategy is difficult if the approved label presents TGCT treatment and 30 mg twice-weekly administration as the principal or only use. A carve-out that removes the patented indication while leaving an identical commercial regimen may not eliminate induced-infringement risk.

What generic launch scenarios exist?

Scenario 1: Launch after all relevant patents expire

This is the lowest-risk scenario. It avoids litigation exposure but delays generic entry until the late 2030s if compound and method patents remain enforceable.

Scenario 2: Paragraph IV settlement

Deciphera and a first-filer could settle for an agreed entry date, potentially with a license, restricted launch date or other commercial terms. No settlement terms should be assumed without a publicly filed agreement, FTC review material or court record.

Scenario 3: Successful Paragraph IV litigation

A generic could launch before nominal expiry if the patent is held invalid, unenforceable or not infringed. The result would depend on the specific claims challenged and other surviving patents.

Scenario 4: Section viii carve-out

A generic could attempt to omit the patented TGCT use. The commercial value of this strategy is limited if no meaningful noninfringing indication exists or if the FDA-approved label necessarily includes the protected regimen.

Scenario 5: At-risk launch

An applicant could launch before final resolution. This creates exposure to damages, an injunction and possible loss of the 180-day exclusivity position for a first Paragraph IV filer.

How does vimseltinib compare with pexidartinib patent protection?

Issue	Vimseltinib	Pexidartinib
Brand	Romvimza	Turalio
Sponsor	Deciphera	Daiichi Sankyo
Target	CSF1R	CSF1R and related kinase activity
TGCT status	FDA approved in 2025	FDA approved in 2019
Dose relevant to approval	30 mg twice weekly	Different continuous oral regimen
Main patent risk	Compound, method, formulation and process portfolio	Compound, formulation and method portfolio
Generic pathway	ANDA with listed-patent certifications	ANDA with listed-patent certifications
Biosimilar pathway	Not applicable	Not applicable
Key differentiation	Twice-weekly dosing and newer approval	Earlier approval but significant liver safety controls

Vimseltinib is a small molecule. Biosimilar risk is therefore not the correct framework. The relevant challengers are ANDA applicants for generic vimseltinib and competing branded CSF1R inhibitors.

What geographic coverage does US 11,679,110 provide?

US 11,679,110 provides rights enforceable in the United States only. Parallel protection may exist in:

• International Patent Cooperation Treaty filings;
• European Patent Convention states;
• Japan;
• China;
• Canada;
• Australia;
• Other markets where national-phase applications were filed.

Foreign counterparts may differ in claim scope, prosecution outcome, expiry and enforceability. A US method claim does not automatically establish protection in Europe or other jurisdictions.

For global launch planning, the relevant comparison is not the international publication alone. It is the issued national patent, granted claims, opposition history, supplementary protection certificate position and local regulatory approval.

What litigation affects US Patent 11,679,110?

The supplied record does not establish a reported Paragraph IV case, settlement or final invalidity judgment specifically involving US 11,679,110. The absence of a disclosed case should not be treated as a finding that no challenge exists.

The key litigation triggers will be:

• Filing of an ANDA with a Paragraph IV certification;
• Deciphera’s receipt of the required notice;
• A patent action under 35 U.S.C. §271(e)(2);
• A 30-month FDA approval stay;
• Any first-filer exclusivity dispute;
• Post-grant review, inter partes review or district-court validity litigation.

The patent’s litigation strength will depend on the full specification, prosecution history, prior-art record and the scope of any asserted claims. The claim text alone supports a strong infringement theory for a labeled 30 mg twice-weekly TGCT generic, but it does not resolve validity.

What revenue exposure does the patent create?

Romvimza’s exposure is concentrated in TGCT because the approved indication is narrow but the product has a differentiated dosing schedule and an addressable population with limited systemic treatment options.

The economic risk from an early generic is asymmetric:

• A single generic could reduce net price substantially.
• Multiple generic entrants could accelerate price erosion.
• Method-only protection may be less effective if a noninfringing label or alternate regimen is commercially viable.
• Compound or formulation patents would provide stronger control than US 11,679,110 alone.
• Competing branded agents could reduce volume before patent expiry without infringing the patent.

Public revenue forecasts and actual sales should be evaluated against the FDA label, treated-patient population, launch timing and Deciphera’s disclosed commercial guidance. [4]

Key Takeaways

• US 11,679,110 is a vimseltinib method-of-treatment patent.
• Its central commercial claim covers 30 mg orally twice weekly for TGCT.
• The patent also covers broader twice-weekly dose ranges and biomarker-associated tumors expressing CSF1R, CSF1 or IL-34.
• Claims 17 and 18 require tumor or microenvironment biomarker determination and are narrower than the core TGCT claims.
• The patent has a nominal term extending into 2037.
• The claims provided do not cover formulation, composition of matter or manufacturing.
• Generic risk is highest where an ANDA label includes TGCT treatment at 30 mg twice weekly.
• Biosimilar competition is not applicable because vimseltinib is a small molecule.
• Pexidartinib is the closest approved branded competitor, while emactuzumab and other CSF1R agents represent clinical substitution risk.
• The full Romvimza freedom-to-operate analysis requires the complete Deciphera patent portfolio, Orange Book listing data and any Paragraph IV litigation record.

FAQs

Is US 11,679,110 a composition-of-matter patent for vimseltinib?

No. The provided claims are method claims. They protect administering vimseltinib in specified doses and schedules for specified tumors.

Does a 30 mg once-weekly regimen infringe US 11,679,110?

Not on the face of the supplied claims, which require twice-weekly administration. Other patents, prosecution history or infringement theories could affect the analysis.

Can a generic avoid this patent by using a different tablet formulation?

A different formulation would not avoid a method claim if the generic product is directed to the claimed oral 30 mg twice-weekly TGCT regimen. It could avoid a separate formulation claim if one exists and is materially different.

Do claims 17 and 18 require a companion diagnostic approved by FDA?

The claims require determining expression of CSF1R, CSF1 or IL-34 from tumor material, extracellular fluid or the tumor microenvironment. They do not, on their face, require a separately FDA-approved companion diagnostic.

Does Turalio infringe US 11,679,110?

Not merely because pexidartinib also targets CSF1R. Infringement would require practice of the claimed vimseltinib-based method, including the claimed compound and dosing limitations.

References

1. U.S. Food and Drug Administration. (2025). FDA approves vimseltinib for adults with tenosynovial giant cell tumor. FDA.

2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. U.S. Food and Drug Administration. (2019). Turalio prescribing information. Daiichi Sankyo, Inc.

4. Deciphera Pharmaceuticals, Inc. (2025). Annual report on Form 10-K. U.S. Securities and Exchange Commission.

5. United States Patent and Trademark Office. (2023). U.S. Patent No. 11,679,110, methods of treating tumors using CSF1R inhibitors. USPTO.

6. ClinicalTrials.gov. (2024). MOTION: A study of vimseltinib in patients with tenosynovial giant cell tumor. National Library of Medicine.

Drugs Protected by US Patent 11,679,110

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-001	Feb 14, 2025		RX	Yes	No						TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-002	Feb 14, 2025		RX	Yes	No						TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-003	Feb 14, 2025		RX	Yes	Yes						TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR

International Family Members for US Patent 11,679,110

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3902547		C20260007	Finland
European Patent Office	3902547		PA2026508	Lithuania
European Patent Office	3902547		202640007	Slovenia
Argentina	117742
Australia	2019416117
Australia	2024205010
Australia	2026200677