Details for Patent: 10,881,618

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Which drugs does patent 10,881,618 protect, and when does it expire?

Patent 10,881,618 protects JORNAY PM and is included in one NDA.

This patent has forty-two patent family members in fourteen countries.

Summary for Patent: 10,881,618

Title:	Compositions for treatment of attention deficit hyperactivity disorder
Abstract:	Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.
Inventor(s):	David Lickrish, Feng Zhang
Assignee:	Ironshore Pharmaceuticals and Development Inc Cayman Island , Formulation Technologies LLC
Application Number:	US16/802,742
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 10,881,618: Claim Scope, ADHD Formulation Protection, and Patent Landscape

U.S. Patent No. 10,881,618 protects nighttime administration of a multiparticulate methylphenidate hydrochloride formulation for pediatric and adolescent ADHD. Its core limitation is a three-part coated particle: a methylphenidate-containing core, a sustained-release layer, and a delayed-release layer that produces a prolonged drug-free lag period before methylphenidate release.

The patent is directed primarily to the product profile associated with JORNAY PM, a bedtime-administered delayed- and extended-release methylphenidate capsule. The strongest protection is the combination of specific excipients, delayed-release performance, pharmacokinetic parameters, pediatric ADHD treatment, and evening dosing.

What does U.S. Patent 10,881,618 protect?

The independent claim requires all of the following:

Required element	Claim 1 requirement
Patient population	Pediatric or adolescent subject
Disease	ADHD
Route	Oral administration
Active ingredient	Methylphenidate hydrochloride
Particle architecture	Coated particles
Core	Hydroxypropyl methylcellulose, microcrystalline cellulose, and methylphenidate hydrochloride
Sustained-release layer	Dibutyl sebacate, ethyl cellulose, hydroxypropyl cellulose, and magnesium stearate
Delayed-release layer	Dibutyl sebacate, methacrylic acid copolymer Type B, monoglycerides, diglycerides, and polysorbate 80
Initial release profile	At least six-hour lag period with no more than 5% methylphenidate release
Subsequent release	Sustained-release period
Pharmacokinetics	Median Tmax of about 12 to 16 hours in healthy adults

The claim is cumulative. A competing formulation must satisfy the structural, compositional, therapeutic, and performance limitations to literally infringe claim 1.

The patent does not broadly cover every delayed-release methylphenidate product. It targets a particular multiparticulate design with a defined excipient system and delayed pharmacokinetic profile.

How do claims 2 through 7 narrow the patent?

Claims 2 through 7 add narrower limitations and create alternative infringement positions.

Claim	Additional limitation	Practical effect
2	At least eight-hour lag with no more than about 5% release	Narrows the lag period and release threshold
3	At least 10-hour lag with no more than 10% release	Protects a later-release profile with a different threshold
4	Composition is contained in a hydroxypropyl methylcellulose capsule	Adds dosage-form protection
5	Evening administration and improved SKAMP combined scores from about 11 to 23 hours after dosing	Protects late-day and next-day functional benefit
6	Evening dosing with improvement in ADHD-RS-IV, BSFQ, or PREMB-R AM scores	Adds clinical outcome limitations
7	Dose of 20, 40, 60, 80, or 100 mg	Covers the commercial strength range

Claims 2 and 3 are formulation-performance claims. Claim 4 is a capsule and dosage-form claim. Claims 5 and 6 are method-of-use claims tied to clinical endpoints. Claim 7 is a dose-selection claim.

A product that fails the six-hour lag limitation may still fall within a different patent, but it would generally avoid literal infringement of claim 1 unless the accused product meets the required release profile.

What formulations are protected by U.S. Patent 10,881,618?

The formulation is a layered multiparticulate system.

Core layer

The core contains:

• Methylphenidate hydrochloride
• Hydroxypropyl methylcellulose
• Microcrystalline cellulose

Hydroxypropyl methylcellulose can function as a binder, matrix former, or release-modifying excipient. Microcrystalline cellulose commonly provides particle structure and processing characteristics. The claim does not specify the relative quantities of these ingredients, particle size, manufacturing process, or drug loading.

Sustained-release layer

The sustained-release layer must include:

• Dibutyl sebacate
• Ethyl cellulose
• Hydroxypropyl cellulose
• Magnesium stearate

Ethyl cellulose is the principal water-insoluble release-controlling polymer in the claimed combination. Dibutyl sebacate acts as a plasticizer. Hydroxypropyl cellulose and magnesium stearate contribute to coating performance and release control.

Delayed-release layer

The outer layer must include:

• Dibutyl sebacate
• Methacrylic acid copolymer Type B
• Monoglycerides
• Diglycerides
• Polysorbate 80

Methacrylic acid copolymer Type B is an enteric or pH-responsive polymer. The delayed-release layer is intended to prevent substantial methylphenidate release during the initial lag period. The combination of enteric polymer, plasticizer, lipid components, and surfactant is more limiting than a generic reference to an enteric coating.

Capsule shell

Claim 4 requires a hydroxypropyl methylcellulose capsule. This limitation may be important for a capsule product using the same coated particles but a different shell material. A gelatin capsule could avoid literal infringement of claim 4 while remaining potentially exposed under claim 1.

When does the claimed formulation release methylphenidate?

The asserted release profile has two stages:

1. A lag period lasting at least six hours, during which no more than 5% of total methylphenidate hydrochloride is released.
2. A sustained-release period producing a median Tmax of approximately 12 to 16 hours in healthy adults.

The dependent claims extend the lag period to at least eight hours or at least 10 hours, subject to different release thresholds.

This profile is designed for bedtime dosing. The product is administered at night while delaying stimulant exposure until the following morning. The pharmacokinetic limitation is measured in healthy adults, while the treatment method is directed to pediatric and adolescent ADHD patients.

That distinction creates a potential claim-construction issue. The formulation must meet the pharmacokinetic benchmark in healthy adults, but the treatment subject is a pediatric or adolescent patient. An accused product could challenge whether the Tmax limitation is satisfied under the specified testing conditions if its label, clinical data, or formulation differs from the patented product.

How do the method-of-use claims protect evening administration?

Claims 5 and 6 extend protection beyond formulation composition.

Claim 5 requires:

• Evening administration
• Pediatric or adolescent ADHD subjects
• Statistically significant improvement versus placebo
• Improvement in combined SKAMP scores
• Benefit from approximately 11 through 23 hours after evening administration

Claim 6 requires:

• Evening administration
• Improvement in at least one specified clinical measure
• ADHD-RS-IV Total Score, BSFQ score, or PREMB-R AM score

These claims are narrower than claim 1 because they require a particular dosing time and clinical effect. They may be relevant in litigation involving a product labeled for bedtime dosing, particularly where the label includes claims regarding morning behavior, school functioning, or late-day symptom control.

Method-of-use claims generally present a different enforcement theory from formulation claims. A manufacturer may avoid direct method infringement if it does not administer the drug. The patent owner may instead assert induced infringement based on labeling, promotional materials, dosing instructions, or other conduct encouraging the patented evening-use method.

What is the significance of the 20 mg to 100 mg dose range?

Claim 7 covers five specified strengths:

• 20 mg
• 40 mg
• 60 mg
• 80 mg
• 100 mg

The claim does not cover every possible methylphenidate dose. A formulation using 10 mg or 120 mg could avoid claim 7 while remaining within claim 1 if all claim 1 limitations are met.

For commercial products, claim 7 is relevant because it tracks the standard strength range associated with JORNAY PM. A generic manufacturer seeking approval for the same strengths would need to assess both the composition claims and the use claims.

How strong is the patent estate for the claimed formulation?

Based on the supplied claims, the patent has moderate-to-strong formulation specificity but narrower breadth than a basic active-ingredient patent.

Strengths

The claims combine several independent technical limitations:

• Defined core excipients
• Defined sustained-release coating
• Defined delayed-release coating
• Quantified lag period
• Quantified release threshold
• Pharmacokinetic Tmax range
• Pediatric or adolescent ADHD treatment
• Evening administration in dependent claims
• Commercial dose strengths

A prior-art reference would need to disclose, or render obvious, the combination rather than merely disclose methylphenidate or an enteric-coated dosage form.

The layered coating architecture also creates potential process and formulation barriers. A generic manufacturer could use a different polymer, plasticizer, surfactant, capsule shell, or release profile to reduce literal infringement risk.

Vulnerabilities

The claims also contain limitations that may create litigation vulnerabilities:

• "About" six, eight, 10, and 12 to 16 hours introduce measurement and boundary questions.
• "Significant improvement" requires statistical and clinical interpretation.
• The claim does not specify the exact dissolution protocol in the text supplied.
• The claim requires a Tmax measured in healthy adults while treating pediatric or adolescent subjects.
• The excipient lists may be vulnerable to obviousness arguments if the prior art disclosed enteric coatings, sustained-release ethyl cellulose coatings, or nighttime methylphenidate administration separately.
• Claims 5 and 6 depend on clinical outcomes that may not be inherent in every formulation meeting claim 1.

The strongest claims are likely claims 1 through 3 if the commercial product closely matches the listed excipient system and release profile. Claims 5 and 6 may provide valuable fallback protection but are more dependent on evidence concerning labeling, patient population, clinical endpoint, and statistical significance.

What is the FDA regulatory status of the associated product?

JORNAY PM is a methylphenidate hydrochloride delayed-release and extended-release capsule approved by the FDA for ADHD. The product is administered in the evening and is available in 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg strengths.[1]

The product is a Schedule II controlled substance. Its regulatory value derives from the combination of delayed onset, extended release, and bedtime dosing. The FDA label describes the product as a delayed-release and extended-release formulation rather than a conventional immediate-release methylphenidate product.[1]

The FDA approval does not independently establish infringement of U.S. Patent 10,881,618. Patent infringement depends on the claim limitations, including the detailed excipient composition and release testing.

What is the Orange Book status of U.S. Patent 10,881,618?

A small-molecule product such as JORNAY PM is evaluated through the FDA Orange Book, not the Purple Book. Orange Book-listed patents may include formulation, method-of-use, and other patents identified by the NDA holder.[2]

The supplied claim language is consistent with a patent that could be listed against a delayed-release methylphenidate capsule. Orange Book listing does not mean that every claim is valid or enforceable. It indicates that the NDA sponsor identified the patent as meeting the statutory listing criteria.

For an ANDA applicant, the relevant certification may be:

• Paragraph I, if no patent information is listed;
• Paragraph II, if the patent has expired;
• Paragraph III, if the applicant will wait until patent expiration;
• Paragraph IV, if the applicant contends that the patent is invalid, unenforceable, or not infringed; or
• A section viii statement, where applicable, for a method-of-use patent that the applicant omits from its labeling.

For this claim set, a section viii strategy would be difficult against claims 1 through 4 because they cover formulation and dosage-form features. It may be more relevant to claims 5 and 6, which are tied to evening administration and specific clinical benefits.

Which companies are challenging the patent?

A challenge cannot be established from the claims alone. A Paragraph IV certification is not itself a public patent-litigation record unless the NDA holder files an infringement action within the statutory period. Relevant sources include FDA Orange Book updates, ANDA litigation complaints, PACER, and district-court dockets.[2,3]

The principal commercial exposure would arise from an ANDA applicant seeking approval for methylphenidate delayed-release and extended-release capsules in the 20 mg through 100 mg strengths. A competing product could pursue one of three broad strategies:

Strategy	Patent risk
Copy the formulation and label	Highest risk under claims 1-7
Use different coating excipients or release profile	Reduces literal infringement risk but may create bioequivalence and development issues
Seek approval with omitted evening-use indications	May reduce exposure under claims 5 and 6 but does not address formulation claims

No biosimilar pathway applies. Methylphenidate hydrochloride is a small-molecule active ingredient, so competitive entry would proceed through the ANDA pathway rather than a biosimilar application.

What generic entry risks exist?

Generic entry risk depends on both patent barriers and regulatory substitution.

Formulation-copy risk

A product using the same three-layer architecture and excipient system could face a direct infringement allegation. The risk is highest if dissolution, lag time, and Tmax closely match the claimed ranges.

Design-around risk

A generic applicant could modify:

• The enteric polymer
• The plasticizer
• The lipid components
• The surfactant
• The sustained-release polymer
• The capsule shell
• The number of coating layers
• The lag period
• The dose strengths

A design-around must still satisfy FDA requirements for pharmaceutical equivalence, bioequivalence, stability, and product performance.

Label risk

A generic label that instructs bedtime administration and describes morning or late-day symptom control could create exposure under claims 5 and 6. Omitting those instructions may reduce method-of-use risk, but it would not eliminate formulation-claim risk.

What manufacturing and intellectual-property barriers exist?

The patent’s technical barriers are concentrated in multiparticulate coating control.

A manufacturer must control:

• Uniformity of methylphenidate loading
• Thickness and integrity of the sustained-release layer
• Thickness and pH response of the delayed-release layer
• Plasticizer distribution
• Particle agglomeration
• Capsule fill-weight uniformity
• Dissolution performance across storage conditions
• Batch-to-batch lag-time variability

The claim does not expressly require a particular manufacturing process. A manufacturer could potentially use a different coating sequence or equipment configuration while still infringing if the final product contains the claimed layers and ingredients.

Trade-secret manufacturing knowledge may therefore remain commercially important even where the patent discloses the broad formulation architecture.

How does U.S. Patent 10,881,618 compare with conventional methylphenidate patents?

Technology	Typical dosing concept	Relationship to Patent 10,881,618
Immediate-release methylphenidate	Multiple daytime doses	Generally outside the claimed delayed-release architecture
Conventional extended-release methylphenidate	Morning administration with daytime release	May avoid the nighttime lag and Tmax limitations
Enteric-coated methylphenidate	Delayed release after a pH trigger	Could overlap only if the full excipient and performance limitations are met
JORNAY PM-type formulation	Evening dosing with delayed morning onset and extended coverage	Closest commercial technology
Non-methylphenidate ADHD products	Atomoxetine, amphetamine products, nonstimulants	Generally outside the active-ingredient limitation

The patent is narrower than a patent covering methylphenidate generally, but it is commercially targeted at a differentiated dosing regimen that conventional extended-release products do not necessarily provide.

What patent litigation and settlement issues should investors monitor?

The most important indicators are:

1. Orange Book listings and delistings.
2. Paragraph IV notices concerning JORNAY PM.
3. Patent litigation filed within 45 days of a Paragraph IV notice.
4. Any 30-month stay of ANDA approval.
5. District-court claim-construction rulings.
6. Inter partes review petitions or institution decisions.
7. Generic launch dates under a settlement agreement.
8. Authorized-generic arrangements.
9. Label carve-outs involving evening administration or clinical endpoints.

A settlement could permit an agreed generic launch before the latest patent expiration date. The commercial value of such a settlement would depend on the number of claims asserted, the availability of noninfringing formulations, and whether the settlement includes an authorized generic or supply arrangement.

What is the likely commercial exposure?

The exposure is concentrated in the branded delayed-release methylphenidate market rather than the entire ADHD market.

Revenue risk would be highest if:

• An ANDA applicant copies the claimed coating system;
• The applicant obtains approval for all five commercial strengths;
• The FDA determines the product is therapeutically substitutable;
• The ANDA applicant prevails in Paragraph IV litigation; or
• A settlement permits early generic launch.

Revenue risk would be lower if the patent survives but generic manufacturers must design around the coating system and cannot demonstrate bioequivalence efficiently. A successful design-around could still erode pricing even without literal infringement.

Key Takeaways

• U.S. Patent 10,881,618 claims a specific multiparticulate methylphenidate formulation and nighttime ADHD treatment method.
• Claim 1 requires a methylphenidate core, sustained-release layer, delayed-release layer, six-hour minimum lag, and 12 to 16-hour median Tmax.
• Claims 2 and 3 strengthen protection for longer lag periods.
• Claim 4 adds a hydroxypropyl methylcellulose capsule limitation.
• Claims 5 and 6 protect evening dosing and specified pediatric clinical outcomes.
• Claim 7 covers the 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg strengths.
• The patent is not a broad methylphenidate patent. Its commercial focus is the JORNAY PM-type delayed-release and extended-release product.
• Generic risk is highest for a product that copies the excipient system, release profile, dosage strengths, and bedtime label.
• Biosimilar competition is irrelevant because methylphenidate is a small molecule.
• Orange Book status, Paragraph IV activity, litigation, settlement terms, and patent expiration should be verified against current FDA and court records before an investment or launch decision.

Frequently Asked Questions

Does U.S. Patent 10,881,618 cover all JORNAY PM capsules?

It potentially covers JORNAY PM-type capsules if the product satisfies the claimed excipient composition, coating architecture, release profile, and treatment limitations. FDA approval alone does not determine infringement.

Can a generic avoid the patent by changing the capsule shell?

Changing the capsule shell may avoid claim 4, but it would not necessarily avoid claim 1. Claim 1 does not require a particular capsule shell.

Does a six-hour lag period mean the drug is released exactly after six hours?

No. The claim requires at least six hours during which no more than 5% of methylphenidate is released, followed by sustained release. It does not require release to begin at precisely six hours.

Are method-of-use claims relevant if a generic label omits bedtime dosing?

Omitting bedtime dosing may reduce exposure under claims 5 and 6. It does not eliminate potential exposure under formulation claims 1 through 4 or dose claim 7.

Can an inter partes review challenge these claims?

Potentially. An interested party could challenge patentability before the Patent Trial and Appeal Board, subject to statutory timing, standing, estoppel, and other procedural requirements. The likely grounds would include anticipation or obviousness based on prior delayed-release methylphenidate and multiparticulate coating references.

References

1. U.S. Food and Drug Administration. (2018). JORNAY PM prescribing information: Methylphenidate hydrochloride delayed-release and extended-release capsules. FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

3. U.S. Patent and Trademark Office. (2024). Patent Center and Patent Trial and Appeal Board administrative records. USPTO.

4. U.S. Patent No. 10,881,618. (2021). Methylphenidate hydrochloride delayed-release and extended-release formulation and methods of use. United States Patent and Trademark Office.

Drugs Protected by US Patent 10,881,618

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						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 10,881,618

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230733
Australia	2016228307
Australia	2018202002
Brazil	112013024401
Canada	2830788
China	103608004
China	110151731