US Patent 10,799,517: Celecoxib Reduced-Dose Formulation, Claim Scope, Expiration and Patent Landscape

US Patent 10,799,517 protects reduced-dose celecoxib liquid compositions that use a medium-chain glyceride to achieve rapid exposure under fasting conditions. The patent is directed to formulation and pharmacokinetic performance, not to celecoxib as a molecule or to conventional 400 mg celecoxib capsules.

The broadest independent claims cover:

An oral composition containing at least 20% less celecoxib than a conventional 400 mg capsule, meaning approximately 320 mg or less.
A medium-chain glyceride.
At least one specified early-exposure or absorption parameter.
A method of providing pain relief within two hours using the same formulation and pharmacokinetic profile.

The claim structure is commercially relevant to ELYXYB, a 120 mg celecoxib oral solution for the acute treatment of migraine with or without aura in adults. The 120 mg dose corresponds to a 70% reduction from a 400 mg reference dose. FDA approved ELYXYB in 2020 under NDA 211873.[1]

What does US Patent 10,799,517 protect?

US Patent 10,799,517 protects a combination of composition limitations and pharmacokinetic results. Claim 1 is the principal composition claim, while claim 17 is the principal method-of-treatment claim.[2]

Claim element	Scope
Active ingredient	Celecoxib
Reference dose	Conventional 400 mg oral celecoxib capsule
Minimum dose reduction	At least 20%
Maximum implied dose under claim 1	Approximately 320 mg
Required lipid component	Medium-chain glyceride
Dosage form	Solution, suspension, emulsion or liquid mixture under dependent claim 10
Pharmacokinetic requirement	At least one of seven specified AUC or Tlag parameters
Administration condition	Oral administration to a human subject under fasting conditions
Additional formulation limits	Optional excipients, solubilizer, solvent, pH and precipitation limitations
Treatment claim	Pain relief within two hours
Geographic scope	United States

The patent does not require every listed pharmacokinetic threshold. Claim 1 requires at least one of the alternatives in paragraphs (a) through (g). A competing formulation could therefore avoid one threshold but still fall within the claim if it satisfies another.

The claim is narrower than a claim covering every rapid-acting celecoxib formulation. The accused product must contain a medium-chain glyceride and satisfy the dose-reduction and pharmacokinetic limitations.

How broad is claim 1?

Claim 1 is broad in formulation architecture but narrow in its performance limitations.

The claim does not require:

A specific medium-chain glyceride species.
A specific solubilizer.
A specific solvent.
A specific commercial flavor, preservative or buffer.
A specific liquid volume.
A particular indication.
A specific manufacturing process.
A specific capsule or bottle configuration.

The claim does require the composition to contain a medium-chain glyceride. A formulation based only on a surfactant, polymeric carrier, cyclodextrin or solid dispersion would not literally satisfy that limitation unless it also contains a qualifying medium-chain glyceride.

The claim also requires a reduced celecoxib dose relative to conventional 400 mg oral capsules. This creates a dose-based boundary:

Reduction from 400 mg	Maximum implied celecoxib dose
At least 20%	320 mg
At least 40%	240 mg
At least 55%	180 mg
At least 70%	120 mg

Claims 3 through 9 create narrower dose subranges. A 120 mg formulation falls within claims 1, 3, 4, 5 and 9 if it also satisfies the remaining formulation and pharmacokinetic elements.

Which pharmacokinetic parameters create infringement risk?

The patent uses early systemic exposure and absorption lag as claim limitations.

Parameter	Threshold
AUC(0-15 min)	At least approximately 10 ng·h/mL
AUC(0-30 min)	At least approximately 80 ng·h/mL
AUC(0-1 hr)	At least approximately 400 ng·h/mL
AUC(0-2 hr)	At least approximately 1,000 ng·h/mL
AUC(0-t)	At least approximately 2,000 ng·h/mL
AUC(0-∞)	At least approximately 2,000 ng·h/mL
Tlag	Not more than 8 minutes

These limitations create two important enforcement issues.

First, infringement may turn on clinical pharmacokinetic testing rather than on the ingredient list alone. A generic applicant could use the same active ingredient and a similar excipient system but argue that its product does not meet any specified threshold.

Second, the testing conditions matter. The claim specifies fasting administration to human subjects. Fed-state data would not necessarily establish or defeat infringement. The relevant study design, sampling intervals, analytical method, subject population and statistical treatment would become central in litigation.

The AUC alternatives are written in the disjunctive. Meeting one threshold is sufficient. This increases the number of possible infringement pathways, particularly because a formulation may fail to demonstrate one early AUC value but meet a later AUC or Tlag limitation.

What formulation features are protected?

Claims 10 through 16 add a formulation-specific perimeter around the broad composition claim.

Medium-chain glyceride

Claim 1 requires a medium-chain glyceride, and claim 12 specifies a concentration of approximately 5% to 75% by weight. Medium-chain glycerides generally include glyceride mixtures containing fatty-acid chains in the medium-chain range. The claim language supplied does not limit the patent to one commercial excipient or one fatty-acid distribution.

A competitor using a materially different lipid system may have a stronger non-infringement position. A formulation using medium-chain triglycerides, glyceryl caprylate, glyceryl caprate or a comparable medium-chain glyceride system would require detailed claim construction and product testing.

Solubilizer

Claim 11 covers a solubilizer concentration of approximately 10% to 70% by weight. The claim does not identify a single solubilizer. This potentially reaches surfactants and other excipients that improve celecoxib incorporation into the liquid vehicle.

The percentage is calculated against total composition weight. That creates a potential design-around route if a competitor uses a different solubilization strategy or remains outside the claimed concentration range.

Solvent

Claim 13 covers at least one solvent at approximately 20% to 80% by weight. This limitation may capture formulations using substantial quantities of water-miscible or organic solvent systems, depending on the patent’s specification and claim construction.

A competing product that uses a solid formulation, a dry powder for reconstitution or a lipid system without a claimed solvent concentration may avoid this dependent claim while remaining exposed under claim 1.

Precipitation behavior

Claim 14 requires a composition essentially free of precipitation inhibitors. Claim 16 requires no precipitation in FaSSGF at pH 2.0, at 37°C ± 0.5°C, under 50 rpm stirring, measured at 60 minutes.

These limitations are technically significant. Celecoxib has poor aqueous solubility, and precipitation after gastric dilution can reduce the benefit of a solubilized formulation. The claim therefore links the commercial formulation concept to dissolution and supersaturation control.

A competitor could challenge the test method, the meaning of “does not show any precipitation,” the detection threshold and the reproducibility of the FaSSGF test. Those issues would affect both infringement and validity.

What pain-treatment methods are covered?

Claim 17 covers administering the composition to provide pain relief within two hours. Claim 18 narrows the result to rendering the subject pain-free within two hours.

Claim 19 lists numerous pain conditions, including:

Acute pain
Migraine and cluster headache
Post-operative and surgical pain
Dental pain
Osteoarthritis and arthritis pain
Neuropathic pain
Chronic lower back pain
Dysmenorrhea
Pain from burns or sunburn
Post-partum pain
Cystitis and genitourinary pain
Bone injury pain
Opioid-resistant pain

The treatment claims are broader than the FDA-approved ELYXYB indication. FDA approval is for acute treatment of migraine with or without aura in adults, not for every condition listed in claim 19.[1] A product label that promotes only the approved migraine indication could still face patent risk if the composition claims are infringed. Method-of-use risk becomes more fact-specific where promotion, prescribing and actual use are limited to the approved indication.

What are the likely validity pressure points?

The strongest validity issues are likely to concern obviousness, written description, enablement and the definiteness of pharmacokinetic limitations.

Obviousness

The patent combines known concepts:

Celecoxib as a selective COX-2 inhibitor.
Lipid-based solubilization.
Medium-chain glycerides.
Reduced dosing.
Faster onset.
Liquid oral delivery.

The patent holder would likely argue that the claimed combination produced an unexpected exposure profile at substantially reduced celecoxib doses. The defense would focus on whether a skilled formulator would have selected a medium-chain glyceride and expected the claimed AUC and Tlag results.

The value of comparative data is central. Data showing rapid exposure, no FaSSGF precipitation and clinical pain relief at 120 mg would support non-obviousness. Data showing only predictable solubilization or conventional dose proportionality would weaken that position.

Written description and enablement

The claims cover broad ranges for solubilizer, solvent and medium-chain glyceride content. An invalidity challenge could argue that the specification does not enable the full breadth of those ranges across all glycerides, excipient combinations and dose levels.

The patent holder would respond that formulation screening and the disclosed examples provide a representative technical teaching. The outcome would depend on the patent specification, not solely on the issued claims.

Definiteness

Terms such as “about,” “essentially free,” “conventional celecoxib,” “does not show any precipitation” and “pain relief” may generate claim-construction disputes.

The most vulnerable phrases are likely:

“Conventional celecoxib in 400 mg oral capsules”
“At least about”
“Essentially free of precipitation inhibitors”
“Does not show any precipitation”
“Pain free within 2 hours”

The specification’s definitions and experimental methods will determine whether these terms provide an objective boundary.

What is the FDA Orange Book status?

FDA’s Orange Book is the principal source for approved drug patent listings and regulatory exclusivity. For ELYXYB, the relevant regulatory pathway is NDA 211873, approved in 2020.[1]

US Patent 10,799,517 is associated with the ELYXYB formulation and is relevant to generic approval analysis. A current Orange Book review should distinguish:

Listed patents covering the drug product.
Method-of-use patents.
Patent expiration dates.
Any pediatric exclusivity.
Whether an ANDA applicant has submitted a Paragraph IV certification.
Whether the listing remains active or has been delisted.

The patent’s ordinary term is generally calculated from the earliest effective nonprovisional priority date, subject to patent-term adjustment and any applicable extension. Public patent records associate the patent family with a January 2015 priority period, which places the unadjusted term near January 2035.[2] The exact expiration date must be taken from the USPTO patent-term data and the current Orange Book listing, rather than inferred solely from the issue date.

The patent does not receive a new chemical entity exclusivity period because celecoxib was previously approved. ELYXYB could qualify for three-year exclusivity based on a new clinical investigation supporting the formulation and indication. That regulatory exclusivity would have been separate from the patent term and would not replace patent protection.[1]

When does celecoxib liquid formulation exclusivity end?

The practical exclusivity picture has three layers:

Protection	Estimated position
Celecoxib molecule	Expired
ELYXYB formulation regulatory exclusivity	Three-year period associated with the 2020 approval, subject to FDA records
US Patent 10,799,517	Approximately 2035 before any applicable adjustment
Later continuation or related patents	Must be reviewed separately in the Orange Book and USPTO records

A generic applicant could pursue an ANDA after regulatory exclusivity expires, but patent certifications would remain important. If US Patent 10,799,517 is listed for the reference product, an applicant would generally need to file a Paragraph III certification, Paragraph IV certification, or another appropriate certification depending on the patent and proposed labeling.

Which companies are challenging the patent?

The supplied claim text does not identify an ANDA filer, Paragraph IV notice letter, district-court action or settlement agreement. No challenger or settlement can be attributed to the patent from the claims alone.

The commercial challenger set would likely include generic companies targeting oral celecoxib liquids or alternative rapid-onset celecoxib products. A conventional 100 mg or 200 mg celecoxib capsule applicant would face a different risk profile because the patent is directed to reduced-dose, medium-chain-glyceride compositions with specified pharmacokinetics.

An ANDA applicant for a 120 mg liquid product would face the highest risk. A 120 mg formulation is within the explicit dose limitation of claim 9 and could satisfy the broadest composition claim if it contains a medium-chain glyceride and meets one pharmacokinetic threshold.

What generic launch scenarios exist?

Scenario 1: Conventional capsule launch

A conventional capsule containing 100 mg or 200 mg celecoxib would generally have a stronger non-infringement position because it would not necessarily contain a medium-chain glyceride and would not be a reduced-dose replacement for a 400 mg conventional capsule in the claimed liquid formulation.

Scenario 2: Liquid celecoxib using a medium-chain glyceride

This is the highest-risk scenario. The applicant would need to address formulation composition, dose reduction, pharmacokinetic performance and potential method-of-use claims.

Scenario 3: Non-lipid solubilized liquid

A liquid using a cyclodextrin, polymer, nanoparticle or another solubilization system could avoid the medium-chain glyceride limitation. It may still face other patent families, formulation patents or regulatory questions.

Scenario 4: Higher-dose liquid

A liquid containing more than 320 mg would fall outside the dose-reduction requirement of claim 1, but such a dose would create separate clinical, labeling and safety issues. It would not be a practical substitute for ELYXYB’s reduced-dose positioning.

Scenario 5: Different pharmacokinetic profile

A formulation could attempt to remain outside the AUC and Tlag thresholds. That strategy would require controlled human pharmacokinetic testing and would not eliminate risk under other patents or under a doctrine-of-equivalents theory.

How strong is the patent estate?

US Patent 10,799,517 has meaningful commercial strength because it connects the composition to measurable performance. A competitor cannot avoid the patent merely by changing the commercial label if its formulation still contains the claimed components and achieves the claimed exposure.

Its principal weaknesses are breadth and measurement dependence. The patent does not monopolize all celecoxib liquids, all rapid-onset celecoxib products or all low-dose celecoxib treatments. Its strength depends on:

The breadth of the patent specification.
The validity of the claimed pharmacokinetic thresholds.
The ability to reproduce the fasting PK results.
The precise identity and amount of the medium-chain glyceride.
The current Orange Book listing.
Any continuation patents covering narrower formulation or manufacturing features.
The existence of Paragraph IV litigation or settlement restrictions.

How does US Patent 10,799,517 compare with conventional celecoxib patents?

Issue	Conventional celecoxib capsule	US 10,799,517
Primary protection	Active ingredient, salt, formulation or use	Reduced-dose liquid formulation and PK performance
Typical dose	100 mg, 200 mg or 400 mg	320 mg or less under claim 1
Medium-chain glyceride required	No	Yes
Early exposure requirement	Usually no	Yes
FaSSGF precipitation limitation	Usually no	Yes, in claim 16
Pain relief within two hours	May be a use objective	Express method limitation
Main generic risk	Active ingredient and listed formulation patents	Liquid formulation and PK matching
Best design-around	Different dosage form or excipient architecture	Avoid medium-chain glyceride and claimed PK profile

Key Takeaways

US Patent 10,799,517 protects reduced-dose celecoxib compositions containing a medium-chain glyceride.
Claim 1 reaches formulations containing approximately 320 mg or less of celecoxib relative to a conventional 400 mg capsule.
The 120 mg dose used by ELYXYB falls within the patent’s most specific dose limitation.
At least one of seven AUC or Tlag thresholds must be satisfied.
Claims 10 through 16 add liquid-formulation, excipient, pH and precipitation limitations.
Claims 17 through 26 cover administration for pain relief within two hours, including migraine and other listed pain conditions.
The patent does not cover celecoxib generally or every celecoxib liquid.
The ordinary patent term appears to extend into approximately 2035, subject to USPTO patent-term adjustment and the current Orange Book record.
The highest-risk generic design is a 120 mg celecoxib liquid using a medium-chain glyceride and demonstrating rapid fasting exposure.
Generic applicants using capsules, non-lipid solubilization systems or materially different PK profiles may have stronger design-around positions.

Frequently Asked Questions

Is a 120 mg celecoxib liquid automatically covered by US Patent 10,799,517?

No. The product must also contain a medium-chain glyceride and satisfy at least one claimed pharmacokinetic threshold, among other limitations.

Does the patent cover all products marketed for migraine?

No. The patent covers specified compositions and administration methods. A migraine product without the claimed formulation features may fall outside the patent.

Can a generic avoid the patent by using the same 120 mg celecoxib dose in a capsule?

Possibly. A capsule would still require analysis of the medium-chain glyceride and pharmacokinetic limitations, but it may not satisfy the liquid-formulation limitations in the dependent claims.

Does the patent cover medium-chain triglycerides specifically?

The claims require a medium-chain glyceride but do not, in the supplied text, limit the invention to one named commercial excipient. The exact treatment of medium-chain triglycerides depends on the specification and claim construction.

Is FDA approval enough to establish freedom to launch?

No. FDA approval addresses regulatory requirements. Launch risk also depends on listed patents, certifications, patent litigation, settlements and the composition and performance of the proposed product.

References

U.S. Food and Drug Administration. (2020). ELYXYB (celecoxib) oral solution prescribing information. FDA.
United States Patent and Trademark Office. (2020). U.S. Patent No. 10,799,517, Celecoxib compositions and methods of use thereof. USPTO.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
United States Patent and Trademark Office. (2024). Patent term adjustment and patent term information. USPTO.

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	10,799,517	⤷ 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	2016267685	⤷ Start Trial
Australia	2019203815	⤷ Start Trial
Brazil	112017025445	⤷ Start Trial
Canada	2987272	⤷ Start Trial
China	107847437	⤷ Start Trial
Eurasian Patent Organization	201792530	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,799,517

Which drugs does patent 10,799,517 protect, and when does it expire?

Summary for Patent: 10,799,517