Details for Patent: 11,576,904

Which drugs does patent 11,576,904 protect, and when does it expire?

Patent 11,576,904 protects QINLOCK and is included in one NDA.

This patent has thirty-six patent family members in twenty-three countries.

Summary for Patent: 11,576,904

Title:	Methods of treating gastrointestinal stromal tumors
Abstract:	The present disclosure relates to methods of treating gastrointestinal stromal tumors to a subject in need thereof, comprising administering to the subject a therapeutically effective amount of ripretinib or a pharmaceutically acceptable salt thereof.
Inventor(s):	Rodrigo Ruiz Soto, Oliver Rosen, Jama Pitman
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US17/735,682
Patent Claim Types: see list of patent claims	Use;

United States Patent 11,576,904 (Ripretinib): What Scope and Claims Cover for GIST Arthralgia Dose-Interruption and Rechallenge

Executive summary: US 11,576,904 is a narrow, dose-management method patent that claims specific ripretinib interruption and re-initiation schedules tied to CTCAE grading of arthralgia in gastrointestinal stromal tumor (GIST) patients on a defined 150 mg daily starting regimen. The core claim elements are (i) identification of Grade 2 or Grade 3 arthralgia, (ii) withholding ripretinib for a defined time window and/or until arthralgia improves to Grade ≤1, and (iii) restart dosing that can be either 150 mg daily (if recovery occurs quickly after withholding in the Grade 2 construct) or 100 mg daily for at least 28 days in the Grade 3 construct, with conditional logic depending on whether recovery occurs within 7 days. The patent is best characterized as a treatment-management IP barrier against generic “dose interruption” labeling designs that would mirror the claimed CTCAE-threshold timing and restart dose patterns.

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What does US 11,576,904 claim for ripretinib arthralgia management in GIST?

Short answer: It claims a method of treating GIST by managing ripretinib in patients who develop Grade 2 or Grade 3 arthralgia, using defined withholding rules and restart doses (100 mg daily for at least 28 days for Grade 3 arthralgia; conditional 150 mg vs 100 mg daily restart for Grade 2 arthralgia based on recovery within 7 days).

Claim 1 structure and operative limitations (parsed for infringement risk mapping)

Claim 1 is a single dependent-style method claim with nested alternatives. It can be reduced to two main embodiments: a Grade 3 arthralgia pathway and a Grade 2 arthralgia pathway. Each pathway has timing triggers and restart dosing.

A. Grade 3 arthralgia pathway (restart is anchored to 100 mg daily for ≥28 days)

The claim requires that the patient:

1. Has GIST.
2. Is “suffering from Grade 2 or Grade 3 arthralgia.”
3. Is administered ripretinib at 150 mg daily (baseline dosing context).
4. For Grade 3 arthralgia, the method includes:
   • Withholding administration of ripretinib for at least 7 days or until the patient has ≤ Grade 1 arthralgia, then
   • Administering 100 mg daily ripretinib for at least 28 days.

This embodiment is tight in two ways:

• Withholding is not merely “until improved,” it must be at least 7 days or until improvement occurs, whichever satisfies that alternative.
• Restart is not “reduced dose” generally; it is explicitly 100 mg daily and must be given for at least 28 days.

B. Grade 2 arthralgia pathway (rechallenge logic varies by recovery within 7 days)

For Grade 2 arthralgia, the claim requires:

1. Withholding ripretinib until the patient has ≤ Grade 1 arthralgia or baseline (this adds a “baseline” concept rather than only CTCAE improvement).
2. Then, the restart depends on whether recovery occurs within 7 days of withholding administration:
   • If the patient recovers within 7 days, administer 150 mg daily.
   • If not recovered, administer 100 mg daily for at least 28 days.

This embodiment adds a second timing gate:

• Not just “improved to ≤1,” but improvement must occur within a 7-day window to justify restarting at 150 mg rather than stepping down to 100 mg with a minimum duration.

What parts of the claim are “hard” versus “soft” for interpretation

Based on the claim language you provided, the “hard” limitations for scope are:

• Indication: Gastrointestinal stromal tumors.
• Patient symptom: arthralgia graded Grade 2 or Grade 3.
• Baseline dosing: ripretinib 150 mg daily.
• Withholding timing rules:
  • Grade 3: withholding for ≥7 days or until ≤ Grade 1.
  • Grade 2: withholding until ≤ Grade 1 or baseline.
• Restart dosing:
  • Grade 3: 100 mg daily for ≥28 days after withholding.
  • Grade 2: restart dose depends on whether recovery occurs within 7 days:
    • If yes: 150 mg daily.
    • If no: 100 mg daily for ≥28 days.

Elements that are more interpretable (and thus can become factual disputes) include:

• How “baseline” is defined operationally (the claim ties it to patient’s baseline arthralgia level).
• The measurement method for “Grade” arthralgia (CTCAE version is not in your recitation of the claim text; it may exist in the specification, but claim 1 as provided is grading-based).

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How broad is US 11,576,904 compared with generic “dose reduction” ripretinib claims?

Short answer: It is narrower than broad dosing-reduction patents. It is limited to a specific starting dose (150 mg), symptom grading (Grade 2 or Grade 3 arthralgia), and exact withholding and restart logic (with minimum days and minimum duration thresholds).

Scope boundaries (practical claim “reach”)

1. Drug specificity: The claim is limited to ripretinib.
2. Symptom specificity: It is limited to arthralgia (not general adverse events).
3. Grade specificity: It covers only Grade 2 or Grade 3 arthralgia.
4. Dose specificity: It starts from 150 mg daily and then moves to 100 mg daily and/or 150 mg daily upon defined conditions.
5. Time specificity: The claim includes:
   • Withholding at least 7 days (Grade 3).
   • Minimum restart duration of at least 28 days when restarting at 100 mg.
   • A 7-day recovery conditional (Grade 2: if recovered within 7 days, restart at 150 mg).

Likely “design-around” areas

• If a competing regimen uses a different restart dose (not 100 mg) or a different duration requirement (less than 28 days), it may avoid literal claim coverage, depending on whether doctrine of equivalents would be asserted.
• If withholding duration and restart timing are altered so they no longer satisfy “at least 7 days or until ≤ Grade 1” (Grade 3) or “within 7 days of withholding” (Grade 2), literal infringement may fail.
• If a regimen does not begin from 150 mg daily, it may not meet the baseline “while being administered 150 mg daily” limitation.

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What are the key claim alternatives that drive infringement analysis (Grade 3 vs Grade 2 arthralgia)?

Short answer: Claim 1 is an alternatives claim; infringement analysis must map which arthralgia grade pathway the accused method follows and whether each timing and dose element is met.

Grade 3 pathway checklist

To read on the Grade 3 pathway, an accused method must do all of:

• Treat GIST.
• Use ripretinib with starting administration at 150 mg daily.
• Identify Grade 3 arthralgia.
• Withhold ripretinib for at least 7 days or until ≤ Grade 1 arthralgia.
• Restart at 100 mg daily.
• Continue 100 mg daily for at least 28 days.

Grade 2 pathway checklist

To read on the Grade 2 pathway, an accused method must do all of:

• Treat GIST.
• Use ripretinib with starting administration at 150 mg daily.
• Identify Grade 2 arthralgia.
• Withhold until ≤ Grade 1 or baseline.
• Determine whether recovery occurs within 7 days of withholding:
  • If yes: restart 150 mg daily.
  • If no: restart 100 mg daily for at least 28 days.

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What is the likely practical legal interpretation of “withholding administration” and “administering … daily” in this claim?

Short answer: The claim is method-of-treatment language that implies a treatment course with discrete dosing discontinuation and subsequent daily dosing schedules, making “when medication is paused” and “how dosing resumes” the core factual issues.

Core evidentiary hooks for litigation

1. Prescribing or administration records: timing of pauses and resumptions.
2. Arthralgia grading documentation: CTCAE grade at decision points.
3. Dose logs: actual daily dose (100 mg vs 150 mg) during restart.
4. Duration proof: whether 100 mg was given for at least 28 days in the applicable branches.

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How does US 11,576,904 relate to ripretinib label dose modifications for arthralgia?

Short answer: This type of claim typically tracks the adverse-event dose interruption and reduction constructs in clinical labeling. If the accused regimen mirrors label instructions, the patent can still be asserted against method-of-use activity, depending on whether the labeling corresponds exactly to the claimed timing and restart logic and the jurisdiction’s approach to induced infringement.

Key label-to-claim matching points

• Whether label uses the same CTCAE grade thresholds (Grade 2 vs Grade 3).
• Whether label specifies:
  • withholding for ≥7 days (or until improvement),
  • restart dose of 100 mg,
  • minimum duration of 28 days,
  • and the Grade 2 “7-day recovery” rule to justify a 150 mg restart.
• Whether “baseline” arthralgia is treated similarly in label and practice.

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What does the patent landscape look like around arthralgia dose interruption/rechallenge for ripretinib?

Short answer: Without the full family data (specifically publication numbers, priority, and related continuations), the landscape cannot be exhaustively mapped from the claim text alone. What can be said from scope logic is that this patent is category-specific: it is an adverse-event management method tied to a particular symptom and a particular dosing algorithm.

Expected cluster types around this claim (based on claim category)

1. Method-of-treatment for adverse-event management (CTCAE grade–linked algorithms).
2. Dosing regimens for adverse-event mitigation (dose interruption, dose reduction, rechallenge timing).
3. Other adverse-event method claims that may share structural similarity but differ by event (e.g., rash, edema, fatigue) and dosing thresholds.

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How many competing patents might overlap this claim’s scope?

Short answer: Multiple patents can overlap conceptually (dose interruption for adverse events), but the practical overlap depends on whether they recite the same symptom (arthralgia) and the same timing/dose logic. US 11,576,904’s claim language indicates high specificity, which reduces the probability of broad overlap unless other patents also include the same 7-day and 28-day thresholds and the Grade 2/Grade 3 divergence.

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What generic entry risks does US 11,576,904 create for ripretinib?

Short answer: Even if a generic can obtain approval with bioequivalence, the main risk is “method” activity: if the generic is marketed and used in a way that induces or contributes to practicing the claimed arthralgia management algorithm. The risk is greatest where:

• clinical practice follows near-identical timing and dose reduction rules, and
• prescribers, pharmacists, and/or training materials align with that algorithm.

Where the risk concentrates

• Clinical protocols and dosing guides for ripretinib during adverse-event management.
• Prescriber workflows that instruct:
  • withholding rules,
  • duration requirements,
  • and dose levels after recovery.

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What Paragraph IV and Hatch-Wax exposure applies to this type of method claim?

Short answer: If a Paragraph IV challenge were filed against ripretinib, a method claim like 11,576,904 can be part of the risk package if it is listed in Orange Book and the challenge disputes patent validity or non-infringement. The exposure hinges on whether the patent is in force and whether the ANDA labeling and proposed prescribing information would be alleged to encourage or induce infringement.

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What settlement dynamics are typical when method-of-treatment patents cover adverse-event dosing algorithms?

Short answer: Settlements frequently involve:

• restrictions on labeling language,
• design-around dosing schedules,
• or agreements on dispute resolution tied to specific adverse-event management instructions. The key legal lever is whether the label or training materials would still require the claimed 7-day/28-day logic and dose levels.

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What would a generic or biosimilar challenger need to change to avoid infringement of US 11,576,904?

Short answer: Based on the claim, an alleged design-around must change at least one of the hard limitations:

• Starting dose context (not administered at 150 mg daily),
• arthralgia grade trigger (not Grade 2/Grade 3 as defined),
• withholding timing rules (not “≥7 days or until ≤ Grade 1” in Grade 3 branch),
• restart dosing and duration (not 100 mg daily for ≥28 days in the applicable branches),
• or the Grade 2 “recovery within 7 days” logic that drives a 150 mg restart vs a 100 mg restart.

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Key Takeaways

• US 11,576,904 claims a narrow method of treating GIST patients on ripretinib using specific arthralgia grade–linked dosing interruption and restart schedules.
• The claim is built around two alternative algorithms: Grade 3 requires withholding for ≥7 days or until ≤ Grade 1, then restarting 100 mg daily for at least 28 days; Grade 2 requires withholding until ≤ Grade 1 or baseline, then restarting 150 mg if recovery occurs within 7 days, otherwise restarting 100 mg daily for at least 28 days.
• The most litigation-relevant facts are CTCAE arthralgia grades at decision points, dates of withholding, and proof that 100 mg restarted courses meet the ≥28-day minimum.
• The strongest design-around lever is to alter the timing and duration thresholds (7-day withholding/recovery and 28-day restart duration) or avoid the 150 mg starting-dose context.

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FAQs

1) If a patient restarts ripretinib at 100 mg for 20 days after Grade 3 arthralgia, does that avoid claim 1?
The claim requires “at least 28 days” for the 100 mg restart in the Grade 3 branch, so shorter duration would not meet a hard limitation.

2) Does claim 1 cover arthralgia management for events other than arthralgia?
No. The symptom element is specifically “arthralgia.”

3) Can a regimen that starts ripretinib at 150 mg daily but omits withholding still practice the claim?
No. “Withholding administration” with the defined timing is an essential limitation.

4) Is the Grade 2 pathway satisfied if the patient reaches ≤ Grade 1 but recovery takes longer than 7 days from withholding?
If recovery is not within 7 days, the claim directs restarting at 100 mg daily for at least 28 days rather than 150 mg daily.

5) Would label-only use of ripretinib dose modifications automatically determine infringement of a method claim?
Infringement analysis depends on whether the claimed method steps are actually practiced using the specified timing and dose logic, and on the jurisdiction’s rules for induced or contributory infringement tied to labeling.

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References (APA)

No sources were provided in the prompt, and no bibliographic details (publication number, priority, assignee, Orange Book listing, prosecution history, or related family members) were included beyond the claim text.

Drugs Protected by US Patent 11,576,904

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes						TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS SUFFERING FROM GRADE 2 OR GRADE 3 ARTHRALGIA WHILE BEING ADMINISTERED RIPRETINIB DAILY

International Family Members for US Patent 11,576,904

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	122301
Australia	2020328538
Australia	2020329956
Australia	2023286024
Australia	2024259651
Brazil	112022002609
Canada	3150433