Patent 10,842,801 (mifepristone food-effect dosing for Cushing’s): scope of claims, infringement contours, and US patent landscape

US Drug Patent 10,842,801 claims a specific clinical dosing regimen for oral mifepristone intended to improve absorption in Cushing’s syndrome/Cushing’s disease by administering the drug within ~30 minutes after consuming a meal for a defined duration, with pharmacokinetic outcomes quantified (AUC and Cmax boosts vs fasted dosing). The independent claim is narrow on regimen timing, dose level, duration, and PK thresholds, creating clear infringement hooks for “food-adjacent” administration practices and corresponding labels, investigator instructions, and commercial patient-use guidance.

What does US Patent 10,842,801 claim, and what is the exact claim scope?

Core independent claim (Claim 1) recites a method of improving mifepristone absorption in a patient with Cushing’s Syndrome, comprising:

Indication
- Patient suffering from Cushing’s Syndrome
Therapy format and dose
- Oral mifepristone
- 900 mg per day
Dosing duration
- Administered for at least 7 days
Food-timing
- Dosing is given within about 30 minutes after consuming a meal
- Comparison baseline is dosing in the fasted state “in the absence of the meal”
Pharmacokinetic performance
- The food-timing administration alters absorption by:
  - Increasing Cmax
  - Increasing AUC
- The AUC increase is at least 44%
Functional endpoint
- “thereby improving” absorption, tied to the above PK increases

Practical claim architecture Claim 1 is a classic “method + regimen + measurable PK effect” claim. Infringement requires proving all structural elements (indication, drug form and route, dose, dosing time window relative to meals, dosing duration) and the functional PK thresholds (at least 44% AUC increase vs fasted dosing).

Claim 1 elements mapped to infringement proof

Element in Claim 1	What accused conduct must show	Typical evidence routes
Patient has Cushing’s Syndrome	Diagnosis or label/usage instructions + treatment context	medical records, study protocol, label/PI, claims/reimbursement codes
Oral mifepristone 900 mg/day	Dose level and route	prescriptions, study dosing logs, manufacturing batch record linkage
For at least 7 days	Treatment length	treatment calendars, dispensing records
Administer within ~30 min after consuming a meal	Exact timing relative to meals	patient instructions, meal logs, clinical protocols
AUC increase ≥ 44% vs fasted	Quantified PK outcome	PK study data, population PK modeling tied to fasted comparator, expert testimony anchored to assays
Cmax increase (no minimum in Claim 1 beyond “increasing”)	Directional increase	PK data

Dependent claims that narrow operational boundaries

Claim 2: patient suffers from Cushing’s disease (narrower than “Cushing’s syndrome,” which can include ectopic ACTH and adrenal causes).
Claim 3: dosing for at least 28 days (adds long-course requirement).
Claim 4: dosing is a single dose (constrains regimen to once-daily vs split dosing).
Claims 5–8: numeric ranges for AUC and Cmax:
- Claim 5: AUC increase between 44% and about 65%
- Claim 6: Cmax increase at least 34%
- Claim 7: Cmax increase between 34% and about 56%
- Claims 8–9 restate the same Cmax ranges but tie them to Claim 5 (Claim 8 depends on Claim 5; Claim 9 depends on Claim 5).
Claims 10–11: patient can be male or female (these do not add technical restrictions beyond sex-based embodiment).

Net effect: The claim set is strongly oriented toward a defined “food-proximate, high-dose, once-daily” regimen producing PK increases with quantified thresholds. Competitors that administer mifepristone at other doses, different meal timing windows, other durations, or without the AUC/Cmax magnitude may avoid literal scope.

How would infringement be argued for Claim 1 (method for improved absorption)?

Literal infringement analysis is regimen-and-PK dependent. A patentee typically must show the accused method satisfies every Claim 1 limitation. In practice, infringement often concentrates on the “within about 30 minutes after consuming a meal” element and the PK threshold element (AUC increase ≥ 44%).

Tight infringement points

Meal timing
- “within about 30 minutes” is a factual fit issue. Literal infringement typically turns on:
  - whether the accused administration falls inside the “about” boundary, and
  - whether meals were actually consumed, not hypothetical or fasting.
Dose and duration
- 900 mg/day and at least 7 days are objective constraints.
PK thresholds vs fasted
- Claim 1 is not merely about timing; it requires AUC ≥ +44% versus fasted dosing “in the absence of the meal.”
- If an accused regimen reliably produces smaller AUC increases, it is outside scope.
- If the regimen produces larger AUC, it can still satisfy “at least 44%” unless dependent claims constrain to upper ranges.

Indirect infringement contours (US context)

If a product is marketed with instructions that prescribe:

900 mg/day,
dosing within ~30 minutes after meals,
for at least 7 days (or longer), then a patentee can pursue:
direct infringement via patient administration, and
inducement theories via labeling or provider instructions, depending on evidence of intent and foreseeability.

What are the scope limits and potential design-around strategies?

Likely avoidable elements

Dose deviation
- Any dosing that is not 900 mg/day falls outside Claim 1’s exact dose anchor.
Timing deviation
- Administration outside “about 30 minutes” can reduce or eliminate literal infringement risk.
Comparator issue
- The claim ties AUC increase to a fasted comparator. If a regimen’s PK is compared to a different baseline or shows less than +44% AUC under relevant comparator conditions, the claim’s functional element may not be met.
Duration
- Short courses under 7 days may fall outside Claim 1, though may still implicate other claims elsewhere in the estate (not addressed here).

Numeric containment via dependent claims

Even if Claim 1 is met, dependent claims may narrow infringement to sub-ranges:

AUC between 44% and ~65% (Claim 5)
Cmax at least 34% and between 34% and ~56% (Claims 6–9)

An accused regimen with very large AUC or Cmax might satisfy Claim 1 but still not match dependent numeric ranges (relevant for remedies and claim selection).

How does this patent relate to other US patent families on mifepristone in Cushing’s?

Without additional identifiers for related publications, the reliable takeaway is structural: 10,842,801 is not a composition-of-matter claim; it is a method-of-treatment dosing-and-food-effect claim anchored to measurable PK outcomes.

In the broader mifepristone patent landscape for Cushing’s, estates typically contain:

composition claims (drug substance/formulations),
methods for treating Cushing’s disease/syndrome,
dosing regimens (dose and schedule),
and in some cases, absorption or food-effect optimization.

10,842,801’s differentiator is the combination of:

900 mg/day
within ~30 minutes after meals
and quantified PK lift (AUC ≥ +44% vs fasted).

That makes it more like a “clinical instruction patent” than a generic “use mifepristone for Cushing’s.”

What does the “AUC ≥ 44%” limitation do to claim enforceability?

This is the enforcement pivot.

If the patentee can generate/own comparative PK data

It strengthens literal infringement because it links the claimed method to a measurable endpoint.
The patentee can argue that the accused regimen inherently produces the required AUC increase, supported by study data.

If PK depends on uncontrolled variables

The “within about 30 minutes after consuming a meal” element still requires the meal event, timing, and likely meal composition. That can create litigation friction around:

what constitutes “a meal,”
variability in patient physiology,
and measurement conditions.

Those disputes become central because the claim is not satisfied by “intuitively improved absorption.” It is satisfied by the quantified AUC increase.

Which claim elements are likely strongest versus weakest in litigation?

Strongest

The explicit dosing regimen: 900 mg/day, oral, and ≥7 days
The timing window: within about 30 minutes after consuming a meal
The objective comparator: fasted state without meal
The quantified endpoint: AUC increase ≥44%

Potentially weaker

Any elasticity in “about 30 minutes” can turn into a factual dispute.
“AUC increase as compared to … fasted state” can raise expert methodology issues (how the fasted comparator is constructed, what baseline is used, and what sampling schedule is applied).

What is the likely geographic and regulatory linkage in the US?

US method patents of this type often intersect with:

FDA labeling instructions,
clinical trial protocols,
and “how-to-take” patient education materials.

If an FDA-approved regimen instructs dosing in a manner that aligns with the claim’s meal timing and dose, the patent becomes more enforceable through:

evidence of standard of care,
and proof that practicing the labeled method meets limitations.

(Orange Book status cannot be determined from the claim text alone, and is not included here.)

Patent estate structure: what would you expect around Claim 1’s regime?

Based on Claim 1’s specificity, related filings in the same family (if present) often include:

different dose strengths or schedules,
additional PK range limitations,
alternative timing windows (shorter or longer than ~30 minutes),
alternative patient subsets (e.g., Cushing’s disease vs broader syndrome),
additional dependent claims tying to specific PK ranges for Cmax/AUC.

Within this claim set, the dependent claims already show:

indication narrowing (Cushing’s disease),
duration narrowing (≥28 days),
dosing format narrowing (single dose),
and PK sub-range narrowing.

This is a common strategy to increase coverage across factual permutations while keeping Claim 1 as the broad anchor.

How does US 10,842,801 compare with typical mifepristone method-of-use patents?

Typical mifepristone method-of-use patents for Cushing’s often claim:

treating Cushing’s disease/syndrome with mifepristone,
sometimes at specified dose levels.

US 10,842,801 is more specific because it claims:

a meal-relative administration timing window,
combined with quantitative PK lift thresholds.

As a result, it is less likely to read on a generic regimen that simply treats Cushing’s with mifepristone, unless the generic or authorized method includes the specified food-proximate timing and yields AUC increases at the required magnitude.

What generic entry risks exist for designs that change meal timing or dose?

Risk profile by design choice

Same dose (900 mg/day), but different food timing
- If dosing is moved earlier or later than “about 30 minutes,” literal infringement risk drops.
Same timing but different dose
- Literal risk drops unless dose equals 900 mg/day.
Same timing and dose but different duration
- Under 7 days avoids Claim 1.
Same timing and dose but different PK
- If measured AUC increase vs fasted comparator is <44%, Claim 1 is not met.

Practical litigation exposure

If an entrant adopts a regimen that is effectively “take with food” inside the same timing window, the PK thresholds can become the main battleground.

Key Takeaways

US 10,842,801 is a dosing-and-absorption method patent for oral mifepristone in Cushing’s syndrome/Cushing’s disease, requiring 900 mg/day, administration within ~30 minutes after a meal, for ≥7 days, and an AUC increase ≥44% vs fasted dosing.
Dependent claims narrow to Cushing’s disease, ≥28 days, single dose, and specific AUC/Cmax ranges (AUC 44% to ~65%; Cmax at least 34% and up to ~56%).
Infringement hinges on objective regimen facts and comparative PK data. The meal timing and the AUC threshold are the principal enforcement levers; “about 30 minutes” and PK comparator methodology are common dispute areas.
Design-around opportunities exist by changing dose, timing relative to meals, treatment duration, or by adopting a regimen that does not meet the required PK AUC increase.

FAQs

Does US 10,842,801 cover dosing with food when the meal timing is outside 30 minutes?
The claim requires dosing within about 30 minutes after consuming a meal, so outside that window is outside literal scope.
If a regimen produces an AUC increase greater than 65%, does it still infringe Claim 5?
Claim 5 requires AUC between 44% and about 65%; exceeding that upper bound would avoid Claim 5 even if Claim 1 (AUC ≥44%) could still be satisfied.
Is Cushing’s disease required for infringement of Claim 1?
No. Claim 1 covers Cushing’s syndrome. Cushing’s disease is a limitation in Claim 2.
Can an accused method avoid infringement by giving mifepristone for less than 7 days?
Yes. Claim 1 requires administration for at least 7 days.
What is the role of Cmax in Claim 1 compared with dependent claims?
Claim 1 only requires that Cmax increases (directional). Dependent claims impose numeric constraints on Cmax (≥34% and up to ~56%).

References (APA)

US Patent No. 10,842,801. (n.d.). United States 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
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,842,801	⤷ Start Trial				TREATING CUSHING'S SYNDROME	⤷ 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

Details for Patent: 10,842,801

Which drugs does patent 10,842,801 protect, and when does it expire?

Summary for Patent: 10,842,801