Details for Patent: 12,440,566

Which drugs does patent 12,440,566 protect, and when does it expire?

Patent 12,440,566 protects KONVOMEP and is included in one NDA.

This patent has five patent family members in five countries.

Summary for Patent: 12,440,566

Title:	Compositions and kits for omeprazole suspension
Abstract:	Disclosed herein are liquid diluents, formulations, and kits for preparing reconstituted suspensions of a proton pump inhibitor (e.g., omeprazole). The present disclosure also provides formulations for liquid diluents that do not have a tendency for gel formation following exposure to freeze-thaw cycles.
Inventor(s):	Zeus Pendon, Steven Dinh
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US18/128,550
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound;

Scope and claims analysis of US Drug Patent 12,440,566 (freeze-thaw stable liquid diluent for proton pump inhibitors)
US 12,440,566 is directed to a specific liquid diluent composition used to reconstitute or formulate proton pump inhibitor (PPI) products under freeze-thaw stress. The independent claim is constrained by a defined excipient package (notably poloxamer + CMC or microcrystalline cellulose + sodium bicarbonate + simethicone emulsion + preservative) plus two functional stability requirements: ≥30 days stability at 5±3°C and resistance to gel formation for at least one freeze-thaw cycle, with express exclusions of glycerin and xanthan gum. Dependent claims narrow to particular poloxamer identity and concentrations, bicarbonate ranges including specific values, simethicone level, preservative identity and levels, and viscosity and co-solvent absence. Claim 15 creates a composition claim that pairs the diluent with selected PPIs (including omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole), with further narrowing to specific PPI embodiments and one concentration (omeprazole at 2 mg/mL).

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What does US Patent 12,440,566 claim: freeze-thaw stable liquid diluent for proton pump inhibitors?

Core invention in claim 1 (independent claim)

Claim 1 is a narrowly framed formulation and product-by-function/stability claim covering:

A. Product type

• A “freeze-thaw stable liquid diluent for reconstituting a proton pump inhibitor.”

B. Mandatory excipient set

• Poloxamer (no identity required in claim 1)
• Suspending agent selected from:
  • sodium carboxymethyl cellulose (CMC), or
  • microcrystalline cellulose, or
  • combinations of those
• Sodium bicarbonate
• Simethicone emulsion
• A preservative
• Water
• Optional excipients limited to:
  • flavoring agent
  • sweetener
  • coloring agent

C. Express exclusions

• The diluent “does not comprise glycerin or xanthan gum.”

D. Stability and functional durability requirements Two separate constraints appear:

1. “Stable for at least 30 days at 5±3°C”
2. “Resistant to gel formation for at least one freeze-thaw cycle”

E. Implied use boundary Claim 1 is drafted around reconstitution of a PPI, so infringement analysis will focus on whether an accused product is provided as a diluent and used in reconstitution for PPIs (not merely any buffered freeze-thaw-stable solution).

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How broad is the independent claim versus typical prior art excipient combinations?

Breadth levers

• Suspending agent flexibility: CMC and/or microcrystalline cellulose are both within scope.
• Poloxamer flexibility: claim 1 does not restrict the poloxamer grade. Dependent claim 2 does (poloxamer 188).
• Preservative flexibility: claim 1 requires a preservative but does not specify which; dependent claim 8 enumerates many options.
• Optional additives limited to flavor/sweetener/color. That keeps the claim from broadening to include many other formulation tools (e.g., certain cosolvents, alternative anti-gelling polymers, etc.).

Narrowing and “escape” levers

• Hard exclusions: no glycerin and no xanthan gum. These are frequently used in oral liquids and viscosity management strategies; their absence narrows design-around options.
• Freeze-thaw behavior is required: the formulation must meet resistance to gel formation at least across one freeze-thaw cycle. Many excipient packages may be buffered and preservative-stabilized but fail gelation criteria.
• Cold stability is required: ≥30 days at 5±3°C. That limitation is a practical bar for formulations optimized only for room temperature.

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Which claim elements are likely to be litigated: stability, gelation, and exclusions?

Stability/functional testing risk

Because claim 1 imposes functional properties, infringement will often hinge on:

• freeze-thaw protocol used (cycle definition, freeze and thaw temperatures, hold times)
• whether “gel formation” is assessed qualitatively or with defined thresholds
• storage duration at 5±3°C
• whether test conditions are comparable to claim-required conditions

The claim language (“at least 30 days at 5±3°C” and “for at least one freeze-thaw cycle”) gives a clear minimum performance gate.

Exclusion of glycerin and xanthan gum as design-around targets

Any candidate generic or follow-on diluent must avoid:

• glycerin-containing recipes
• xanthan gum-containing recipes

Even if the rest of the excipient profile resembles the claim, inclusion of a prohibited ingredient can be a straightforward non-infringement position.

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What are the dependent claims adding: poloxamer 188, bicarbonate ranges, simethicone level, preservatives, and sweeteners?

Poloxamer scope and concentration

• Claim 2: poloxamer is poloxamer 188
• Claim 3: poloxamer at 1% w/v, 2% w/v, or 4% w/v

Practical effect: claim 1 covers any poloxamer; claims 2-3 tighten to poloxamer 188 at specific concentrations.

Sodium bicarbonate concentration narrowing

Claims 4–6 layer increasing specificity:

• Claim 4: sodium bicarbonate at 4.0%–20% w/v
• Claim 5: sodium bicarbonate at 10% w/v to 20% w/v
• Claim 6: sodium bicarbonate at 8.4% w/v

Note the structure: claim 6’s 8.4% is inside claim 4’s 4–20% window but not inside claim 5’s 10–20% range.

Simethicone emulsion level

• Claim 7: simethicone emulsion at 0.15% w/v

This is a classic “precision lock” claim. If an accused product uses a different simethicone level, claim 7 may not be met, but claim 1 may still be asserted if claim 1’s broader language is satisfied and the dependent claim is not required.

Preservative identity and concentration

• Claim 8: preservative comprises one of many listed actives (including benzyl alcohol, ascorbic acid, parabens, sodium benzoate, metabisulfite, BHA/BHT, etc.) or combinations
• Claim 9: preservative is benzyl alcohol
• Claim 10: benzyl alcohol about 0.5% w/v
• Claim 11: preservative is a paraben or mixture of parabens

This provides both “either/or” breadth (claim 8) and narrow handles (benzyl alcohol at ~0.5% and paraben systems).

Sweetener package

• Claim 12: diluent comprises sweetener; sweetener comprises:
  • 70% sorbitol solution and sucralose
• Claim 13: 70% sorbitol solution at 2.5% w/v and sucralose at 0.4% w/v

These are highly specific and likely track a concrete product formulation rather than a general class concept.

Temperature stability tightening

• Claim 14: stable for at least 30 days at 25±5°C

This expands the functional requirement from refrigerated stability to room-temperature stability, creating additional infringement/testing touchpoints.

Absence of co-solvents

• Claim 20: diluent “does not comprise any co-solvents.”

This is another design-around “hard boundary.” It may overlap with functional excipient choices (e.g., ethanol, propylene glycol) that could be used to solubilize other ingredients in diluent systems.

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How claim 15 expands into product claims with specific PPIs?

Pharmaceutical composition claim (claim 15)

• A “pharmaceutical composition” comprising:
  • the freeze-thaw stable liquid diluent of claim 1, and
  • a PPI selected from:
    • omeprazole
    • esomeprazole
    • lansoprazole
    • rabeprazole
    • pantoprazole
    • dexlansoprazole

Further PPI narrowing

• Claim 16: PPI is lansoprazole
• Claim 17: PPI is omeprazole
• Claim 18: omeprazole at 2 mg/mL

Claim 15 matters for licensing and dispute scoping because it captures the pairing of the diluent with the drug substance used in compositions. Even if an infringer uses the same PPI but a different diluent, or vice versa, claim coverage may depend on whether the accused “composition” includes the claimed diluent as claimed in claim 1.

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What does the viscosity requirement (claim 19) do for scope and proof?

• Claim 19: viscosity between 50 and 300 mPa·s measured with:
  • Brookfield Model LVT viscometer
  • #2 spindle at 30 RPM
  • 25±1°C

This is an operational characterization requirement that helps distinguish the claimed diluent from formulations that are freeze-thaw stable but differ in rheology. It also supplies a relatively concrete method for testing and expert analysis.

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What patents are likely in the landscape around this one: how to map “freeze-thaw diluents,” “PPIs reconstitution,” and “poloxamer/xanthan/glycerin exclusions”?

Because the only information provided is the claim text and the patent number, a full landscape cannot be completed to the level required for actionable freedom-to-operate or enforcement planning (e.g., listing specific family members, prosecution history, examiner citations, co-pending applications, or Orange Book ties). Under the constraints, no landscape is produced.

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Key claim scope implications for generic and biosimilar risk (US regulatory posture)

Is this a drug-substance patent or a formulation/diluent patent?

• It is a formulation/diluent patent (excipients, buffers, emulsions, stabilizers, rheology, storage stability).
• The inclusion of a “pharmaceutical composition” pairing with PPIs extends claim coverage to the combination product, but the inventive content is the diluent.

Paragraph IV and generic entry risk framing

For generic entry, the risk is typically tied to:

• whether the generic’s reconstitution diluent matches the claimed excipient package and exclusions
• whether the generic’s stability/gelation performance at the specified conditions satisfies the functional limitations

A generic that launches with the same PPI but uses a different diluent is a litigation design choice; claim 15 may still be asserted if the diluent is within claim 1.

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How strong are the claims as written: litigation-friendly anchors vs broad functional terms?

Litigation-friendly anchors

• Exact ingredient exclusions (glycerin, xanthan gum)
• Specific ingredient identities:
  • poloxamer 188 (dependent)
  • simethicone emulsion level (0.15% w/v)
  • benzyl alcohol (~0.5% w/v) and optional paraben systems
• Concentration windows for bicarbonate
• Viscosity measurement parameters

These elements reduce interpretive ambiguity compared with purely functional claims.

Litigation-sensitive anchors

• “Resistant to gel formation for at least one freeze-thaw cycle”
• “Stable for at least 30 days at 5±3°C”
• “Stable for at least 30 days at 25±5°C” (dependent)

These drive expert work, protocol matching, and disputes about what constitutes “gel formation” and what freeze-thaw cycle conditions were used.

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Design-around and invalidity angles implied by claim structure (without asserting outcome)

Design-around opportunities suggested by claim wording

• Remove or replace prohibited excipients:
  • eliminate glycerin and xanthan gum
• Avoid the exact anchored excipient package quantities:
  • use different simethicone emulsion levels
  • adjust sodium bicarbonate to outside cited ranges or different buffer chemistry
• Alter rheology:
  • move viscosity outside 50–300 mPa·s (if claim 19 is asserted)
• Change preservative system:
  • select a preservative not covered by claim 8 or use a system that changes measured functional stability profile

Invalidity angles suggested by claim structure

• The claim is built on common excipient classes:
  • poloxamers (gelation control and surfactant/stabilization)
  • CMC or microcrystalline cellulose suspending/thickening
  • bicarbonate buffering
  • simethicone anti-foaming properties
  • standard preservative systems Prior art may exist that discloses freeze-thaw stability in buffered aqueous systems, but a full invalidity assessment requires actual prior art citations and claim construction context, which is not provided.

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Key Takeaways

• US 12,440,566 is a freeze-thaw stable liquid diluent patent centered on a defined excipient package for PPI reconstitution, with explicit exclusions of glycerin and xanthan gum.
• The independent claim requires (1) ≥30 days stability at 5±3°C and (2) resistance to gel formation for at least one freeze-thaw cycle, alongside a mandatory set including poloxamer, CMC or microcrystalline cellulose, sodium bicarbonate, simethicone emulsion, preservative, and water.
• Dependent claims lock in specific embodiments: poloxamer 188, bicarbonate concentration ranges and exact 8.4%, simethicone at 0.15%, benzyl alcohol at ~0.5%, and specific sweetener composition plus viscosity and no co-solvents limits.
• Claim 15 expands to a pharmaceutical composition by pairing the claimed diluent with major PPIs, including omeprazole and lansoprazole, with a further example concentration omeprazole 2 mg/mL.
• For enforcement and design-around, the strongest practical choke points are the excluded excipients and the functional freeze-thaw/gelation and stability requirements, supplemented by the anchored quantitative formulation elements.

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FAQs

1. How do “freeze-thaw resistant to gel formation” requirements affect infringement testing for US 12,440,566?
2. What parts of the claim are most relevant if a competitor uses a different poloxamer grade or different poloxamer concentration?
3. Does claim coverage shift materially between claim 1 (broad) and claim 7/10/13/18 (narrow quantitative embodiments)?
4. How do the “no glycerin/no xanthan gum” and “no co-solvents” constraints guide formulation design-around?
5. If a product pairs the diluent with omeprazole at 2 mg/mL, which claim(s) are implicated most directly?

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References

No sources were provided or cited.

Drugs Protected by US Patent 12,440,566

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	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes			Y

International Family Members for US Patent 12,440,566

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3147586
China	114761002
European Patent Office	3999066