Scope and Claims Breakdown of US Patent 12,329,752 (Proton Pump Inhibitor Oral Liquid Suspension)

US Drug Patent 12,329,752 claims an oral liquid suspension for a proton pump inhibitor (PPI) with a tightly specified formulation system: poloxamer-based suspension stability, specific suspending-agent systems (CMC ± microcrystalline cellulose), high % acid-neutralizing agent, a defined defoamer, a defined preservative band, and a stability requirement (homogeneous and stable at ambient and refrigerated conditions for at least 30 days). Independent claim 1 also recites optional buffers and excipients (sweetener/color/flavor), and dependent claims narrow to specific PPIs and quantitative embodiments, including omeprazole ~2 mg/mL and poloxamer 188.

What does US Patent 12,329,752 claim for an oral liquid proton pump inhibitor suspension?

Answer (core claim 1 structure): The patent claims an oral liquid suspension of a PPI that “consists essentially of” a defined PPI plus a specific set of excipients in defined concentration ranges, including:

Poloxamer: 1.0% to 4.0% w/v
Suspending agent: 0.5% to 5% w/v, defined as either:
- (i) sodium CMC, or
- (ii) sodium CMC + microcrystalline cellulose
Acid neutralizing agent: 8.0% to 8.8% w/v
Defoamer: 0.1% to 0.3% w/v
Preservative: 0.2% to 1.2% w/v
Water
Optional buffer pH 8 to 9.5
Optional sweetener/color/flavor
Performance: homogeneous and stable for at least 30 days at both ambient and refrigerated conditions
Route/use: formulated for oral administration to a human subject

Claim 1 “consisting essentially of” implications

“Consisting essentially of” generally preserves coverage for the recited ingredients while allowing additional components that do not materially affect the basic and novel characteristics. Here, the “basic characteristics” appear to be:

the specific suspension architecture (poloxamer + CMC ± microcrystalline cellulose),
the alkalinizing/neutralizing system (8.0% to 8.8% acid neutralizer, optional buffer maintaining pH 8 to 9.5),
the stability envelope for 30 days under ambient and refrigerated storage.

This means design-arounds that remove one of these pillars are likely to fall outside claim scope, while “minor” excipient additions may still infringe if they do not materially change suspension stability/homogeneity, pH behavior, or compatibility.

Which excipient ranges and functional elements define the formulation scope of US 12,329,752?

Answer: Claim 1 is defined by interlocking concentration ranges and functional roles:

Poloxamer suspension system (1.0% to 4.0% w/v)

Poloxamer is required at 1.0%–4.0% w/v
Dependent claim 4 narrows poloxamer identity by molecular characteristics (below)

Business/IP relevance: Poloxamers are thermoreversible surfactants used to prevent caking/aggregation in suspensions. By fixing a concentration range, the claim blocks low-dosage poloxamer systems and very high poloxamer systems that change rheology/phase behavior.

Suspensing agent identity and band (0.5% to 5% w/v)

Claim 1 requires a suspending agent in 0.5%–5% w/v, restricted to:

sodium carboxymethylcellulose (CMC), or
sodium CMC + microcrystalline cellulose

Dependent claims narrow composition and amount:

Claim 6: sodium CMC at 1.0%–2.0% w/v
Claim 7: combination of sodium CMC + microcrystalline cellulose
Claim 8: combination present at about 4.0% w/v total in the liquid diluent

Claim construction pressure point: “Suspending agent” is constrained to these materials (CMC and optionally microcrystalline cellulose). A formulation using different suspension polymers (e.g., HPMC, xanthan gum, alginates) would likely avoid claim 1 unless they are argued to satisfy “suspending agent is (i) CMC or (ii) CMC + microcrystalline cellulose.”

Acid neutralizing agent (8.0% to 8.8% w/v)

This is a major numerical handle. The formulation has a strong alkali/neutralization component at 8.0%–8.8% w/v.

Dependent claim 17: specifically recites sodium bicarbonate as the acid neutralizing agent.

Commercial/IP relevance: Many PPI liquid formulations rely on acid stabilization or protective buffering. Here, the claim explicitly builds a high neutralizing/alkalinizing system and optionally buffer pH 8–9.5, indicating a deliberate chemical microenvironment designed for stability.

Defoamer (0.1% to 0.3% w/v)

Requires a defoamer at 0.1%–0.3%
Claim 13: defoamer is simethicone emulsion

Preservative (0.2% to 1.2% w/v)

Requires preservative at 0.2%–1.2% w/v
Claim 9: preservative chosen from a defined list (benzyl alcohol, paraben family, salts of benzoic acids, sulfites, etc.)
Claims 10–11: benzyl alcohol at about 0.4% to about 0.6% w/v

Optional buffer pH 8 to 9.5

Optional buffer maintaining pH 8 to 9.5
Claims 15–16: specific buffer families and examples:
- citrate, tartrate, acetate, carbonate, phosphate, etc.
- sodium citrate and sodium bicarbonate, individually or combined

Interlock with neutralizer: If sodium bicarbonate is both the “acid neutralizing agent” and also part of the buffer system, accused formulations must match the quantitative and functional roles.

How do the dependent claims narrow US 12,329,752 beyond the independent claim?

Answer: Dependent claims target specific PPIs, quantitative embodiments, poloxamer specification, excipient identity, and specific preservatives/sweeteners.

PPI identity and dose embodiments

Claim 2: PPI is omeprazole or lansoprazole
Claim 3: if omeprazole, present at about 2 mg/mL

Poloxamer identity by molecular characteristics

Claim 4: poloxamer has:
- number average molecular weight ~7000–10,000 Da
- ethylene glycol content ~80 wt%–85 wt%
Claim 5: poloxamer is poloxamer 188

Practical meaning: Claim 4 captures poloxamer grades meeting the defined Mw and ethylene glycol content, while claim 5 provides a clean literal fallback to “Poloxamer 188.”

Sodium CMC amount and combined suspending system

Claim 6: sodium CMC at 1.0%–2.0% w/v
Claim 7: CMC + microcrystalline cellulose
Claim 8: combination at about 4.0% w/v

Preservative embodiments

Claim 9: preservative is selected from the enumerated group
Claim 10: preservative is benzyl alcohol
Claim 11: benzyl alcohol at ~0.4% to ~0.6% w/v

Defoamer embodiment

Claim 13: simethicone emulsion defoamer

Sweeteners

Claim 12: recites a broad sweetener list (sugar and sugar alcohols plus intense sweeteners), including sucralose, aspartame, neotame, saccharin salts, etc.

Buffer and pH

Claims 14–16: buffer optional and family restrictions; examples include sodium citrate and sodium bicarbonate.

Neutralizing agent

Claim 17: acid neutralizing agent is sodium bicarbonate

What is the likely scope boundary for infringement under “homogeneous and stable for at least 30 days”?

Answer: Claim 1 includes an objective performance limitation. It requires:

oral liquid suspension remains homogeneous
and stable for at least 30 days under:
- ambient conditions
- refrigerated temperature conditions

From an enforcement standpoint, this is a strong limitation for formulation-by-formulation comparisons:

A generic or licensed formulation could match excipient identities/ranges yet fail if it does not maintain homogeneity/stability over the specified time windows.
Conversely, a competitor might argue stability failure to avoid literal infringement, though doctrine of equivalents exposure depends on claim construction and factual record.

For litigation strategy, this performance clause creates a data-driven battleground for:

physical appearance/homogeneity criteria
particle size/settlement behavior
chemical stability of PPI in the matrix under storage conditions

Which design-arounds are most likely to avoid coverage of US 12,329,752?

Answer: The tightest avoidance routes are to break at least one of the core claim pillars:

Remove or change the required suspending-agent system
- Avoid using sodium CMC as the (required) suspending agent, or avoid “CMC + microcrystalline cellulose” when CMC is present.
Change the poloxamer component
- Stay outside 1.0%–4.0% w/v or use a different surfactant system not captured by “poloxamer.”
Change the acid neutralizing agent concentration
- Avoid 8.0%–8.8% w/v, and/or avoid sodium bicarbonate if claim 17 is asserted.
Change the preservative selection or concentration
- Avoid the listed preservative set, and/or avoid 0.2%–1.2% w/v or the benzyl alcohol band 0.4%–0.6% w/v.
Defoamer substitution
- Avoid 0.1%–0.3% w/v, and/or avoid simethicone emulsion if claim 13 is asserted.
Avoid the pH/alkalinizing regime
- If the buffer is included, avoid maintaining pH 8–9.5. This is optional in claim 1, but buffer-dependent claims 14–16 and chemistry arguments may matter.
Fail the homogeneity/stability performance
- Ensure the formulation does not qualify as “homogeneous and stable for at least 30 days at ambient and refrigerated conditions.”

How does this patent compare with typical PPI liquid suspension IP patterns?

Answer: This patent is unusually explicit on excipients by identity and concentration bands plus a quantified stability/homogeneity requirement. Many PPI liquid patents focus on:

protecting acid-labile PPIs (e.g., enteric coating, stabilized salts, buffered microenvironments)
taste masking
manufacturing methods (freeze-thaw, milling, homogenization, particle size)

Here, the “IP lever” is the formula matrix: poloxamer + CMC (± microcrystalline cellulose) + high % sodium bicarbonate (or equivalent neutralizer) + defined defoamer/preservative with a 30-day stability performance condition.

What U.S. regulatory and “Orange Book” positioning would this formulation patent be tied to?

Answer: The claim language is drafted to align with an FDA drug product (oral liquid suspension) and typical listing mechanics where formulation patents are submitted as method-of-use and/or drug product formulation patents. The patent’s direct claim to the “oral liquid suspension” indicates it is likely intended for Orange Book listing as a drug product/formulation patent, not a method-of-use-only patent.

However, the user-provided content does not include:

the listed drug name linked to US 12,329,752
the application/Reference Listed Drug (RLD)
the Orange Book code (e.g., “drug substance,” “drug product,” “method of use”)

Because those facts are not included, no definitive Orange Book status, reference product linkage, or FDA submission timing can be stated here.

What generic entry risks exist for an omeprazole or lansoprazole oral liquid suspension?

Answer: The key litigation/entry risk for potential generic challengers is that the claim 1 formulation is narrow enough to require very close excipient-matching:

poloxamer at 1.0%–4.0%
suspending agent limited to CMC or CMC + microcrystalline cellulose at 0.5%–5%
acid neutralizing agent at 8.0%–8.8% (sodium bicarbonate likely for dependent embodiments)
preservative within 0.2%–1.2% with a benzyl alcohol band fallback
simethicone defoamer (if dependent claim 13 is asserted)
30-day ambient + refrigerated homogeneity and stability

A generic challenger would likely assess exposure in tiers:

Tier 1: Does the product literally match the required excipient system and ranges?
Tier 2: If not, is there potential doctrine-of-equivalents coverage for the excluded excipients?
Tier 3: Does the product fail the 30-day stability/homogeneity requirement in objective testing?

Key Takeaways

US 12,329,752 claims a specific PPI oral liquid suspension formula with hard-edged concentration ranges for poloxamer, CMC-based suspending agent, high % acid neutralizing agent, defoamer, and preservative.
The independent claim’s scope is driven by the “consisting essentially of” formulation core plus an objective performance limitation: homogeneous and stable for at least 30 days at both ambient and refrigerated conditions.
Dependent claims lock in major commercial design points: omeprazole at ~2 mg/mL, poloxamer 188, sodium CMC bands, benzyl alcohol at ~0.4%–0.6%, and simethicone emulsion.
Design-around leverage is strongest where it breaks one of the locked pillars: CMC/CMC+microcrystalline cellulose, poloxamer concentration/identity, 8.0%–8.8% neutralizer, preservative selection, or the 30-day stability/homogeneity criteria.

FAQs

1) Does US 12,329,752 cover omeprazole and lansoprazole oral liquid suspensions?

Yes. Claim 2 limits the PPI to omeprazole or lansoprazole, and claim 3 further specifies an omeprazole embodiment at about 2 mg/mL.

2) What excipient choices are allowed for the suspending agent in claim 1?

Only sodium CMC or sodium CMC combined with microcrystalline cellulose, at 0.5% to 5% w/v.

3) What is the critical range for the acid neutralizing agent?

Claim 1 requires 8.0% to 8.8% w/v. Claim 17 specifies sodium bicarbonate as the acid neutralizing agent.

4) Which preservatives are covered, and is benzyl alcohol specifically claimed?

Claim 9 lists multiple preservatives; claim 10 specifies benzyl alcohol, with claim 11 limiting it to ~0.4% to ~0.6% w/v.

5) Is buffer required, and what pH range does the patent target?

Buffer is optional in claim 1, but where present the buffer maintains pH 8 to 9.5 (claims 14–16).

References (APA)

No external sources were provided or cited in the prompt beyond the claim text itself.

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:	US17/463,258
Patent Claim Types: see list of patent claims	Compound;
Patent landscape, scope, and claims:	Scope and Claims Breakdown of US Patent 12,329,752 (Proton Pump Inhibitor Oral Liquid Suspension) US Drug Patent 12,329,752 claims an oral liquid suspension for a proton pump inhibitor (PPI) with a tightly specified formulation system: poloxamer-based suspension stability, specific suspending-agent systems (CMC ± microcrystalline cellulose), high % acid-neutralizing agent, a defined defoamer, a defined preservative band, and a stability requirement (homogeneous and stable at ambient and refrigerated conditions for at least 30 days). Independent claim 1 also recites optional buffers and excipients (sweetener/color/flavor), and dependent claims narrow to specific PPIs and quantitative embodiments, including omeprazole ~2 mg/mL and poloxamer 188. What does US Patent 12,329,752 claim for an oral liquid proton pump inhibitor suspension? Answer (core claim 1 structure): The patent claims an oral liquid suspension of a PPI that “consists essentially of” a defined PPI plus a specific set of excipients in defined concentration ranges, including: Poloxamer: 1.0% to 4.0% w/v Suspending agent: 0.5% to 5% w/v, defined as either: (i) sodium CMC, or (ii) sodium CMC + microcrystalline cellulose Acid neutralizing agent: 8.0% to 8.8% w/v Defoamer: 0.1% to 0.3% w/v Preservative: 0.2% to 1.2% w/v Water Optional buffer pH 8 to 9.5 Optional sweetener/color/flavor Performance: homogeneous and stable for at least 30 days at both ambient and refrigerated conditions Route/use: formulated for oral administration to a human subject Claim 1 “consisting essentially of” implications “Consisting essentially of” generally preserves coverage for the recited ingredients while allowing additional components that do not materially affect the basic and novel characteristics. Here, the “basic characteristics” appear to be: the specific suspension architecture (poloxamer + CMC ± microcrystalline cellulose), the alkalinizing/neutralizing system (8.0% to 8.8% acid neutralizer, optional buffer maintaining pH 8 to 9.5), the stability envelope for 30 days under ambient and refrigerated storage. This means design-arounds that remove one of these pillars are likely to fall outside claim scope, while “minor” excipient additions may still infringe if they do not materially change suspension stability/homogeneity, pH behavior, or compatibility. Which excipient ranges and functional elements define the formulation scope of US 12,329,752? Answer: Claim 1 is defined by interlocking concentration ranges and functional roles: Poloxamer suspension system (1.0% to 4.0% w/v) Poloxamer is required at 1.0%–4.0% w/v Dependent claim 4 narrows poloxamer identity by molecular characteristics (below) Business/IP relevance: Poloxamers are thermoreversible surfactants used to prevent caking/aggregation in suspensions. By fixing a concentration range, the claim blocks low-dosage poloxamer systems and very high poloxamer systems that change rheology/phase behavior. Suspensing agent identity and band (0.5% to 5% w/v) Claim 1 requires a suspending agent in 0.5%–5% w/v, restricted to: sodium carboxymethylcellulose (CMC), or sodium CMC + microcrystalline cellulose Dependent claims narrow composition and amount: Claim 6: sodium CMC at 1.0%–2.0% w/v Claim 7: combination of sodium CMC + microcrystalline cellulose Claim 8: combination present at about 4.0% w/v total in the liquid diluent Claim construction pressure point: “Suspending agent” is constrained to these materials (CMC and optionally microcrystalline cellulose). A formulation using different suspension polymers (e.g., HPMC, xanthan gum, alginates) would likely avoid claim 1 unless they are argued to satisfy “suspending agent is (i) CMC or (ii) CMC + microcrystalline cellulose.” Acid neutralizing agent (8.0% to 8.8% w/v) This is a major numerical handle. The formulation has a strong alkali/neutralization component at 8.0%–8.8% w/v. Dependent claim 17: specifically recites sodium bicarbonate as the acid neutralizing agent. Commercial/IP relevance: Many PPI liquid formulations rely on acid stabilization or protective buffering. Here, the claim explicitly builds a high neutralizing/alkalinizing system and optionally buffer pH 8–9.5, indicating a deliberate chemical microenvironment designed for stability. Defoamer (0.1% to 0.3% w/v) Requires a defoamer at 0.1%–0.3% Claim 13: defoamer is simethicone emulsion Preservative (0.2% to 1.2% w/v) Requires preservative at 0.2%–1.2% w/v Claim 9: preservative chosen from a defined list (benzyl alcohol, paraben family, salts of benzoic acids, sulfites, etc.) Claims 10–11: benzyl alcohol at about 0.4% to about 0.6% w/v Optional buffer pH 8 to 9.5 Optional buffer maintaining pH 8 to 9.5 Claims 15–16: specific buffer families and examples: citrate, tartrate, acetate, carbonate, phosphate, etc. sodium citrate and sodium bicarbonate, individually or combined Interlock with neutralizer: If sodium bicarbonate is both the “acid neutralizing agent” and also part of the buffer system, accused formulations must match the quantitative and functional roles. How do the dependent claims narrow US 12,329,752 beyond the independent claim? Answer: Dependent claims target specific PPIs, quantitative embodiments, poloxamer specification, excipient identity, and specific preservatives/sweeteners. PPI identity and dose embodiments Claim 2: PPI is omeprazole or lansoprazole Claim 3: if omeprazole, present at about 2 mg/mL Poloxamer identity by molecular characteristics Claim 4: poloxamer has: number average molecular weight ~7000–10,000 Da ethylene glycol content ~80 wt%–85 wt% Claim 5: poloxamer is poloxamer 188 Practical meaning: Claim 4 captures poloxamer grades meeting the defined Mw and ethylene glycol content, while claim 5 provides a clean literal fallback to “Poloxamer 188.” Sodium CMC amount and combined suspending system Claim 6: sodium CMC at 1.0%–2.0% w/v Claim 7: CMC + microcrystalline cellulose Claim 8: combination at about 4.0% w/v Preservative embodiments Claim 9: preservative is selected from the enumerated group Claim 10: preservative is benzyl alcohol Claim 11: benzyl alcohol at ~0.4% to ~0.6% w/v Defoamer embodiment Claim 13: simethicone emulsion defoamer Sweeteners Claim 12: recites a broad sweetener list (sugar and sugar alcohols plus intense sweeteners), including sucralose, aspartame, neotame, saccharin salts, etc. Buffer and pH Claims 14–16: buffer optional and family restrictions; examples include sodium citrate and sodium bicarbonate. Neutralizing agent Claim 17: acid neutralizing agent is sodium bicarbonate What is the likely scope boundary for infringement under “homogeneous and stable for at least 30 days”? Answer: Claim 1 includes an objective performance limitation. It requires: oral liquid suspension remains homogeneous and stable for at least 30 days under: ambient conditions refrigerated temperature conditions From an enforcement standpoint, this is a strong limitation for formulation-by-formulation comparisons: A generic or licensed formulation could match excipient identities/ranges yet fail if it does not maintain homogeneity/stability over the specified time windows. Conversely, a competitor might argue stability failure to avoid literal infringement, though doctrine of equivalents exposure depends on claim construction and factual record. For litigation strategy, this performance clause creates a data-driven battleground for: physical appearance/homogeneity criteria particle size/settlement behavior chemical stability of PPI in the matrix under storage conditions Which design-arounds are most likely to avoid coverage of US 12,329,752? Answer: The tightest avoidance routes are to break at least one of the core claim pillars: Remove or change the required suspending-agent system Avoid using sodium CMC as the (required) suspending agent, or avoid “CMC + microcrystalline cellulose” when CMC is present. Change the poloxamer component Stay outside 1.0%–4.0% w/v or use a different surfactant system not captured by “poloxamer.” Change the acid neutralizing agent concentration Avoid 8.0%–8.8% w/v, and/or avoid sodium bicarbonate if claim 17 is asserted. Change the preservative selection or concentration Avoid the listed preservative set, and/or avoid 0.2%–1.2% w/v or the benzyl alcohol band 0.4%–0.6% w/v. Defoamer substitution Avoid 0.1%–0.3% w/v, and/or avoid simethicone emulsion if claim 13 is asserted. Avoid the pH/alkalinizing regime If the buffer is included, avoid maintaining pH 8–9.5. This is optional in claim 1, but buffer-dependent claims 14–16 and chemistry arguments may matter. Fail the homogeneity/stability performance Ensure the formulation does not qualify as “homogeneous and stable for at least 30 days at ambient and refrigerated conditions.” How does this patent compare with typical PPI liquid suspension IP patterns? Answer: This patent is unusually explicit on excipients by identity and concentration bands plus a quantified stability/homogeneity requirement. Many PPI liquid patents focus on: protecting acid-labile PPIs (e.g., enteric coating, stabilized salts, buffered microenvironments) taste masking manufacturing methods (freeze-thaw, milling, homogenization, particle size) Here, the “IP lever” is the formula matrix: poloxamer + CMC (± microcrystalline cellulose) + high % sodium bicarbonate (or equivalent neutralizer) + defined defoamer/preservative with a 30-day stability performance condition. What U.S. regulatory and “Orange Book” positioning would this formulation patent be tied to? Answer: The claim language is drafted to align with an FDA drug product (oral liquid suspension) and typical listing mechanics where formulation patents are submitted as method-of-use and/or drug product formulation patents. The patent’s direct claim to the “oral liquid suspension” indicates it is likely intended for Orange Book listing as a drug product/formulation patent, not a method-of-use-only patent. However, the user-provided content does not include: the listed drug name linked to US 12,329,752 the application/Reference Listed Drug (RLD) the Orange Book code (e.g., “drug substance,” “drug product,” “method of use”) Because those facts are not included, no definitive Orange Book status, reference product linkage, or FDA submission timing can be stated here. What generic entry risks exist for an omeprazole or lansoprazole oral liquid suspension? Answer: The key litigation/entry risk for potential generic challengers is that the claim 1 formulation is narrow enough to require very close excipient-matching: poloxamer at 1.0%–4.0% suspending agent limited to CMC or CMC + microcrystalline cellulose at 0.5%–5% acid neutralizing agent at 8.0%–8.8% (sodium bicarbonate likely for dependent embodiments) preservative within 0.2%–1.2% with a benzyl alcohol band fallback simethicone defoamer (if dependent claim 13 is asserted) 30-day ambient + refrigerated homogeneity and stability A generic challenger would likely assess exposure in tiers: Tier 1: Does the product literally match the required excipient system and ranges? Tier 2: If not, is there potential doctrine-of-equivalents coverage for the excluded excipients? Tier 3: Does the product fail the 30-day stability/homogeneity requirement in objective testing? Key Takeaways US 12,329,752 claims a specific PPI oral liquid suspension formula with hard-edged concentration ranges for poloxamer, CMC-based suspending agent, high % acid neutralizing agent, defoamer, and preservative. The independent claim’s scope is driven by the “consisting essentially of” formulation core plus an objective performance limitation: homogeneous and stable for at least 30 days at both ambient and refrigerated conditions. Dependent claims lock in major commercial design points: omeprazole at ~2 mg/mL, poloxamer 188, sodium CMC bands, benzyl alcohol at ~0.4%–0.6%, and simethicone emulsion. Design-around leverage is strongest where it breaks one of the locked pillars: CMC/CMC+microcrystalline cellulose, poloxamer concentration/identity, 8.0%–8.8% neutralizer, preservative selection, or the 30-day stability/homogeneity criteria. FAQs 1) Does US 12,329,752 cover omeprazole and lansoprazole oral liquid suspensions? Yes. Claim 2 limits the PPI to omeprazole or lansoprazole, and claim 3 further specifies an omeprazole embodiment at about 2 mg/mL. 2) What excipient choices are allowed for the suspending agent in claim 1? Only sodium CMC or sodium CMC combined with microcrystalline cellulose, at 0.5% to 5% w/v. 3) What is the critical range for the acid neutralizing agent? Claim 1 requires 8.0% to 8.8% w/v. Claim 17 specifies sodium bicarbonate as the acid neutralizing agent. 4) Which preservatives are covered, and is benzyl alcohol specifically claimed? Claim 9 lists multiple preservatives; claim 10 specifies benzyl alcohol, with claim 11 limiting it to ~0.4% to ~0.6% w/v. 5) Is buffer required, and what pH range does the patent target? Buffer is optional in claim 1, but where present the buffer maintains pH 8 to 9.5 (claims 14–16). References (APA) No external sources were provided or cited in the prompt beyond the claim text itself. 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	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	12,329,752	⤷ 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

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3147586	⤷ Start Trial
China	114761002	⤷ Start Trial
European Patent Office	3999066	⤷ Start Trial
Mexico	2022000623	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,329,752

Which drugs does patent 12,329,752 protect, and when does it expire?

Summary for Patent: 12,329,752