US Patent 12,390,442 (Artesunate): What the Claims Actually Cover and Where the Patent Fence Likely Sits

What is US 12,390,442?

US 12,390,442 claims a specific method of treating malaria using a micronized artesunate-containing powder with tightly defined solid-state, powder electrostatics, moisture-state control, and downstream sterile manufacture into a buffered composition for parenteral dosing. The core claim (claim 1) is not a broad “artesunate for malaria” product claim; it is a process-and-conditions claim tied to:

Micronized powder comprising artesunate (4-oxo-4-[[(1R,4S,5R,8S,9R,10S,12R,13R)-1,5,9-trimethyl-11,14,15,16-tetraoxatetracyclo[10.3.1.04,13.08,13]hexadecan-10-yl]oxy]butanoic acid) or a salt.
Powder solid form and crystalline amount window.
Powder static charge window determined by a defined humidity aging test and static meter protocol.
A defined manufacturing sequence: packaging, sterilization, and filling into a container under controlled humidity and temperature.
Mixing the sterilized powder with a buffer solution to produce a pharmaceutical composition, then administering the composition for malaria.

This structure makes infringement analysis highly sensitive to whether an accused process matches the powder electrostatics test, the humidity/temperature fill conditions, and the buffer composition/pH/ion concentration.

What does claim 1 cover (scope map)?

1) Therapeutic indication and active

Treating a malaria patient.
Using a therapeutically effective amount of micronized artesunate or pharmaceutically acceptable salt.

2) Powder composition: crystalline content

The micronized powder contains a crystalline form of artesunate or its salt in > 0 wt% to about 1 wt% of total powder weight.

Practical reading: the patent targets a powder state that is “mostly non-crystalline or amorphous” with a limited crystalline presence. This is unusually narrow versus many artesunate solid-form patents that center on polymorph identity and not a “trace crystalline fraction” window.

3) Powder electrostatics: “average static charge” test window

The micronized powder must have an average static charge from about −0.05 kV to 0.05 kV.
The test definition in claim 1 includes:
- Relative humidity: about 30% to 40% for at least five days.
- Place powder on weighing paper.
- Measure with a static meter:
  - at least three times
  - measurement occurs at least 25 mm from the powder surface
- Compute average from the measured values.

This turns the claim into a measurement-defined property. If an accused powder’s static charge lies outside the window under the same conditioning and measurement geometry, it can fall outside claim 1.

4) Powder preparation and controlled filling conditions

Claim 1 also requires a process that comprises:

Packaging the micronized powder
Sterilizing the micronized powder
Filling sterilized micronized powder into a container at:
- relative humidity 30% to 40%
- temperature 15°C to 30°C

This “post-sterilization fill” environmental control is a second infringement hinge that is independent of the initial milling/crystalline fraction.

5) Formulation step: buffer mixing

Mix the micronized powder with a buffer solution to create a pharmaceutical composition.
Later claims narrow buffer identity (claims 2-5).

6) Administration

Administer the pharmaceutical composition to treat malaria.
Dependent claims specify IV route and infusion timing (claims 6-8) and dosing windows (claims 9-12).

How do dependent claims narrow the scope (what you can design around)?

Below are the dependent claims and the “likely freedom-to-operate pressure points” they create.

Buffer system and pH/ionic strength (claims 2–5)

Claim 2: Buffer is bicarbonate buffer solution comprising:
- sodium phosphate monobasic monohydrate
- sodium phosphate dibasic dihydrate
- sodium hydroxide
- phosphoric acid
- water
Claim 3: pH 7.9 to 8.1
Claim 4: phosphate ions 0.25 to 0.35 M
Claim 5: buffer is sterilized before mixing

Fence effect: If a competitor uses a different buffer family, different pH band, or different phosphate molarity, those dependent claim paths narrow, but claim 1 can still be asserted if claim 1’s “buffer solution” term reads broadly enough in the operative claim construction. In US practice, the dependent claims do not limit claim 1, but they influence interpretation and arguments of intentional narrowness.

Route and administration kinetics (claims 6–8)

Claim 6: intravenous injection
Claim 7: slow IV infusion
Claim 8: slow IV infusion duration up to 5 minutes

Fence effect: If a competitor administers intramuscularly, bolus IV, or a different infusion length protocol, dependent claims 6-8 are harder to meet.

Dose and regimen (claims 9–12)

Claim 9: 1 mg/kg to 8 mg/kg (pharmaceutical composition amount range)
Claim 10: IV 2–3 mg/kg for at least three days
Claim 11: about 2.4 mg/kg
Claim 12: administered for at least three days

Fence effect: These are typical malaria dosing ranges. If an accused regimen departs from the claimed daily mg/kg and duration pairing, dependent claims become avoidable, but claim 1 still has the “therapeutically effective amount” language, which can be read broadly.

Powder moisture and flow (claims 14–16)

Claim 14: moisture absorption 0.01 wt% to 0.03 wt%
Claim 15: angle of repose < 40° through funnel opening 8–12 mm
Claim 16: particle size:
- D90 < 20 μm and/or
- D100 < 100 μm and/or
- D50 < 5 μm

Fence effect: These are manufacturing/process-linked and can be distinctive versus generic micronized powders.

Microbial/impurity profile (claims 17–18)

Claim 17: artesunate or salt free of Corynebacterium auris growth
Claim 18: powder has limits:
- water ≤ 0.5%
- dihydroartemisinin ≤ 0.5%
- didehydrodeoxyartemisinin ≤ 0.2%
- other impurities ≤ 0.2%

Fence effect: Sterility specifications and impurity profiles can be measured. If an accused powder fails these limits, it may avoid dependent claims 17-18.

Bulk/tap densities and flow propensity (claims 19–22)

Claim 19: Hausner ratio ≥ 1.6 at 30%–40% RH
Claim 21: bulk density < 0.2 g/mL
Claim 22: tap density > 0.3 g/mL

Fence effect: These properties track powder handling and conditioning. They can be used as practical proxies for whether a powder matches the “formulation-ready” state demanded by the patent.

Specific solid form (claim 20)

Claim 20: crystalline form is 10-α artesunate

Fence effect: This gives a specific polymorph anchor. If an accused product uses a different crystalline form distribution, it may be harder to meet the “crystalline form” requirement in claim 1 (but claim 1 is not limited to 10-α; claim 20 is limited).

Packaging and sterilization method (claims 23–24)

Claim 23: packaging includes at least three polyethylene containers
Claim 24: sterilization via ethylene oxide

Fence effect: Ethylene oxide sterilization is a strong process marker. A different sterilization route (e.g., gamma, steam, electron beam) could avoid dependent claim 24. Likewise, different packaging count/material can avoid claim 23.

What is the effective “infringement test” for US 12,390,442?

Because claim 1 is comprehensive, an infringement assessment typically reduces to whether an accused workflow satisfies:

Micronized artesunate powder with:
- crystalline form fraction >0 to ~1 wt%
- average static charge between -0.05 and 0.05 kV after the RH 30–40% at least five days conditioning and the static meter protocol (distance ≥25 mm; at least 3 readings; average calculated)
Powder preparation that includes:
- packaging, sterilization
- filling into container at RH 30–40% and 15–30°C
Mixing with a buffer solution (claim 1)
Administration to treat malaria (claim 1), with dependent claims 6–12 adding route/timing/dose features.

The patent landscape implication: designing around static charge (and/or conditioning protocol), moving away from the crystalline fraction window, or changing humidity-controlled fill conditions can be more decisive than changing the active dose regimen.

What is the patent landscape likely to look like around this claim set?

US 12,390,442 is a formulation and manufacturing-condition claim around artesunate. The likely adjacent landscape categories for “related risk” (by claim structure) are:

A) Static charge and electrostatics control patents

Claims with:

measurement-defined electrostatic properties (kV windows)
defined humidity conditioning
static meter geometry and averaging

Landscape pattern: such claims usually cluster in formulation and drug product manufacturability IP, not purely in drug substance polymorph space.

B) Sterilization and controlled humidity fill/process patents

Claims that require:

sterilization step (often EO in dependent claim 24)
filling at specified RH and temperature bands

Landscape pattern: packaging and aseptic processing related patents frequently overlap with stability and manufacturability IP for powders.

C) Solid form and amorphous-crystalline balance patents

This patent combines:

a specific crystalline form reference (claim 20)
a tight crystalline fraction range (claim 1)

Landscape pattern: artesunate polymorph and amorphous content patents often cover:

polymorph identity
XRPD-based classification
stabilization via milling or excipients This patent adds “fraction above 0 up to about 1 wt%,” which is a key discriminator.

D) Artesunate impurity/specification and moisture uptake patents

Claims that limit:

dihydroartemisinin and didehydrodeoxyartemisinin impurity levels
water content
moisture absorption range

Landscape pattern: impurity control and packaging moisture barrier patents are common adjacent layers.

E) Buffered IV administration formulations

Dependent claims narrow buffer identity (bicarbonate buffer with phosphate components), pH band, and phosphate molarity. IV artesunate formulations usually occupy a dense area in generics and follow-on product IP, especially where solubility, pH compatibility, and compatibility with IV administration matter.

Where is the scope tightest (highest “claim compliance” burden)?

The highest compliance burden in US 12,390,442 sits in claim 1 elements that are both:

precisely quantified, and
explicitly defined by protocol.

Top tightness drivers

Static charge window: −0.05 kV to 0.05 kV
Static charge test definition: RH 30–40% aging for at least five days; weigh paper; ≥25 mm distance; ≥3 readings; average
Crystalline fraction: >0 to about 1 wt%
Post-sterilization fill conditions: RH 30–40% and 15–30°C
Sterilization method (dependent 24): ethylene oxide

These are harder to “accidentally” satisfy than generic formulation parameters.

Key claim-to-competitor design levers

For product developers and investors, the actionable levers implied by the claim text are:

1) Powder electrostatics

If an accused powder does not fall into −0.05 to 0.05 kV after the same humidity conditioning and measurement geometry, claim 1 is harder to meet.

2) Humidity profile across manufacturing

If the sterilized powder is filled under conditions outside RH 30–40% or temperature outside 15°C to 30°C, dependent claim coverage is impacted and claim 1’s “prepared according to a process comprising” element is less likely to be met.

3) Solid-state distribution

Changing the crystalline fraction out of >0 to ~1 wt% avoids the claim 1 solid-form quantity element.

4) Sterilization and containerization

Switching sterilization away from ethylene oxide avoids claim 24.
Packaging count/material deviating from claim 23 avoids that dependent path.

5) Buffer formulation and pH/ions

Using a different buffer system, outside pH 7.9 to 8.1, or outside phosphate ions 0.25–0.35 M avoids dependent claims 2–4.

6) Administration protocol

Changing route away from slow IV infusion (claims 6–8), or regimen away from 2–3 mg/kg for at least three days (claims 10–12), can avoid dependent coverage.

Key Takeaways

US 12,390,442 is a manufacturing-and-measurement-defined malaria treatment patent centered on micronized artesunate powder with trace crystalline fraction, static charge controlled within −0.05 to 0.05 kV, and humidity-controlled post-sterilization filling into containers at RH 30–40% and 15–30°C.
Dependent claims layer in buffer identity and ionic composition, IV administration timing, dosing regimen, and powder specification (moisture absorption, flow, densities, impurity limits), plus ethylene oxide sterilization and multi-container polyethylene packaging.
The patent fence is most sensitive to compliance with (i) the static charge protocol and window and (ii) the humidity-temperature fill and preparation steps, not just to the presence of artesunate.

FAQs

Does claim 1 require ethylene oxide sterilization?
No. Ethylene oxide is required only by dependent claim 24. Claim 1 requires “sterilizing” but does not specify the method.
Is the static charge requirement tied to a specific measurement protocol?
Yes. Claim 1 defines RH conditioning (30%–40% for at least five days), measurement placement and distance (≥25 mm), number of readings (≥3), and averaging.
Is the patent limited to one artesunate polymorph?
Claim 1 covers “a crystalline form” and restricts the crystalline fraction to >0 to about 1 wt%. Dependent claim 20 specifies 10-α artesunate.
Can a different buffer avoid the patent?
Dependent claims 2–5 are specific to a bicarbonate/phosphate-related composition, pH 7.9–8.1, and phosphate ion concentration 0.25–0.35 M. Claim 1 still requires a “buffer solution,” so a buffer deviation primarily affects dependent claim coverage unless claim 1’s buffer term is construed narrowly to those specifics.
What parameters are likely to dominate infringement risk in practice?
The powder’s crystalline fraction window, the static charge test outcome, and the RH/temperature conditions for filling sterilized powder into containers.

References

[1] User-provided claim text for US Drug Patent 12,390,442 (claims 1–24).

Title:	Artesunate powders, pharmaceutical compositions and methods of manufacture
Abstract:	Disclosed herein are powders including a therapeutically effective amount of 4-oxo-4-[[(1R,4S,5R,8S,9R,10S,12R,13R)-1,5,9-trimethyl-11,14,15,16-tetraoxatetracyclo[10.3.1.04,13.08,13]1exadecane-10-yl]oxy]butanoic acid (artesunate) or a pharmaceutically acceptable salt thereof that can be easily manufactured, sterilized and packaged. Processes for producing these powders and pharmaceutical compositions containing these powders are also disclosed.
Inventor(s):	Bryan L. Smith, Lisa Thomas Read
Assignee:	Amivas Inc
Application Number:	US18/908,438
Patent Claim Types: see list of patent claims	Use; Composition;
Patent landscape, scope, and claims:	US Patent 12,390,442 (Artesunate): What the Claims Actually Cover and Where the Patent Fence Likely Sits What is US 12,390,442? US 12,390,442 claims a specific method of treating malaria using a micronized artesunate-containing powder with tightly defined solid-state, powder electrostatics, moisture-state control, and downstream sterile manufacture into a buffered composition for parenteral dosing. The core claim (claim 1) is not a broad “artesunate for malaria” product claim; it is a process-and-conditions claim tied to: Micronized powder comprising artesunate (4-oxo-4-[[(1R,4S,5R,8S,9R,10S,12R,13R)-1,5,9-trimethyl-11,14,15,16-tetraoxatetracyclo[10.3.1.04,13.08,13]hexadecan-10-yl]oxy]butanoic acid) or a salt. Powder solid form and crystalline amount window. Powder static charge window determined by a defined humidity aging test and static meter protocol. A defined manufacturing sequence: packaging, sterilization, and filling into a container under controlled humidity and temperature. Mixing the sterilized powder with a buffer solution to produce a pharmaceutical composition, then administering the composition for malaria. This structure makes infringement analysis highly sensitive to whether an accused process matches the powder electrostatics test, the humidity/temperature fill conditions, and the buffer composition/pH/ion concentration. What does claim 1 cover (scope map)? 1) Therapeutic indication and active Treating a malaria patient. Using a therapeutically effective amount of micronized artesunate or pharmaceutically acceptable salt. 2) Powder composition: crystalline content The micronized powder contains a crystalline form of artesunate or its salt in > 0 wt% to about 1 wt% of total powder weight. Practical reading: the patent targets a powder state that is “mostly non-crystalline or amorphous” with a limited crystalline presence. This is unusually narrow versus many artesunate solid-form patents that center on polymorph identity and not a “trace crystalline fraction” window. 3) Powder electrostatics: “average static charge” test window The micronized powder must have an average static charge from about −0.05 kV to 0.05 kV. The test definition in claim 1 includes: Relative humidity: about 30% to 40% for at least five days. Place powder on weighing paper. Measure with a static meter: at least three times measurement occurs at least 25 mm from the powder surface Compute average from the measured values. This turns the claim into a measurement-defined property. If an accused powder’s static charge lies outside the window under the same conditioning and measurement geometry, it can fall outside claim 1. 4) Powder preparation and controlled filling conditions Claim 1 also requires a process that comprises: Packaging the micronized powder Sterilizing the micronized powder Filling sterilized micronized powder into a container at: relative humidity 30% to 40% temperature 15°C to 30°C This “post-sterilization fill” environmental control is a second infringement hinge that is independent of the initial milling/crystalline fraction. 5) Formulation step: buffer mixing Mix the micronized powder with a buffer solution to create a pharmaceutical composition. Later claims narrow buffer identity (claims 2-5). 6) Administration Administer the pharmaceutical composition to treat malaria. Dependent claims specify IV route and infusion timing (claims 6-8) and dosing windows (claims 9-12). How do dependent claims narrow the scope (what you can design around)? Below are the dependent claims and the “likely freedom-to-operate pressure points” they create. Buffer system and pH/ionic strength (claims 2–5) Claim 2: Buffer is bicarbonate buffer solution comprising: sodium phosphate monobasic monohydrate sodium phosphate dibasic dihydrate sodium hydroxide phosphoric acid water Claim 3: pH 7.9 to 8.1 Claim 4: phosphate ions 0.25 to 0.35 M Claim 5: buffer is sterilized before mixing Fence effect: If a competitor uses a different buffer family, different pH band, or different phosphate molarity, those dependent claim paths narrow, but claim 1 can still be asserted if claim 1’s “buffer solution” term reads broadly enough in the operative claim construction. In US practice, the dependent claims do not limit claim 1, but they influence interpretation and arguments of intentional narrowness. Route and administration kinetics (claims 6–8) Claim 6: intravenous injection Claim 7: slow IV infusion Claim 8: slow IV infusion duration up to 5 minutes Fence effect: If a competitor administers intramuscularly, bolus IV, or a different infusion length protocol, dependent claims 6-8 are harder to meet. Dose and regimen (claims 9–12) Claim 9: 1 mg/kg to 8 mg/kg (pharmaceutical composition amount range) Claim 10: IV 2–3 mg/kg for at least three days Claim 11: about 2.4 mg/kg Claim 12: administered for at least three days Fence effect: These are typical malaria dosing ranges. If an accused regimen departs from the claimed daily mg/kg and duration pairing, dependent claims become avoidable, but claim 1 still has the “therapeutically effective amount” language, which can be read broadly. Powder moisture and flow (claims 14–16) Claim 14: moisture absorption 0.01 wt% to 0.03 wt% Claim 15: angle of repose < 40° through funnel opening 8–12 mm Claim 16: particle size: D90 < 20 μm and/or D100 < 100 μm and/or D50 < 5 μm Fence effect: These are manufacturing/process-linked and can be distinctive versus generic micronized powders. Microbial/impurity profile (claims 17–18) Claim 17: artesunate or salt free of Corynebacterium auris growth Claim 18: powder has limits: water ≤ 0.5% dihydroartemisinin ≤ 0.5% didehydrodeoxyartemisinin ≤ 0.2% other impurities ≤ 0.2% Fence effect: Sterility specifications and impurity profiles can be measured. If an accused powder fails these limits, it may avoid dependent claims 17-18. Bulk/tap densities and flow propensity (claims 19–22) Claim 19: Hausner ratio ≥ 1.6 at 30%–40% RH Claim 21: bulk density < 0.2 g/mL Claim 22: tap density > 0.3 g/mL Fence effect: These properties track powder handling and conditioning. They can be used as practical proxies for whether a powder matches the “formulation-ready” state demanded by the patent. Specific solid form (claim 20) Claim 20: crystalline form is 10-α artesunate Fence effect: This gives a specific polymorph anchor. If an accused product uses a different crystalline form distribution, it may be harder to meet the “crystalline form” requirement in claim 1 (but claim 1 is not limited to 10-α; claim 20 is limited). Packaging and sterilization method (claims 23–24) Claim 23: packaging includes at least three polyethylene containers Claim 24: sterilization via ethylene oxide Fence effect: Ethylene oxide sterilization is a strong process marker. A different sterilization route (e.g., gamma, steam, electron beam) could avoid dependent claim 24. Likewise, different packaging count/material can avoid claim 23. What is the effective “infringement test” for US 12,390,442? Because claim 1 is comprehensive, an infringement assessment typically reduces to whether an accused workflow satisfies: Micronized artesunate powder with: crystalline form fraction >0 to ~1 wt% average static charge between -0.05 and 0.05 kV after the RH 30–40% at least five days conditioning and the static meter protocol (distance ≥25 mm; at least 3 readings; average calculated) Powder preparation that includes: packaging, sterilization filling into container at RH 30–40% and 15–30°C Mixing with a buffer solution (claim 1) Administration to treat malaria (claim 1), with dependent claims 6–12 adding route/timing/dose features. The patent landscape implication: designing around static charge (and/or conditioning protocol), moving away from the crystalline fraction window, or changing humidity-controlled fill conditions can be more decisive than changing the active dose regimen. What is the patent landscape likely to look like around this claim set? US 12,390,442 is a formulation and manufacturing-condition claim around artesunate. The likely adjacent landscape categories for “related risk” (by claim structure) are: A) Static charge and electrostatics control patents Claims with: measurement-defined electrostatic properties (kV windows) defined humidity conditioning static meter geometry and averaging Landscape pattern: such claims usually cluster in formulation and drug product manufacturability IP, not purely in drug substance polymorph space. B) Sterilization and controlled humidity fill/process patents Claims that require: sterilization step (often EO in dependent claim 24) filling at specified RH and temperature bands Landscape pattern: packaging and aseptic processing related patents frequently overlap with stability and manufacturability IP for powders. C) Solid form and amorphous-crystalline balance patents This patent combines: a specific crystalline form reference (claim 20) a tight crystalline fraction range (claim 1) Landscape pattern: artesunate polymorph and amorphous content patents often cover: polymorph identity XRPD-based classification stabilization via milling or excipients This patent adds “fraction above 0 up to about 1 wt%,” which is a key discriminator. D) Artesunate impurity/specification and moisture uptake patents Claims that limit: dihydroartemisinin and didehydrodeoxyartemisinin impurity levels water content moisture absorption range Landscape pattern: impurity control and packaging moisture barrier patents are common adjacent layers. E) Buffered IV administration formulations Dependent claims narrow buffer identity (bicarbonate buffer with phosphate components), pH band, and phosphate molarity. IV artesunate formulations usually occupy a dense area in generics and follow-on product IP, especially where solubility, pH compatibility, and compatibility with IV administration matter. Where is the scope tightest (highest “claim compliance” burden)? The highest compliance burden in US 12,390,442 sits in claim 1 elements that are both: precisely quantified, and explicitly defined by protocol. Top tightness drivers Static charge window: −0.05 kV to 0.05 kV Static charge test definition: RH 30–40% aging for at least five days; weigh paper; ≥25 mm distance; ≥3 readings; average Crystalline fraction: >0 to about 1 wt% Post-sterilization fill conditions: RH 30–40% and 15–30°C Sterilization method (dependent 24): ethylene oxide These are harder to “accidentally” satisfy than generic formulation parameters. Key claim-to-competitor design levers For product developers and investors, the actionable levers implied by the claim text are: 1) Powder electrostatics If an accused powder does not fall into −0.05 to 0.05 kV after the same humidity conditioning and measurement geometry, claim 1 is harder to meet. 2) Humidity profile across manufacturing If the sterilized powder is filled under conditions outside RH 30–40% or temperature outside 15°C to 30°C, dependent claim coverage is impacted and claim 1’s “prepared according to a process comprising” element is less likely to be met. 3) Solid-state distribution Changing the crystalline fraction out of >0 to ~1 wt% avoids the claim 1 solid-form quantity element. 4) Sterilization and containerization Switching sterilization away from ethylene oxide avoids claim 24. Packaging count/material deviating from claim 23 avoids that dependent path. 5) Buffer formulation and pH/ions Using a different buffer system, outside pH 7.9 to 8.1, or outside phosphate ions 0.25–0.35 M avoids dependent claims 2–4. 6) Administration protocol Changing route away from slow IV infusion (claims 6–8), or regimen away from 2–3 mg/kg for at least three days (claims 10–12), can avoid dependent coverage. Key Takeaways US 12,390,442 is a manufacturing-and-measurement-defined malaria treatment patent centered on micronized artesunate powder with trace crystalline fraction, static charge controlled within −0.05 to 0.05 kV, and humidity-controlled post-sterilization filling into containers at RH 30–40% and 15–30°C. Dependent claims layer in buffer identity and ionic composition, IV administration timing, dosing regimen, and powder specification (moisture absorption, flow, densities, impurity limits), plus ethylene oxide sterilization and multi-container polyethylene packaging. The patent fence is most sensitive to compliance with (i) the static charge protocol and window and (ii) the humidity-temperature fill and preparation steps, not just to the presence of artesunate. FAQs Does claim 1 require ethylene oxide sterilization? No. Ethylene oxide is required only by dependent claim 24. Claim 1 requires “sterilizing” but does not specify the method. Is the static charge requirement tied to a specific measurement protocol? Yes. Claim 1 defines RH conditioning (30%–40% for at least five days), measurement placement and distance (≥25 mm), number of readings (≥3), and averaging. Is the patent limited to one artesunate polymorph? Claim 1 covers “a crystalline form” and restricts the crystalline fraction to >0 to about 1 wt%. Dependent claim 20 specifies 10-α artesunate. Can a different buffer avoid the patent? Dependent claims 2–5 are specific to a bicarbonate/phosphate-related composition, pH 7.9–8.1, and phosphate ion concentration 0.25–0.35 M. Claim 1 still requires a “buffer solution,” so a buffer deviation primarily affects dependent claim coverage unless claim 1’s buffer term is construed narrowly to those specifics. What parameters are likely to dominate infringement risk in practice? The powder’s crystalline fraction window, the static charge test outcome, and the RH/temperature conditions for filling sterilized powder into containers. References [1] User-provided claim text for US Drug Patent 12,390,442 (claims 1–24). More… ↓ ⤷ Start Trial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amivas	ARTESUNATE	artesunate	POWDER;INTRAVENOUS	213036-001	May 26, 2020		RX	Yes	Yes	12,390,442	⤷ Start Trial				A METHOD OF TREATING MALARIA USING MICRONIZED POWDER OF CRYSTALLINE ARTESUNATE PREPARED BY STERILIZING AND FILLING THE POWDER INTO A CONTAINER AT A RELATIVE HUMIDITY OF 30 TO 40%, MIXING THE POWDER WITH A BUFFER AND ADMINISTERING THE COMPOSITION	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Summary for Patent: 12,390,442