United States Patent 10,722,456: Celecoxib Oral-Liquid Claims, Patent Scope, and Market Landscape

U.S. Patent No. 10,722,456 protects selected therapeutic uses of a stable oral liquid celecoxib formulation. The core combination requires celecoxib at approximately 120 to 240 mg and a medium-chain glyceride, specifically glyceryl monocaprylate, glyceryl tricaprylate/tricaprate, or both. The patent does not broadly claim every liquid celecoxib formulation. Its enforceable scope depends on the formulation composition, the dose, the glyceride identity and concentration, and the claimed clinical result.

The patent has three independent claims. Claims 1 and 10 cover pain treatment. Claim 19 covers reduction of migraine-associated nausea, photophobia, or phonophobia. The dependent claims add formulation and clinical-performance limitations.

What does U.S. Patent 10,722,456 protect?

The patent protects methods that administer a stable oral liquid celecoxib composition meeting specified formulation and therapeutic limitations.

Claim group	Protected subject matter	Principal limitations
Claim 1	Providing pain freedom	Celecoxib, 120-240 mg; medium-chain glyceride, 5%-75% by weight; oral liquid; pain freedom
Claims 2-9	Narrowed versions of claim 1	Pain duration, dosage form, pH, solubilizer, polar solvent, and concentration ranges
Claim 10	Providing partial pain relief	Same core formulation architecture; partial pain relief
Claims 11-18	Narrowed versions of claim 10	At least one-level pain reduction, duration, pH, solubilizer, polar solvent, and dosage form
Claim 19	Reducing migraine symptoms	Reduction in nausea, photophobia, and/or phonophobia
Claims 20-25	Narrowed versions of claim 19	Dosage form, pH, solubilizer, polar solvent, and concentration ranges

The patent is primarily a formulation-use patent. It does not claim celecoxib as a molecule, conventional celecoxib capsules, or every pharmaceutical use of celecoxib.

How broad is independent claim 1?

Claim 1 requires all of the following:

A human subject suffering from pain.
Administration of a stable oral liquid pharmaceutical composition.
Celecoxib in an amount from about 120 mg to about 240 mg.
At least one medium-chain glyceride at 5% to 75% by weight.
The glyceride must include glyceryl monocaprylate, glyceryl tricaprylate/tricaprate, or a combination.
At least one pharmaceutically acceptable excipient.
The method must provide pain freedom.

The claim is compositionally broad in some respects. It allows a solution, suspension, emulsion, or liquid mixture through dependent claim 3. It also permits a wide medium-chain glyceride concentration range. The claim is narrower than a general oral-liquid claim because it specifies both the celecoxib dose and the glyceride chemistry.

The therapeutic limitation is significant. A product may satisfy the composition elements but avoid literal infringement if the claimed pain outcome is not established or if the product labeling does not direct the claimed use. Direct evidence of use, prescribing instructions, clinical data, or induced-infringement theories could still affect enforcement.

What formulation features are protected?

The dependent claims create several overlapping formulation zones.

Feature	Claimed range
Celecoxib dose	About 120-240 mg
Medium-chain glyceride	About 5%-75% w/w
pH	About 3-7
Solubilizer-to-celecoxib ratio	About 4:1 to 20:1
Solubilizer concentration	About 35%-45% w/w
Solubilizer-to-polar-solvent ratio	0.60:1 to 1.8:1
Polar solvent concentration	About 25%-42% w/w
Pain-free duration under claim 2	About 2-24 hours
Partial pain-relief duration under claim 12	At least about 4 hours

Claims 7-9 and 16-18 are particularly relevant to design-around analysis. A competing formulation can attempt to use a different solvent system, a solubilizer outside the claimed concentration range, a polar solvent outside the claimed range, or a different lipid excipient. Those changes do not automatically avoid infringement because the doctrine of equivalents may apply, but they create stronger noninfringement positions than a formulation that reproduces the claimed ranges.

Does claim 10 contain a drafting defect?

Claim 10 states that the composition comprises “i. in an amount from about 120 mg to about 240 mg,” without expressly identifying celecoxib in the quoted claim text. Claims 15-18 refer back to a composition containing celecoxib, and claims 10-18 otherwise track claim 1 closely.

This omission is material. A court would likely examine the issued patent, specification, prosecution history, claim-construction record, and any certificate of correction before determining whether “celecoxib” should be read into claim 10. The defect could provide a noninfringement argument, an indefiniteness argument, or a basis for correction if the statutory requirements are met. It should not be treated as automatically fatal to the claim.

Claims 1 and 19 expressly identify celecoxib and therefore do not depend on resolving the omission in claim 10.

What does claim 19 add for migraine products?

Claim 19 targets treatment of migraine symptoms rather than the broader pain outcomes in claims 1 and 10. It requires a stable oral liquid composition containing the same core formulation elements and administration to a migraine subject, with reduction of:

nausea;
photophobia;
phonophobia; or
any combination of those symptoms.

The claim does not require pain freedom or a specified pain-intensity reduction. A migraine product could therefore fall within claim 19 even if its label emphasizes improvement in associated migraine symptoms rather than complete pain relief.

Claim 19 also lacks the explicit duration limitation found in claim 2 and the numerical pain-scale limitation found in claim 11. That makes it potentially broader as to clinical timing, while remaining narrower as to the disease context and claimed symptoms.

How strong is the patent estate based on the issued claims?

The patent has moderate-to-strong blocking potential for a directly substitutable oral-liquid celecoxib product that uses the specified medium-chain glycerides and a 120-240 mg dose.

Its strongest elements are:

the combination of a liquid celecoxib dosage form with a defined lipid excipient;
the limited list of expressly identified glycerides;
the commercially relevant 120 mg and 240 mg dose range;
overlapping claims directed to pain relief and migraine symptoms;
multiple dependent claims covering common solubilizer and polar-solvent architectures.

Its principal vulnerabilities are:

the method-of-treatment format;
the need to prove or establish the claimed clinical result;
potential prior art involving liquid celecoxib, self-emulsifying systems, lipid vehicles, and rapid-onset NSAID formulations;
the drafting defect in claim 10;
possible design-around opportunities using other lipid excipients or materially different solvent systems.

The patent does not prevent competitors from developing non-liquid celecoxib products, using a dose below 120 mg or above 240 mg, or selecting a formulation that does not contain the specified glycerides, subject to equivalence and other patent rights.

What patents protect the commercial oral-liquid celecoxib product?

The commercial product most closely associated with this technology is Elyxyb, a 120 mg oral solution of celecoxib approved by the FDA for the acute treatment of migraine with or without aura in adults. The FDA-approved product is a ready-to-use oral liquid rather than a conventional solid capsule.[2]

Patent 10,722,456 is relevant because its claims correspond to the product’s principal technical profile: celecoxib in a liquid formulation, a medium-chain glyceride system, and migraine-related therapeutic effects. The complete Orange Book position, however, must be determined from the current FDA listing for the applicable NDA. A patent’s relationship to an approved product is not established solely by matching the active ingredient and dosage form.

Orange Book analysis should distinguish among:

patents listed for the approved drug product;
patents listed for a method of use;
patents directed to formulation or composition;
patents covering manufacturing processes;
patents that have expired, been delisted, or been removed;
patents that may be relevant but are not Orange Book-listed.

When does celecoxib oral-liquid exclusivity expire?

Patent expiration cannot be determined from the claims alone. The relevant date depends on the patent’s earliest effective nonprovisional priority date, any patent-term adjustment, terminal disclaimer, patent-term extension, and later legal events.

FDA regulatory exclusivity is separate from patent protection. Celecoxib was approved as a small-molecule active ingredient long before approval of the oral-liquid product. The oral-liquid NDA could receive a period of three-year exclusivity for new clinical investigations supporting the approval, but that regulatory exclusivity does not extend the underlying compound patent and does not necessarily block every abbreviated application.[3]

For commercial planning, the controlling timeline should include:

Event	Business significance
Patent issue date	Establishes the issued claim set
Earliest effective filing date	Starting point for ordinary patent-term calculation
Patent-term adjustment	May extend the nominal expiration date
Orange Book listing date	Determines notice and certification exposure for an ANDA
NDA approval date	Starts applicable regulatory exclusivity
Terminal disclaimer	Can limit expiration to another patent’s expiration
Continuation or divisional filings	May create later-expiring claim sets

What Paragraph IV risks exist?

An ANDA applicant seeking approval for a generic oral-liquid celecoxib product could face several certification issues.

A Paragraph IV challenge could argue that the patent is invalid, unenforceable, or not infringed. The most likely technical arguments would concern:

anticipation or obviousness based on prior oral-liquid celecoxib formulations;
lack of written description for the full 5%-75% glyceride range;
lack of enablement across all permitted excipients, ratios, pH levels, and liquid forms;
indefiniteness of terms such as “stable,” “pain freedom,” and “partial pain relief”;
failure of claim 10 to identify the active ingredient;
lack of nexus between the formulation and the claimed clinical outcome;
noninfringement through a different glyceride, solvent, or dosage strength.

A generic applicant could also seek a section viii statement for a method-of-use patent if the approved labeling can omit the patented indication or symptom claim. That route is more difficult where the listed claims cover the principal labeled use of the oral-liquid product.

Under the Hatch-Waxman framework, a Paragraph IV notice can trigger patent litigation and a potential 30-month stay of FDA approval, subject to statutory exceptions and court rulings.[4]

Which companies are challenging the patent?

The supplied claims do not establish the identity of any Paragraph IV challenger, litigation defendant, settlement participant, or licensee. Those matters require review of the FDA Orange Book, FDA Paragraph IV notice records where available, PACER or district-court dockets, and assignment records.

No challenger, settlement agreement, license, or litigation outcome should be attributed to this patent without a corresponding public record.

Are biosimilar risks relevant?

No. Celecoxib is a small-molecule drug, not a biologic. Biosimilar applications under the Public Health Service Act are therefore not the relevant competitive pathway.

The relevant competitors are:

ANDA applicants for generic oral-liquid celecoxib;
505(b)(2) applicants pursuing modified liquid formulations;
manufacturers of conventional celecoxib capsules;
branded migraine products using triptans, gepants, or ditans;
nonprescription NSAID products for less severe pain.

A 505(b)(2) applicant could face patent certification and litigation issues similar to those affecting an ANDA applicant, while pursuing a formulation or clinical profile that differs from the reference product.

What generic launch scenarios are most plausible?

Scenario 1: Same 120 mg liquid and same glyceride system

This presents the highest infringement risk. A product reproducing the dose, specified glycerides, liquid form, and labeled migraine or pain indication would likely require a successful patent challenge, a license, or expiration of the relevant claims.

Scenario 2: Same dose but different lipid excipient

This creates a stronger design-around position if the substitute is not glyceryl monocaprylate or glyceryl tricaprylate/tricaprate and is not equivalent in function, way, and result.

Scenario 3: Different solvent and solubilizer architecture

A formulation outside the dependent ratios and concentration ranges may avoid claims 5, 7-9, 15-18, and 22-25. It could still implicate the broader independent claims if it uses the specified glyceride and satisfies the therapeutic limitations.

Scenario 4: Solid oral celecoxib product

A capsule or tablet would generally fall outside the oral-liquid limitations. It would compete commercially but would not ordinarily practice the claimed liquid method.

Scenario 5: Label carve-out

A generic applicant may attempt to omit patented migraine-symptom or pain indications. The feasibility depends on the approved labeling, the scope of the listed method claims, and whether the remaining label still encourages the patented use.

What manufacturing and geographic barriers matter?

The claims do not require a particular manufacturing process, equipment, container, filling method, or site. Their principal barrier is formulation replication, not process exclusivity.

A freedom-to-operate review should separately assess:

U.S. patent families covering the glyceride vehicle;
international counterparts in Europe, Canada, Japan, China, and other launch markets;
formulation stability and preservative systems;
container-closure compatibility;
manufacturing methods for dissolving or dispersing celecoxib;
patents covering solubilizers, polar solvents, or self-emulsifying delivery systems;
local regulatory data-exclusivity rules.

A U.S. patent does not create enforceable rights in foreign markets. Each jurisdiction requires separate validity, term, listing, and litigation analysis.

Key Takeaways

U.S. Patent 10,722,456 is directed to methods using a stable oral liquid celecoxib composition.
The core dose is approximately 120-240 mg.
The core excipient limitation is 5%-75% medium-chain glyceride containing glyceryl monocaprylate, glyceryl tricaprylate/tricaprate, or both.
Claims 1 and 10 target pain outcomes; claim 19 targets migraine-associated nausea, photophobia, and phonophobia.
The dependent claims add meaningful barriers through pH, solubilizer, polar-solvent, ratio, and duration limitations.
Claim 10 contains an apparent omission of the active ingredient and requires claim-construction analysis.
The main competitive threat is a generic or 505(b)(2) oral-liquid celecoxib product.
Biosimilar competition is irrelevant because celecoxib is a small molecule.
Current expiration, Orange Book listing, Paragraph IV activity, litigation, and licensing conclusions require the governing FDA and court records, not the claims alone.

FAQs

Does Patent 10,722,456 cover celecoxib capsules?

No. The asserted claims require administration of a stable oral liquid pharmaceutical composition. Conventional celecoxib capsules generally fall outside those limitations.

Does the patent cover a 240 mg celecoxib liquid?

Potentially. A 240 mg product falls within the claimed 120-240 mg range if it also contains the specified medium-chain glyceride and satisfies the applicable method and therapeutic limitations.

Can a competitor avoid the patent by using glyceryl monocaprylate below 5%?

That approach may avoid the express 5%-75% concentration limitation in the independent claims, but infringement analysis would depend on the complete formulation, claim construction, prosecution history, and possible equivalents analysis.

Is Elyxyb a biologic or biosimilar product?

No. Elyxyb is a small-molecule celecoxib oral solution. Generic competition would proceed primarily through the ANDA or, depending on the product and regulatory strategy, a 505(b)(2) pathway.

Does a patent grant guarantee Orange Book protection?

No. Orange Book listing is governed by FDA regulations and statutory requirements. A granted patent may be relevant to an approved product without being listed for that product.

References

United States Patent and Trademark Office. (2020). U.S. Patent No. 10,722,456, methods of treatment using oral liquid celecoxib compositions.
U.S. Food and Drug Administration. (2020). Elyxyb (celecoxib) oral solution prescribing information.
U.S. Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations.
U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application regulations and patent certification requirements.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		RX	Yes	Yes	10,722,456	⤷ Start Trial	Y			ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS	⤷ 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
Australia	2017275844	⤷ Start Trial
Brazil	112018074486	⤷ Start Trial
Canada	3025734	⤷ Start Trial
China	109496151	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,722,456

Which drugs does patent 10,722,456 protect, and when does it expire?

Summary for Patent: 10,722,456