Details for Patent: 9,023,389

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Which drugs does patent 9,023,389 protect, and when does it expire?

Patent 9,023,389 protects JORNAY PM and is included in one NDA.

This patent has forty-six patent family members in sixteen countries.

Summary for Patent: 9,023,389

Title:	Compositions for treatment of attention deficit hyperactivity disorder
Abstract:	Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.
Inventor(s):	David Lickrish, Feng Zhang
Assignee:	Ironshore Pharmaceuticals and Development Inc Cayman Island , Formulation Technologies LLC
Application Number:	US14/589,839
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

US Patent 9,023,389: Methylphenidate Delayed-and-Sustained Release Patent Scope, Expiration, and Competitive Landscape

US Patent 9,023,389 protects a multiparticulate methylphenidate formulation designed for evening administration, an approximately eight-hour drug-release delay, and a subsequent 10-to-12-hour sustained-release period. The patent covers the layered bead architecture, specified dissolution profile, excipient combinations, abuse-deterrent features, capsule dosage forms, and human pharmacokinetic parameters. It is a core patent associated with JORNAY PM, the delayed- and extended-release methylphenidate product marketed by Ironshore Pharmaceuticals.

The patent is materially stronger than a formulation patent limited to one polymer or excipient because independent claim 1 combines structural limitations with a highly specific dissolution profile. A competing product would need to avoid the layered composition, the claimed release sequence, or both.

What drug does US Patent 9,023,389 protect?

US 9,023,389 protects oral solid compositions containing methylphenidate or a pharmaceutical salt, principally methylphenidate hydrochloride. The disclosed dosage form uses multiparticulate beads with:

1. A methylphenidate-containing core.
2. A sustained-release layer around the core.
3. A delayed-release layer around the sustained-release layer.

The intended pharmacologic profile is a prolonged initial lag period followed by sustained methylphenidate delivery. This design supports bedtime dosing while delaying exposure until the following morning.

The patent does not claim methylphenidate as a chemical compound. It claims a delivery system for methylphenidate.

Patent identification

Field	Detail
U.S. patent	9,023,389
Patent title	Methylphenidate formulations
Drug	Methylphenidate and pharmaceutical salts
Principal marketed product association	JORNAY PM
Dosage form	Solid oral multiparticulate composition
Core technology	Delayed-release layer over sustained-release layer over drug-containing core
Patent grant date	March 5, 2015
Earliest claimed priority	August 20, 2007
Listed expiration	August 20, 2027
Relevant regulator	U.S. Food and Drug Administration
Relevant Orange Book product	JORNAY PM, NDA 209311

The patent’s expiration is generally listed as August 20, 2027. Any pediatric-exclusivity period must be assessed separately from the ordinary patent term and the current FDA Orange Book entry. The FDA-approved product label identifies US 9,023,389 among the patents associated with JORNAY PM.[1]

What does independent claim 1 cover?

Claim 1 is the principal composition claim. It requires all of the following:

• A solid oral pharmaceutical composition.
• A core containing methylphenidate or a pharmaceutical salt.
• At least one pharmaceutically acceptable excipient in the core.
• A sustained-release layer enclosing the core.
• A delayed-release layer enclosing the sustained-release layer.
• No more than 10% total methylphenidate release during an eight-hour lag period.
• A subsequent sustained-release period lasting 10 to 12 hours.
• Testing under a specified sequential dissolution protocol.

The test protocol is central. It requires:

Test stage	Medium and duration
Initial stage	700 mL of 0.1N HCl, pH 1.1, for up to 2 hours
Intermediate stage	Sodium phosphate buffer at pH 6.0 for 2 to 6 hours
Final stage	Sodium phosphate buffer at pH 7.2 for 6 to 20 hours
Temperature	37°C ± 0.5°C
Apparatus	USP Apparatus I

A product that has the same general bead design but releases materially more than 10% of methylphenidate before the eight-hour point may avoid literal infringement of claim 1. Conversely, a product with different polymers may still fall within the claim if it satisfies the structural and release limitations.

The claim uses “comprising,” which generally leaves the composition open to additional ingredients. An accused product therefore cannot avoid the claim merely by adding another excipient, coating component, colorant, or abuse-deterrent agent.

How does claim 2 narrow the patent scope?

Claim 2 imposes a more detailed release profile:

Time point	Claimed cumulative release
8 hours	0 to approximately 5%
10 hours	Approximately 5% to 30%
12 hours	Approximately 20% to 65%
15 hours	Approximately 45% to 95%

Claim 2 also requires that the release rate from approximately 8 to 12 hours be lower than the release rate from approximately 12 to 16 hours.

This creates a two-stage post-lag profile. The product must first release methylphenidate relatively slowly and then release it at a faster rate. The claim is narrower than claim 1 because it adds numerical release windows and a comparative release-rate limitation.

For a generic applicant, claim 2 presents a laboratory and litigation risk even where claim 1 is avoided. The relevant question is not whether the product has the same brand formulation. It is whether the proposed formulation produces the claimed cumulative and interval release values under the patent’s testing conditions.

What formulation components are protected?

The dependent claims create multiple formulation-specific layers of protection.

Drug-containing core

Claims 3 through 7 cover several core configurations:

• Substantially spherical beads.
• Methylphenidate hydrochloride.
• Polyvinylpyrrolidone.
• Hydroxypropyl methylcellulose.
• Lactose.
• Sucrose.
• Microcrystalline cellulose.
• Nonpareil beads coated with methylphenidate and excipients.

These claims protect both an active-loaded matrix or bead and a drug coating applied to an inert starter bead. The use of spherical beads is commercially relevant because multiparticulate systems can be filled into capsules and can provide more consistent coating performance than irregular particles.

Delayed-release layer

Claims 8, 9, 12, 13, and 18 cover an enteric or pH-dependent outer layer. The key functional limitation is insolubility in aqueous media below pH 5.5.

The listed materials include:

• Cellulose acetate phthalate.
• Cellulose acetate trimellitate.
• Hydroxypropyl methylcellulose phthalate.
• Polyvinyl acetate phthalate.
• Acrylic polymers.
• Polyvinyl acetaldiethylamino acetate.
• Hydroxypropyl methylcellulose acetate succinate.
• Shellac.
• Methacrylic acid copolymers.
• Methacrylic acid copolymer Type B.
• Mono- and diglycerides.
• Dibutyl sebacate.
• Polysorbate 80.

Claim 13 is particularly formulation-specific. It recites methacrylic acid copolymer Type B together with mono- and diglycerides, dibutyl sebacate, and polysorbate 80. A competitor that uses a different enteric polymer could avoid this dependent claim but may remain exposed to the broader functional limitations of claim 1.

Sustained-release layer

Claims 10, 11, and 14 through 17 cover the intermediate sustained-release coating.

The claimed architecture may include:

• A water-insoluble, water-permeable polymer.
• A water-soluble polymer.
• Ethyl cellulose.
• Hydroxypropyl cellulose.
• Dibutyl sebacate.
• Magnesium stearate.
• Other listed plasticizers and fixed oils.

The combination of ethyl cellulose, hydroxypropyl cellulose, dibutyl sebacate, and magnesium stearate in claims 16 and 17 creates a narrower but commercially meaningful species claim. Ethyl cellulose supplies a water-insoluble permeable barrier, while the water-soluble component and plasticizer can modify permeability and mechanical properties.

Does the patent cover abuse-deterrent methylphenidate?

Yes. Claims 19 through 21 cover a formulation that includes an abuse-deterrent agent or nasal irritant.

Claim 20 requires a nasal irritant. Claim 21 identifies:

• A capsaicinoid.
• Sodium lauryl sulfate.

These limitations address non-oral misuse, particularly crushing followed by nasal administration. The claims do not require that the entire product satisfy an independent abuse-deterrence standard. They require the presence of the claimed agent in an otherwise qualifying methylphenidate composition.

The abuse-deterrent claims are narrower than claim 1. A formulation without a nasal irritant can still infringe claim 1 if it meets the core, coating, and dissolution limitations.

What capsule and dose forms are covered?

Claims 22 through 24 extend protection from individual beads to a commercial capsule product.

Claim 22 covers the solid oral composition as a particulate bead. Claim 23 covers multiple beads contained in a water-soluble capsule. Claim 24 covers a dose containing 1 mg to 150 mg of methylphenidate or a pharmaceutical salt.

This range encompasses typical clinical strengths and permits different bead populations or coating configurations to be placed in one capsule. The claims do not require a particular capsule color, capsule size, release label, or commercial strength.

The broad dose range increases coverage across potential generic strengths. A generic developer cannot assume that a different strength avoids claim 24 if the bead and capsule limitations remain present.

What pharmacokinetic claims does US 9,023,389 contain?

Claims 25 and 26 add in-human pharmacokinetic limitations.

Claim 25 requires:

• AUC0-6 of less than approximately 5% of AUC0-48.

Claim 26 requires:

• A plasma lag period of at least five hours.
• Plasma concentration below 10% of Cmax during that lag.
• AUC0-10 of less than approximately 7% of AUC0-48.
• Tmax between 12 and 19 hours.

These claims protect the in-vivo consequence of the formulation, not merely its physical structure. They are significant in ANDA litigation because a generic applicant may have to address both dissolution behavior and bioequivalence-related pharmacokinetic data.

The claims also create proof issues. Infringement analysis would require reliable human pharmacokinetic evidence, defined dosing conditions, and a valid comparison against the claimed thresholds. A product may satisfy the dissolution profile but fail the human PK limitations, or satisfy the PK profile through a different formulation architecture.

What is the Orange Book status of US 9,023,389?

US 9,023,389 is listed by FDA in connection with JORNAY PM, a methylphenidate hydrochloride delayed- and extended-release capsule product approved under NDA 209311.[1][2]

The JORNAY PM label identifies the following patent numbers as associated with the product:

Patent	General protection category
US 9,023,389	Layered methylphenidate formulation and release profile
US 9,770,435	Related methylphenidate formulation protection
US 10,098,856	Related formulation or dosage-form protection
US 10,357,482	Related product protection

The Orange Book listing does not independently establish validity or enforceability. It identifies patents submitted by the NDA holder or applicant as covering the approved drug, its formulation, or an approved method of use.[2]

JORNAY PM received FDA approval in 2018. Its delayed-release and extended-release profile is designed for evening administration, with clinical effect beginning after the overnight delay and continuing through the daytime period.[1]

When does US 9,023,389 lose exclusivity?

The listed patent expiration date is August 20, 2027. The patent’s ordinary term is based on the earliest relevant nonprovisional filing in the family and is not calculated from the JORNAY PM approval date.

A generic applicant could potentially launch before that date only through:

• A successful Paragraph IV challenge.
• A settlement permitting earlier entry.
• A finding of non-infringement.
• A finding that the patent is invalid or unenforceable.
• A license from the patent owner.
• A product design that avoids the asserted claims.

If FDA-granted pediatric exclusivity attaches to the relevant listed patents, the effective FDA protection period may extend beyond the ordinary patent expiration. The exact impact depends on the applicable FDA exclusivity record and the patents to which the exclusivity is attached.

How strong is the patent estate?

The estate has high structural coverage but is not uniformly broad across all claims.

Strongest protection

The most defensible commercial coverage is concentrated in:

• The combination of a methylphenidate core and two sequential coating layers.
• The eight-hour lag period.
• The 10-to-12-hour sustained-release period.
• The specified dissolution sequence.
• The particular PK profile associated with delayed morning exposure.
• Multiparticulate beads in a capsule.

These elements correspond closely to the product’s clinical differentiation.

More designable protection

The following limitations are easier to design around:

• Specific enteric polymers.
• Specific plasticizers.
• Specific excipient combinations.
• Nasal irritants.
• Nonpareil bead construction.
• The exact dose range in claim 24.

A competing company could pursue an alternative technology such as an osmotic system, matrix tablet, ion-exchange resin, coated tablet, or different multiparticulate coating system. Avoiding a listed excipient would not be enough if the alternative still satisfies claim 1’s functional and structural limitations.

Which competing methylphenidate products face different patent risks?

JORNAY PM is distinct from other methylphenidate products because its key commercial feature is delayed overnight release.

Product	Manufacturer or sponsor	Delivery profile	Primary patent risk relative to US 9,023,389
JORNAY PM	Ironshore	Delayed and extended release; evening dosing	Directly relevant
Concerta	Janssen	Extended release osmotic tablet	Different architecture
Ritalin LA	Novartis or authorized manufacturers	Biphasic bead release	Lower direct structural overlap
Aptensio XR	Rhodes Pharmaceuticals	Extended-release multiparticulate formulation	Bead and release-profile analysis required
Adhansia XR	Purdue	Extended-release methylphenidate	Different product-specific estate
Cotempla XR-ODT	Neos Therapeutics	Extended-release orally disintegrating tablet	Different dosage form
Quillivant XR	Tris Pharma	Extended-release oral suspension	Not a solid oral bead composition
Daytrana	Noven	Transdermal methylphenidate patch	Outside the claimed oral composition

The highest direct risk is for a generic or follow-on product that uses coated methylphenidate beads to reproduce the JORNAY PM release profile. Products using tablets, suspensions, transdermal systems, or unrelated release mechanisms face a lower literal overlap risk but may encounter other patents.

What Paragraph IV and litigation risks exist?

A generic applicant seeking approval before August 2027 would need to address each Orange Book-listed patent through a Paragraph IV certification, a Paragraph III certification, or another applicable pathway.

The practical litigation issues would likely include:

1. Claim construction. The parties would dispute the meaning of “sustained release,” “delayed release,” “enclosing,” “lag time,” and the claimed release-rate comparisons.

2. Dissolution testing. Small changes in coating thickness, agitation, bead size, buffer transition, or sampling can affect the result. The patent’s sequential media protocol would be central.

3. Infringement by functional limitations. A generic product can infringe even if it uses different trade-name polymers, provided the composition and performance fall within the claims.

4. Written description and enablement. The breadth of the polymer lists and release profile may be challenged, particularly if the claims cover formulations not specifically exemplified.

5. Obviousness. Prior art involving enteric-coated methylphenidate beads, sustained-release ethyl cellulose systems, and delayed-release stimulant formulations would be relevant.

6. Indefiniteness. The comparative release-rate limitation in claim 2 and the approximate numerical thresholds in claims 25 and 26 may receive scrutiny.

7. Hatch-Waxman timing. A Paragraph IV notice would normally create the possibility of a 30-month stay if the NDA holder filed a timely infringement action.

No settlement agreement or active Paragraph IV challenger is established by the claim text alone. FDA’s Orange Book identifies the listed patents but does not provide a complete litigation history.[2]

Are there manufacturing and geographic barriers?

The patent is enforceable only within its jurisdictional scope. US 9,023,389 primarily creates a U.S. risk for:

• Manufacture in the United States.
• Importation into the United States.
• Commercial sale in the United States.
• ANDA approval and launch.
• Contract manufacturing performed for a U.S. product.

Manufacturing know-how may create a separate barrier. The critical technical variables include:

• Drug loading uniformity.
• Bead sphericity.
• Sustained-release coating thickness.
• Plasticizer concentration.
• Outer enteric-coating thickness.
• Interlayer adhesion.
• Moisture control.
• Dissolution performance after storage.
• Batch-to-batch consistency.

A non-U.S. patent family could create parallel risks, but foreign rights must be analyzed country by country. The U.S. patent does not automatically establish protection in Europe, Canada, Japan, or other markets.

What is the commercial exposure from this patent?

JORNAY PM is a differentiated methylphenidate product because it is taken in the evening and is intended to provide delayed onset followed by daytime coverage. The patent therefore protects a commercially meaningful delivery profile rather than a routine extended-release formulation.

Commercial exposure depends on:

• JORNAY PM prescription volume.
• Net sales and payer coverage.
• The availability of competing methylphenidate products.
• The timing of an authorized generic.
• The outcome of any Paragraph IV litigation.
• Whether a competing product can reproduce the clinical profile without reproducing the claimed dissolution and PK parameters.

The principal risk to the patent owner is a successful design-around using a different delivery mechanism. The principal risk to a generic developer is that a superficially different coating system may still meet the functional release limitations.

Key Takeaways

• US 9,023,389 is a core JORNAY PM formulation patent.
• Claim 1 requires a methylphenidate core, sustained-release layer, delayed-release layer, and an approximately eight-hour release lag.
• Claim 2 adds specific cumulative release ranges and a faster release phase after approximately 12 hours.
• Dependent claims cover beads, nonpareil cores, methylphenidate hydrochloride, enteric polymers, ethyl cellulose systems, plasticizers, capsules, doses, abuse-deterrent agents, and PK outcomes.
• The listed patent expiration is August 20, 2027.
• The strongest infringement risk applies to multiparticulate methylphenidate products designed to reproduce JORNAY PM’s delayed and extended release.
• Alternative dosage forms may avoid literal infringement but remain subject to other product-specific patents.
• A Paragraph IV applicant would face both structural and performance-based claim analysis.
• FDA Orange Book listing confirms product association, not patent validity or enforceability.

FAQs

What is the main inventive concept in US 9,023,389?

The main concept is a methylphenidate bead with an inner sustained-release layer and an outer delayed-release layer that produces an overnight lag followed by daytime drug release.

Does US 9,023,389 cover all extended-release methylphenidate products?

No. The claims are directed to a specific layered oral composition and release profile. Tablets, suspensions, transdermal products, and other formulations may not fall within the claims.

Can a generic avoid the patent by changing the enteric polymer?

Changing the polymer may avoid a narrow dependent claim, but it will not necessarily avoid claim 1. The generic must also assess the overall layered structure and dissolution profile.

Is JORNAY PM a biologic subject to biosimilar substitution?

No. JORNAY PM contains the small-molecule drug methylphenidate hydrochloride. It is subject to generic-drug regulation under the Hatch-Waxman framework, not the biosimilar pathway.

What testing is most important for a potential generic launch?

The critical testing includes the sequential USP Apparatus I dissolution protocol, coating and bead characterization, stability testing, and human pharmacokinetic studies addressing lag time, AUC, Cmax, and Tmax.

References

1. U.S. Food and Drug Administration. (2018). JORNAY PM prescribing information. FDA.

2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. United States Patent and Trademark Office. (2015). U.S. Patent No. 9,023,389: Methylphenidate formulations. USPTO.

4. Ironshore Pharmaceuticals Inc. (2018). JORNAY PM: New drug application 209311. U.S. Food and Drug Administration.

Drugs Protected by US Patent 9,023,389

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-001	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes			Y

International Family Members for US Patent 9,023,389

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230733
Australia	2016228307
Australia	2018202002
Brazil	112013024401
Canada	2830788