Details for Patent: 11,103,507

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Which drugs does patent 11,103,507 protect, and when does it expire?

Patent 11,103,507 protects ROMVIMZA and is included in one NDA.

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

Summary for Patent: 11,103,507

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:	US16/725,282
Patent Claim Types: see list of patent claims	Use;

U.S. Patent 11,103,507: Scope, Claims, Exclusivity and Patent Landscape for Vimseltinib

U.S. Patent No. 11,103,507 protects oral treatment of tenosynovial giant cell tumor (TGCT), including diffuse-type TGCT, with vimseltinib, a selective colony-stimulating factor 1 receptor (CSF1R) inhibitor. The patent also covers loading-dose and maintenance-dose regimens for broader cancers and biomarker-selected tumors expressing CSF1R, CSF1 or IL-34.

The patent is commercially significant because its claims reach the dosing architecture used for Romvimza, the FDA-approved vimseltinib product. The strongest claims are claims 1, 6, 21 and 29. Claim 1 is broad because it requires the compound and disease indication but does not impose a specific dose. Claims 6, 21 and 29 narrow infringement to regimens using a loading period followed by maintenance dosing.

What drug and therapeutic target does U.S. Patent 11,103,507 cover?

The claimed compound is vimseltinib, also known as DCC-3014. The compound is a small-molecule CSF1R inhibitor developed by Deciphera Pharmaceuticals.

The claims identify vimseltinib by its chemical name rather than by the generic name:

2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one

Vimseltinib inhibits CSF1R signaling. CSF1R is expressed on macrophages and other myeloid-lineage cells. CSF1R signaling is implicated in the recruitment and survival of tumor-associated macrophages in TGCT.

Romvimza was approved by the FDA on February 14, 2025, for adults with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The labeled dosage is 30 mg orally twice weekly, with or without food, subject to dose modifications for toxicity. [1]

What is the difference between vimseltinib and pexidartinib?

Vimseltinib and pexidartinib are separate CSF1R inhibitors.

Attribute	Vimseltinib	Pexidartinib
Brand	Romvimza	Turalio
Developer	Deciphera Pharmaceuticals	Daiichi Sankyo, originally Plexxikon
Target	CSF1R	CSF1R and related kinases
FDA TGCT approval	February 14, 2025	August 2, 2019
Approved TGCT use	Adults with symptomatic TGCT not amenable to surgery	Adults with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
Commercial dosing	30 mg twice weekly	400 mg twice daily, subject to label requirements
Key safety issue	Liver toxicity and other adverse reactions	Serious hepatotoxicity, including boxed-warning liver injury

The compound in U.S. Patent 11,103,507 is vimseltinib, not pexidartinib.

What diseases are covered by the claims?

The patent contains three principal therapeutic coverage groups.

TGCT claims

Claims 1 through 20 cover treatment of TGCT. Claim 1 is the principal indication claim:

• oral administration;
• vimseltinib or a pharmaceutically acceptable salt;
• a therapeutically effective amount;
• treatment of a patient with TGCT.

The dependent claims expand the protection to:

• diffuse-type TGCT;
• benign tumors;
• dose ranges from approximately 2 mg to 90 mg;
• once-weekly, twice-weekly, three-times-weekly or daily administration;
• loading-dose and maintenance-dose regimens;
• treatment periods ranging from several days to nine months or longer;
• additional loading and maintenance cycles;
• improved tumor response;
• improved range of motion;
• reduced macrophage infiltration or inflammatory chemokines and cytokines.

The claims are drafted as method-of-treatment claims rather than composition claims. They do not independently prevent manufacture or sale of vimseltinib as a chemical substance. They can, however, create infringement exposure for an unauthorized manufacturer or distributor whose product is labeled, promoted or intended for the claimed treatment.

Broader oncology claims

Claims 21 through 28 cover treatment of a broader cancer group using a loading-dose followed by maintenance-dose schedule.

The covered cancers include:

• solid tumors;
• acute myeloid leukemia;
• myelodysplastic syndrome;
• acute lymphocytic leukemia;
• chronic lymphocytic leukemia;
• breast, cervical, pancreatic, bladder, prostate, gastric, ovarian and lung cancers;
• melanoma;
• glioma and glioblastoma multiforme;
• osteosarcoma;
• osteolytic cancers;
• chondrosarcoma;
• histiocytosis.

The claims also cover patients whose tumors progressed after another cancer therapy and combination treatment with immunomodulatory therapies or chemotherapeutic agents.

These claims have broader disease coverage than Romvimza's current FDA indication. Their practical value depends on clinical development, labeling, promotion and whether a competing product is used for one of the listed cancer indications.

Biomarker-selected tumor claims

Claims 29 and 30 cover treatment of tumors known to express:

• CSF1R;
• CSF1; or
• IL-34.

Claim 30 covers determining expression from an extracted tumor sample or extracellular fluid. This creates a biomarker-selection element that may be relevant to precision-oncology development programs.

How strong is claim 1 of U.S. Patent 11,103,507?

Claim 1 is the broadest and commercially most important claim for TGCT. It has five central limitations:

1. A method of treating a patient.
2. The patient has TGCT.
3. The compound is vimseltinib or a pharmaceutically acceptable salt.
4. The compound is administered orally.
5. The amount is therapeutically effective.

Claim 1 does not require:

• diffuse-type disease;
• a particular tumor size;
• a CSF1R biomarker test;
• a specified dose;
• a loading dose;
• a maintenance dose;
• a particular treatment duration;
• a particular clinical response;
• concomitant therapy.

That structure gives claim 1 substantial scope for the approved TGCT use. A product administered orally to treat TGCT could fall within claim 1 even if it uses a dose or schedule not listed in the dependent claims, provided the administration is directed to treatment and the amount is therapeutically effective.

The principal validity and enforcement issues would likely concern claim construction, written description, enablement, obviousness and whether the accused conduct constitutes inducement or contributory infringement. The compound itself is specifically identified, which reduces the chemical-identity dispute that often affects broad genus claims.

What dosing regimens are protected?

The patent claims several overlapping dosing architectures.

Claim group	Dosing protection
Claims 4-5	Approximately 2-60 mg or 10-90 mg, administered daily or one to three times weekly
Claims 6-10	Loading dose followed by maintenance dose
Claims 7-9	Loading dose of approximately 10-80 mg/day, including 20-60 mg/day
Claims 10-11	Maintenance dose of approximately 2-60 mg, including specified 2-50 mg amounts twice or three times weekly
Claims 12-15	Loading period of approximately four days to two weeks and maintenance period of one month to nine months or longer
Claims 16-17	Additional loading and maintenance cycles
Claims 18-20	Clinical and biological response limitations

The FDA-approved Romvimza dose is 30 mg twice weekly. That dose falls within the maintenance-dose ranges in claims 10 and 11 and aligns closely with the claimed intermittent administration concept.

The approved regimen does not necessarily require every limitation in claims 6 through 17. A twice-weekly 30 mg regimen may implicate claim 1 without implicating a loading-dose claim if the approved or commercial regimen does not include the claimed loading period. The loading-dose claims remain relevant where a competing label, clinical protocol or promotional instruction adopts a loading phase.

What patent claims cover FDA-approved Romvimza?

The most direct claim-to-product relationship is as follows:

Romvimza product characteristic	Relevant patent coverage
Vimseltinib active ingredient	Claim 1 and related method claims
Oral administration	Claim 1
TGCT indication	Claims 1-3
Twice-weekly dosing	Claims 4-5, 10-11
30 mg dose	Claims 4-5 and 11
Long-term treatment	Claims 14-15
Tumor response and functional improvement	Claims 18-20
CSF1R-driven tumor biology	Claims 29-30

The patent is therefore more closely tied to the approved clinical use and dosing regimen than to the underlying chemical entity. Separate compound, formulation, manufacturing and solid-state patents may provide additional protection.

What is the Orange Book status of U.S. Patent 11,103,507?

FDA Orange Book patent listings are the principal mechanism for identifying patents submitted by an NDA holder for an approved drug. A listed method-of-use patent can support a Paragraph IV certification and, if properly litigated, a 30-month stay of FDA approval for an ANDA under the Hatch-Waxman Act. [2]

U.S. Patent 11,103,507 is associated with the vimseltinib/Romvimza patent estate and is relevant to the product's method-of-use exclusivity. The listing must be evaluated together with the current FDA Orange Book entry because patent listings, expiration dates, pediatric extensions and delisting status can change.

The patent's practical Orange Book significance depends on:

• whether it is listed against Romvimza's NDA;
• the listed use code;
• the expiration date recorded by FDA;
• whether the approved label contains the patented method;
• whether an ANDA applicant submits a Paragraph IV certification;
• whether Deciphera files a timely infringement action.

A method-of-use listing does not automatically block every generic vimseltinib product. An ANDA applicant may use a section viii statement to carve out a patented indication if the remaining label does not encourage or require the patented use. [2]

When does U.S. Patent 11,103,507 expire?

The patent term cannot be determined reliably from the patent number or issue date alone. U.S. patent expiration depends on the earliest effective nonprovisional or international filing date, patent-term adjustment, terminal disclaimers and any applicable patent-term extension.

The relevant legal framework is:

• 20 years from the earliest effective U.S. nonprovisional filing date for most modern utility patents;
• patent-term adjustment under 35 U.S.C. §154;
• possible patent-term extension under 35 U.S.C. §156 for regulatory review;
• possible pediatric exclusivity under 21 U.S.C. §355a;
• terminal disclaimers that can shorten the term.

The FDA Orange Book expiration entry and the USPTO patent record should control any transaction, launch or litigation analysis. A patent expiration date inferred solely from the September 2021 issue date would not be reliable.

Romvimza also has regulatory exclusivity separate from patent protection. FDA orphan-drug exclusivity generally provides seven years of protection from approval against approval of the same drug for the same disease or condition, subject to statutory exceptions. For Romvimza, the ordinary orphan exclusivity period runs from the February 14, 2025 approval date toward February 14, 2032. [1, 3]

Are Paragraph IV challenges or generic litigation publicly established?

A Paragraph IV challenge would require an ANDA applicant to certify that a listed Romvimza patent is invalid, unenforceable or not infringed. The NDA holder would then have 45 days to bring an infringement action, potentially triggering a 30-month approval stay. [2]

Publicly established litigation involving U.S. Patent 11,103,507 must be confirmed through PACER, FDA listing records and USPTO assignment data. The patent number alone does not establish that an ANDA has been filed, that a Paragraph IV notice has been served or that litigation is pending.

Because Romvimza was approved in 2025, generic entry risk is more likely to emerge through:

• an ANDA filed after the product and patent records are fully populated;
• a Paragraph IV certification against listed method-of-use patents;
• a section viii carve-out targeting non-TGCT uses;
• a 505(b)(2) application for a different dosage form, dosing schedule or indication;
• a later applicant challenging compound or formulation patents rather than this method patent.

What other patents are likely to matter in the vimseltinib landscape?

U.S. Patent 11,103,507 should be analyzed as one layer of a broader portfolio.

Compound patents

Compound patents may cover vimseltinib and related CSF1R inhibitor structures. These patents generally present the strongest barrier to a chemically identical generic product if they remain enforceable and unexpired.

Formulation and solid-state patents

Potential formulation coverage may include:

• tablets or capsules;
• salt forms;
• crystalline or amorphous forms;
• particle-size specifications;
• excipient combinations;
• dissolution and stability characteristics.

These patents can create manufacturing barriers even after a broad compound claim expires.

Method-of-use patents

The 11,103,507 patent is principally a method-of-use patent. Related patents may cover:

• TGCT treatment;
• diffuse-type TGCT;
• intermittent dosing;
• biomarker-selected CSF1R tumors;
• combination therapy;
• treatment after failure of prior therapy;
• safety management or dose modification.

Manufacturing and process patents

Process patents may cover preparation of vimseltinib intermediates, coupling reactions, purification, crystallization and scale-up. They are most relevant to API suppliers and may raise freedom-to-operate issues even where the finished product claims are avoided.

How does the patent estate compare with the competitive CSF1R landscape?

Product	Company	Principal indication	Competitive patent issue
Romvimza, vimseltinib	Deciphera	TGCT	Product, method, dosing and potential formulation protection
Turalio, pexidartinib	Daiichi Sankyo	TGCT	Separate chemical and method-of-use portfolio
Emactuzumab	Roche/clinical development	CSF1R-related oncology	Antibody and clinical-use patents
Cabiralizumab	Bristol Myers Squibb/clinical development	CSF1R-related oncology	Antibody, combination and method patents

Vimseltinib has a differentiated commercial position because it was approved with an intermittent twice-weekly regimen. That dosing pattern is directly relevant to the dependent claims of U.S. Patent 11,103,507.

What generic entry risks exist?

The principal generic-entry risks are:

1. A chemically identical vimseltinib product may face compound patents in addition to this method patent.
2. A generic seeking the TGCT indication may encounter claim 1 and related method claims.
3. A section viii carve-out may be difficult if the proposed label still encourages TGCT treatment.
4. A 505(b)(2) applicant may face method, formulation and dosing patents even if it avoids a conventional ANDA pathway.
5. Orphan exclusivity may delay approval of a competing product for the same disease even after a patent challenge.
6. A biosimilar pathway is not applicable because vimseltinib is a small molecule, not a biologic.

Key Takeaways

• U.S. Patent 11,103,507 covers oral vimseltinib treatment of TGCT and broader CSF1R-related oncology uses.
• Claim 1 is the principal broad TGCT claim and does not require a specific dose or loading regimen.
• Claims 6 through 17 specifically protect loading-dose, maintenance-dose and intermittent dosing schedules.
• The approved Romvimza regimen of 30 mg twice weekly falls within important dependent dosing claims.
• Claims 21 through 30 extend protection to multiple cancers and biomarker-selected tumors expressing CSF1R, CSF1 or IL-34.
• Patent protection must be analyzed together with compound, formulation, solid-state and manufacturing patents.
• FDA orphan exclusivity for Romvimza is separate from patent exclusivity and generally extends toward February 14, 2032.
• Paragraph IV, section viii and 505(b)(2) strategies present different entry pathways.
• No biosimilar pathway applies because vimseltinib is a small-molecule drug.

FAQs

Does U.S. Patent 11,103,507 cover the vimseltinib molecule itself?

No. The claims provided are method-of-treatment claims. They cover use of vimseltinib in specified patients and regimens. Separate composition-of-matter patents may protect the molecule itself.

Does a 30 mg twice-weekly vimseltinib regimen fall within the patent claims?

Yes. A 30 mg twice-weekly regimen falls within the numerical maintenance-dose ranges in claims 10 and 11 and also fits the broader dose and frequency language in claims 4 and 5, subject to the remaining claim elements.

Can a generic avoid the patent by removing TGCT from its label?

Potentially, but a label carve-out is effective only if the remaining labeling, prescribing information and promotional conduct do not encourage the patented use. FDA's section viii framework and the actual use code would control.

Does orphan-drug exclusivity prevent all competing vimseltinib products?

No. Orphan exclusivity generally applies to the same drug for the same disease or condition. It does not operate identically to a composition patent and does not necessarily block every different indication, formulation or regulatory pathway.

Is a CSF1R biomarker test required for Romvimza treatment?

No. The approved TGCT indication does not generally require biomarker testing. Claims 29 and 30 separately address tumors selected or evaluated for CSF1R, CSF1 or IL-34 expression.

References

1. U.S. Food and Drug Administration. (2025). Romvimza (vimseltinib) prescribing information. FDA.

2. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.

3. U.S. Food and Drug Administration. (2024). Orphan drug designation and exclusivity. FDA.

4. U.S. Patent and Trademark Office. (2021). U.S. Patent No. 11,103,507, methods of treating cancer using vimseltinib. USPTO.

5. U.S. Code. (2024). 35 U.S.C. §§ 154, 156; 21 U.S.C. §§ 355, 355a. Government Publishing Office.

Drugs Protected by US Patent 11,103,507

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	11,103,507					TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-002	Feb 14, 2025		RX	Yes	No	11,103,507					TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-003	Feb 14, 2025		RX	Yes	Yes	11,103,507					TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR

International Family Members for US Patent 11,103,507

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