US 11,684,620: What Is Claimed, How Broad It Is, and Where It Sits in the US Bladder/Urothelial Patent Landscape
What does US 11,684,620 claim in the US?
US Drug Patent 11,684,620 claims a specific bladder/urothelial cancer treatment method using a specific small-molecule drug substance formulated with a specific formaldehyde scavenger.
Core claimed method (Claim 1)
A method of treating cancer by administering to a patient in need a pharmaceutical composition comprising:
- Active ingredient:
N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine
(including a pharmaceutically acceptable salt and/or solvate)
- Formaldehyde scavenger: meglumine base
- Carrier: pharmaceutically acceptable carrier
- Cancer scope (explicitly limited in Claim 1 to):
- bladder cancer
- urothelial cancer
- metastatic urothelial cancer
- surgically unresectable urothelial cancer
- non-muscle-invasive bladder cancer
Dose and composition-dependent dependent claims
The claims then narrow the formulation and dosing:
Formaldehyde scavenger concentration (Claims 2–3)
- Claim 2: formaldehyde scavenger (meglumine base) 0.1% to 3% w/w
- Claim 3: formaldehyde scavenger 0.5% to 1.5% w/w
Dosage form (Claim 4)
Optional impurity/related compound limit (Claims 5–6)
- Claim 5: composition comprises 0–2% w/w of
6,8-dimethoxy-4-(1-methylethyl)-1-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]-2,3,4,5-tetrahydro-1H-1,4-benzodiazepine
(including salt/solvate)
- Claim 6: further tightens that related compound to 0–0.05% w/w
Active dose range and fixed dose embodiments (Claims 7 and 9–17)
- Claim 7: 2 mg to 6 mg base equivalent of the named active compound (free base equivalent), salt/solvate included
- Claims 9–17 provide fixed examples by tablet/capsule strength:
(These fixed dose claims are tied to the formaldehyde scavenger percentage window in dependent chains, because Claims 9–14 depend from Claim 2 or Claim 3.)
Cancer-type dependent claims
Claims 22–26 restate Claim 1’s indications by listing each subtype.
Biomarker / FGFR genomic-alteration subgroup (Claims 27–43; and mirrored in 38–54)
Claims introduce a molecularly defined subgroup for the same method:
- FGFR genomic alteration (Claims 27, 38, 41, 49, 52, etc.)
- FGFR translocation (Claims 28, 39, 50, etc.)
- specifically FGFR3-TACC3 (Claims 29, 40, 51, etc.)
- FGFR mutation (Claims 30, 41, 52, etc.)
- FGFR3 R248C (Claims 31, 42, 53, etc.)
- FGFR3 S249C (Claims 32, 43, 54, etc.)
Mirrored dependent claim chains
Claims 33–67 and 81–87 repeat the cancer subtype and biomarker limitations inside the concentration/dose chains (Claims 2–3 and Claims 9–11, with additional constraints on the cancer type being bladder cancer, urothelial cancer, metastatic disease, etc., and FGFR subtypes).
What Claim 87 adds
- Claim 87 depends from Claim 26 and specifies the composition includes the active ingredient base form (not just “salt/solvate” generic).
How broad is the protection across formulation and use?
US 11,684,620 sits at the intersection of:
1) method-of-treatment (US patent-style “medical use”)
2) specific formulation composition (active + meglumine base as formaldehyde scavenger + carrier)
3) specific oncology indications (bladder/urothelial, including metastatic/unresectable/NMIBC)
4) optional molecular subgroups (FGFR genomic alterations, translocations, mutations)
Bottlenecks that constrain infringement
The claims are constrained by several “must-have” elements:
- Active ingredient identity is fixed to the precise chemical structure name.
- Formaldehyde scavenger is fixed to meglumine base.
- Cancer is explicitly limited to bladder/urothelial subtypes listed.
- If a product does not include meglumine base at the claimed w/w range, it can avoid narrower dependent claims (Claims 2–3, etc.), but may still face Claim 1 if it uses meglumine base as scavenger (without the w/w limitations).
- Dosage form limitation applies only to Claim 4, not Claim 1.
Strength of the biomarker layer
FGFR subgroup language increases relevance for targeted patient selection but does not replace the core requirement:
- the method still requires the same active + meglumine base composition (and carrier).
In practice, biomarker restrictions reduce the set of eligible clinical uses that map cleanly to the claim set, but they also strengthen enforceability for trials and label expansions that specify FGFR-defined populations.
What is the likely “infringement map” for R&D and commercial formulations?
The claim architecture suggests a clean infringement checklist.
Claim 1 infringement checklist
A product/clinical protocol infringes Claim 1 if it includes all of:
- Administration to treat:
- bladder cancer / urothelial cancer / metastatic urothelial cancer / surgically unresectable urothelial cancer / non-muscle-invasive bladder cancer
- Pharmaceutical composition containing:
- the named N-(3,5-dimethoxyphenyl)...ethane-1,2-diamine (including salts/solvates)
- Formaldehyde scavenger = meglumine base
- Pharmaceutically acceptable carrier
Dependent-claim risk amplifiers
If the commercial product aligns with any of the following, exposure rises:
- meglumine base at 0.1–3% w/w (Claim 2)
- meglumine base at 0.5–1.5% w/w (Claim 3)
- tablet/capsule (Claim 4)
- impurity/related compound bounded to 0–2% w/w (Claim 5) or 0–0.05% w/w (Claim 6)
- strength matches 2–6 mg base equivalent (Claim 7) and/or 3/4/5 mg embodiments (Claims 9–17)
- protocol and label restricts to FGFR-defined tumors:
- FGFR translocations (including FGFR3-TACC3) (Claims 28–29, 39–40, 50–51)
- FGFR mutations (including FGFR3 R248C and FGFR3 S249C) (Claims 30–32, 41–43, 52–54)
What does this imply for the patent landscape in US bladder/urothelial cancer?
1) This patent is formulation-plus-use, not just a molecule patent
The claim is not only “use the molecule for bladder cancer.” It is “use the molecule in a specific formulation that includes meglumine base as a formaldehyde scavenger.”
That shifts the competitive landscape toward:
- competitors needing different scavengers
- or different formulation chemistry that eliminates meglumine base as a scavenger
- or changes in w/w levels that avoid dependent ranges
2) It likely overlaps method-of-treatment and dosing patents
Within bladder/urothelial therapeutics, patents often split across:
- drug substance and crystalline forms
- formulation excipients and scavengers
- biomarker-stratified indications (FGFR, etc.)
- dosing regimens and strengths
US 11,684,620 explicitly covers:
- excipient-function (scavenger role)
- strength ranges (mg base equivalent)
- patient subsets (FGFR-altered cancers)
3) The FGFR subgroup signals positioning against targeted FGFR programs
The claim’s FGFR3 alterations and FGFR3-TACC3 translocation tie into the established US market categories for urothelial cancers enriched for FGFR pathway activation.
For business planning, this means the competitive threat is likely to come from:
- next-generation FGFR agents and combination regimens that still rely on the same formulation logic
- label expansions and clinical programs selecting for FGFR-altered populations
- generic or “authorized” alternatives that attempt a label carve-out via different excipient strategy
Claim coverage matrix (quick reference)
| Claim group |
What is constrained |
Key ranges/specifics |
| Claim 1 |
Core method for bladder/urothelial subtypes |
Active molecule + meglumine base scavenger + carrier |
| Claims 2–3 |
Scavenger level |
0.1–3% w/w; or 0.5–1.5% w/w |
| Claim 4 |
Dosage form |
tablet or capsule |
| Claims 5–6 |
Related compound level |
0–2% w/w; or 0–0.05% w/w |
| Claim 7 |
Strength window |
2–6 mg base equivalent |
| Claims 9–17 |
Fixed strength examples |
3 mg, 4 mg, 5 mg (in specific chains) |
| Claims 22–26 |
Indication specificity |
bladder, urothelial, metastatic, surgically unresectable, NMIBC |
| Claims 27–32 |
FGFR subgroup |
genomic alteration; translocation (FGFR3-TACC3); mutation (R248C, S249C) |
| Claims 33–43, 44–54, 55–64, 66–87 |
Repetition inside dependent chains |
cancer subtype + scavenger/dose chain + FGFR subtype |
Where the scope is “practically hard to design around”
This patent becomes difficult to design around if the commercial product must keep:
- the same active ingredient identity (fixed by chemical name)
- meglumine base as the formaldehyde scavenger (fixed by claim language)
- clinical use in bladder/urothelial populations as listed
- and especially if it targets FGFR-defined subsets with the specified translocations/mutations
That combination narrows the design-around space sharply because it affects both:
- formulation chemistry (scavenger)
- and clinical labeling/intent (indication and biomarker subset)
What is the actionable patent landscape takeaway for investors and R&D?
US 11,684,620 is best treated as a composition-with-scavenger, biomarker-aware medical use patent. Competitive intelligence should focus on whether rival formulations:
- substitute meglumine base with a different formaldehyde scavenger
- shift scavenger concentration outside the dependent windows (0.1–3% or 0.5–1.5%)
- change dosage strength
- and whether clinical programs avoid bladder/urothelial subtypes or avoid FGFR3-specific subgroups in how they are framed
Key Takeaways
- US 11,684,620 claims a bladder/urothelial cancer treatment method using a fixed active compound plus meglumine base as a formaldehyde scavenger in a pharmaceutically acceptable carrier.
- The claim set is not only use-based. It is formulation-based with excipient-function, meglumine base w/w ranges, dosage form (tablet/capsule), and strength ranges.
- The patent adds biomarker-constrained subsets including FGFR3-TACC3 and FGFR3 R248C / S249C, narrowing certain clinical uses while reinforcing enforceability for FGFR-targeted programs.
- Design-around primarily hinges on whether competitors can avoid meglumine base as the formaldehyde scavenger and/or avoid the specified concentration and strength embodiments while maintaining the same therapeutic intent.
FAQs
1) Is the indication limited to bladder cancer and urothelial subtypes?
Yes. Claim 1 enumerates bladder cancer, urothelial cancer, metastatic urothelial cancer, surgically unresectable urothelial cancer, and non-muscle-invasive bladder cancer.
2) Does the patent require meglumine base specifically as a formaldehyde scavenger?
Yes. Claim 1 requires the formaldehyde scavenger to be meglumine base.
3) Are the meglumine base concentration ranges mandatory for all claims?
No. Claim 1 does not state a specific w/w range. Claims 2–3 impose 0.1–3% w/w and 0.5–1.5% w/w respectively.
4) Does the patent cover tablets and capsules?
Claim 4 limits to tablet or capsule, while Claim 1 is broader in that it does not require that dosage form.
5) Does the patent include FGFR biomarker limitations?
Yes. It includes FGFR genomic alterations, specifically FGFR translocations (including FGFR3-TACC3) and FGFR mutations (including FGFR3 R248C and FGFR3 S249C), embedded through dependent claim chains.
References
[1] US Drug Patent 11,684,620 (claims as provided by user).
