US Patent 11,103,492: Scope, Claims, Expiration, Orange Book Status, and PPI Formulation Patent Landscape

US Patent 11,103,492 protects a specific liquid diluent platform for reconstituting proton pump inhibitors, particularly omeprazole and lansoprazole. The core combination requires poloxamer, sodium carboxymethylcellulose or sodium carboxymethylcellulose/microcrystalline cellulose, an acid-neutralizing agent, a defoamer, a preservative, water, and defined storage-performance characteristics. The patent does not broadly claim every liquid PPI suspension, every omeprazole formulation, or the PPI active ingredient itself.

The strongest infringement position is against a product that uses poloxamer 188, sodium bicarbonate, sodium carboxymethylcellulose, simethicone, and benzyl alcohol within the claimed concentration ranges and demonstrates the claimed refrigerated stability and freeze-thaw resistance.

What does US Patent 11,103,492 cover?

The patent covers a liquid diluent used to reconstitute a PPI suspension. Independent claim 1 is the controlling claim. Claims 2 through 19 narrow the formulation by specifying excipients, concentrations, buffers, preservatives, and the PPI.

Claim 1: the principal formulation claim

Claim 1 requires all of the following:

Required element	Claimed limitation
Poloxamer	1.0%-4.0% w/v
Suspending agent	1.0%-5.0% w/v
Suspending agent identity	Sodium CMC, or sodium CMC plus microcrystalline cellulose
Acid-neutralizing agent	8.0%-8.8% w/v
Defoamer	0.1%-0.3% w/v
Preservative	0.2%-1.2% w/v
Vehicle	Water
Buffer	Optional; maintains pH 8-9.5
Other excipients	Sweetener, coloring agent, and flavoring agent are optional
Refrigerated stability	Stable for at least 30 days at 5 ± 3°C
Freeze-thaw performance	Resistant to gel formation for at least one freeze-thaw cycle

The claim uses “consisting essentially of.” That transitional phrase generally permits additional ingredients if they do not materially affect the basic and novel characteristics of the claimed formulation. In pharmaceutical litigation, the dispute would likely focus on whether an unlisted excipient materially changes the formulation’s relevant properties, including suspension behavior, stability, pH, reconstitution performance, or gel resistance.

A formulation that omits one required component generally falls outside literal infringement of claim 1. A formulation that includes every component but changes a concentration may still present doctrine-of-equivalents risk, depending on the magnitude and technical significance of the difference.

How do the dependent claims narrow the patent scope?

Claims 2 through 19 create narrower positions around commercially practical formulations.

Poloxamer limitations

Claims 2 through 4 narrow the poloxamer limitation:

Claim 2: number-average molecular weight of approximately 7,000-10,000 Da.
Claim 3: ethylene glycol content of approximately 80-85 wt%.
Claim 4: poloxamer 188 at 1%, 2%, or 4% w/v.

Poloxamer 188 is commercially important because it is a specific excipient rather than a generic reference to any poloxamer. A product using poloxamer 188 at one of the stated concentrations may infringe claim 4 if the remaining claim 1 limitations are present.

A product using poloxamer 407, another grade of poloxamer 188, or a concentration outside the claim 1 range would require a separate analysis. The molecular-weight and ethylene-glycol limitations in claims 2 and 3 may create factual disputes involving supplier specifications, lot testing, and the applicable analytical method.

Suspending-agent limitations

Claims 5 through 7 cover two suspension systems:

Sodium CMC alone at 1.0%-2.0% w/v.
Sodium CMC combined with microcrystalline cellulose at approximately 4.0% w/v.

The claim does not cover every cellulose-based suspending system. Hydroxypropyl methylcellulose, hydroxypropyl cellulose, xanthan gum, carbomer, or sodium alginate would not literally satisfy the sodium CMC limitation unless another theory of infringement applies.

The combination of sodium CMC and microcrystalline cellulose is commercially significant because it provides a potential design-around target. A competitor may attempt to use another structured vehicle or a different cellulose blend, but it would need to preserve suspension uniformity and freeze-thaw performance.

Buffer and acid-neutralizing-agent limitations

Claims 9 through 12 address sodium bicarbonate and buffer systems.

Claim 9 identifies sodium bicarbonate as the acid-neutralizing agent.
Claim 10 requires that a buffer be present.
Claim 11 identifies sodium citrate, sodium bicarbonate, or both.
Claim 12 expands the buffer group to citrate, tartrate, acetate, carbonate, phosphate, metaphosphate, glycerophosphate, polyphosphate, and pyrophosphate systems.

The claim structure creates an important distinction between an acid-neutralizing agent and a buffer. Sodium bicarbonate may perform both functions, but a product’s formulation record and pH-control rationale would be relevant to claim construction and infringement analysis.

The pH range of 8-9.5 is expressly optional in claim 1 but becomes mandatory where the claim requires a buffer that maintains that pH. A product with a pH outside this range may avoid claims that depend on the buffer limitation, while potentially remaining within claim 1 if all other limitations are satisfied.

What formulations are protected by US 11,103,492?

The patent’s most commercially relevant protected formulation is a reconstitutable PPI diluent containing the following approximate profile:

Ingredient or property	Representative claimed profile
Poloxamer 188	1%, 2%, or 4% w/v
Sodium CMC	1%-2% w/v, or part of a 4% w/v CMC/MCC system
Sodium bicarbonate	8.0%-8.8% w/v
Simethicone emulsion	0.1%-0.3% w/v
Benzyl alcohol	0.4%-0.6% w/v
pH	8-9.5 where the buffer limitation applies
PPI	Omeprazole or lansoprazole
Stability	At least 30 days at refrigerated conditions
Freeze-thaw	Resistant to gel formation through at least one cycle

Claims 8, 14, 15, and 17 add optional flavoring, coloring, sweetening, and preservative alternatives. These claims have less value against a product that does not use those optional excipients because claim 1 does not require them.

Does the patent cover omeprazole and lansoprazole themselves?

No. Claims 18 and 19 identify omeprazole and lansoprazole as the PPI associated with the diluent. They do not claim the chemical compounds broadly.

The patent therefore does not prevent:

Manufacture of omeprazole API.
Manufacture of lansoprazole API.
Conventional omeprazole capsules or tablets.
Lansoprazole delayed-release capsules using a different delivery system.
A PPI formulation that does not use the claimed diluent architecture.

The commercial relevance is narrower: a competing liquid omeprazole or lansoprazole product may face risk if its diluent meets the composition and performance limitations.

How strong is the patent estate based on the claim structure?

The patent has moderate formulation-specific strength and limited platform breadth.

Strengths

The patent combines structural and functional limitations. A competitor must avoid both the specified excipient architecture and the stability performance. The formulation also uses narrow numerical ranges for the acid-neutralizing agent, defoamer, and preservative.

The stability limitations may strengthen validity if the specification demonstrates that the claimed combination solves a recognized formulation problem. A claimed result such as freeze-thaw gel resistance can be limiting when the claim language requires that result, although enforceability depends on how the test is defined and reproduced.

The dependent claims provide commercial fallback positions around poloxamer 188, sodium CMC, microcrystalline cellulose, sodium bicarbonate, simethicone, and benzyl alcohol.

Weaknesses

Many individual ingredients are conventional pharmaceutical excipients. Poloxamers, sodium CMC, microcrystalline cellulose, sodium bicarbonate, simethicone, benzyl alcohol, sweeteners, buffers, and preservatives are all familiar formulation materials.

The principal validity issue would likely be obviousness based on a combination of prior-art PPI suspensions, alkaline bicarbonate vehicles, and conventional suspension or stabilization systems. The patent’s strongest defense would be evidence that the particular concentration ranges and combination produce an unexpected result, especially resistance to gel formation after freeze-thaw exposure.

The claim also contains terms that may require technical interpretation:

“Stable for at least 30 days.”
“Resistant to gel formation.”
“At least one freeze-thaw cycle.”
“Consisting essentially of.”
“About” the stated concentrations and molecular weights.

A patent challenger would likely examine the specification’s testing protocols, acceptance criteria, number of cycles, temperatures, thaw duration, and analytical methods.

What is the likely patent expiration date?

The expiration date cannot be determined reliably from the patent number and claim text alone. US utility patents generally expire 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and relevant priority claims under 35 U.S.C. §154 and §156.[2]

The issue date, August 31, 2021, does not establish the expiration date. A definitive term analysis requires the patent’s continuity data, earliest effective filing date, patent-term-adjustment certificate, and any terminal disclaimer. The patent’s USPTO Patent Center record is the controlling source for those calculations.[1]

A commercial freedom-to-operate review should therefore use the official term data rather than an expiration date inferred from the issue date.

What is the Orange Book status of US 11,103,492?

A patent number is not automatically an Orange Book-listed patent. Listing depends on the approved NDA holder submitting the patent for an eligible drug product and the FDA accepting it under the listing requirements in 21 C.F.R. §314.53.[3]

For a liquid omeprazole or lansoprazole product, the relevant questions are:

Orange Book issue	Relevance
Approved NDA	Identifies the covered commercial product
Patent submission	Shows whether the NDA holder submitted US 11,103,492
Patent type	Determines whether the patent is eligible for listing
Expiration date	Controls the listed protection period
Use code	Matters if the patent is listed as method-of-use protection
Delisting or correction history	May affect reliance on the listing

Because US 11,103,492 is directed to a diluent formulation, its listing status cannot be assumed from the claims. The FDA Orange Book must be checked by NDA and patent number. If listed, an ANDA applicant may be required to make a Paragraph IV certification if it seeks approval before the listed patent expires.[4]

What Paragraph IV challenges could arise?

A Paragraph IV challenge would likely attack one or more of the following:

Anticipation

The challenger would need a single prior-art reference disclosing every limitation of the asserted claim, including the required concentration ranges and the stability and freeze-thaw limitations.

A reference disclosing a liquid PPI suspension with sodium bicarbonate would not necessarily anticipate claim 1 if it lacks poloxamer, the specified suspending agent, the defoamer, the preservative range, or the claimed performance characteristics.

Obviousness

Obviousness is the more likely challenge. The analysis would combine references concerning:

Alkaline PPI vehicles.
Sodium bicarbonate buffering or acid neutralization.
Poloxamer-based suspension systems.
Cellulose suspension agents.
Simethicone or other defoamers.
Preservative systems.
Refrigerated storage.
Freeze-thaw stability.

The patent owner would likely rely on unexpected results, criticality of the concentration ranges, and evidence that routine formulation experimentation did not predict the claimed gel resistance.

Written description and enablement

The breadth of the Markush excipient groups may invite written-description and enablement arguments. The question would be whether the specification supports the full range of poloxamers, buffers, preservatives, sweeteners, and suspension systems without undue experimentation.

The claims covering both omeprazole and lansoprazole could also be tested against the data in the specification. If the examples concentrate on one PPI, a challenger may argue that the disclosure does not adequately support the full scope.

Which companies could challenge or design around the patent?

Potential challengers would include manufacturers of liquid or reconstitutable PPI products, generic applicants, and branded companies with competing oral-suspension technologies. The principal design-around options are:

Replace poloxamer with another surfactant or wetting agent.
Use a suspending agent other than sodium CMC.
Use a non-alkaline or differently buffered vehicle.
Change sodium bicarbonate concentration outside 8.0%-8.8% w/v.
Remove or replace simethicone.
Use a preservative outside the claimed range.
Develop a single-use product that does not require 30-day refrigerated stability.
Use a powder, granule, capsule, tablet, or separately packaged diluent.
Avoid the claimed freeze-thaw performance profile, if commercially acceptable.

Design-around analysis must consider whether the alternative still satisfies the full claim under the doctrine of equivalents. A small numerical change, particularly in the sodium bicarbonate range, may not eliminate all risk.

How does this patent compare with broader PPI patent rights?

Patent category	Typical protection	Relationship to US 11,103,492
API composition patents	Omeprazole or lansoprazole chemical entities	Generally separate
Salt or polymorph patents	Specific solid forms or salts	Separate
Delayed-release patents	Enteric coatings and dosage forms	Separate
Method-of-use patents	Treatment of specified diseases or populations	Separate
Manufacturing patents	API synthesis or dosage-form manufacturing	Separate
Liquid formulation patents	Excipients, pH, stability, delivery format	Directly relevant
Device or packaging patents	Dosing systems and containers	Potentially complementary
US 11,103,492	PPI reconstitution diluent composition and performance	Narrow but product-facing

The patent is more relevant to liquid PPI competitors than to conventional generic capsules. It may operate as one layer in a larger product-specific patent portfolio that includes formulation, packaging, dosing, manufacturing, and method-of-use rights.

What litigation and settlement risks should be assessed?

The patent number alone does not establish an infringement lawsuit, Paragraph IV notice, settlement, consent judgment, or launch agreement. Those matters must be confirmed through PACER, district-court dockets, FDA records, and company disclosures.

A litigation review should examine:

ANDA or 505(b)(2) filings involving liquid omeprazole or lansoprazole.
Paragraph IV notices naming the patent.
Hatch-Waxman actions filed within 45 days of notice.
Preliminary injunction or temporary restraining-order proceedings.
Covenants not to sue.
Launch-at-risk statements.
License or settlement agreements.
Patent-listing disputes before FDA.

Under the Hatch-Waxman framework, a timely infringement action based on a Paragraph IV certification can trigger a statutory approval stay of up to 30 months, subject to statutory exceptions and court decisions.[4]

What is the generic launch risk?

The launch risk is product-specific rather than API-wide.

High-risk product profile

Risk is highest for a product using:

Poloxamer 188 at 1%, 2%, or 4%.
Sodium CMC or sodium CMC/microcrystalline cellulose.
Sodium bicarbonate at 8.0%-8.8%.
Simethicone at 0.1%-0.3%.
Benzyl alcohol at approximately 0.4%-0.6%.
pH 8-9.5.
At least 30 days of refrigerated stability.
Freeze-thaw gel resistance.

Lower-risk product profile

Risk is lower where the product:

Uses a different suspension system.
Uses a non-poloxamer surfactant.
Uses a different neutralizing agent.
Is packaged as a single-use preparation.
Does not require refrigerated multidose stability.
Uses a solid or delayed-release dosage form.
Does not contain the claimed excipient combination.

The patent does not block a generic omeprazole capsule or lansoprazole delayed-release product merely because the active ingredient is the same.

What manufacturing and IP barriers does the patent create?

The patent creates a formulation barrier rather than a fundamental API-manufacturing barrier. A competing manufacturer may be able to source all individual excipients, but it must develop a formulation that remains physically stable, adequately suspends the PPI, avoids excessive foaming, maintains an alkaline environment, and remains acceptable after storage and temperature cycling.

The practical barrier is therefore a combination of:

Excipient compatibility.
Viscosity control.
Uniform dosing.
Reconstitution behavior.
Freeze-thaw robustness.
Preservative effectiveness.
pH maintenance.
Analytical reproducibility.

A manufacturer’s batch records, supplier certificates, process parameters, and stability data would be central to any infringement investigation.

Key Takeaways

US Patent 11,103,492 is a formulation patent for a liquid PPI reconstitution diluent.
Claim 1 requires a defined combination of poloxamer, sodium CMC-based suspension technology, acid-neutralizing agent, defoamer, preservative, water, and stability performance.
Claims 4, 5, 7, 9, 13, 16, 18, and 19 create commercially important fallback positions around poloxamer 188, sodium CMC, sodium bicarbonate, simethicone, benzyl alcohol, omeprazole, and lansoprazole.
The patent does not broadly cover omeprazole, lansoprazole, PPI capsules, API manufacturing, or all liquid PPI products.
The principal validity risk is likely obviousness based on known PPI suspension and bicarbonate formulations combined with conventional excipient technology.
The principal infringement risk is concentrated in a product that reproduces the claimed excipient combination and stability profile.
Orange Book listing, Paragraph IV activity, litigation, settlements, and final patent expiration require verification in FDA, USPTO, and court records.
The most credible design-arounds replace poloxamer, sodium CMC, sodium bicarbonate, or the claimed multidose refrigerated formulation architecture.

Frequently Asked Questions

Does US 11,103,492 cover a liquid omeprazole product with sodium bicarbonate alone?

No. Sodium bicarbonate alone does not satisfy the full claim. The product must also meet the poloxamer, sodium CMC-based suspending-agent, defoamer, preservative, concentration, and performance limitations.

Can a manufacturer avoid the patent by using poloxamer 407 instead of poloxamer 188?

Possibly, but not automatically. Claim 1 covers poloxamer generally within the stated concentration range. Claim 4 is narrower and specifically recites poloxamer 188, but replacing poloxamer 188 with poloxamer 407 does not by itself avoid claim 1.

Does a single-use liquid PPI product infringe the 30-day stability limitation?

A single-use product may avoid the stability limitation if it does not satisfy the claimed 30-day refrigerated stability requirement. The formulation could still face risk under another claim theory if the evidence shows that it inherently possesses the claimed stability.

Is a sodium CMC-free PPI suspension outside the patent?

It is likely outside the literal scope of claims requiring sodium CMC or a sodium CMC/microcrystalline cellulose combination. The complete formulation and any equivalents analysis remain relevant.

Does patent expiration eliminate all exclusivity for a branded liquid PPI?

No. Other patents, regulatory exclusivities, trademarks, formulation rights, packaging patents, or method-of-use patents may remain relevant after this patent expires.

References

United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
35 U.S.C. §§ 154, 156. (2024). Patent term and patent term extension.
21 C.F.R. § 314.53. (2024). Submission of patent information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugsatfda
U.S. Food and Drug Administration. (2024). Small business and industry assistance: Abbreviated new drug application submissions and patent certifications. https://www.fda.gov/drugs/development-resources/abbreviated-new-drug-application-anda-process-questions-and-answers

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	⤷ Start Trial	⤷ 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
World Intellectual Property Organization (WIPO)	2021011669	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,103,492

Which drugs does patent 11,103,492 protect, and when does it expire?

Summary for Patent: 11,103,492