US Patent 11,241,392: Scope, Claim Construction, Orange Book Exposure, and Generic Entry Risk

US Patent 11,241,392 protects an evening-administered methylphenidate hydrochloride multiparticulate formulation designed to delay drug release for at least six hours and then provide sustained exposure. The claims cover both the formulation architecture and pharmacokinetic performance. The commercial product most closely associated with this technology is Jornay PM, an FDA-approved delayed-release and extended-release methylphenidate capsule marketed by Ironshore Therapeutics.[1][2]

The patent’s strongest protection is the combination of:

Methylphenidate hydrochloride cores;
A sustained-release coating;
A delayed-release outer coating;
A defined excipient set;
A six-hour or longer release lag;
A median Tmax of approximately 12 to 16 hours in healthy adults.

The patent does not broadly cover all methylphenidate extended-release products. It targets a specific coated-particle design and release profile.

What does US Patent 11,241,392 protect?

The independent claims protect solid oral compositions containing coated methylphenidate particles.

Claim	Principal subject matter	Key limitation
1	Composition with coated methylphenidate particles	Core, sustained-release layer, delayed-release layer, listed excipients, six-hour lag, Tmax of 12-16 hours
8	Composition with coated particles	Similar structure, but the particles “consist of” the listed components
2	Dependent formulation	At least eight-hour lag with no more than about 5% release
3	Dependent formulation	At least 10-hour lag with no more than 10% release
4	Capsule dosage form	Hydroxypropyl methylcellulose capsule
5	Clinical performance	Improved SKAMP scores from approximately 11 to 23 hours after evening administration
6	Clinical performance	Improvement in ADHD-RS-IV, BSFQ, or PREMB-R AM scores
7	Dosage strengths	20, 40, 60, 80, or 100 mg methylphenidate hydrochloride
9-14	Claims dependent from claim 8	Corresponding lag-time, capsule, clinical, and dosage-strength limitations

The patent claims a drug-delivery system rather than methylphenidate as a molecule. Methylphenidate hydrochloride is an established active ingredient. The potentially differentiating intellectual property lies in the layered particle construction and its timing characteristics.

How is the formulation architecture constructed?

The claims require three sequential structural elements:

A core containing methylphenidate hydrochloride.
A sustained-release layer enclosing the core.
A delayed-release layer enclosing the sustained-release layer.

This architecture creates two release controls. The sustained-release layer limits the rate of release after the formulation begins releasing drug. The delayed-release layer postpones the start of release after evening administration.

The claimed excipients are:

Microcrystalline cellulose;
Dibutyl sebacate;
Diglycerides;
Ethyl cellulose;
Hydroxypropyl cellulose;
Hydroxypropyl methylcellulose;
Magnesium stearate;
Methacrylic acid copolymer Type B;
Monoglycerides;
Polysorbate 80; and
Talc.

The claims do not expressly assign each excipient to a particular coating layer. That issue would likely depend on the specification, examples, manufacturing disclosures, and claim-construction principles. A formulation containing the same ingredients but assigning them to materially different processing stages could still face infringement risk if the resulting particles satisfy the structural and performance limitations.

What is the difference between claim 1 and claim 8?

Claim 1 uses “comprising” for the coated particles. Claim 8 uses “consisting of.”

That distinction is commercially important.

“Comprising” is an open-ended transitional term. A particle that contains all listed components may fall within claim 1 even if it includes additional ingredients, subject to the remaining limitations.

“Consisting of” is narrower. It generally excludes additional material components that materially alter the claimed composition, although ordinary impurities, residual solvents, processing artifacts, and legally permissible incidental materials may not necessarily avoid infringement.

Issue	Claim 1	Claim 8
Transitional language	Comprising	Consisting of
Additional particle ingredients	Generally permitted	Generally excluded
Design-around difficulty	Higher	Lower
Enforcement value	Broader composition coverage	Narrower fallback composition
Relevance to product testing	Ingredient presence and performance	Exact particle composition becomes more important

A generic applicant could attempt to avoid claim 8 by adding or substituting a coating excipient. That strategy would not necessarily avoid claim 1, because claim 1 is open-ended.

What release profile is required?

The core performance limitation in claims 1 and 8 is a two-stage pharmacokinetic and dissolution profile:

At least a six-hour lag period;
No more than 5% release during that period;
Sustained release after the lag period;
Median Tmax of about 12 to 16 hours in healthy adults.

The dependent claims increase the lag-time requirements:

Claim	Lag requirement	Maximum release during lag
1 and 8	At least 6 hours	No more than 5%
2 and 9	At least 8 hours	About 5%
3 and 10	At least 10 hours	10%

The claims therefore combine structural limitations with measurable product-performance limitations. A competing product may contain similar coatings but avoid infringement if it fails the claimed lag-time or Tmax range. Conversely, a formulation with different excipients could still face risk under claim 1 if it contains the required listed ingredients and meets the release profile.

The testing protocol would matter. The patent specifies administration to healthy adults for the Tmax limitation. The exact statistical treatment, sampling schedule, fed or fasted state, and definition of median Tmax could affect infringement analysis.

What clinical uses are protected?

Claims 5, 6, 12, and 13 add clinical-performance limitations for pediatric or adolescent patients with ADHD.

The claimed outcomes include:

Statistically significant improvement in SKAMP combined scores from approximately 11 through 23 hours after evening administration;
Improvement in ADHD-RS-IV Total Score;
Improvement in the Before School Functioning Questionnaire;
Improvement in the Parent Rating of Evening and Morning Behavior-Revised morning score.

These claims seek to protect the clinical use of the formulation, not merely its physical composition. They are narrower than claims 1 and 8 because infringement would require satisfaction of the underlying composition limitations and the specified clinical-performance limitation.

A generic company seeking approval for the same dosage form could face a divided risk:

A formulation claim may be relevant even if the applicant omits the patented method-of-use information from its labeling.
A clinical-performance claim may be more difficult to enforce against an ANDA applicant if the proposed label does not directly induce the claimed use.
FDA-approved labeling, promotional conduct, prescribing patterns, and the scope of any section viii statement would affect method-of-use litigation.

What dosage strengths are covered?

Claims 7 and 14 cover 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg methylphenidate hydrochloride strengths.

Those strengths correspond to the marketed Jornay PM product range identified in FDA labeling.[1] The claims do not cover every possible methylphenidate dose. A formulation using a different strength could avoid these dependent claims but would remain exposed to the broader independent claims if the other limitations are met.

What is the relationship to Jornay PM?

Jornay PM is an evening-administered methylphenidate hydrochloride capsule designed to delay release overnight and provide therapeutic coverage during the following morning and day.[1] FDA labeling describes delayed-release and extended-release capsules in 20 mg through 100 mg strengths.[1]

The claim profile is technically consistent with the product’s commercial positioning:

Product characteristic	Claimed technology
Evening administration	Claims 5, 6, 12, and 13
Overnight delay	Claims 1-3 and 8-10
Morning and daytime coverage	Clinical claims
Multiparticulate dosage form	Claims 1 and 8
Sustained release after delay	Claims 1 and 8
20-100 mg strengths	Claims 7 and 14
HPMC capsule	Claims 4 and 11

The patent should not be treated as proof by itself that every marketed batch practices every claim. That determination requires comparison of the approved product’s composition, manufacturing process, dissolution data, and pharmacokinetic profile with the issued claims.

What is the Orange Book status of US 11,241,392?

Orange Book listing is a regulatory fact separate from patent issuance. A patent can be enforceable without being listed in the Orange Book, and an Orange Book listing does not establish ultimate validity or infringement.

For an NDA product such as Jornay PM, the relevant Orange Book categories may include:

Drug substance patents;
Drug product or formulation patents;
Method-of-use patents.

The supplied claims are principally drug-product claims. They cover the composition and release profile rather than methylphenidate’s chemical structure.

An Orange Book-listed patent can create an ANDA certification issue. A generic applicant may:

Wait for the listed patent to expire;
Submit a Paragraph IV certification alleging invalidity, unenforceability, or noninfringement;
Submit a section viii statement for a method-of-use patent that is not relevant to the proposed label.

The current listing status, expiration date, and any pediatric extension must be confirmed against the FDA Orange Book entry for the relevant NDA and patent number.[3]

When does US 11,241,392 lose exclusivity?

The patent’s expiration date cannot be established from the claims alone. The controlling calculation depends on:

The earliest effective nonprovisional application date;
Patent-term adjustment;
Any terminal disclaimer;
Patent-term extension;
Regulatory exclusivity that operates separately from patent term.

The patent issued on February 8, 2022. Its enforceable term is governed by the 20-year term measured from the applicable earliest nonprovisional filing date, subject to statutory adjustments under 35 U.S.C. §§ 154 and 156.[4]

The patent term should not be confused with FDA exclusivity. Jornay PM also received FDA regulatory exclusivity associated with its approval. FDA exclusivity can delay approval of a competing application even when no patent blocks approval.[2][3]

How strong is the patent estate?

US 11,241,392 is strongest against an exact or near-exact copy of the claimed multiparticulate architecture. Its principal strengths are:

Multiple independent composition claims;
A defined excipient fingerprint;
Objective lag-time limitations;
A Tmax limitation tied to human pharmacokinetics;
Separate claims for commercial dosage strengths;
Clinical claims covering overnight administration and next-day ADHD control.

The main vulnerability is claim specificity. A challenger may attack:

Written description support for the full excipient combination;
Enablement across the full six-to-10-hour lag range;
Obviousness based on known sustained-release and enteric coating technologies;
Whether the claimed pharmacokinetic limitations distinguish the prior art;
The meaning and reproducibility of “about 12-16 hours”;
Whether the clinical endpoints are inherent or adequately tied to the claimed composition.

The excipient list can help identify the commercial formulation, but it can also provide design-around options. A competitor could change the polymer system, plasticizer, surfactant, particle architecture, or lag-time target.

What generic entry risks exist?

A generic applicant would likely evaluate four technical pathways.

Exact formulation pathway

This carries the highest infringement risk. Matching the layered particle structure, excipient set, lag time, and Tmax would create direct exposure under claims 1 and 8.

Excipient substitution pathway

Changing one or more listed excipients may avoid claim 8. It may not avoid claim 1 if the formulation still contains every listed ingredient and satisfies the performance limits.

Release-profile pathway

A product that releases more than 5% before six hours, or has a median Tmax outside the claimed range, may avoid the principal independent claims. This approach could reduce infringement risk but may also reduce therapeutic comparability and complicate FDA approval.

Different dosage-form pathway

A tablet, liquid, or capsule containing a different delivery system may avoid the coated-particle limitations. FDA’s suitability of an alternative dosage form would depend on bioequivalence, abuse-deterrence considerations, product labeling, and the approved reference product.

Because methylphenidate is a small molecule, biosimilar risk is not relevant. The competitive threat is generic ANDA entry, not a 351(k) biosimilar application.

What litigation and settlement issues should be monitored?

The material litigation triggers are:

A Paragraph IV notice letter;
A patent-holder complaint under 35 U.S.C. § 271(e)(2);
A 30-month stay under the Hatch-Waxman framework;
A preliminary injunction request;
A settlement agreement with a licensed or authorized generic;
A final judgment on validity, enforceability, or infringement.

A settlement could establish an agreed generic launch date before patent expiry. It could also include restrictions on an authorized generic, supply arrangements, or a license limited to particular strengths or formulations. The patent number alone does not establish whether a Paragraph IV challenge, settlement, or final judgment exists.

How does this patent compare with competing methylphenidate products?

Product	Release concept	Evening dosing	Delayed overnight release	Relevance to US 11,241,392
Jornay PM	Delayed-release plus extended-release multiparticulates	Yes	Yes	Closest commercial product
Concerta	Extended-release osmotic tablet	Generally morning	No	Different architecture
Ritalin LA	Biphasic bead system	Generally morning	No	Different timing profile
Aptensio XR	Extended-release multiparticulate system	Generally morning	No	Potential formulation-art reference
Quillivant XR	Extended-release liquid suspension	Generally morning	No	Different dosage form
Generic methylphenidate ER	Various	Usually morning	Usually no	Competitive substitution, not necessarily claim overlap

The relevant competitive distinction is not simply extended release. It is overnight delay followed by sustained daytime exposure.

Key Takeaways

US 11,241,392 targets a layered methylphenidate hydrochloride particle system.
Claims 1 and 8 are the principal composition claims.
Claim 1 is broader because it uses “comprising”; claim 8 is narrower because it uses “consisting of.”
The critical performance limits are a six-hour or longer lag, limited early release, and a median Tmax of approximately 12 to 16 hours.
Dependent claims cover eight- and 10-hour lag periods, HPMC capsules, clinical ADHD outcomes, and 20-100 mg strengths.
The patent is closely aligned with the formulation and use profile of Jornay PM.
Generic risk is highest for products reproducing the same coated-particle architecture and release profile.
Biosimilar risk does not apply because methylphenidate is a small-molecule drug.
Current Orange Book listing, patent-term adjustment, Paragraph IV activity, litigation, and settlement status require review of the FDA and court records rather than the claims alone.

FAQs

Does US 11,241,392 cover all delayed-release methylphenidate products?

No. The claims require a specific coated-particle structure, listed ingredients, and defined release or pharmacokinetic characteristics.

Can a generic avoid claim 8 by changing one excipient?

Potentially, because claim 8 uses “consisting of.” The change would not necessarily avoid claim 1, which uses the broader “comprising” language.

Does the patent cover methylphenidate hydrochloride itself?

No. The patent claims a pharmaceutical composition and delivery system. It does not claim the active molecule in isolation.

Are the 20 mg to 100 mg strengths independently protected?

Claims 7 and 14 specifically recite those strengths. The independent claims may still apply to other strengths if all of their limitations are satisfied.

Is a different release profile enough to avoid infringement?

It may avoid a claim requiring the specified lag time or Tmax, but the complete formulation must still be evaluated against every limitation, including the structural and excipient requirements.

References

U.S. Food and Drug Administration. (2018). Jornay PM prescribing information. Ironshore Pharmaceuticals & Development, Inc.
U.S. Food and Drug Administration. (2018). FDA approves new treatment for ADHD with evening dosing. FDA.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.
United States Code. 35 U.S.C. §§ 154, 156, and 271(e).
United States Patent No. 11,241,392. (2022). Methylphenidate hydrochloride modified-release pharmaceutical composition. U.S. Patent and Trademark Office.

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	11,241,392	⤷ Start Trial	Y				⤷ Start Trial
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No	11,241,392	⤷ Start Trial	Y				⤷ Start Trial
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No	11,241,392	⤷ 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
Australia	2012230733	⤷ Start Trial
Australia	2016228307	⤷ Start Trial
Australia	2018202002	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,241,392

Which drugs does patent 11,241,392 protect, and when does it expire?

Summary for Patent: 11,241,392