US Patent 11,583,510: Scope, Claim Construction, Exclusivity and Sodium Oxybate Patent Landscape

US Patent 11,583,510 protects method-of-use protocols for administering a once-nightly gamma-hydroxybutyrate formulation to treat narcolepsy, cataplexy, or excessive daytime sleepiness. The patent’s commercial relevance is its linkage of once-nightly dosing with a defined high-fat meal effect: a 33% reduction in mean Cmax and an approximately one-hour delay in Tmax. The broadest independent claims do not expressly recite a particular dose, sodium oxybate salt, brand, formulation composition, or particle size.

The patent is most relevant to Avadel Pharmaceuticals’ once-nightly sodium oxybate product, Lumryz. It is not a conventional composition patent. Its principal protection is a pharmacokinetic method-of-treatment claim that may be infringed by a product label, prescribing instructions, patient counseling, or clinical use that satisfies the claimed fed-state conditions.

What does US Patent 11,583,510 cover?

The patent has two independent method claims.

Claim	Core subject matter	Principal limitations
1	Treatment of narcolepsy, cataplexy, or excessive daytime sleepiness	Human subject; oral once-nightly gamma-hydroxybutyrate formulation; immediate-release and modified-release portions; high-fat meal produces 33% lower Cmax and approximately one-hour longer Tmax
9	Treatment of narcolepsy, cataplexy, or excessive daytime sleepiness	Human subject; oral gamma-hydroxybutyrate formulation; once-daily administration; same 33% Cmax reduction and Tmax increase from 0.5 to 1.5 hours

Claim 1 is formulation-specific. It requires both an immediate-release portion and a modified-release portion.

Claim 9 is potentially broader in formulation scope because it does not expressly require immediate-release and modified-release portions. It remains limited by the once-daily administration and the specified pharmacokinetic response after a high-fat meal.

The claims are directed to treatment methods, not to gamma-hydroxybutyrate as a chemical compound.

How should claim 1 of US 11,583,510 be construed?

Claim 1 requires all of the following elements:

A human subject.
Narcolepsy, cataplexy, or excessive daytime sleepiness.
Oral administration.
A once-nightly dosage.
A gamma-hydroxybutyrate formulation.
An immediate-release portion.
A modified-release portion.
Administration immediately after a high-fat meal.
A mean Cmax reduction of 33% compared with fasted administration.
A Tmax increase of approximately one hour compared with fasted administration.

The claim does not state a specific amount of gamma-hydroxybutyrate. It also does not expressly require sodium oxybate, although sodium oxybate is the principal pharmaceutical form of gamma-hydroxybutyrate used in narcolepsy products.

The formulation limitation is functional and structural. “Immediate release portion” and “modified release portion” may be satisfied by separate particle populations, separate dosage-form compartments, coated particles, or another formulation architecture that produces the required release profiles. Claims 7 and 8 expressly identify microparticles, but claim 1 does not require microparticles.

How does claim 9 differ from claim 1?

Claim 9 is the principal broad claim in the patent.

Issue	Claim 1	Claim 9
Release architecture	Requires immediate-release and modified-release portions	No express dual-release requirement
Dosing frequency	Once nightly	Once daily
PK limitation	33% lower Cmax and approximately one-hour longer Tmax	33% lower Cmax and Tmax increase from 0.5 to 1.5 hours
Treatment indication	Narcolepsy, cataplexy, or excessive daytime sleepiness	Same
Product-specific limitation	Formulation must have IR and modified-release portions	Formulation type is less expressly constrained

The “once nightly” limitation in claim 1 is narrower than “only once daily” in claim 9 in ordinary usage. A once-nightly product will generally satisfy both temporal concepts, but the interpretation depends on the dosing instructions and the evidence used to establish infringement.

Claim 9’s fixed Tmax comparison may create a different proof issue from claim 1. Claim 9 requires an average Tmax increase from 0.5 hour to 1.5 hours, while claim 1 uses “approximately 1 h longer.” A product with a one-hour delay but different absolute Tmax values may fall within claim 1 while creating a dispute under claim 9.

What do dependent claims 2 through 8 and 10 through 14 protect?

Claims	Limitation	Commercial significance
2, 10	Fed-state mean Cmax of 64.0 µg/mL	Narrows the PK profile to a specific measured concentration
3, 11	Fat equals 50% of total meal content	Defines the meal composition
4, 12	Meal contains 500-600 kcal derived from fat	Adds a measurable meal-calorie condition
5, 13	AUCinf is lower in the fed state	Adds an exposure limitation
6, 14	Patient is advised that alcohol is contraindicated and may cause more rapid release	Links the treatment method to patient counseling and labeling
7	Modified-release portion includes gamma-hydroxybutyrate microparticles	Narrows the controlled-release architecture
8	Immediate-release portion includes gamma-hydroxybutyrate microparticles	Narrows the immediate-release architecture

Claims 2 through 5 and 10 through 13 are pharmacokinetic limitations. Their practical value depends on how the claim’s fed and fasted states, subject population, sampling protocol, and statistical calculation are defined in the specification and prosecution history.

Claims 6 and 14 are counseling claims. They may be relevant where a product label or standard patient instructions expressly warn against alcohol and identify accelerated release as a risk. A generic or follow-on product could face a “skinny label” issue if it removes the patented indication or counseling language while still using a product whose label otherwise directs conduct falling within the claim.

What formulation is associated with the patent?

The claim set is directed to a once-nightly gamma-hydroxybutyrate dosage form with immediate and modified release behavior. This corresponds commercially to sodium oxybate extended-release technology rather than the twice-nightly immediate-release dosing used for Xyrem.

The formulation-related scope includes:

Immediate-release gamma-hydroxybutyrate particles or microparticles.
Modified-release gamma-hydroxybutyrate particles or microparticles.
A combined dosage form administered once per night.
A formulation whose fed-state exposure is lower and delayed relative to the fasted state.
A product subject to accelerated release concerns with alcohol.

The patent does not, based on the supplied claims alone, require:

A particular polymer.
A particular coating material.
A specific particle diameter.
A specified dose.
A particular salt counterion.
A specific capsule, tablet, sachet, or suspension.
A specific manufacturing process.

Those omissions make the independent claims potentially broad as to formulation design, but they also create claim-construction and enablement issues if the specification does not adequately support the full range of covered formulations.

What is the pharmacokinetic limitation in US 11,583,510?

The central limitation is a fed-state effect after administration immediately following a high-fat meal.

Parameter	Fasted state	Fed state	Claimed change
Mean Cmax	Comparator value	64.0 µg/mL in dependent claims	33% reduction
Tmax	Approximately 0.5 hour in claim 9	Approximately 1.5 hours in claim 9	Approximately one-hour delay
AUCinf	Higher comparator value	Lower value	Required only by claims 5 and 13
Meal	Fasted comparator	500-600 kcal from fat; fat is 50% of total content in dependent claims	Required by narrower claims

The patent does not merely claim administration with food. It claims administration producing a defined pharmacokinetic result. This distinction matters in litigation. A competing product may be administered after a high-fat meal but avoid infringement if its clinical data do not establish the claimed 33% reduction and Tmax change. Conversely, an accused product may infringe even if its formulation differs materially, provided the method and PK limitations are met.

What are the principal claim vulnerabilities?

Are the pharmacokinetic terms indefinite?

Potential disputes may concern:

The meaning of “immediately after” a meal.
The comparator definition for “fasted state.”
The required number of subjects.
Whether “mean reduction” means arithmetic mean, geometric mean, or another statistical measure.
The meaning of “approximately 1 h.”
Whether a 33% reduction means exactly 33%, at least 33%, or a value within a tolerance.
The required meal composition and timing.
Whether the claimed result must be present in every patient or only in a clinical-study mean.

Claims 1 and 9 use performance-based limitations. The specification and prosecution history will be important in determining whether those terms provide objective boundaries.

Could the claims face enablement or written-description challenges?

The independent claims potentially cover a broad class of gamma-hydroxybutyrate formulations, while the disclosed clinical data may concern a narrower formulation. An accused infringer could argue that the patent does not enable all formulations capable of producing the claimed fed-state PK profile without undue experimentation.

That argument is stronger if the specification provides one formulation example but claims all immediate-release/modified-release gamma-hydroxybutyrate formulations. It is weaker if the specification identifies formulation parameters, release mechanisms, meal conditions, and clinical data that permit routine replication.

Does the patent claim the formulation itself?

No. The supplied independent claims are method claims. A product could avoid literal infringement of claim 1 by lacking the claimed dual-release structure, but it could still face claim 9 if it is administered once daily and produces the claimed PK effect.

What is the FDA and Orange Book significance?

Lumryz, an extended-release sodium oxybate product, received FDA approval in 2023 for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. The product is subject to the sodium oxybate central nervous system depressant and abuse-related risk framework, including restricted distribution and REMS requirements. [1]

The Orange Book is relevant because listed patents can affect abbreviated new drug application timing, Paragraph IV certifications, and 30-month litigation stays. FDA Orange Book listings must be reviewed by patent number and product-specific NDA. Patent listing status is separate from patent validity and enforceability. [2]

A method-of-use patent may be listed for an approved product if it claims an approved method of use and satisfies FDA listing requirements. Listing does not establish that the patent covers every formulation, dose, or use of the product.

When does US Patent 11,583,510 lose exclusivity?

A precise expiration date cannot be established from the claims alone. The relevant calculation requires:

The earliest effective nonprovisional application date.
Any benefit claims to earlier applications.
Patent-term adjustment.
Patent-term extension, if any.
Terminal disclaimers.
Certificates of correction or reexamination.
Post-grant proceedings affecting claim enforceability.

The nominal patent term is generally 20 years from the earliest effective nonprovisional filing date, subject to the adjustment and extension rules in 35 U.S.C. §§ 154 and 156. [3] The issue date, February 21, 2023, does not determine the expiration date.

Regulatory exclusivity is separate. FDA approval of Lumryz provides an approval and marketing framework, but it does not itself establish the patent term. A generic sponsor may pursue an ANDA strategy before patent expiry through Paragraph IV certification, a section viii carve-out, or approval limited to noninfringing uses.

Which companies are challenging the sodium oxybate market?

The competitive field includes:

Company/product	Active ingredient	Dosing profile	Competitive position
Avadel/Lumryz	Sodium oxybate	Once nightly, extended release	Direct commercial relevance to the patent
Jazz/Xyrem	Sodium oxybate	Twice nightly, immediate release	Established incumbent
Jazz/Xywav	Calcium, magnesium, potassium, and sodium oxybates	Twice nightly, lower sodium	Competes on sodium reduction and product switching
Generic sodium oxybate	Sodium oxybate	Generally tied to approved reference-product labeling	Potential ANDA competition, subject to patents and exclusivity
Future modified-release oxybate products	Oxybate salts or related formulations	Potentially once nightly	Could face method, formulation, and manufacturing claims

The patent is more directly relevant to once-nightly products than to conventional twice-nightly immediate-release sodium oxybate. Xywav may compete clinically but does not necessarily practice every claim of a gamma-hydroxybutyrate formulation with the claimed release architecture and PK profile.

What patent litigation affects US Patent 11,583,510?

Jazz Pharmaceuticals and Avadel have engaged in litigation concerning once-nightly sodium oxybate and Jazz’s Xyrem patent estate. The disputes have included patents directed to sodium oxybate formulations, dosing, and treatment methods. The major commercial dispute concerned Avadel’s FT218 development program and the ability to launch Lumryz.

The supplied information does not establish that US 11,583,510 itself has been adjudicated invalid, unenforceable, or not infringed. A litigation search should distinguish:

Litigation involving the patent number itself.
Litigation involving related continuation patents.
Jazz patents asserted against Avadel.
Hatch-Waxman litigation against future ANDA filers.
Inter partes review or post-grant proceedings.

A settlement involving other patents does not automatically resolve, license, or invalidate US 11,583,510.

What generic entry risks exist?

Paragraph IV risk

An ANDA applicant targeting an approved once-nightly sodium oxybate product could challenge the patent by asserting that:

The claims are anticipated by prior controlled-release oxybate formulations.
The fed-state PK result is an inherent property of a known formulation.
The claims are obvious over prior release formulations and food-effect studies.
The claim terms are indefinite.
The patent lacks enablement or written description.
The proposed product does not satisfy the dual-release or once-daily limitations.

A Paragraph IV notice could trigger a 45-day infringement action and a statutory 30-month stay, subject to FDA and court-specific developments. [4]

Section viii carve-out risk

A generic applicant may seek approval for indications or dosing instructions that omit the patented once-nightly method. This strategy is difficult if the approved label necessarily instructs once-nightly administration or contains counseling language that maps onto claims 6 and 14.

Clinical-data risk

Infringement may require evidence of the accused product’s PK behavior under fed and fasted conditions. A generic sponsor could seek to design around the claimed PK profile, but avoiding a precise Cmax or Tmax result may be difficult if the product uses a similar release architecture.

How strong is the patent estate?

US 11,583,510 has meaningful commercial value because it combines a once-nightly dosing method with measurable PK behavior and patient counseling. Its strength is highest against a product that:

Is used for narcolepsy or excessive daytime sleepiness.
Is taken once nightly.
Uses immediate- and modified-release oxybate components.
Has the claimed high-fat meal effect.
Carries alcohol-release warnings.

Its strength is lower against:

Twice-nightly products.
Products with a materially different release profile.
Products without the claimed fed-state PK result.
Products approved only for noninfringing indications.
Formulations that do not contain the claimed release portions.

The patent does not appear, from the supplied claims, to create a complete product-level monopoly over all sodium oxybate formulations. It creates a focused barrier around a once-nightly treatment method and its associated food-effect profile.

What manufacturing and geographic barriers apply?

The patent is a U.S. right. Its claims do not directly control sales or manufacturing outside the United States unless corresponding foreign patents exist. International freedom-to-operate analysis requires review of national family members, prosecution outcomes, expiration dates, and local claim scope.

Manufacturing risk may arise under other patents covering:

Controlled-release particles.
Polymer coatings.
Oxybate salts.
Dose uniformity.
Abuse-deterrent formulations.
Suspension or capsule manufacture.
Packaging and restricted-distribution systems.

US 11,583,510 alone does not claim a manufacturing process. A manufacturer could still face infringement under separate composition or process patents in the same family or in third-party portfolios.

Key Takeaways

US 11,583,510 is a method-of-treatment patent, not a basic compound patent.
Claim 1 requires a once-nightly dual-release gamma-hydroxybutyrate formulation.
Claim 9 is broader as to formulation structure but requires once-daily treatment and a defined fed-state PK profile.
The central limitation is a 33% mean Cmax reduction and approximately one-hour Tmax delay after a high-fat meal.
Dependent claims add a 64.0 µg/mL fed-state Cmax, specified meal composition, lower AUCinf, alcohol counseling, and microparticle limitations.
The patent is commercially most relevant to Lumryz and competing once-nightly sodium oxybate products.
Xyrem and Xywav are clinically relevant competitors but do not necessarily satisfy every limitation.
The claims may face disputes over “immediately after,” “approximately,” mean PK calculations, and the fasted-state comparator.
A Paragraph IV challenge could rely on anticipation, obviousness, inherency, indefiniteness, written description, or enablement.
The patent’s exact expiration date cannot be calculated from the claims and issue date alone. USPTO continuity, PTA, PTE, and terminal-disclaimer records control.

FAQs About US Patent 11,583,510

Does US 11,583,510 cover Lumryz?

The claims are highly relevant to Lumryz because they recite once-nightly gamma-hydroxybutyrate treatment and a dual-release formulation with the claimed fed-state PK behavior. Product coverage depends on the approved label, formulation evidence, and the patent’s complete specification and prosecution history.

Can a generic sodium oxybate product avoid this patent?

Potentially. A generic may avoid literal infringement by using twice-daily dosing, omitting the patented once-nightly method, using a formulation without the claimed release portions, or demonstrating a materially different fed-state PK profile.

Is US 11,583,510 a formulation patent?

It is primarily a method-of-treatment patent. Claims 7 and 8 add microparticle formulation limitations, but the independent claims do not claim a composition in isolation.

Does the alcohol warning create separate patent exposure?

Claims 6 and 14 make alcohol counseling an additional limitation. A product label that includes the claimed warning may support infringement if all other elements are met. The warning alone cannot establish infringement without the underlying treatment and PK limitations.

Are biosimilars relevant to this patent?

No. Sodium oxybate is a small-molecule drug, so the relevant competitors are ANDA-based generics and follow-on formulations, not biosimilars under the Public Health Service Act.

References

U.S. Food and Drug Administration. (2023). Lumryz (sodium oxybate) prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term extension guidance.
U.S. Food and Drug Administration. (2024). Abbreviated new drug application submissions: Patent certifications and 30-month stays.
U.S. Patent and Trademark Office. (2023). U.S. Patent No. 11,583,510.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alkermes Inc	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-001	May 1, 2023		RX	Yes	Yes	11,583,510	⤷ Start Trial				TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION	⤷ Start Trial
Alkermes Inc	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No	11,583,510	⤷ Start Trial				TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION	⤷ Start Trial
Alkermes Inc	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	11,583,510	⤷ Start Trial				TREATMENT OF NARCOLEPSY, CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS USING A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION	⤷ 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

Details for Patent: 11,583,510

Which drugs does patent 11,583,510 protect, and when does it expire?

Summary for Patent: 11,583,510