United States Patent 12,343,372 (Drug): Scope, Claim Strength, and Patent Landscape
What is US Drug Patent 12,343,372 claiming, at the highest level?
US 12,343,372 claims methods of treating a defined set of diseases or conditions by giving a liquid, ready-to-use pharmaceutical composition that contains:
- Desmopressin acetate
- Water
- A two-component dual-functional preservative-buffer system comprising:
- Sodium benzoate
- Benzoic acid
The claims tie treatment scope to specific therapeutic targets and lock down formulation parameters (concentration ranges, pH, impurity limits, stability, and exposure equivalence).
The claim set is organized to create both:
- Broad coverage (generic “method of treating” with the specified composition system and disease list), and
- Narrower fallback positions (composition is restricted to specific parameter windows, pH, impurity/stability requirements, ready-to-use, administration routes, pediatric age).
What are the core claim elements and how do they constrain infringement?
1) Claim 1 is a “use + specific composition system” combination claim
Independent claim 1 requires all of the following in a single treated method:
- A method of treating a disease/condition or symptoms
- Administering a therapeutically effective amount of a liquid pharmaceutical composition
- The composition must include:
- Desmopressin acetate
- Sodium benzoate
- Benzoic acid
- Water
- The disease/condition must be one of the enumerated list:
Enumerated disease/condition list in claim 1
- diabetes insipidus
- nocturnal enuresis
- nocturia
- hypothalamic injury-induced obesity (HIO)
- hemophilia A
- von willebrand disease
- postoperative bleeding
- polyurea
- high blood urea levels
This structure is critical for enforcement: even if a product treats one of these diseases, it must match the liquid composition having the dual-functional sodium benzoate + benzoic acid system.
2) The formulation system is the enforcement center of gravity
The patent does not claim desmopressin broadly; it claims a particular liquid formulation concept:
- Two-component preservative-buffer system
- Sodium benzoate + benzoic acid
- Together with water and desmopressin acetate
That means a generic liquid desmopressin using a different preservative system (or different buffer chemistry) would miss claim 1 unless it still falls within the “two-component” system requirement.
3) Dependent claims tighten with quantitative composition, pH, stability, and performance
Key dependencies include:
Desmopressin concentration bands
- 0.01 to 0.1 mg/mL (claim 2)
- 0.05 mg/mL (claim 3)
- Further windows in claims 12-14 (and implicitly 15-16)
Benzoic acid banding
- 0.005% to 0.1% w/v (claim 4)
- 0.02% to 0.05% w/v (claim 5)
Sodium benzoate banding
- 0.01% to 0.6% w/v (claim 6)
- 0.15% to 0.32% w/v (claim 7)
Paired benzoic acid + sodium benzoate windows
- 0.25% to 0.35% w/v (claim 8)
- (Read as the combined constraint stated in claim 8 as drafted: both are “present … in an amount of from about 0.25% w/v to about 0.35% w/v.”)
Specific “target recipes”
- Claim 12: desmopressin 0.01 to 0.1 mg/mL; sodium benzoate 0.18 to 0.4% w/v; benzoic acid 0.02 to 0.1% w/v; water
- Claim 13: desmopressin 0.025 to 0.075 mg/mL; sodium benzoate 0.2 to 0.35% w/v; benzoic acid 0.03 to 0.04% w/v; water
- Claim 14: desmopressin 0.05 mg/mL; sodium benzoate 0.285% w/v; benzoic acid 0.034% w/v; water
- Claims 15 and 16: same numerical “consists essentially of” or “consists of” recipe as claim 14 (desmopressin 0.05 mg/mL; sodium benzoate 0.285% w/v; benzoic acid 0.034% w/v; water)
pH constraints
- 4.0 to 6.0 (claim 11)
- pH about 5.0 (claim 21)
Preservatives beyond the benzoate system
- claim 9: may further comprise a preservative with antimicrobial/chelating/antioxidant function
- claim 10: preservatives may be parabens
- Note the independence logic: claim 1 already includes the sodium benzoate + benzoic acid system. Claim 9 and 10 broaden “additional preservative” cover unless constrained by “consists of” language in later claims.
Ready-to-use
- composition is ready-to-use “without dilution or addition” (claim 17)
Impurity and stability requirements
- claim 18: impurities limits after 6 months at 40° C ±2° C and 75% ±5% RH (HPLC determination)
- limits expressed as:
- “no more than 5% wt of total impurities”
- “not more than 1% wt of each” impurity species list
- claim 19: retains at least 90% wt of initial desmopressin acetate under same stress storage
Bioequivalence-style performance
- claim 20: bioavailability bioequivalent to an oral tablet reference composition, measured as:
- total AUC after oral administration, and/or
- Cmax after oral administration
Route and patient demographic
- claim 28: oral or nasogastric/jejuno/gastrostomy tube administration
- claim 29: subject age less than 18 years
4) Disease targeting spans conventional DDAVP uses and expanded bleeding and obesity claims
The enumerated disease list is broader than typical central diabetes insipidus/nocturnal enuresis use alone. It includes:
- hemophilia A
- von Willebrand disease
- postoperative bleeding
- HIO (hypothalamic injury-induced obesity)
- polyurea
- high blood urea levels
From an enforcement perspective, the list creates multiple downstream clinical indications that can be asserted, provided the administered composition is the same liquid desmopressin + sodium benzoate + benzoic acid system.
How broad is the independent claim and where are the built-in “carve points”?
Breadth
Claim 1 is broad on three axes:
- Disease list is fixed but includes multiple conditions.
- Compositional requirement is specific (desmopressin + benzoate system + water), but does not in claim 1 itself lock to exact numeric concentrations or pH. Those are in dependent claims.
- Method context is “treating a disease or condition, or symptoms thereof” with “therapeutically effective amount.”
Constraints that reduce design-around freedom
Even though numeric ranges appear in dependent claims, claim 1 already fixes the essential formulation chemistry:
- If sodium benzoate is absent or benzoic acid is absent, the composition does not meet claim 1.
- If benzoic acid is replaced with a different acid, or sodium benzoate replaced with a different salt, the dual-component requirement is not met.
In addition, dependent claims create narrower, high-value embodiments anchored to:
- pH around 5
- exact benzoate recipe (claim 15/16)
- ready-to-use
- impurity profile after storage
- bioequivalent exposure characteristics
- pediatric use and specific administration routes
These create multiple “overlapping” claim targets likely to be aligned with clinical packaging specs.
What is the claim map (by scope and fallback strength)?
Below is a structured map of where each dependent claim sits in the “coverage ladder.”
| Claim |
Layer |
Key limitations (what must be true) |
Likely role in enforcement |
| 1 |
Independent |
Treat disease in list using liquid composition with desmopressin + sodium benzoate + benzoic acid + water |
Broad anchor claim |
| 2-3 |
Dependent |
Desmopressin concentration: 0.01-0.1 mg/mL or 0.05 mg/mL |
Concentration locking |
| 4-5 |
Dependent |
Benzoic acid: 0.005-0.1% w/v or 0.02-0.05% w/v |
Tightens acid window |
| 6-7 |
Dependent |
Sodium benzoate: 0.01-0.6% w/v or 0.15-0.32% w/v |
Tightens salt window |
| 8 |
Dependent |
Paired benzoic acid and sodium benzoate at 0.25-0.35% w/v |
Constrains both concurrently |
| 9-10 |
Dependent |
Optional added preservative; parabens possible |
Helps capture variants |
| 11 |
Dependent |
pH 4.0-6.0 |
Buffer envelope |
| 12-13 |
Dependent |
Two/three-component windows (recipe ranges) |
Intermediate fallbacks |
| 14-16 |
Dependent |
Exact recipe: 0.05 mg/mL desmopressin; 0.285% w/v Na benzoate; 0.034% w/v benzoic acid; water; “consists”/“consists essentially” in 15-16 |
Narrowest, likely strongest embodiment |
| 17 |
Dependent |
Ready-to-use |
Packaging/format constraint |
| 18-19 |
Dependent |
Impurities + stability thresholds after 6 months |
Device-like product performance |
| 20 |
Dependent |
Bioequivalent to oral tablet by AUC and/or Cmax |
Bio-performance hook |
| 21 |
Dependent |
pH about 5.0 |
Narrow buffer target |
| 22-25 |
Dependent |
Specific disease subsets (central DI, primary nocturnal enuresis, etc.) |
Indication-specific assertions |
| 26-27 |
Dependent |
Additional therapy; anticholinergic |
Combination therapy coverage |
| 28 |
Dependent |
Administration route: oral or via specified tubes |
Delivery device/process constraint |
| 29 |
Dependent |
Pediatric population (<18) |
Demographic-specific coverage |
What does the “consists essentially of” and “consists of” language likely do to the landscape?
Claims 15 and 16 provide a tighter compliance perimeter than claim 1.
This matters because it blocks formulations that attempt to keep the benzoate system but add other excipients outside what would be considered permitted in the “consists essentially of” claim, and it creates an exclusion zone for “drop-in” reformulations.
How does performance-based language expand claim leverage beyond composition?
Two dependent claims convert formulation into a product-performance claim layer:
-
Stability and impurity profile (claims 18-19)
- Storage conditions: 40° C ±2° C and 75% ±5% RH for 6 months
- Impurity limits:
- total impurities ≤ 5% wt
- each listed impurity ≤ 1% wt
- Assay retention:
- desmopressin acetate retains at least 90% wt vs initial after storage
- Impurities identified by specific desmopressin-related species such as [Asp5]desmopressin, [Glu4]desmopressin, [Gly9OH]desmopressin, [L-Arg8]desmopressin, [Gln4(Acm)]desmopressin, [Asn5(Acm)]desmopressin, and [Gly9N(CH3)2]desmopressin.
-
Exposure equivalence to oral tablets (claim 20)
- bioequivalent to a reference oral tablet composition based on:
- AUC and/or Cmax after oral administration
- This creates an additional hook for litigating around “same composition but different pharmacokinetics” arguments.
What are the practical implications for freedom-to-operate (FTO) within this patent family?
From the claim language alone, product design should treat these as high-risk features:
High-risk “must-match” elements
- Liquid pharmaceutical composition (not solid)
- Desmopressin acetate present at an amount within or consistent with dependent ranges (and within claim 1’s implicit “therapeutically effective amount”)
- Dual-functional preservative-buffer system: sodium benzoate + benzoic acid
- Treatment of diseases/conditions within the enumerated list
High-risk “tight” elements
- pH: claim 11 (4.0-6.0) and claim 21 (about 5.0)
- Exact recipe: claims 14-16
- Ready-to-use packaging format: claim 17
- Stability/impurity thresholds under specified stress testing: claims 18-19
- Oral vs tube administration and pediatric patient treatment: claims 28-29
- Combination therapy with anticholinergic: claims 26-27
Potential design-around levers (by claim construction logic)
- Substituting either sodium benzoate or benzoic acid breaks claim 1’s composition requirement.
- Shifting to a different preservative-buffer system may avoid the core dual-functional chemistry.
- Avoiding the enumerated indications may reduce method claim exposure, but this depends on what is practiced and how claims are asserted.
What does the “scope” look like by indication?
Based on the enumerated disease list and dependent indication claims:
- Diabetes insipidus (claim 22) including central diabetes insipidus (claim 23)
- Nocturnal enuresis including primary nocturnal enuresis (claim 24)
- Nocturia
- Hypothalamic injury-induced obesity (HIO)
- Hemophilia A
- Von Willebrand disease
- Postoperative bleeding
- Polyurea
- High blood urea levels
The method claims likely support marketing/labeling strategies tied to these indications if the formulation is used as described.
How to read the “patient and administration” coverage
Two dependent claims materially expand method practice coverage:
-
Administration route:
- Oral
- Nasogastric tube
- Jejunostomy tube
- Gastrostomy tube (claim 28)
-
Pediatric:
For product lifecycle planning, these features extend beyond a typical adult oral tablet paradigm and align with real-world pediatric administration constraints.
Patent landscape positioning: what is known from the claim text alone
A complete US landscape requires bibliographic data (assignees, priority dates, family members, prosecution history, cited art, and related continuation/divisional claims). That information is not provided here, so a full mapping of overlapping filings cannot be constructed from the claim text alone.
What can be concluded from the claim structure:
- The patent is a formulation-driven method claim combining:
- specific liquid composition chemistry (desmopressin + sodium benzoate + benzoic acid)
- specific treatment indications
- and product-performance constraints (stability, impurities, bioequivalence)
That combination is characteristic of a landscape where:
- composition claims and method claims are often interlocked (even if only method claims are recited in what you supplied)
- enforcement can be brought against both formulation equivalents and practical dosing/use patterns
Key Takeaways
- US 12,343,372 claims method-of-treatment using a liquid desmopressin acetate composition with a fixed two-component sodium benzoate + benzoic acid preservative-buffer system and water.
- Independent claim 1 is broad across a defined indication list but narrow on the dual-functional benzoate system as an essential formulation requirement.
- Dependent claims add high-value constraints on: exact recipe (0.05 mg/mL desmopressin; 0.285% w/v sodium benzoate; 0.034% w/v benzoic acid; water), pH (including about 5.0), ready-to-use format, six-month stress stability and impurity limits, and bioequivalence vs an oral tablet by AUC and/or Cmax.
- The inclusion of administration routes (tube delivery) and pediatric patients (<18) expands method practice scope beyond standard adult oral dosing.
FAQs
-
Does claim 1 require exact benzoate concentrations?
Claim 1 does not state numeric ranges; it requires the presence of desmopressin acetate plus sodium benzoate plus benzoic acid in a liquid composition with water. Numeric concentration and pH ranges appear in dependent claims.
-
What are the narrowest “drop-in” embodiments?
Claims 14 to 16 are the tightest: the exact recipe of desmopressin acetate 0.05 mg/mL, sodium benzoate 0.285% w/v, benzoic acid 0.034% w/v, and water, with claim 16 using “consists of.”
-
Can a formulation that keeps desmopressin but replaces the benzoate system avoid claim 1?
If either sodium benzoate or benzoic acid is not present as required, it does not satisfy claim 1’s composition requirement.
-
Is the patent only about diabetes insipidus?
No. The claim 1 disease list includes nocturnal enuresis, nocturia, HIO, hemophilia A, von Willebrand disease, postoperative bleeding, polyurea, and high blood urea levels.
-
What performance tests appear in the claims?
The claims include storage stability and impurity limits after 6 months at 40° C ±2° C and 75% ±5% RH (HPLC-based), plus bioequivalence metrics to an oral tablet reference (AUC/Cmax).
References
- User-provided claim text for US Drug Patent 12,343,372 (claims 1-29).
