Executive summary US Patent 10,471,067 claims a 30 mg injectable meloxicam composition and related administration method where meloxicam is formulated as sub-2000 nm (and narrower sub-ranges) particles in a defined excipient system (polyvinylpyrrolidone, sodium deoxycholate, sucrose, water) with explicit exclusion of vasomodulator co-formulation. The core novelty is the particle-size-defined injectable and the combination exclusion. The claims appear structured for coverage against (i) generic reformulations that maintain the same particle-size window and excipient set, and (ii) product designs that avoid vasomodulators. Potential design-around vectors include altering excipient selection, particle-size distribution (beyond the claimed effective average cutoffs), or using different injection particle engineering approaches that shift the “effective average particle size” metric.

US Patent 10,471,067 scope and claim-by-claim coverage

Core claim set

Independent claim 1: Injectable dosage form comprising:
- 30 mg meloxicam (or salt)
- meloxicam particles with effective average particle size ≤ about 2000 nm
- excipients: polyvinylpyrrolidone (PVP), sodium deoxycholate, sucrose, water
- exclusion: “does not comprise a combination of meloxicam and a vasomodulator.”
Dependent claims 2-3: Narrow the particle size to multiple stepwise thresholds (≤1500, ≤1000, ≤900, …, ≤50 nm) or corresponding “about” variants.
Dependent claim 4: Adds that additional active agents are permitted only if not vasomodulators.
Claim 5 (method): Administering meloxicam by IV or IM injecting the dosage form of claim 1.
Independent claim 6 (alternative independent): “Consisting essentially of” formulation with the same elements, but particle size limited to < about 400 nm, plus the same excipients (PVP, sodium deoxycholate, sucrose, water).
Dependent claims 7-8: Additional particle-size narrowing for claim 6, again with multiple thresholds and “about” ranges.

How claim 1 scopes the product design

Claim 1 is broad in the sense that the only numeric cap is the particle size (≤2000 nm). Coverage is anchored by:

Dose amount: 30 mg meloxicam (or salt).
Particle attribute: meloxicam in particles with defined effective average particle size.
Excipient package: PVP + sodium deoxycholate + sucrose + water.
Negative limitation: no co-formulated “meloxicam + vasomodulator” combination.

Any accused product that:

matches the 30 mg dose,
uses sub-2000 nm meloxicam particles,
includes the same excipient set,
and avoids adding a vasomodulator, falls into the claim 1 frame.

How claim 6 scopes the tighter engineered product

Claim 6 is a narrower independent claim with:

“consisting essentially of” language (tends to preserve infringement even with minor, non-material differences, but bars addition of material ingredients outside the recited list),
the same excipients,
same 30 mg structure,
but a tighter particle size cutoff: < about 400 nm.

So claim 6 is best read as targeting highly milled/engineered meloxicam particulate systems that sit in a smaller particle window.

Particle-size thresholds: the functional risk zone

Claims 2, 3, 7, 8 create a ladder of particle-size limitations. From a litigation and design-around perspective:

If a generic or follow-on product has an effective average particle size that lands above a threshold, it may attempt to avoid multiple dependent claims at once.
If it lands below one or more thresholds, it may inadvertently capture dependent claim ranges.

Notably, the claim language ties to “effective average particle size.” That phrase can create evidentiary complexity in infringement because measurement methods can influence reported “effective average” values. Still, as drafted, the numeric caps are clear infringement targets.

Method claim 5: “injecting the dosage form”

Claim 5 covers:

IV or IM injection
of the specific dosage form defined by claim 1.

This is important because it can capture distribution and use even if there are debates over commercial labeling, assuming the formulation being injected is the claimed one.

Key limitations and exclusions: what your product must avoid to design around

1) “Does not comprise a combination of meloxicam and a vasomodulator.” This is a strong negative limitation. Two practical implications:

A product that includes meloxicam plus a vasomodulator co-ingredient may avoid claim 1 and claim 4, but may still face other patents covering that combination (not addressed here).
A product that avoids vasomodulators is pulled back into the claim scope, assuming particle size and excipients align.

2) Excipient lock-in Claim 1 and claim 6 both require:

PVP
sodium deoxycholate
sucrose
water

If an alternative formulation uses different surfactants, stabilizers, or bulking agents, it may escape on literal wording. If “consisting essentially of” in claim 6 is asserted, adding additional excipients could still be permissible only if they are not material; that becomes a factual question.

3) Dose amount Both independent claims recite 30 mg meloxicam. A different labeled dose (for example, 7.5 mg or 15 mg units) is not explicitly covered. A litigant could argue structural equivalence (not a given under these claim terms) but the recited dose number is a clear literal anchor.

Claim chart style mapping: element-by-element infringement checklist

For claim 1 (injectable dosage form)

Injectable formulation: yes, must be injectable dosage form
Active: 30 mg meloxicam or salt
Particle metric: meloxicam as particles with effective average particle size ≤ about 2000 nm
Excipient set: PVP + sodium deoxycholate + sucrose + water
Negative limitation: formulation does not comprise meloxicam + vasomodulator combination

For dependent claim 2/3

Must satisfy claim 1 plus:
- particle size within selected thresholds (e.g., ≤1500, ≤1000, …, ≤50 nm; and “about” variants).

For claim 4

Must satisfy claim 1 plus:
- any non-meloxicam active agent must not be a vasomodulator.

For claim 5 (method)

Must satisfy claim 1 dosage form injected IV or IM.

For claim 6 (consisting essentially of)

Must satisfy: injectable dosage form with:
- 30 mg meloxicam
- meloxicam particles with effective average particle size < about 400 nm
- excipients: PVP + sodium deoxycholate + sucrose + water
- and no additional material ingredients beyond what “consisting essentially of” permits.

For dependent claim 7/8

Must satisfy claim 6 plus:
- particle size narrowing ladder.

How strong is this patent estate based on the claim architecture?

Strength drivers

Specificity: The composition is defined with a dose amount, excipient set, and particle-size numeric criteria.
Multiple independent handles: claim 1 covers broader particle size; claim 6 captures a smaller particle-engineered range.
Negative limitation: “no vasomodulator combination” is a direct limiter that can narrow prior art but also restrict design-around options depending on competitor strategy.
Method coverage: claim 5 covers IV/IM use of the claimed dosage form.

Strength vulnerabilities (practical)

Numeric measurement issues: “effective average particle size” can be contested through sampling and analytical methodology.
Dose-number constraint: if competitors target different dose units, literal coverage can weaken.
Excipient lock-in: a redesign using different excipients can avoid claims without needing to alter the API particle engineering.

What patent landscape surrounds US 10,471,067 (inference from claim scope)

Because the prompt provides only claim text, not the full patent bibliographic data, listed patents citing it, or family members, a complete US landscape cannot be produced here. What can be analyzed from the claim scope is the likely surrounding IP clusters that competitors must check as part of a freedom-to-operate (FTO) posture:

1) Particle engineering and nanoparticle/ultrafine meloxicam formulation patents

The use of sub-2000 nm and sub-400 nm thresholds is consistent with a formulation IP cluster around:

milling/crystallization processes,
particle stabilization,
wet-milling or precipitation processes,
and measurement protocols defining “effective average particle size.”

2) Surfactant and solubilizer system patents

The excipient combination PVP + sodium deoxycholate + sucrose indicates a known formulation strategy:

PVP as stabilizer,
sodium deoxycholate as bile salt-type surfactant,
sucrose as tonicity or stabilizer matrix,
water as carrier.

Competitors typically seek alternative systems using different stabilizers/surfactants to avoid literal claim wording.

3) Vasomodulator combination exclusion and related combination patents

The explicit limitation suggests there may be:

separate patents covering meloxicam + vasomodulator combinations (which the present claims exclude), and
different competitive product concepts that add a vasomodulator to address vascular effects.

This exclusion can act as a signaling mechanism to track other patent families in the same business area.

4) Administration route and device patents

Claim 5 is route-limited to IV or IM. If a competitor uses alternative administration (e.g., subcutaneous) or device-specific delivery, claim 5 may not fit without a dosage form that still matches claim 1.

Generic entry risk: where a challenger is most likely to face 10,471,067

High-risk overlap scenarios

Generic or follow-on injectable meloxicam at 30 mg units.
Meloxicam formulated as sub-2000 nm particles (and especially those targeting <400 nm).
Using the same excipient combination including PVP and sodium deoxycholate and sucrose.
Avoiding vasomodulators.

Lower-risk entry scenarios

Different dose strength (not 30 mg).
Formulation changes that replace one of the required excipients.
Particle sizes above the claimed cutoffs (e.g., “effective average” >2000 nm for claim 1, or >400 nm for claim 6).
Adding vasomodulators, depending on whether other patents block that route and whether “vasomodulator” is interpreted broadly.

Commercial implications for litigation and licensing posture

Patent leverage points

The patent is built for a composition infringement narrative: same dose, same excipient package, same particulate property, and a specific negative limitation about vasomodulators.
If the challenger’s product matches the particle size and formulation, the claim set creates a strong path for asserting both:
- composition infringement (claims 1 or 6),
- and use infringement (claim 5).

Licensing tendency

Licensing discussions for this kind of patent typically focus on:
- validating particle size and excipient match,
- analyzing whether “effective average particle size” and measurement method align with the claim language,
- and whether the challenger can change formulation to exit the claim space without degrading stability and injection performance.

Key Takeaways

US Patent 10,471,067 is a composition-and-particle-size patent centered on 30 mg injectable meloxicam with PVP + sodium deoxycholate + sucrose + water.
The claim scope is defined by effective average particle size caps: broadly ≤ about 2000 nm (claim 1) and narrowly < about 400 nm (“consisting essentially of,” claim 6).
The claims contain an explicit exclusion of meloxicam + vasomodulator combinations, tightening scope around non-vasomodulator injectables.
The associated method claim covers IV or IM injection of the claimed dosage form.
The strongest infringement risk is for products that match: 30 mg unit dose + excipient package + particle-size window + absence of vasomodulators.

FAQs

1) What “effective average particle size” thresholds are most important in US 10,471,067?
Claim 1 targets ≤ about 2000 nm; claim 6 targets < about 400 nm. Dependent claims enumerate additional caps down to ≤ about 50 nm with both “less than” and “about” variants.

2) Does US 10,471,067 cover injectable meloxicam formulations that include a vasomodulator?
The independent claim 1 explicitly excludes formulations that comprise a “combination of meloxicam and a vasomodulator,” and dependent claim 4 limits any additional active agents to those that are not vasomodulators.

3) Is the patent limited to intravenous administration only?
No. Claim 5 covers administering by injecting the dosage form into a human intravenously or intramuscularly.

4) What formulation components are mandatory in the claimed dosage form?
Both independent claims require PVP, sodium deoxycholate, sucrose, and water, with meloxicam present as particles meeting the particle-size criteria.

5) How can a competitor most directly design around this patent?
The clearest routes are changing at least one of the claim anchors: dose amount (30 mg), excipient system (replace one of the required excipients), particle-size profile (move above the claimed effective-average cutoffs), or the vasomodulator status depending on overall product strategy and other patents.

References

United States Patent 10,471,067 (claims as provided in prompt).

Title:	Nanoparticulate meloxicam formulations
Abstract:	The present invention is directed to nanoparticulate compositions comprising meloxicam particles having an effective average particle size of less than about 2000 nm.
Inventor(s):	Eugene R. Cooper, Tuula Ryde, John Pruitt, Laura Kline
Assignee:	Alkermes Pharma Ireland Ltd , DV Technology LLC
Application Number:	US15/437,534
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,471,067
Patent Claim Types: see list of patent claims	Use; Dosage form;
Patent landscape, scope, and claims:	Executive summary US Patent 10,471,067 claims a 30 mg injectable meloxicam composition and related administration method where meloxicam is formulated as sub-2000 nm (and narrower sub-ranges) particles in a defined excipient system (polyvinylpyrrolidone, sodium deoxycholate, sucrose, water) with explicit exclusion of vasomodulator co-formulation. The core novelty is the particle-size-defined injectable and the combination exclusion. The claims appear structured for coverage against (i) generic reformulations that maintain the same particle-size window and excipient set, and (ii) product designs that avoid vasomodulators. Potential design-around vectors include altering excipient selection, particle-size distribution (beyond the claimed effective average cutoffs), or using different injection particle engineering approaches that shift the “effective average particle size” metric. US Patent 10,471,067 scope and claim-by-claim coverage Core claim set Independent claim 1: Injectable dosage form comprising: 30 mg meloxicam (or salt) meloxicam particles with effective average particle size ≤ about 2000 nm excipients: polyvinylpyrrolidone (PVP), sodium deoxycholate, sucrose, water exclusion: “does not comprise a combination of meloxicam and a vasomodulator.” Dependent claims 2-3: Narrow the particle size to multiple stepwise thresholds (≤1500, ≤1000, ≤900, …, ≤50 nm) or corresponding “about” variants. Dependent claim 4: Adds that additional active agents are permitted only if not vasomodulators. Claim 5 (method): Administering meloxicam by IV or IM injecting the dosage form of claim 1. Independent claim 6 (alternative independent): “Consisting essentially of” formulation with the same elements, but particle size limited to < about 400 nm, plus the same excipients (PVP, sodium deoxycholate, sucrose, water). Dependent claims 7-8: Additional particle-size narrowing for claim 6, again with multiple thresholds and “about” ranges. How claim 1 scopes the product design Claim 1 is broad in the sense that the only numeric cap is the particle size (≤2000 nm). Coverage is anchored by: Dose amount: 30 mg meloxicam (or salt). Particle attribute: meloxicam in particles with defined effective average particle size. Excipient package: PVP + sodium deoxycholate + sucrose + water. Negative limitation: no co-formulated “meloxicam + vasomodulator” combination. Any accused product that: matches the 30 mg dose, uses sub-2000 nm meloxicam particles, includes the same excipient set, and avoids adding a vasomodulator, falls into the claim 1 frame. How claim 6 scopes the tighter engineered product Claim 6 is a narrower independent claim with: “consisting essentially of” language (tends to preserve infringement even with minor, non-material differences, but bars addition of material ingredients outside the recited list), the same excipients, same 30 mg structure, but a tighter particle size cutoff: < about 400 nm. So claim 6 is best read as targeting highly milled/engineered meloxicam particulate systems that sit in a smaller particle window. Particle-size thresholds: the functional risk zone Claims 2, 3, 7, 8 create a ladder of particle-size limitations. From a litigation and design-around perspective: If a generic or follow-on product has an effective average particle size that lands above a threshold, it may attempt to avoid multiple dependent claims at once. If it lands below one or more thresholds, it may inadvertently capture dependent claim ranges. Notably, the claim language ties to “effective average particle size.” That phrase can create evidentiary complexity in infringement because measurement methods can influence reported “effective average” values. Still, as drafted, the numeric caps are clear infringement targets. Method claim 5: “injecting the dosage form” Claim 5 covers: IV or IM injection of the specific dosage form defined by claim 1. This is important because it can capture distribution and use even if there are debates over commercial labeling, assuming the formulation being injected is the claimed one. Key limitations and exclusions: what your product must avoid to design around 1) “Does not comprise a combination of meloxicam and a vasomodulator.” This is a strong negative limitation. Two practical implications: A product that includes meloxicam plus a vasomodulator co-ingredient may avoid claim 1 and claim 4, but may still face other patents covering that combination (not addressed here). A product that avoids vasomodulators is pulled back into the claim scope, assuming particle size and excipients align. 2) Excipient lock-in Claim 1 and claim 6 both require: PVP sodium deoxycholate sucrose water If an alternative formulation uses different surfactants, stabilizers, or bulking agents, it may escape on literal wording. If “consisting essentially of” in claim 6 is asserted, adding additional excipients could still be permissible only if they are not material; that becomes a factual question. 3) Dose amount Both independent claims recite 30 mg meloxicam. A different labeled dose (for example, 7.5 mg or 15 mg units) is not explicitly covered. A litigant could argue structural equivalence (not a given under these claim terms) but the recited dose number is a clear literal anchor. Claim chart style mapping: element-by-element infringement checklist For claim 1 (injectable dosage form) Injectable formulation: yes, must be injectable dosage form Active: 30 mg meloxicam or salt Particle metric: meloxicam as particles with effective average particle size ≤ about 2000 nm Excipient set: PVP + sodium deoxycholate + sucrose + water Negative limitation: formulation does not comprise meloxicam + vasomodulator combination For dependent claim 2/3 Must satisfy claim 1 plus: particle size within selected thresholds (e.g., ≤1500, ≤1000, …, ≤50 nm; and “about” variants). For claim 4 Must satisfy claim 1 plus: any non-meloxicam active agent must not be a vasomodulator. For claim 5 (method) Must satisfy claim 1 dosage form injected IV or IM. For claim 6 (consisting essentially of) Must satisfy: injectable dosage form with: 30 mg meloxicam meloxicam particles with effective average particle size < about 400 nm excipients: PVP + sodium deoxycholate + sucrose + water and no additional material ingredients beyond what “consisting essentially of” permits. For dependent claim 7/8 Must satisfy claim 6 plus: particle size narrowing ladder. How strong is this patent estate based on the claim architecture? Strength drivers Specificity: The composition is defined with a dose amount, excipient set, and particle-size numeric criteria. Multiple independent handles: claim 1 covers broader particle size; claim 6 captures a smaller particle-engineered range. Negative limitation: “no vasomodulator combination” is a direct limiter that can narrow prior art but also restrict design-around options depending on competitor strategy. Method coverage: claim 5 covers IV/IM use of the claimed dosage form. Strength vulnerabilities (practical) Numeric measurement issues: “effective average particle size” can be contested through sampling and analytical methodology. Dose-number constraint: if competitors target different dose units, literal coverage can weaken. Excipient lock-in: a redesign using different excipients can avoid claims without needing to alter the API particle engineering. What patent landscape surrounds US 10,471,067 (inference from claim scope) Because the prompt provides only claim text, not the full patent bibliographic data, listed patents citing it, or family members, a complete US landscape cannot be produced here. What can be analyzed from the claim scope is the likely surrounding IP clusters that competitors must check as part of a freedom-to-operate (FTO) posture: 1) Particle engineering and nanoparticle/ultrafine meloxicam formulation patents The use of sub-2000 nm and sub-400 nm thresholds is consistent with a formulation IP cluster around: milling/crystallization processes, particle stabilization, wet-milling or precipitation processes, and measurement protocols defining “effective average particle size.” 2) Surfactant and solubilizer system patents The excipient combination PVP + sodium deoxycholate + sucrose indicates a known formulation strategy: PVP as stabilizer, sodium deoxycholate as bile salt-type surfactant, sucrose as tonicity or stabilizer matrix, water as carrier. Competitors typically seek alternative systems using different stabilizers/surfactants to avoid literal claim wording. 3) Vasomodulator combination exclusion and related combination patents The explicit limitation suggests there may be: separate patents covering meloxicam + vasomodulator combinations (which the present claims exclude), and different competitive product concepts that add a vasomodulator to address vascular effects. This exclusion can act as a signaling mechanism to track other patent families in the same business area. 4) Administration route and device patents Claim 5 is route-limited to IV or IM. If a competitor uses alternative administration (e.g., subcutaneous) or device-specific delivery, claim 5 may not fit without a dosage form that still matches claim 1. Generic entry risk: where a challenger is most likely to face 10,471,067 High-risk overlap scenarios Generic or follow-on injectable meloxicam at 30 mg units. Meloxicam formulated as sub-2000 nm particles (and especially those targeting <400 nm). Using the same excipient combination including PVP and sodium deoxycholate and sucrose. Avoiding vasomodulators. Lower-risk entry scenarios Different dose strength (not 30 mg). Formulation changes that replace one of the required excipients. Particle sizes above the claimed cutoffs (e.g., “effective average” >2000 nm for claim 1, or >400 nm for claim 6). Adding vasomodulators, depending on whether other patents block that route and whether “vasomodulator” is interpreted broadly. Commercial implications for litigation and licensing posture Patent leverage points The patent is built for a composition infringement narrative: same dose, same excipient package, same particulate property, and a specific negative limitation about vasomodulators. If the challenger’s product matches the particle size and formulation, the claim set creates a strong path for asserting both: composition infringement (claims 1 or 6), and use infringement (claim 5). Licensing tendency Licensing discussions for this kind of patent typically focus on: validating particle size and excipient match, analyzing whether “effective average particle size” and measurement method align with the claim language, and whether the challenger can change formulation to exit the claim space without degrading stability and injection performance. Key Takeaways US Patent 10,471,067 is a composition-and-particle-size patent centered on 30 mg injectable meloxicam with PVP + sodium deoxycholate + sucrose + water. The claim scope is defined by effective average particle size caps: broadly ≤ about 2000 nm (claim 1) and narrowly < about 400 nm (“consisting essentially of,” claim 6). The claims contain an explicit exclusion of meloxicam + vasomodulator combinations, tightening scope around non-vasomodulator injectables. The associated method claim covers IV or IM injection of the claimed dosage form. The strongest infringement risk is for products that match: 30 mg unit dose + excipient package + particle-size window + absence of vasomodulators. FAQs 1) What “effective average particle size” thresholds are most important in US 10,471,067? Claim 1 targets ≤ about 2000 nm; claim 6 targets < about 400 nm. Dependent claims enumerate additional caps down to ≤ about 50 nm with both “less than” and “about” variants. 2) Does US 10,471,067 cover injectable meloxicam formulations that include a vasomodulator? The independent claim 1 explicitly excludes formulations that comprise a “combination of meloxicam and a vasomodulator,” and dependent claim 4 limits any additional active agents to those that are not vasomodulators. 3) Is the patent limited to intravenous administration only? No. Claim 5 covers administering by injecting the dosage form into a human intravenously or intramuscularly. 4) What formulation components are mandatory in the claimed dosage form? Both independent claims require PVP, sodium deoxycholate, sucrose, and water, with meloxicam present as particles meeting the particle-size criteria. 5) How can a competitor most directly design around this patent? The clearest routes are changing at least one of the claim anchors: dose amount (30 mg), excipient system (replace one of the required excipients), particle-size profile (move above the claimed effective-average cutoffs), or the vasomodulator status depending on overall product strategy and other patents. References United States Patent 10,471,067 (claims as provided in prompt). More… ↓ ⤷ Start Trial

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Details for Patent: 10,471,067

Summary for Patent: 10,471,067