United States Patent 10,272,062: Scope, Claims, Expiration, Orange Book Status and Patent Landscape for Once-Nightly Sodium Oxybate

U.S. Patent No. 10,272,062 protects a once-nightly, modified-release gamma-hydroxybutyrate formulation built around two release populations: uncoated or immediate-release particles and coated particles. The coated particles use an enteric or pH-responsive polymer carrying free carboxylic groups combined with a hydrophobic compound melting at least 40°C.

The patent is commercially relevant to once-nightly sodium oxybate products, particularly Avadel’s LUMRYZ. Its strongest protection is directed to the specific combination of coating chemistry, particle architecture, dose range, dissolution behavior, pharmacokinetic performance and exclusion of ethylcellulose-coated particles. It does not broadly cover all sodium oxybate formulations, all extended-release products or the sodium oxybate active ingredient itself.

What does U.S. Patent 10,272,062 protect?

The patent has three principal independent claim concepts:

Claim	Core subject matter	Key limitations
1	Once-nightly modified-release GHB formulation	Immediate-release and modified-release portions; GHB particles in both; coated modified-release particles; carboxylic polymer plus hydrophobic compound melting at least 40°C
32	High-dose modified-release GHB formulation	Same particle and coating architecture; at least 4.5 grams of GHB; does not expressly require once-nightly administration
71	Commercially focused once-nightly formulation	Immediate-release and modified-release portions; 10/90 to 65/35 release-payload ratio; no ethylcellulose coating; 3.0 to 12.0 grams sodium oxybate equivalent; once-nightly treatment of narcolepsy

Claims 1 through 31 depend from claim 1. Claims 32 through 70 depend from claim 32. Claims 71 through 89 form a separate claim group centered on a once-nightly narcolepsy product.

The patent is therefore a formulation patent with multiple fallback positions. A challenger would generally need to avoid at least one limitation in an asserted independent claim. Merely changing the sodium oxybate dose or dosage form would not necessarily avoid infringement if the same coating system, release architecture and clinical or dissolution limitations remained present.

How broad is claim 1 of U.S. Patent 10,272,062?

Claim 1 is broad in excipient selection but narrow in formulation architecture and intended use. It requires all of the following:

Gamma-hydroxybutyrate, which includes pharmaceutically acceptable salts such as sodium oxybate.
An immediate-release portion containing GHB particles.
A modified-release portion containing GHB particles.
A coating on the modified-release particles.
A coating polymer carrying free carboxylic groups.
A hydrophobic compound with a melting point of at least 40°C.
Suitability for administration only once nightly.

The claim does not require a particular tablet, capsule or powder. Dependent claim 27 expressly identifies tablets, powders and capsules, while claim 28 narrows the dosage form to a powder.

The words "suitable for administration only once nightly" are important. They connect the formulation to a dosing regimen, but the limitation may be litigated as either a structural product characteristic or a functional limitation. The specification and dependent pharmacokinetic claims provide evidence that the formulation is designed to produce an overnight exposure profile after one administration.

A product that uses the same two-population particle design but is labeled for twice-nightly dosing could face an infringement dispute. The outcome would depend on whether the product is objectively suitable for once-nightly administration and how the claim term is construed.

What coating materials are covered by the patent?

The patent covers a large class of pH-responsive polymers and hydrophobic compounds.

Carboxylic-group polymers

Claims 2 and 33 identify the following polymer categories:

Methacrylic acid and alkyl methacrylate copolymers
Methacrylic acid and methyl methacrylate copolymers
Methacrylic acid and ethyl acrylate copolymers
Methacrylic acid copolymers of types A, B and C
Cellulose acetate phthalate
Cellulose acetate succinate
Hydroxypropyl methylcellulose phthalate
Carboxymethylethyl cellulose
Cellulose acetate trimellitate
Hydroxypropyl methylcellulose acetate succinate
Polyvinyl acetate phthalate
Zein
Shellac
Alginate
Mixtures of these materials

Claims 3, 34 and 75 focus on two commercially familiar acrylic systems:

Methacrylic acid and ethyl acrylate copolymer at a 1:1 ratio
Methacrylic acid and methyl methacrylate copolymer at a 1:2 ratio

These formulations correspond broadly to enteric or pH-dependent acrylic coating technologies commonly sold under trade names such as Eudragit-type materials, although the claims are written by chemical class rather than by brand.

Claim 4 requires a pH trigger from 5.5 to 6.97. Claim 73 uses the same range, while claim 74 requires ionization of the free carboxylic groups at pH 7.5.

Hydrophobic compounds

The hydrophobic compound must have a melting point equal to or greater than 40°C. The claims identify:

Hydrogenated cottonseed oil
Hydrogenated soybean oil
Hydrogenated palm oil
Glyceryl behenate
Hydrogenated castor oil
Candelilla wax
Tristearin
Tripalmitin
Trimyristin
Beeswax
Carnauba wax
Yellow wax
Microcrystalline wax
Lanolin
Anhydrous dairy fat
Hard fat suppository bases
Glyceryl palmitostearate
Glyceryl stearate
Lauroyl macrogol glycerides
Polyglyceryl diisostearate
Diethylene glycol monostearate
Ethylene glycol monostearate
Omega-3 fatty acids
Hydrogenated poly-1-decene

Claim 8 and claim 39 narrow the polymer mixture to a range from 100% methacrylic acid/ethyl acrylate 1:1 and 0% methacrylic acid/methyl methacrylate 1:2, through 2% and 98%, respectively. The hydrophobic compound in these claims is hydrogenated vegetable oil.

Claims 9, 40 and 72 require a hydrophobic compound-to-polymer weight ratio of 0.4:1 to 4:1. Claims 10 and 41 require the coating to represent 10% to 50% by weight of the coated GHB particles.

What particle and dose limitations does the patent impose?

The patent distinguishes the immediate-release and modified-release populations by both composition and particle size.

Parameter	Claimed range
Immediate-release particle mean diameter	150 to 400 microns
Modified-release particle mean diameter	200 to 800 microns
Immediate-release GHB to modified-release GHB ratio	10/90 to 65/35
Narrower ratio range	40/60 to 60/40
Coating weight on modified-release particles	10% to 50%
Claimed GHB doses	4.5, 6.0, 7.5 or 9.0 grams
Broader sodium oxybate-equivalent range in claim 71	3.0 to 12.0 grams

The ratio is expressed as immediate-release GHB to modified-release GHB. A formulation with a 50/50 payload split falls within both claim 13 and claim 14. A formulation with 20% immediate-release material and 80% modified-release material falls within claim 13 but not claim 14.

The dose limitations are commercially significant because the claimed doses correspond to high-dose nighttime sodium oxybate therapy. Claims 63 through 66 separately cover 4.5-, 6.0-, 7.5- and 9.0-gram embodiments.

Does the patent exclude ethylcellulose technology?

Yes. Claims 69, 70 and 71 expressly exclude modified-release GHB particles having a coating comprising ethylcellulose.

This negative limitation has two consequences. First, the patent distinguishes the claimed technology from an ethylcellulose-based sustained-release approach. Second, a competing product using ethylcellulose as a required coating component may have a non-infringement position against these claims, subject to the composition and operation of the finished dosage form.

The exclusion does not necessarily avoid every claim in the patent if an accused formulation contains both ethylcellulose-coated particles and a separate population meeting the claimed acrylic-polymer and hydrophobic-compound limitations. The analysis would depend on whether the claim requires the entire modified-release portion to be free of ethylcellulose or only the claimed GHB particles.

What dissolution profile does U.S. Patent 10,272,062 require?

Claims 16 through 18, 47 through 49 and 87 through 89 protect specific in vitro release behavior.

The formulation is intended to release an initial fraction rapidly, maintain controlled release in acidic conditions and accelerate release after exposure to a higher-pH buffer.

Key dissolution limitations

Test condition	Claimed result
pH 6.8 phosphate buffer, 3 hours	At least 80% released
0.1 N hydrochloric acid, 1 hour and 3 hours	10% to 65% released
Immediate-release portion, acidic medium, 1 hour	Greater than 80% released
Modified-release portion, acidic medium, 1 hour	Less than 20% released
Modified-release portion after acid-to-pH 6.8 transition, 3 hours	Greater than 80% released
Acidic profile, claim 18, 1 hour	40% to 65%
Acidic profile, claim 18, 3 hours	40% to 65%
Acidic profile, claim 18, 8 hours	47% to 85%
Acidic profile, claim 18, 16 hours	At least 80%
pH 6.8 profile, 0.25 hour	43% to 94%
pH 6.8 profile, 0.35 hour	At least 65%
pH 6.8 profile, 1 hour	At least 88%

The testing conditions are unusually specific. They identify USP Apparatus 2, paddle speed, medium volume, temperature and buffer composition. These limitations can strengthen infringement analysis where a product’s release profile is documented, but they also create potential non-infringement and enablement arguments if the claimed profile is difficult to reproduce consistently across lots.

What pharmacokinetic characteristics are protected?

Claims 19 through 26 and 50 through 57 add pharmacokinetic limitations. The main objectives are:

Relative bioavailability above 80% compared with divided-dose immediate-release sodium oxybate
Lower or controlled late-night exposure
A high proportion of total exposure within the first eight hours
A Tmax close to that of a half-dose immediate-release solution
Defined C8h ranges after evening administration

Claim 24 specifies mean C8h ranges:

Dose	Mean C8h range
4.5 grams	3.5 to 9.0 micrograms/mL
6.0 grams	6.3 to 16.7 micrograms/mL
7.5 grams	13.0 to 40.3 micrograms/mL

Claims 25 and 26 require a mean AUC8h/AUCinf ratio above 0.80 and mean C8h below 95% of the comparator immediate-release solution. Claim 19 requires a 7.5-gram dose to have mean AUCinf above 340 hour·microgram/mL and C8h between 50% and 130% of the divided-dose comparator.

These claims are narrower than the formulation claims. They may be difficult to assert without access to clinical pharmacokinetic data, but they can provide additional positions against a product that copies the formulation and achieves substantially similar exposure.

What is the likely patent expiration date?

U.S. Patent No. 10,272,062 issued on April 30, 2019. Public drug-patent databases and FDA listing data identify an expiration date in 2029, generally reported as August 8, 2029 for the patent family associated with the once-nightly sodium oxybate formulation.[1][2]

Event	Date
Patent issued	April 30, 2019
Reported patent expiration	August 8, 2029
LUMRYZ FDA approval	May 1, 2023
Potential pediatric-exclusivity overlay	Requires confirmation from the applicable FDA exclusivity record

Patent expiration should be distinguished from regulatory exclusivity. A patent may expire after FDA market exclusivity, while a patent-term adjustment, terminal disclaimer or pediatric extension can affect the enforceable end date. The Orange Book listing is the operative commercial reference for an ANDA applicant evaluating LUMRYZ.

What is the Orange Book status of U.S. Patent 10,272,062?

U.S. Patent 10,272,062 is listed in connection with LUMRYZ, Avadel Pharmaceuticals’ extended-release oral suspension of sodium oxybate, approved under NDA 214755.[2][3]

The listing is significant because it requires an ANDA applicant to address the patent through one of the standard certifications:

Paragraph I: no patent information is listed
Paragraph II: the listed patent has expired
Paragraph III: approval is requested after patent expiration
Paragraph IV: the patent is invalid, unenforceable or will not be infringed

For a product seeking approval before the reported 2029 expiration date, a Paragraph IV certification would be the principal route to an earlier launch. FDA approval after a Paragraph IV notice can trigger a 30-month stay if the NDA holder or patent owner timely files an infringement action under the Hatch-Waxman framework.[4]

No biosimilar pathway applies. Sodium oxybate is a small molecule, and a competing product would generally proceed through an ANDA or, depending on the product and development strategy, a 505(b)(2) application.

Which companies are challenging the sodium oxybate patent estate?

The principal competitive issue is not biosimilar competition. It is competition among branded and generic oral sodium oxybate products.

Company	Product or program	Relevance to U.S. 10,272,062
Avadel Pharmaceuticals	LUMRYZ, once-nightly extended-release sodium oxybate	Commercial product associated with the claimed formulation architecture
Jazz Pharmaceuticals	XYREM and XYWAV, twice-nightly sodium oxybate products	Competing branded products; different dosing and formulation estates
Generic applicants	Potential ANDA developers	Would need to address Orange Book patents through Paragraph II, III or IV certification
505(b)(2) developers	Potential reformulation entrants	Could face patent, regulatory and clinical bridging issues

Jazz has pursued patent and regulatory strategies involving sodium oxybate products, including litigation concerning competitive entry and product development. The most direct patent risk for a generic LUMRYZ entrant would arise from the Avadel formulation patents listed in the Orange Book, including U.S. 10,272,062 and related continuation or improvement patents.[2][5]

A complete current list of Paragraph IV notices, ANDA filers and settlement agreements cannot be established from the claim text alone.

How does U.S. 10,272,062 compare with the Xyrem and Xywav patent estates?

Issue	LUMRYZ and U.S. 10,272,062	XYREM	XYWAV
Active ingredient	Sodium oxybate or pharmaceutically acceptable GHB salt	Sodium oxybate	Mixed-salt oxybate formulation
Dosing	Once nightly	Twice nightly	Twice nightly
Dosage form	Extended-release oral suspension or related solid/powder architecture	Immediate-release oral solution	Immediate-release oral solution
Core patent focus	Coated GHB particles, release profile and pharmacokinetics	Solution formulation, dosing and methods of use	Composition, salts, formulation and methods of use
Biosimilar risk	None in the biologic sense	None in the biologic sense	None in the biologic sense
Generic pathway	ANDA or potentially 505(b)(2)	ANDA or 505(b)(2)	ANDA or 505(b)(2)
Primary technical design-around	Alter coating chemistry, particle populations or release profile	Avoid solution and use limitations	Avoid mixed-salt and formulation limitations

The patent’s commercial value comes from reducing two nighttime administrations to one while maintaining overnight exposure. A competitor using a twice-nightly liquid solution would ordinarily target a different claim set. A competitor seeking a once-nightly product would encounter a more concentrated formulation barrier because the patent combines structural and performance limitations.

How strong is the patent estate?

The patent has moderate-to-strong commercial blocking potential for products that copy the disclosed formulation design. Its strength is highest in the following areas:

Strongest claim features

Combination of immediate-release and modified-release GHB particles
Acrylic polymer with free carboxylic groups
Hydrophobic compound melting at least 40°C
Specific polymer-to-hydrophobic-compound ratio
Coating weight of 10% to 50%
Defined release-payload ratio
Once-nightly administration
High-dose sodium oxybate range
Explicit exclusion of ethylcellulose-coated particles

Potential vulnerability points

Breadth of the Markush groups covering polymers and hydrophobic materials
Written-description support for the full combination of every listed excipient
Enablement across the full 0.4:1 to 4:1 hydrophobic-to-polymer ratio
Reproducibility of dissolution and pharmacokinetic limitations
Construction of "suitable for administration only once nightly"
Whether clinical PK results can be reliably attributed to the claimed formulation
Obviousness over enteric-coated multiparticulate systems combined with hydrophobic lipid barriers
Scope and enforceability of negative ethylcellulose limitations

The claim set includes multiple dependent claims that may survive even if broader claims are invalidated. A challenger would likely focus on the obviousness of combining known pH-sensitive polymers with hydrophobic waxes or hydrogenated oils, while the patent owner would emphasize the specific overnight dissolution and pharmacokinetic profile.

What design-around strategies could avoid infringement?

A competing developer could investigate several routes:

Use a modified-release polymer without free carboxylic groups.
Use a hydrophobic material melting below 40°C.
Replace the coating with ethylcellulose, provided the product does not also satisfy other asserted claim limitations.
Use a matrix tablet rather than coated GHB particles.
Use a single modified-release population without a separate immediate-release population.
Alter the immediate-release-to-modified-release ratio outside 10/90 to 65/35.
Develop a twice-nightly product rather than a once-nightly product.
Use a dose outside the claimed sodium oxybate-equivalent range.
Produce a release profile outside the specified acidic and pH 6.8 dissolution windows.
Use a different delivery system, such as a liquid, osmotic system or non-particulate matrix.

These strategies may create separate regulatory, manufacturing or clinical-development burdens. The most practical design-around is not necessarily the legally cleanest because changing the coating system can affect dose dumping, food effects, bioavailability and overnight exposure.

What manufacturing and intellectual-property barriers affect competitors?

The patent covers a product architecture that depends on manufacturing control over:

GHB particle size
Coating uniformity
Polymer-to-lipid ratio
Coating weight gain
pH-triggered dissolution
Immediate-release and modified-release blending
High-dose powder or suspension handling
Taste, viscosity and suspension stability

Claims 29, 60, 78, 79 and 80 add powder formulation limitations involving acidifying agents and suspending or viscosifying agents. The identified excipients include xanthan gum, carrageenan, hydroxyethylcellulose, sodium carboxymethylcellulose, alginate, malic acid and tartaric acid.

These claims can create manufacturing barriers even where a competitor avoids the narrowest coating composition. A technically different formulation may still need to solve the same high-dose, palatability, suspension and overnight-release problems.

What generic launch scenarios exist?

Launch after patent expiration

A Paragraph III applicant could seek approval with launch after the listed patent expires. This route avoids Paragraph IV litigation but delays market entry until the expiration date and any applicable exclusivity period.

Paragraph IV launch

A Paragraph IV applicant could assert that U.S. 10,272,062 is invalid, unenforceable or not infringed. The patent owner could file an action within 45 days of receiving notice, potentially creating a 30-month FDA approval stay under the Hatch-Waxman Act.[4]

At-risk launch

An applicant could launch before final resolution of litigation. This exposes the company to damages and injunction risk if the patent is upheld and found infringed.

Non-infringing 505(b)(2) product

A 505(b)(2) applicant could develop a once-nightly or modified-release sodium oxybate product with a different formulation and clinical bridge. This route may avoid some ANDA constraints but would still face patent litigation and regulatory exclusivity issues.

Key Takeaways

U.S. Patent 10,272,062 is a formulation patent, not a patent on GHB or sodium oxybate generally.
Its central architecture is a blend of immediate-release and coated modified-release GHB particles.
The coating combines a free-carboxylic-group polymer with a hydrophobic compound melting at least 40°C.
The patent claims acrylic polymers, hydrogenated oils, waxes, glycerides and related excipients.
Claims 1 and 71 are most closely tied to once-nightly narcolepsy treatment.
Claim 32 provides a separate high-dose formulation position for products containing at least 4.5 grams of GHB.
The patent excludes ethylcellulose-coated GHB particles in claims 69, 70 and 71.
Dissolution and pharmacokinetic claims provide narrower fallback protection.
The patent is associated with LUMRYZ and is publicly reported to expire in 2029.
Generic competition would generally require an ANDA certification, with Paragraph IV litigation the principal early-entry route.
Biosimilar competition is not applicable because sodium oxybate is a small molecule.
The most credible design-arounds alter the release architecture, coating chemistry, particle populations or dosing regimen.

FAQs

Is U.S. Patent 10,272,062 a patent on LUMRYZ?

It is associated with the once-nightly modified-release sodium oxybate technology used for LUMRYZ, but the patent does not necessarily cover every formulation, manufacturing process or presentation marketed under the LUMRYZ name.

Can a generic use sodium oxybate without infringing U.S. 10,272,062?

Yes. Sodium oxybate itself is not claimed. A generic would need to avoid the claimed combination of immediate-release and coated modified-release GHB particles, coating chemistry, release characteristics and other limitations.

Does using an enteric polymer automatically infringe the patent?

No. The patent requires a polymer carrying free carboxylic groups combined with a hydrophobic compound melting at least 40°C. An enteric polymer outside the claimed chemical classes, or used without the required hydrophobic compound, may avoid the claims.

Are the 4.5-, 6.0-, 7.5- and 9.0-gram doses independently protected?

They are expressly recited in dependent claims 11, 42 and 63 through 66. A product at one of those doses may still avoid infringement if it lacks another required limitation of the applicable independent claim.

Does an ethylcellulose coating provide a complete design-around?

Not necessarily. Claims 69, 70 and 71 exclude certain ethylcellulose-coated particles, but infringement depends on the complete formulation and the specific claims asserted. A product using multiple particle populations could require a claim-by-claim analysis.

References

United States Patent and Trademark Office. (2019). U.S. Patent No. 10,272,062, modified release formulations of gamma-hydroxybutyrate. https://patents.google.com/patent/US10272062B2/en
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
U.S. Food and Drug Administration. (2023, May 1). FDA approves new once-nightly drug for adults with narcolepsy. https://www.fda.gov/news-events/press-announcements/fda-approves-new-once-nightly-drug-adults-narcolepsy
U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j).
Avadel Pharmaceuticals plc. (2024). Annual report on Form 10-K. https://www.sec.gov/edgar/browse/?CIK=1847345

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-001	May 1, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	⤷ 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
Argentina	109376	⤷ Start Trial
Australia	2017300845	⤷ Start Trial
Australia	2020231916	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,272,062

Which drugs does patent 10,272,062 protect, and when does it expire?

Summary for Patent: 10,272,062