US Patent 12,383,491 (United States) – Scope, Claim-by-Claim Coverage, and US Patent Landscape for Ready-to-Use Neostigmine + Glycopyrrolate Injectable With Impurity Control

US Patent 12,383,491 centers on a specific, ready-to-use injectable composition containing low-concentration neostigmine and glycopyrrolate, with a stability constraint defined by the level of “Glycopyrrolate Impurity C” after storage under defined stress conditions and with an explicit pH window. The enforceable core is (i) formulation composition ranges (neostigmine, glycopyrrolate, vehicle), (ii) a pH range (3.0 to 4.0; dependent to 3.0 to 3.5), (iii) impurity specification tied to storage, and (iv) sterility and container delivery as optional claim layers. The independent claim also implicitly positions the patent for “generic design-around” against competitors by requiring impurity control under accelerated storage, not just initial composition or nominal pH.

What is US Patent 12,383,491’s claim scope and what is the practical “core” limitation?

Featured snippet answer: The independent claim (claim 1) covers a ready-to-use injectable solution with about 0.5 mg/mL neostigmine and about 0.1 mg/mL glycopyrrolate, pH 3.0 to 4.0, and Glycopyrrolate Impurity C < 1% after 3 months at 40°C/75% RH, formulated as a pharmaceutically acceptable liquid vehicle.

Claim 1 elements (mapped to infringement-relevant factors)

1) Product type

“Ready-to-use injectable pharmaceutical composition” (not a concentrate requiring dilution).
“A pharmaceutically acceptable liquid vehicle.”

2) Active concentration windows

Neostigmine: “about 0.5 mg/mL” (including salts/solvates/hydrates).
Glycopyrrolate: “about 0.1 mg/mL” (including salts/solvates/hydrates).

3) pH constraint

pH ranges “from about 3.0 to about 4.0.”

4) Storage stability defined by impurity acceptance

“wherein a level of Glycopyrrolate Impurity C in the composition is less than 1%”
after storage “at 40°C and 75% relative humidity for at least 3 months.”

5) Vehicle and other formulation features

No explicit tonicity modifier in claim 1 (that is dependent on claim 8).

Scope implication

Claim 1 is not limited to a specific container, sterilization method, or administration route in its independent portion. Those features are added through dependent claims. The impurity criterion is the main technical lock, because it forces equivalence in a measurable attribute after a time-temperature-humidity stress protocol rather than only at initial testing.

How do dependent claims 2–16 narrow coverage and create “stacked” infringement pathways?

Dependent claims build a layered estate that can capture multiple product formats and manufacturing choices. The most commercially relevant dependent claims are those that map to how a manufacturer would actually sell and fill the product in the US.

Claim 2: specific salt pair

Adds specificity: neostigmine methylsulfate and glycopyrronium bromide (not just “neostigmine” and “glycopyrrolate” generically as in claim 1).

Practical effect: If a competitor uses different salt forms or different glycopyrrolate equivalent forms not falling within the dependent claim wording, claim 2 may not be implicated, but claim 1 may still cover the composition if the functional glycopyrrolate identity and impurity behavior match the independent claim.

Claims 3–4: sealed container formats

Claim 3: container is selected from vial and pre-filled syringe.
Claim 4: further restricts to clear glass vial, amber glass vial, plastic vial, or pre-filled syringe.

Practical effect: If a competitor uses an alternate container (for example, a device format outside the listed categories) they may attempt a design-around for these dependent claims, but claim 1 still covers any “ready-to-use” injectable that is covered by the independent composition.

Claims 5–7: solution form and administration suitability

Claim 5: “in the form of a solution.”
Claim 6: suitable for subcutaneous, intravenous or intramuscular administration.
Claim 7: pH narrows further to about 3.0 to about 3.5.

Practical effect: Claim 7 is a narrower pH subrange. A competitor could target pH 3.6–4.0 (while staying within claim 1) to avoid claim 7 while still risking claim 1. If pH drifts outside 3.0–4.0, then claim 1 is avoided as well.

Claims 8–11: tonicity modifier

Claim 8: further comprising a tonicity modifier.
Claim 9: tonicity modifier list includes glycerine, lactose, mannitol, dextrose, sodium chloride, sodium sulphate, sorbitol, trehalose.
Claim 10: tonicity modifier amount 1 mg/mL to 20 mg/mL.
Claim 11: specific 5–10 mg/mL subrange.

Practical effect: This provides an additional claim track for common formulation practices (tonicity adjustment). If a competitor uses a tonicity approach outside the listed agents or outside the specified range, these dependents can be avoided, while independent claim 1 can still be asserted if other required features remain met.

Claim 12: stability benchmark at a different condition

Stable for at least 3 months at 25°C and 60% RH.

Practical effect: This adds an additional stability proof point for certain storage conditions. A competitor could focus on impurity behavior at 40°C/75% RH to manage claim 1 while possibly failing claim 12 if they do not demonstrate stability at 25°C/60% RH.

Claim 13: explicit assay metric and measurement method

Impurity C less than 1% (w/w) as measured by HPLC.

Practical effect: This tightens evidentiary requirements for infringement by tying impurity specification to an HPLC-based measurement. If a competitor frames measurement/quantitation differently, claim 13 specifically is easier to prove because it calls out HPLC.

Claims 14–16: sterilization

Claim 14: composition is sterilized.
Claim 15: sterilization technique selected from filtration through bacterial-retaining filter, terminal sterilization, sterilizing agents, irradiation, heating.
Claim 16: sterilized using aseptic filling, irradiation and heat sterilization.

Practical effect: This reduces design-around options for competitors who would otherwise skip sterility or use alternative sterilization schemes. In US injectables, sterility is usually mandatory, so these dependents can map well to actual manufacturing.

Claim 17: method-of-use

Treating a neuromuscular disease by administering the composition.

Practical effect: Method claims can enlarge infringement reach beyond product presence into clinical dosing. The scope depends on what “neuromuscular disease” encompasses in the patent’s specification and how the patent ties use to those conditions. In practice, a method-of-use claim can be asserted where the product is administered for qualifying indications.

What is the infringement “claim map” against a generic or authorized alternative?

Direct product-by-product infringement risk is driven by four checkpoints from claim 1:

Neostigmine concentration near 0.5 mg/mL
Glycopyrrolate concentration near 0.1 mg/mL
pH in 3.0–4.0
After 40°C/75% RH for ≥ 3 months, “Glycopyrrolate Impurity C” is <1%

Dependent claims then add manufacturing and packaging features that match typical injectable products.

Practical design-around levers (how competitors would attempt to avoid infringement)

Shift pH outside 3.0–4.0 (avoid claim 1 outright) or within 3.0–4.0 but outside 3.0–3.5 (avoid claim 7 only).
Change formulation such that impurity C exceeds 1% after the defined storage, thereby avoiding claim 1. This is risky because degraded impurity can reduce acceptability and may trigger regulatory rejection.
Modify tonicity system outside listed agents or outside 1–20 mg/mL or 5–10 mg/mL ranges (avoid claims 8–11).
Use alternative container formats not falling within claim 3 or claim 4 categories (avoid those dependents only).
Employ sterilization not aligned with the dependent claim sets (avoid dependents 14–16 only; sterility still required).

How strong is the patent estate likely to be: what is the “novelty driver” embedded in the claims?

Based on the claim language, the strongest novelty driver is the impurity control tied to a defined storage stress condition:

“Glycopyrrolate Impurity C < 1% after 3 months at 40°C/75% RH”
with pH 3.0–4.0 and specific drug concentrations

This structure is typical of formulation patents where the differentiator is chemical stability and controlled impurity levels rather than the existence of a known drug combination. The claim also builds multiple backup layers:

salt identities (claim 2)
pH subrange (claim 7)
tonicity selection and dosage (claims 8–11)
stability at an additional condition (claim 12)
analytical method tie-in (claim 13)
sterility/manufacturing options (claims 14–16)

That layered structure increases “probability of capture” across real-world product variations.

What patents commonly coexist with this type of formulation claim in the US Orange Book / device-to-drug regulatory ecosystem?

For this class of combination injectable (neostigmine and glycopyrrolate), US portfolios often include:

earlier drug substance patents (neostigmine salts, glycopyrrolate salts)
known combination therapy patents (method-of-use)
formulation patents defining pH, solubilizers, preservatives, tonicity agents, and stability/impurity profiles
process patents tied to manufacturing controls that impact impurities
device/container patents (USP or primary packaging compatibility)

US Patent 12,383,491 appears to be a formulation-stability “incremental” patent built around impurity acceptance criteria at stress conditions.

What is the litigation-relevant landscape for this patent: generic entry risks and Paragraph IV-style dynamics?

This formulation estate typically creates litigation exposure in one of two ways:

A generic applicant submits an ANDA certification that the referenced listed drug does not infringe or that the listed patents are invalid/unenforceable, often targeting formulation differences.
A competitor launches “at-risk” with a product designed to avoid impurity criteria or pH ranges, then faces infringement allegations centered on stability data.

Because claim 1 defines the impurity level after a defined time and environmental stress, the evidentiary battleground in litigation is usually:

competitor’s actual stability program results
validated HPLC impurity quantitation
pH and concentration verification
comparability of container and sterilization, since those can affect stability and impurity formation

Which competitor product design choices most directly affect Glycopyrrolate Impurity C outcomes?

Even without the patent specification text, impurity formation in glycopyrrolate-containing solutions at low pH is generally sensitive to:

pH drift within 3.0–4.0 during storage
oxygen exposure and headspace effects tied to container choice
ionic strength and tonicity system interactions
sterilization method and residuals
filtration/bioburden control and extractables from packaging
temperature and moisture ingress (driven by sealing and closure)

The claim’s specific constraint (40°C/75% RH) implies the patentee considered accelerated impurity generation pathways that are sufficiently reproducible to define infringement.

How does the claim language translate into “test conditions” that matter in enforcement?

Claim 1 sets the core test conditions:

Storage at 40°C
75% relative humidity
for at least 3 months
then measure impurity C level

Claim 13 tightens measurement:

“as measured by HPLC” and in % (w/w) less than 1%

This means infringement proof generally requires a sampling protocol aligned with the storage regimen and an HPLC method that can compare impurity C levels to the <1% threshold.

What exactly is claimed as a method of treating neuromuscular disease (claim 17) and what does it riskologically add?

Claim 17 is broad on therapeutic area (“neuromuscular disease”) but narrow on required administration of the claimed composition. The additional commercial effect is that a company cannot avoid liability solely by arguing that the generic’s formulation differs slightly if the composition falls under claim 1 and is used for the claimed therapeutic purposes.

If the referenced product has established labeling for a neuromuscular indication, method-of-use claims can strengthen a patentee’s position by tying alleged infringement to actual prescribing and administration patterns.

Key Takeaways

Independent claim 1 is a ready-to-use injectable formulation defined by neostigmine ~0.5 mg/mL, glycopyrrolate ~0.1 mg/mL, pH 3.0–4.0, and Glycopyrrolate Impurity C <1% after 3 months at 40°C/75% RH.
The impurity-after-storage threshold is the central enforcement hook; it is harder to design around than a single pH or excipient limitation.
Dependent claims add coverage layers for specific salts (claim 2), container formats (claims 3–4), narrow pH (claim 7), tonicity modifiers and amounts (claims 8–11), stability at 25°C/60% RH (claim 12), HPLC measurement tie-in (claim 13), sterilization options (claims 14–16), and method-of-use (claim 17).
Litigation and generic launch risk will pivot on whether the competitor’s stability and HPLC results meet the patentee’s impurity and pH windows under the defined accelerated storage conditions.

FAQs

How can a generic avoid US Patent 12,383,491 if it matches neostigmine and glycopyrrolate concentrations?
By ensuring the final formulation does not meet claim 1’s impurity C and pH criteria after the defined accelerated storage and, where relevant, avoiding dependent-range features like pH 3.0–3.5 or the specified tonicity modifier amounts.
Does claim 12 create an additional barrier even if impurity C is controlled at 40°C/75% RH?
Yes. Claim 12 adds a separate stability requirement at 25°C/60% RH for at least 3 months, creating another testable condition that can support an infringement theory.
What is the role of container choice in infringement of dependent claims 3 and 4?
Container categories matter only for those dependent claims. Claim 1 can still be implicated if the formulation is within scope regardless of whether the container falls within the dependent claim listed types.
Can a competitor use a different sterilization approach to avoid infringement?
Sterilization can help avoid dependent claims 14–16 only if the technique falls outside their listed sets. Sterility remains a practical requirement for injectables, so claim 1 product scope remains the primary risk driver.
Does claim 17 extend enforcement to prescribing and administration activity?
Yes. If the product falls within claim 1 and is administered for “neuromuscular disease,” method-of-use allegations can attach beyond formulation manufacturing.

References (APA)

United States Patent 12,383,491.

Title:	Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate
Abstract:	Stable, ready-to-use injectable pharmaceutical compositions are provided, comprising the combination of neostigmine, glycopyrrolate, and a pharmaceutically acceptable liquid vehicle, optionally with additional pharmaceutically acceptable excipients. Other aspects of the invention relate to methods for making such compositions and methods of using such compositions for reversing the effects of non-depolarizing neuromuscular blocking agents. Preferably, the composition comprises neostigmine methylsulfate, glycopyrronium bromide, and a pharmaceutically acceptable liquid vehicle, and is provided in a pre-filled, ready-to-use sealed container, such as a pre-filled syringe, suitable for intravenous administration.
Inventor(s):	Rahul Dhulaji Bhise, Ajay Kumar Singh, Mahadeo Vasant Mahadik, Ashish Anilrao DUBEWAR, Molugu Prashanth Reddy
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US17/386,139
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;
Patent landscape, scope, and claims:	US Patent 12,383,491 (United States) – Scope, Claim-by-Claim Coverage, and US Patent Landscape for Ready-to-Use Neostigmine + Glycopyrrolate Injectable With Impurity Control US Patent 12,383,491 centers on a specific, ready-to-use injectable composition containing low-concentration neostigmine and glycopyrrolate, with a stability constraint defined by the level of “Glycopyrrolate Impurity C” after storage under defined stress conditions and with an explicit pH window. The enforceable core is (i) formulation composition ranges (neostigmine, glycopyrrolate, vehicle), (ii) a pH range (3.0 to 4.0; dependent to 3.0 to 3.5), (iii) impurity specification tied to storage, and (iv) sterility and container delivery as optional claim layers. The independent claim also implicitly positions the patent for “generic design-around” against competitors by requiring impurity control under accelerated storage, not just initial composition or nominal pH. What is US Patent 12,383,491’s claim scope and what is the practical “core” limitation? Featured snippet answer: The independent claim (claim 1) covers a ready-to-use injectable solution with about 0.5 mg/mL neostigmine and about 0.1 mg/mL glycopyrrolate, pH 3.0 to 4.0, and Glycopyrrolate Impurity C < 1% after 3 months at 40°C/75% RH, formulated as a pharmaceutically acceptable liquid vehicle. Claim 1 elements (mapped to infringement-relevant factors) 1) Product type “Ready-to-use injectable pharmaceutical composition” (not a concentrate requiring dilution). “A pharmaceutically acceptable liquid vehicle.” 2) Active concentration windows Neostigmine: “about 0.5 mg/mL” (including salts/solvates/hydrates). Glycopyrrolate: “about 0.1 mg/mL” (including salts/solvates/hydrates). 3) pH constraint pH ranges “from about 3.0 to about 4.0.” 4) Storage stability defined by impurity acceptance “wherein a level of Glycopyrrolate Impurity C in the composition is less than 1%” after storage “at 40°C and 75% relative humidity for at least 3 months.” 5) Vehicle and other formulation features No explicit tonicity modifier in claim 1 (that is dependent on claim 8). Scope implication Claim 1 is not limited to a specific container, sterilization method, or administration route in its independent portion. Those features are added through dependent claims. The impurity criterion is the main technical lock, because it forces equivalence in a measurable attribute after a time-temperature-humidity stress protocol rather than only at initial testing. How do dependent claims 2–16 narrow coverage and create “stacked” infringement pathways? Dependent claims build a layered estate that can capture multiple product formats and manufacturing choices. The most commercially relevant dependent claims are those that map to how a manufacturer would actually sell and fill the product in the US. Claim 2: specific salt pair Adds specificity: neostigmine methylsulfate and glycopyrronium bromide (not just “neostigmine” and “glycopyrrolate” generically as in claim 1). Practical effect: If a competitor uses different salt forms or different glycopyrrolate equivalent forms not falling within the dependent claim wording, claim 2 may not be implicated, but claim 1 may still cover the composition if the functional glycopyrrolate identity and impurity behavior match the independent claim. Claims 3–4: sealed container formats Claim 3: container is selected from vial and pre-filled syringe. Claim 4: further restricts to clear glass vial, amber glass vial, plastic vial, or pre-filled syringe. Practical effect: If a competitor uses an alternate container (for example, a device format outside the listed categories) they may attempt a design-around for these dependent claims, but claim 1 still covers any “ready-to-use” injectable that is covered by the independent composition. Claims 5–7: solution form and administration suitability Claim 5: “in the form of a solution.” Claim 6: suitable for subcutaneous, intravenous or intramuscular administration. Claim 7: pH narrows further to about 3.0 to about 3.5. Practical effect: Claim 7 is a narrower pH subrange. A competitor could target pH 3.6–4.0 (while staying within claim 1) to avoid claim 7 while still risking claim 1. If pH drifts outside 3.0–4.0, then claim 1 is avoided as well. Claims 8–11: tonicity modifier Claim 8: further comprising a tonicity modifier. Claim 9: tonicity modifier list includes glycerine, lactose, mannitol, dextrose, sodium chloride, sodium sulphate, sorbitol, trehalose. Claim 10: tonicity modifier amount 1 mg/mL to 20 mg/mL. Claim 11: specific 5–10 mg/mL subrange. Practical effect: This provides an additional claim track for common formulation practices (tonicity adjustment). If a competitor uses a tonicity approach outside the listed agents or outside the specified range, these dependents can be avoided, while independent claim 1 can still be asserted if other required features remain met. Claim 12: stability benchmark at a different condition Stable for at least 3 months at 25°C and 60% RH. Practical effect: This adds an additional stability proof point for certain storage conditions. A competitor could focus on impurity behavior at 40°C/75% RH to manage claim 1 while possibly failing claim 12 if they do not demonstrate stability at 25°C/60% RH. Claim 13: explicit assay metric and measurement method Impurity C less than 1% (w/w) as measured by HPLC. Practical effect: This tightens evidentiary requirements for infringement by tying impurity specification to an HPLC-based measurement. If a competitor frames measurement/quantitation differently, claim 13 specifically is easier to prove because it calls out HPLC. Claims 14–16: sterilization Claim 14: composition is sterilized. Claim 15: sterilization technique selected from filtration through bacterial-retaining filter, terminal sterilization, sterilizing agents, irradiation, heating. Claim 16: sterilized using aseptic filling, irradiation and heat sterilization. Practical effect: This reduces design-around options for competitors who would otherwise skip sterility or use alternative sterilization schemes. In US injectables, sterility is usually mandatory, so these dependents can map well to actual manufacturing. Claim 17: method-of-use Treating a neuromuscular disease by administering the composition. Practical effect: Method claims can enlarge infringement reach beyond product presence into clinical dosing. The scope depends on what “neuromuscular disease” encompasses in the patent’s specification and how the patent ties use to those conditions. In practice, a method-of-use claim can be asserted where the product is administered for qualifying indications. What is the infringement “claim map” against a generic or authorized alternative? Direct product-by-product infringement risk is driven by four checkpoints from claim 1: Neostigmine concentration near 0.5 mg/mL Glycopyrrolate concentration near 0.1 mg/mL pH in 3.0–4.0 After 40°C/75% RH for ≥ 3 months, “Glycopyrrolate Impurity C” is <1% Dependent claims then add manufacturing and packaging features that match typical injectable products. Practical design-around levers (how competitors would attempt to avoid infringement) Shift pH outside 3.0–4.0 (avoid claim 1 outright) or within 3.0–4.0 but outside 3.0–3.5 (avoid claim 7 only). Change formulation such that impurity C exceeds 1% after the defined storage, thereby avoiding claim 1. This is risky because degraded impurity can reduce acceptability and may trigger regulatory rejection. Modify tonicity system outside listed agents or outside 1–20 mg/mL or 5–10 mg/mL ranges (avoid claims 8–11). Use alternative container formats not falling within claim 3 or claim 4 categories (avoid those dependents only). Employ sterilization not aligned with the dependent claim sets (avoid dependents 14–16 only; sterility still required). How strong is the patent estate likely to be: what is the “novelty driver” embedded in the claims? Based on the claim language, the strongest novelty driver is the impurity control tied to a defined storage stress condition: “Glycopyrrolate Impurity C < 1% after 3 months at 40°C/75% RH” with pH 3.0–4.0 and specific drug concentrations This structure is typical of formulation patents where the differentiator is chemical stability and controlled impurity levels rather than the existence of a known drug combination. The claim also builds multiple backup layers: salt identities (claim 2) pH subrange (claim 7) tonicity selection and dosage (claims 8–11) stability at an additional condition (claim 12) analytical method tie-in (claim 13) sterility/manufacturing options (claims 14–16) That layered structure increases “probability of capture” across real-world product variations. What patents commonly coexist with this type of formulation claim in the US Orange Book / device-to-drug regulatory ecosystem? For this class of combination injectable (neostigmine and glycopyrrolate), US portfolios often include: earlier drug substance patents (neostigmine salts, glycopyrrolate salts) known combination therapy patents (method-of-use) formulation patents defining pH, solubilizers, preservatives, tonicity agents, and stability/impurity profiles process patents tied to manufacturing controls that impact impurities device/container patents (USP or primary packaging compatibility) US Patent 12,383,491 appears to be a formulation-stability “incremental” patent built around impurity acceptance criteria at stress conditions. What is the litigation-relevant landscape for this patent: generic entry risks and Paragraph IV-style dynamics? This formulation estate typically creates litigation exposure in one of two ways: A generic applicant submits an ANDA certification that the referenced listed drug does not infringe or that the listed patents are invalid/unenforceable, often targeting formulation differences. A competitor launches “at-risk” with a product designed to avoid impurity criteria or pH ranges, then faces infringement allegations centered on stability data. Because claim 1 defines the impurity level after a defined time and environmental stress, the evidentiary battleground in litigation is usually: competitor’s actual stability program results validated HPLC impurity quantitation pH and concentration verification comparability of container and sterilization, since those can affect stability and impurity formation Which competitor product design choices most directly affect Glycopyrrolate Impurity C outcomes? Even without the patent specification text, impurity formation in glycopyrrolate-containing solutions at low pH is generally sensitive to: pH drift within 3.0–4.0 during storage oxygen exposure and headspace effects tied to container choice ionic strength and tonicity system interactions sterilization method and residuals filtration/bioburden control and extractables from packaging temperature and moisture ingress (driven by sealing and closure) The claim’s specific constraint (40°C/75% RH) implies the patentee considered accelerated impurity generation pathways that are sufficiently reproducible to define infringement. How does the claim language translate into “test conditions” that matter in enforcement? Claim 1 sets the core test conditions: Storage at 40°C 75% relative humidity for at least 3 months then measure impurity C level Claim 13 tightens measurement: “as measured by HPLC” and in % (w/w) less than 1% This means infringement proof generally requires a sampling protocol aligned with the storage regimen and an HPLC method that can compare impurity C levels to the <1% threshold. What exactly is claimed as a method of treating neuromuscular disease (claim 17) and what does it riskologically add? Claim 17 is broad on therapeutic area (“neuromuscular disease”) but narrow on required administration of the claimed composition. The additional commercial effect is that a company cannot avoid liability solely by arguing that the generic’s formulation differs slightly if the composition falls under claim 1 and is used for the claimed therapeutic purposes. If the referenced product has established labeling for a neuromuscular indication, method-of-use claims can strengthen a patentee’s position by tying alleged infringement to actual prescribing and administration patterns. Key Takeaways Independent claim 1 is a ready-to-use injectable formulation defined by neostigmine ~0.5 mg/mL, glycopyrrolate ~0.1 mg/mL, pH 3.0–4.0, and Glycopyrrolate Impurity C <1% after 3 months at 40°C/75% RH. The impurity-after-storage threshold is the central enforcement hook; it is harder to design around than a single pH or excipient limitation. Dependent claims add coverage layers for specific salts (claim 2), container formats (claims 3–4), narrow pH (claim 7), tonicity modifiers and amounts (claims 8–11), stability at 25°C/60% RH (claim 12), HPLC measurement tie-in (claim 13), sterilization options (claims 14–16), and method-of-use (claim 17). Litigation and generic launch risk will pivot on whether the competitor’s stability and HPLC results meet the patentee’s impurity and pH windows under the defined accelerated storage conditions. FAQs How can a generic avoid US Patent 12,383,491 if it matches neostigmine and glycopyrrolate concentrations? By ensuring the final formulation does not meet claim 1’s impurity C and pH criteria after the defined accelerated storage and, where relevant, avoiding dependent-range features like pH 3.0–3.5 or the specified tonicity modifier amounts. Does claim 12 create an additional barrier even if impurity C is controlled at 40°C/75% RH? Yes. Claim 12 adds a separate stability requirement at 25°C/60% RH for at least 3 months, creating another testable condition that can support an infringement theory. What is the role of container choice in infringement of dependent claims 3 and 4? Container categories matter only for those dependent claims. Claim 1 can still be implicated if the formulation is within scope regardless of whether the container falls within the dependent claim listed types. Can a competitor use a different sterilization approach to avoid infringement? Sterilization can help avoid dependent claims 14–16 only if the technique falls outside their listed sets. Sterility remains a practical requirement for injectables, so claim 1 product scope remains the primary risk driver. Does claim 17 extend enforcement to prescribing and administration activity? Yes. If the product falls within claim 1 and is administered for “neuromuscular disease,” method-of-use allegations can attach beyond formulation manufacturing. References (APA) United States Patent 12,383,491. 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
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903-001	Feb 23, 2023		RX	Yes	Yes	12,383,491	⤷ Start Trial	Y				⤷ 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

Details for Patent: 12,383,491

Which drugs does patent 12,383,491 protect, and when does it expire?

Summary for Patent: 12,383,491