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Patent landscape, scope, and claims: |
United States Patent 10,722,473 (ADHD pediatric 6–11, fasted methylphenidate exposure window): claim scope, coverage map, and US patent landscape
Patent US 10,722,473 claims a method of treating ADHD in pediatric subjects (age 6–11) using an oral solid methylphenidate hydrochloride composition that, when dosed in a fasted state, produces defined pharmacokinetic exposure windows (AUC0–4, and optionally later intervals) and provides efficacious treatment for 16 hours after a single oral administration. The claim is a PK-targeted, pediatric, and duration-of-effect-limited method claim, anchored to methylphenidate hydrochloride dose (25–100 mg) and exposure-to-dose linear relationships.
What is US 10,722,473 claim scope for pediatric ADHD treatment with fasted methylphenidate?
Core claim (Claim 1) is directed to a specific patient population, dosing context, PK metrics, dose range, and duration:
Claim 1 elements (scope-defining features)
- Population: “pediatric subject from 6 to 11 years of age.”
- Indication: “method of treating Attention Deficit Hyperactivity Disorder (ADHD).”
- Dosage form & route: “oral pharmaceutical composition” and “oral solid pharmaceutical composition.”
- Drug identity: “methylphenidate hydrochloride.”
- Dose range: administered “from 25 to 100 mg.”
- Feeding condition: administration “in a fasted state.”
- PK exposure window (primary):
- Average AUC0–4 must be 80% to 125% of a computed value from:
- *Average AUC0–4 = 804.42(dose in mg) − 8994.4**
- Duration requirement: the composition provides “efficacious treatment of ADHD for 16 hours after a single oral administration.”
Claims 2–4 add additional PK interval targets
- Claim 2: additional constraint that AUC8–14 is 80% to 125% of:
- *Average AUC8–14 = 1580.3(dose in mg) − 1860**
- Claim 3: additional constraint that AUC14–24 is 80% to 125% of:
- *Average AUC14–24 = 1392.2(dose in mg) − 9239.1**
- Claim 4: additional constraint that AUC0–∞ is 80% to 125% of:
- *Average AUC0–∞ = 5932(dose in mg) − 51578**
Practical reading of scope
- The patent is not claiming a specific named product (no mention of XR/ER/OS/IR), but it is claiming a method whose infringement hinges on what exposure profile the oral solid produces in fasted 6–11 year olds and on the observed therapeutic duration.
- Coverage is driven by PK conformity to the specific linear formulas and windows. Even if another formulation uses methylphenidate hydrochloride and treats ADHD, it can fall outside the claim if it does not meet the AUC window or the 16-hour efficacy after a single dose in this pediatric fasted context.
How do the AUC0–4, AUC8–14, AUC14–24, and AUC0–∞ formulas define infringement risk?
The exposure limitations are the highest-friction elements for design-around because they are quantitative and time-windowed.
AUC0–4 anchor (Claim 1)
- The composition must deliver:
- AUC0–4 = 0.80 to 1.25 × (804.42 × dose − 8994.4)
Optional extended-coverage intervals (Claims 2–4)
- AUC8–14 constraint uses:
- AUC14–24 constraint uses:
- AUC0–∞ constraint uses:
Design-around levers implied by the claim text
Because the claim ties infringement to AUC windows computed from dose:
- Any candidate pediatric fasted formulation that shifts exposure below 80% or above 125% of the predicted AUC in the required interval could avoid meeting the claim.
- Any candidate that produces exposure that may be within window but fails the “16 hours efficacious” functional requirement could also avoid Claim 1.
Dose-range gating
- The claimed composition is framed around 25–100 mg methylphenidate hydrochloride. A product outside that dose range (in that patient population) does not land in the claim by the plain text constraint.
What patents protect the pediatric ADHD fasted PK exposure method for methylphenidate in the US?
A complete “landscape” requires identifying the assignee, priority chain, and related continuations and then mapping against the Orange Book for any methylphenidate products. Those inputs are not provided. With only the claim text and the US patent number, the only defensible coverage map is the type and locus of protection represented by US 10,722,473.
What this patent type protects
- Method-of-treatment protection with:
- pediatric age bracket (6–11),
- ADHD indication,
- dosing regimen (single administration),
- fasted-state PK exposure windows (AUC-based),
- and duration-of-effect (16 hours).
Where other patents are likely to sit (structurally)
For methylphenidate products used in ADHD, adjacent US patent estates commonly include:
- formulation patents (matrices, coatings, osmotic systems, bead technology),
- PK/food-effect patents (fasted/fed bioavailability, exposure equivalence),
- pediatric use patents (age-specific dosing and efficacy),
- method-of-use patents based on therapeutic windows or symptom control duration,
- AND possibly process/manufacturing patents for sustained-release oral solids.
Those categories are probable neighbors, but without the actual patent family details, it is not possible to list specific US patents or claim numbers with accuracy.
When does US 10,722,473 lose exclusivity (expiration and term drivers)?
Term analysis requires:
- filing date(s),
- priority date(s),
- patent term adjustment (PTA),
- and any terminal disclaimer.
Those facts are not provided. A precise expiration schedule cannot be produced from the claim text alone.
What is the Orange Book status of US 10,722,473-linked methylphenidate product?
Orange Book status analysis requires the listed drug name(s) and the Orange Book “patent numbers” associated with that application. Those facts are not provided.
Which companies are challenging methylphenidate pediatric method claims via Paragraph IV?
Paragraph IV challengers cannot be enumerated without knowing:
- the Orange Book listed patents tied to the relevant drug application,
- the ANDA/BLA application numbers,
- and the litigation dockets.
None are provided.
How strong is the patent estate strength for fasted pediatric PK-defined ADHD methods?
Based on claim structure alone, strength is driven by:
- specificity (age, fasted state, oral solid, dose range),
- quantitative PK bounds (AUC0–4 fixed formula and 80–125% window),
- functional requirement (16-hour efficacy),
- and multi-interval optional dependent coverage (AUC8–14, AUC14–24, AUC0–∞).
Strength-positive features
- High evidentiary burden for challengers to show non-infringement because infringement turns on measurable PK endpoints in the defined population and state.
- A “fasted” limitation can be a narrow but meaningful qualifier, depending on how the marketed regimen is actually used and how bioequivalence studies are performed.
Strength-risk features
- If commercial use is consistently in fed conditions, or if pivotal efficacy data are not generated in exactly the claimed fasted pediatric context, proof of infringement can become complicated.
- If competitor generics have PK profiles that fall outside the 80–125% bands for AUC0–4 in the claimed population, a clean design-around exists.
What generic entry risks exist for methylphenidate pediatric fasted AUC0–4 80–125% windows?
The generic entry risk is not only about generic approval. It is about:
- whether the generic’s clinical use, in practice, matches:
- age (6–11),
- fasted dosing,
- the 25–100 mg dose range, and
- the exposure and 16-hour efficacy requirements.
Method-of-use claims often face enforcement challenges if labeling and real-world dosing differ from the claim’s conditions. But enforcement risk remains material where:
- labeling includes the same pediatric age range and indication,
- labeling instructs fasted administration,
- and performance evidence supports 16-hour efficacy with the claimed AUC profile.
Without the formulation identity and labeling/PK study facts for the products, the risk can’t be quantified for any particular generic or route.
How do formulation and PK patents for methylphenidate compare with US 10,722,473’s method claim?
Comparison is conceptual, not product-specific:
US 10,722,473 is not a formulation claim
It does not claim:
- a particular release mechanism,
- excipient recipes,
- coating thickness,
- osmotic drive,
- or bead size.
Instead it claims the outcome
It claims a dosing method where:
- oral solid methylphenidate hydrochloride at 25–100 mg,
- given fasted to 6–11-year-olds,
- achieves AUC-defined exposure bands,
- and yields 16-hour ADHD efficacy after one dose.
A competitor can use a different formulation architecture and still infringe if it produces the required AUC and efficacy. Conversely, a competitor can mirror the formulation but design away from the specific AUC windows.
What litigation, settlements, or enforcement history affects US 10,722,473?
No litigation history is included in the prompt, and there is no safe way to assert any cases, settlement terms, or court findings without verified docket data tied to US 10,722,473.
Key Takeaways
- US 10,722,473 claims a pediatric (6–11) ADHD treatment method using oral solid methylphenidate hydrochloride (25–100 mg) given fasted, requiring:
- AUC0–4 within 80% to 125% of *804.42(dose) − 8994.4**, and
- 16-hour efficacious treatment after a single oral administration.
- Dependent claims add further quantitative constraints on:
- AUC8–14, AUC14–24, and AUC0–∞, each within the same 80% to 125% band around dose-based linear formulas.
- The claim’s quantitative PK windows and fasted pediatric context are the principal design-around and infringement-determining features.
- A complete landscape for:
- expiration/term,
- Orange Book status,
- Paragraph IV challenges,
- and related family member patents,
cannot be produced from the provided information alone.
FAQs
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Does US 10,722,473 cover fed-state dosing for pediatric ADHD?
No, Claim 1 requires administration “in a fasted state.”
-
Can a formulation with the same active ingredient avoid infringement by altering exposure timing?
Yes, if it moves AUC0–4 outside the 80–125% band defined by the stated formula and dose range in fasted 6–11-year-olds.
-
Is the 16-hour efficacy requirement a separate limitation from the AUC targets?
Yes. Claim 1 independently requires “efficacious treatment … for 16 hours after a single oral administration.”
-
Do dependent claims broaden or narrow the coverage of US 10,722,473?
They narrow coverage by adding further AUC interval constraints.
-
Is US 10,722,473 limited to a specific branded methylphenidate product?
The claim text provided does not name a brand; it is limited by the method conditions (pediatric age, fasted dosing, dose range, PK windows, and 16-hour efficacy).
References
- United States Patent US 10,722,473: Claims provided in prompt (methylphenidate hydrochloride; pediatric 6–11 ADHD; fasted; oral solid; AUC0–4 and related AUC intervals; 16-hour efficacy).
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