Details for Patent: 11,911,518

Which drugs does patent 11,911,518 protect, and when does it expire?

Patent 11,911,518 protects JORNAY PM and is included in one NDA.

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

Summary for Patent: 11,911,518

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:	US17/557,524
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Patent 11,911,518: Methylphenidate Delayed-Release Patent Scope, Claims, Orange Book Position and Generic Risk

US Patent 11,911,518 protects a method of treating pediatric or adolescent ADHD with an evening-administered methylphenidate capsule that combines a delayed-release period with sustained release. The commercial profile corresponds closely to Jornay PM, an evening-dosed methylphenidate hydrochloride product approved by the FDA for ADHD.[1]

The patent does not broadly claim every methylphenidate formulation or every extended-release ADHD treatment. Its principal coverage depends on four elements:

1. The patient must be pediatric or adolescent and have ADHD.
2. The product must be an oral solid composition containing multiparticulate methylphenidate.
3. Each particle must have a methylphenidate core, sustained-release layer and delayed-release layer.
4. The composition must achieve a defined pharmacokinetic profile, including at least a six-hour lag period and a median Tmax of about 12 to 16 hours in healthy adults.

The strongest commercial protection is directed to evening dosing that controls early-morning and school-day ADHD symptoms without requiring administration upon waking.

What does US Patent 11,911,518 claim?

Claim 1 is an independent method-of-treatment claim. It requires both product limitations and patient-treatment limitations.

Claim element	Required scope
Patient	Pediatric or adolescent subject
Disease	ADHD
Route	Oral administration
Dosage form	Solid oral pharmaceutical composition
Particle structure	Multiple particles
Active ingredient	Methylphenidate or a pharmaceutical salt
Inner structure	Core containing an effective amount of active ingredient
Release coating 1	Sustained-release layer
Release coating 2	Delayed-release layer
Initial release	At least six-hour lag with no more than 5% release
Later release	Sustained-release period
Pharmacokinetics	Median Tmax of approximately 12 to 16 hours in healthy adults

The claim is a treatment claim rather than a standalone composition claim. A party that makes or sells a formulation with the claimed particle structure may not infringe claim 1 solely by manufacturing the product. Infringement requires the additional method limitations, including treatment of a pediatric or adolescent ADHD patient.

Claims 2 through 8 narrow claim 1. They do not create independent protection for formulations that fall outside claim 1.

How do claims 2 through 8 narrow the patent?

Claims 2 and 3: extended lag-time limitations

Claim 2 requires at least an eight-hour lag period with no more than approximately 5% methylphenidate release.

Claim 3 requires at least a 10-hour lag period with no more than 10% release. The supplied text repeats “methylphenidate” and likely contains a drafting or transcription error. The operative limitation is the 10-hour lag and release threshold.

These claims target formulations that delay pharmacological exposure until nighttime sleep has progressed. They are narrower than claim 1 because they impose longer delay periods, but they may be commercially important if the marketed product consistently demonstrates an eight- to 10-hour delay.

The wording creates two technical questions in an infringement dispute:

• Whether “lag time” is measured from administration or from the beginning of the dissolution test.
• Whether the release threshold is assessed under a specific dissolution protocol incorporated by the patent specification or regulatory product testing.

A generic developer could seek to design around these claims by producing a product with a shorter delay, a different early-release percentage, or a different release mechanism. Such a design would still need to avoid claim 1.

Claim 4: capsule dosage form

Claim 4 limits the composition to a capsule. It is commercially relevant because Jornay PM is supplied as capsules that can be swallowed whole or opened and sprinkled over certain soft foods under the FDA-approved labeling.[1]

A tablet, liquid, orally disintegrating dosage form or transdermal product would not satisfy claim 4, although it could still fall within claim 1 if it met the broader “solid, oral pharmaceutical composition” language and particle limitations.

Claims 5 and 6: evening administration and clinical outcomes

Claim 5 requires evening dosing and a statistically significant improvement over placebo in combined SKAMP scores from approximately 11 through 23 hours after administration.

Claim 6 requires evening administration and a significant improvement in one or more of the following:

• ADHD-RS-IV Total Score;
• Before School Functioning Questionnaire score; or
• PREMB-R AM score.

These limitations link patent scope to clinical performance. They are difficult to evaluate from the product label alone because “significant improvement” is ordinarily assessed against the clinical-trial data and statistical methodology described in the patent and regulatory record.

A competing product could have the same broad delayed-release concept but avoid claims 5 or 6 if it does not demonstrate the specified endpoints, time window or statistical result. That would not necessarily avoid claim 1.

Claim 7: dosage strengths

Claim 7 specifies 20 mg, 40 mg, 60 mg, 80 mg or 100 mg of methylphenidate or a pharmaceutical salt.

These strengths correspond to the marketed Jornay PM dosage range. The FDA label identifies 20 mg, 40 mg, 60 mg, 80 mg and 100 mg capsules and provides titration instructions for patients six years of age and older.[1]

A product using 10 mg or 120 mg could avoid claim 7 but would remain exposed to claim 1 if the other limitations were present.

Claim 8: remaining drug released during sustained release

Claim 8 requires that, after the lag period, the remaining methylphenidate be released during the sustained-release period.

This limitation excludes a formulation that releases a portion of the dose during the lag phase and then releases the remainder through a separate immediate-release pulse, unless the entire remaining amount is still released during the claimed sustained-release period.

What formulation technology does US 11,911,518 protect?

The patent protects a multiparticulate delivery architecture with sequential release functions:

1. A methylphenidate-containing core.
2. A sustained-release layer that controls the rate of drug release.
3. A delayed-release layer that prevents meaningful release for several hours.

The claimed architecture is different from a conventional extended-release tablet that begins releasing methylphenidate shortly after administration. It is also different from a simple immediate-release dose taken at bedtime.

The patent’s functional center is the combination of:

• delayed onset;
• prolonged exposure;
• evening administration; and
• next-day ADHD symptom control.

The use of “a plurality of particles” is important. A formulation consisting of coated beads, pellets, granules or similar multiparticulates may fall within the particle limitation if each particle has the required core and coating layers.

The claim does not expressly require a particular polymer, coating material, particle size, capsule shell or manufacturing process. Those details may be relevant to infringement only if the patent specification or asserted claim construction gives them limiting significance.

What is the relationship between US 11,911,518 and Jornay PM?

Jornay PM is the leading commercial product associated with the claimed profile. The FDA approved Jornay PM in 2018 as a methylphenidate hydrochloride delayed-release and extended-release capsule for ADHD.[1]

The FDA label describes evening administration, generally between 6:30 p.m. and 9:30 p.m., with dosage adjustment based on the patient’s response and morning or daytime adverse effects.[1] The product is intended to provide therapeutic coverage beginning after waking and continuing through the day.

The patent claims track the product’s regulatory and clinical positioning:

Product characteristic	Jornay PM profile	Relevance to Patent 11,911,518
Active ingredient	Methylphenidate hydrochloride	Expressly covered
Dosage form	Capsule	Claim 4
Strengths	20, 40, 60, 80 and 100 mg	Claim 7
Administration	Evening	Claims 5 and 6
Release design	Delayed-release plus extended-release	Claim 1
Target population	Pediatric ADHD, with labeling for patients six years and older	Claim 1
Clinical objective	Morning and daytime symptom control	Claims 5 and 6

The patent therefore has a high product-to-claim correlation with Jornay PM. That correlation increases practical enforcement value even though the claims are formally limited to specific methods and performance characteristics.

What is the Orange Book status of US Patent 11,911,518?

The Orange Book listing is the central FDA mechanism for identifying patents submitted for an approved drug and for triggering statutory patent-certification procedures in an abbreviated new drug application.[2]

Patent 11,911,518 should be analyzed together with the other patents listed for methylphenidate hydrochloride delayed-release and extended-release products, rather than treated as the entire Jornay PM estate. Orange Book protection can include patents directed to:

• composition architecture;
• delayed-release and extended-release coatings;
• pharmacokinetic performance;
• dosing methods;
• pediatric or adolescent treatment;
• clinical-use methods; and
• dosage forms.

The relevant generic applicant must evaluate every listed patent. A Paragraph IV certification against one patent does not remove the need to address other listed patents.

Patent listing and patent enforceability are separate questions. The FDA generally does not determine validity, infringement or enforceability when it lists a patent. Those issues are litigated under the Hatch-Waxman framework or in a separate patent action.[2][3]

When does US Patent 11,911,518 lose exclusivity?

The patent’s enforceable term is determined from its patent-term calculation, priority chain, terminal disclaimers and any applicable patent-term adjustment or extension. The expiration date should be taken from the official USPTO patent record and the current Orange Book listing, not inferred solely from the issue date.

The patent issued on February 27, 2024. The relevant commercial question is not the issue date but the expiration date and whether the patent is listed against the applicable Jornay PM NDA.

A practical exclusivity timeline has four components:

Event	Business significance
FDA approval of Jornay PM	Established the product’s regulatory market
Patent issuance	Created an additional enforceable patent right
Orange Book listing	Enabled a potential statutory stay after a Paragraph IV notice and suit
Patent expiration or successful invalidity ruling	Opens the relevant patent barrier to generic entry

FDA regulatory exclusivity is separate from patent protection. The initial FDA exclusivity period for Jornay PM is not the same as the life of Patent 11,911,518. FDA exclusivity may expire while later-issued patents remain enforceable.[1][2]

Which companies are challenging Jornay PM patents?

A Paragraph IV challenge requires an ANDA applicant to certify that a listed patent is invalid, unenforceable or will not be infringed. The filing of a Paragraph IV certification does not itself establish a challenge in court. The brand company generally must sue within the statutory period to obtain the 30-month stay under the Hatch-Waxman Act.[3]

Publicly assessable risk should be separated into three categories:

1. Confirmed ANDA challenge with litigation filed.
2. Paragraph IV certification reported but litigation not confirmed.
3. Potential competitive entry without a public patent challenge.

The supplied claim text does not identify an ANDA applicant, Paragraph IV notice, district court case or settlement. No challenger or settlement should be attributed to Patent 11,911,518 without a corresponding FDA, court or company record.

Generic methylphenidate products that use conventional immediate-release or extended-release technologies are not direct substitutes for the claimed evening-dosed profile. The most relevant challenger would need to reproduce the delayed-release, sustained-release and pharmacokinetic characteristics while avoiding at least one limitation in each asserted claim.

What generic launch risks exist for a product covered by Patent 11,911,518?

Risk from a full-product copy

A generic that replicates the Jornay PM capsule, strengths, multiparticulate architecture and evening-use profile would face the highest risk under claims 1, 4, 5, 6 and 7.

The method-of-treatment format does not eliminate risk. Under Hatch-Waxman litigation, infringement can be based on the intended use and labeling of the ANDA product. A proposed label instructing evening administration to pediatric or adolescent ADHD patients could support an infringement theory.

Risk from a formulation design-around

Potential design-around strategies include:

• using a tablet rather than a multiparticulate capsule;
• changing the delayed-release coating;
• producing less than a six-hour lag;
• using a median Tmax outside the claimed range;
• using a different dosage strength;
• avoiding an evening-use indication;
• changing the clinical-use language in the proposed label.

Each strategy must be evaluated against the independent claim. Avoiding claim 7, for example, does not avoid claim 1.

Risk from an authorized generic or license

An authorized generic or licensed launch could enter without relying on the same freedom-to-operate position as an independent Paragraph IV challenger. The commercial outcome would depend on the brand owner’s licensing strategy, supply agreement, settlement terms and any limitations on timing or product presentation.

No licensing or settlement arrangement is established by the claim text alone.

How strong is the patent estate for delayed-release methylphenidate?

The estate appears commercially strong against a close copy because the claims combine structural and performance limitations. A challenger must address both the particle architecture and the release profile.

Its principal strengths are:

• close alignment with the marketed product;
• coverage of evening dosing;
• specific pediatric and adolescent treatment;
• protection for commercially relevant dosage strengths;
• pharmacokinetic limitations that map to the product’s clinical rationale;
• clinical-outcome claims covering morning and daytime function.

Its principal vulnerabilities are:

• claim 1 is a method claim rather than a pure composition claim;
• the claim requires proof of multiple technical limitations;
• the “about 12-16 hours” Tmax range may create claim-construction and testing disputes;
• “significant improvement” in claims 5 and 6 raises statistical and evidentiary issues;
• a properly designed alternative formulation may avoid one or more structural limitations;
• patent validity may be challenged using prior art involving delayed-release methylphenidate, multiparticulate coatings, chronotherapy or evening administration.

The patent is stronger as a blocking right against a Jornay PM substitute than as a broad platform patent covering all delayed-release stimulant technologies.

How does Jornay PM compare with competing ADHD medicines?

Product	Active ingredient	Typical administration	Release concept	Relationship to Patent 11,911,518
Jornay PM	Methylphenidate HCl	Evening	Delayed-release and extended-release	Direct commercial reference
Concerta	Methylphenidate HCl	Morning	Extended-release tablet	Different administration and dosage architecture
Ritalin LA	Methylphenidate HCl	Morning	Biphasic extended release	No evening lag profile
Quillivant XR	Methylphenidate HCl	Morning	Extended-release liquid	Not a solid multiparticulate capsule
Vyvanse	Lisdexamfetamine	Morning	Prodrug conversion	Different active ingredient
Azstarys	Serdexmethylphenidate and dexmethylphenidate	Morning	Prodrug plus immediate release	Different active ingredients and release strategy

The patent does not create biosimilar risk. Methylphenidate is a small-molecule drug, so competing products would generally use the ANDA generic pathway rather than the FDA biosimilar pathway.[2]

What patent litigation and settlement issues matter?

For a listed drug patent, the key litigation dates are:

• Paragraph IV notice date;
• date the NDA holder receives notice;
• date of patent-infringement complaint;
• 30-month stay start and end;
• any preliminary injunction ruling;
• claim-construction decision;
• trial or summary-judgment result;
• settlement or license effective date;
• first permissible commercial launch date.

A settlement may permit an agreed launch before patent expiration, but the actual date can depend on FDA approval, other patents, supply obligations, pediatric exclusivity and restrictions imposed by the agreement.

Patent 11,911,518 should not be assessed in isolation. A generic launch can remain blocked by another listed patent even if the challenger defeats this patent. Conversely, a patent may have little practical value if it is not listed, if the proposed generic label omits the patented use, or if a court finds the claims invalid or not infringed.

Key Takeaways

• US Patent 11,911,518 is directed to evening treatment of pediatric or adolescent ADHD with multiparticulate methylphenidate having delayed and sustained release.
• Claim 1 requires a six-hour minimum lag, no more than 5% initial release and a median Tmax of about 12 to 16 hours in healthy adults.
• Claims 2 and 3 extend the lag requirement to eight and 10 hours, respectively.
• Claims 5 and 6 add evening dosing and clinical ADHD outcome limitations.
• Claim 7 covers the 20 mg through 100 mg strengths associated with Jornay PM.
• The patent is a method patent, not an unrestricted composition patent.
• The principal generic risk is a close Jornay PM copy with the same capsule, particle architecture, strengths, evening labeling and pharmacokinetic profile.
• Methylphenidate competitors are subject to generic-drug analysis, not biosimilar analysis.
• Orange Book and litigation analysis must include the entire Jornay PM patent estate, not Patent 11,911,518 alone.
• A confirmed Paragraph IV challenger, litigation outcome or settlement cannot be established from the claim language provided.

FAQs

Is US Patent 11,911,518 a composition patent or a method patent?

It is principally a method-of-treatment patent. Its independent claim requires administration to a pediatric or adolescent ADHD patient. The formulation limitations define the product used in the method.

Does a generic methylphenidate tablet infringe Patent 11,911,518?

A conventional methylphenidate tablet would generally not satisfy the multiparticulate core, sustained-release layer and delayed-release layer limitations. It also would need to meet the claimed lag time and Tmax profile.

Does taking Jornay PM in the morning avoid the patent claims?

Morning administration could avoid the express evening-administration limitations in claims 5 and 6. It would not necessarily avoid claim 1, which does not expressly require evening administration.

Can a product with a 10-hour lag avoid claim 1?

Not necessarily. A 10-hour lag would generally satisfy the six-hour lag requirement in claim 1 if the product also met the release threshold, sustained-release and Tmax limitations.

Are the 20 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths independently protected?

They are expressly recited in dependent claim 7. A product using one of those strengths may still face claim 1 even if claim 7 is found invalid or not infringed.

References

1. U.S. Food and Drug Administration. (2018). Jornay PM (methylphenidate hydrochloride) delayed-release and extended-release capsules: Prescribing information. FDA.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations (Orange Book). FDA.
3. U.S. Code, 21 U.S.C. § 355(j). Abbreviated new drug applications and patent certifications.
4. United States Patent and Trademark Office. (2024). U.S. Patent No. 11,911,518. USPTO.

Drugs Protected by US Patent 11,911,518

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)

International Family Members for US Patent 11,911,518

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230733
Australia	2016228307
Australia	2018202002