United States Drug Patent 11,529,336: Scope, Claims, Expiration, and Ripretinib Patent Landscape

U.S. Patent No. 11,529,336 protects a dose-modification sequence for ripretinib in gastrointestinal stromal tumor treatment. The claimed sequence begins with 150 mg daily dosing, requires withholding ripretinib for no more than 28 days after a Grade 3 adverse reaction, and then requires 100 mg daily dosing for at least 28 days. Claim 2 adds a subsequent return to 150 mg daily if the adverse reaction remains at Grade 1 or baseline after the 28-day reduced-dose period.

The patent is a regimen patent, not a composition-of-matter patent. Its commercial relevance depends on whether the FDA-approved Qinlock label, generic labeling, or clinical practice uses the claimed dose-reduction sequence. The patent does not broadly cover ripretinib, all GIST treatment, all adverse-event management, or every dose reduction from 150 mg.

What does U.S. Patent 11,529,336 protect?

The patent protects a specific method of treating a patient with GIST who is receiving ripretinib at 150 mg daily and develops a Grade 3 adverse reaction.

Claim element	Claim 1 requirement	Scope consequence
Disease	Gastrointestinal stromal tumors	The claim is limited to GIST treatment
Drug	Ripretinib	Other tyrosine kinase inhibitors are outside the literal claim
Starting dose	150 mg daily	The patient must be receiving this dose before the adverse reaction
Adverse event	Grade 3 adverse reaction	Grade 1, Grade 2, or Grade 4 events are not expressly recited
Interruption	Withhold ripretinib for a maximum of 28 days	The interruption cannot exceed 28 days under the claim
Resolution threshold	Adverse reaction resolves to Grade 1 or baseline	Resumption is tied to the clinical grade
Reduced dose	100 mg daily	The dose must be reduced to 100 mg daily
Duration	At least 28 days	The reduced-dose phase cannot be shorter than 28 days
Further escalation	Not required by claim 1	Claim 1 can be infringed without returning to 150 mg
Return to full dose	Required only under claim 2	Claim 2 requires 150 mg daily after the 28-day reduced-dose period

The claims should be read as a sequence of required treatment steps. A product or treatment protocol that uses only 100 mg ripretinib without the preceding 150 mg dose, Grade 3 event, and interruption period would not satisfy all limitations of claim 1.

How do the claims of U.S. Patent 11,529,336 differ?

Claim 1 is the principal independent method claim. Claim 2 narrows claim 1 by adding a later dose increase.

Claim 1 scope

Claim 1 requires:

A patient suffering from GIST.
Administration of 150 mg ripretinib daily.
A Grade 3 adverse reaction during that treatment.
Withholding ripretinib for no more than 28 days.
Waiting until the reaction resolves to Grade 1 or baseline.
Administering 100 mg ripretinib daily for at least 28 days.

The claim does not require the adverse reaction to be a particular named toxicity. “Grade 3 adverse reaction” is broad as drafted, although the term would be interpreted in the clinical and regulatory context applicable to adverse-event grading.

The claim also does not require a specific age, sex, mutation, line of therapy, tumor genotype, concomitant medicine, or anatomical site. It is narrower than a general dose-reduction instruction because it combines the clinical event, interruption duration, resolution threshold, and reduced-dose duration.

Claim 2 scope

Claim 2 adds a conditional escalation:

After 28 days at 100 mg daily, the adverse reaction must remain at Grade 1 or baseline.
The patient is then administered 150 mg daily.

Claim 2 is narrower than claim 1. A protocol that satisfies claim 2 will ordinarily satisfy claim 1, but a protocol that satisfies claim 1 does not necessarily satisfy claim 2 because claim 1 does not require re-escalation.

What treatment scenarios fall outside the patent claims?

Several clinically plausible regimens would not literally meet the claims.

Scenario	Likely claim result
Patient begins at 100 mg daily	Outside claim 1 because the required starting dose is 150 mg
Grade 2 adverse reaction	Outside the express Grade 3 limitation
Grade 4 adverse reaction	Outside the express Grade 3 limitation, subject to claim-construction issues
Ripretinib withheld for more than 28 days	Outside the “maximum of 28 days” limitation
Ripretinib resumed before resolution to Grade 1 or baseline	Outside the express sequence
Reduced dose is 50 mg daily	Outside the 100 mg limitation
Reduced dose lasts 21 days	Outside the “at least 28 days” limitation
Patient receives 100 mg indefinitely	May satisfy claim 1, but not claim 2 unless the escalation step occurs
Treatment is for a non-GIST tumor	Outside the express disease limitation
Treatment uses another KIT or PDGFRA inhibitor	Outside the ripretinib limitation
Grade 3 event occurs after the patient was already dose-reduced	Likely outside the required 150 mg starting-dose sequence

The principal design-around opportunities are changes to the starting dose, interruption duration, dose selected after the interruption, clinical-grade threshold, or duration of reduced dosing. Each design-around must be assessed against the complete patent family, FDA labeling, and potential equivalents analysis.

When does U.S. Patent 11,529,336 expire?

U.S. Patent 11,529,336 issued on December 20, 2022, to Deciphera Pharmaceuticals, LLC, according to the patent record.[1] The patent belongs to the later ripretinib method-of-use estate rather than the original compound patent family.

Public patent records associate the patent with a term extending into 2037. The operative expiration date must be determined from the patent’s term calculation, including any patent-term adjustment, terminal disclaimer, disclaimer filing, or other USPTO term event.[1,2] FDA-listed expiration data should control for Hatch-Waxman analysis where the patent is listed in the Orange Book.[3]

The practical exclusivity point is that this patent can remain relevant after earlier ripretinib composition patents expire. A generic applicant may therefore face a later method-of-use barrier even if the active-ingredient patent is no longer enforceable.

Is U.S. Patent 11,529,336 listed in the Orange Book?

Qinlock is the FDA-approved ripretinib product. FDA Orange Book listings are the relevant source for determining whether U.S. Patent 11,529,336 creates a listed-patent obligation for an abbreviated new drug application.[3]

A listed method-of-use patent generally does not block approval of every generic version of the active ingredient. The effect depends on the patent’s use code and the applicant’s labeling strategy. A generic applicant may pursue:

A Paragraph IV certification challenging validity, enforceability, or infringement;
A section viii statement carving out the patented method from the proposed labeling; or
A Paragraph III certification accepting delayed approval until patent expiration.

The commercial importance of the patent is therefore tied to the use code and the extent to which the patented dose-management method appears in the proposed generic label. A use patent is more vulnerable to a section viii carve-out when the generic can omit the protected indication or dosing instruction without making the product label inconsistent with safe use.

The FDA-approved Qinlock prescribing information states that the recommended dosage is 150 mg orally once daily. The label also provides dose-modification instructions involving interruption and reduction to 100 mg once daily for certain adverse reactions.[4] That label overlap increases the relevance of the patent in any generic-label analysis.

How does the patent compare with other ripretinib patents?

Ripretinib has a layered patent estate. The estate includes composition, pharmaceutical-form, formulation, treatment, and dosing patents. U.S. Patent 11,529,336 is strongest in the dose-management segment.

Patent category	Typical protected subject matter	Relevance to generic entry
Compound patents	Ripretinib chemical structure and related compounds	Broadest technical protection; usually the most important early barrier
Solid-state or salt patents	Crystalline forms, salts, or physical forms	Can create manufacturing and product-form barriers
Formulation patents	Dosage forms, excipients, stability, or delivery characteristics	Relevant if the generic uses the protected formulation
Treatment patents	Patient population, line of therapy, tumor type, or mutation	May be addressed through label carve-outs
Dose-management patents	Interruption, dose reduction, and re-escalation	Relevant to prescribing information and clinical-use instructions
Manufacturing patents	Processes, intermediates, purification, or crystallization	May affect API sourcing even if the finished product is not directly covered

U.S. Patent 11,529,336 does not replace the earlier compound or formulation patents. It operates as a separate method-of-use layer. A generic company could avoid literal infringement of this patent while still facing other listed patents covering ripretinib, its formulation, or the approved product.

What is the patent strength of U.S. Patent 11,529,336?

The patent has moderate commercial strength as a method-of-use patent and narrower strength than a composition patent.

Strengths

It tracks a clinically recognizable dose-reduction sequence.
It covers an adverse-reaction management protocol rather than a narrow molecular biomarker.
It includes both interruption and subsequent 100 mg dosing.
Claim 1 does not require eventual return to 150 mg, giving it broader practical reach than claim 2.
The claims align closely with the type of dosing instructions that may appear in an FDA label.

Weaknesses

The claim is limited to GIST.
It requires a 150 mg daily starting dose.
It is limited to a Grade 3 adverse reaction.
It requires a specific 100 mg reduced dose.
The interruption cannot exceed 28 days.
The claim may be vulnerable to a noninfringing label or treatment protocol that omits the protected sequence.
The patent does not prevent use of ripretinib for every clinical purpose.

The most important enforcement question is whether a generic label would actively instruct physicians to perform the claimed sequence. Induced-infringement risk is generally stronger where the proposed label reproduces the patented dose modification than where the generic label omits the method and physicians independently use it.

What Paragraph IV challenges could target the patent?

A Paragraph IV challenge could raise several issues:

Invalidity for lack of novelty if an earlier publication disclosed the same GIST population, 150 mg starting dose, Grade 3 interruption, 100 mg reduction, and 28-day timing sequence.
Obviousness based on combining the Qinlock clinical-development protocol, FDA dose-modification guidance, and standard oncology adverse-event management.
Indefiniteness involving terms such as “Grade 3 adverse reaction,” “baseline,” “resolves,” or “maximum of 28 days.”
Written-description or enablement challenges if the patent specification does not adequately support the full breadth of the claimed adverse reactions or dosing sequence.
Noninfringement based on a proposed label that omits the patented dose-adjustment instructions.

The patent’s defense would focus on the specific combination of limitations and the clinical evidence supporting the 150 mg-to-100 mg sequence. Routine dose reduction alone would not necessarily establish obviousness if the claimed timing, adverse-event grade, and return-to-dose conditions were not taught in combination.

What patent litigation and settlement risks affect ripretinib?

A generic filing with a Paragraph IV certification against a listed Qinlock patent could trigger Hatch-Waxman litigation under 21 U.S.C. § 271(e)(2). A timely lawsuit could impose a 30-month stay of FDA approval, subject to statutory exceptions and court action.[5]

The principal settlement structures could include:

A licensed generic entry date;
A delayed launch tied to one or more patent expirations;
A no-challenge or restricted-challenge arrangement;
An authorized generic agreement;
A carve-out limited to non-patented uses; or
A settlement covering only the method patent while other patents remain in dispute.

No settlement should be evaluated solely against U.S. Patent 11,529,336. The economic outcome depends on the full listed-patent set, the earliest unexpired blocking patent, the scope of any use-code carve-out, and the generic applicant’s ability to market without reproducing the patented dose sequence.

What biosimilar risk applies to Qinlock?

Biosimilar risk is not the principal threat to ripretinib. Ripretinib is a small-molecule oral drug, so competitive entry would normally proceed through the ANDA generic pathway rather than the biologics license application and biosimilar pathway.

The relevant competitors are therefore generic ripretinib manufacturers and potentially authorized-generic suppliers. Their main barriers are listed patents, formulation and manufacturing controls, bioequivalence requirements, and the ability to omit patented use instructions from labeling.

What generic launch scenarios are most likely?

Three launch scenarios are commercially relevant.

Full-label launch after patent expiry

A generic applicant accepts or defeats all relevant patents and launches with dosing instructions substantially matching Qinlock. This creates the highest infringement exposure before expiration but the cleanest post-expiration entry.

Carved-out-label launch

The applicant removes the patented GIST dose-management language through a section viii statement. This can permit earlier approval if the remaining label supports safe use without the patented instruction.

Litigation-driven launch

The applicant files Paragraph IV certifications and seeks approval after prevailing in litigation, reaching a settlement, or launching at risk. The business value depends on the remaining composition, formulation, and method-of-use patents.

What are the key commercial implications for Qinlock?

The patent protects a treatment-management step that may be used frequently in clinical practice, but it does not control the entire ripretinib market. Its commercial value is highest if:

The FDA Orange Book lists the patent with a broad use code;
The approved label substantially reproduces claim 1;
A generic cannot safely omit the relevant dose-modification language;
The core and formulation patents expire earlier; and
Deciphera can establish induced infringement from generic labeling or promotional conduct.

The patent is less valuable if the generic can obtain approval with a compliant carve-out or if the relevant treatment instructions are treated as unavoidable standard clinical practice without label-based inducement.

Key Takeaways

U.S. Patent 11,529,336 covers a specific ripretinib dose-reduction sequence for GIST.
Claim 1 requires 150 mg daily dosing, a Grade 3 adverse reaction, withholding for no more than 28 days, resolution to Grade 1 or baseline, and 100 mg daily dosing for at least 28 days.
Claim 2 narrows claim 1 by requiring a return to 150 mg daily after the 28-day 100 mg period.
The patent does not broadly cover ripretinib, all GIST therapy, or every dose reduction.
The patent is a later method-of-use layer in the Qinlock estate and is commercially distinct from compound, formulation, and manufacturing patents.
Generic risk will turn on Orange Book listing, use-code scope, section viii carve-out feasibility, and Paragraph IV litigation.
Biosimilar competition is not the relevant pathway because ripretinib is a small-molecule oral drug.
The patent’s commercial strength is meaningful but narrower than that of a composition-of-matter patent.

FAQs

What adverse reactions are covered by U.S. Patent 11,529,336?

The claims cover a Grade 3 adverse reaction without limiting the reaction to a named toxicity. The specification and clinical context would be relevant to interpreting the term.

Does claim 1 require the patient to return to 150 mg ripretinib?

No. Claim 1 ends with administration of 100 mg daily for at least 28 days. The return to 150 mg is added only by claim 2.

Can a generic manufacturer avoid the patent by using 100 mg ripretinib from the start?

That regimen would not satisfy the express 150 mg starting-dose limitation of claim 1. Other patents and regulatory requirements would still require separate analysis.

Does the patent cover ripretinib treatment outside gastrointestinal stromal tumors?

No. The claims expressly recite treatment of gastrointestinal stromal tumors.

Is U.S. Patent 11,529,336 a composition patent?

No. It is a method-of-treatment patent directed to dose interruption, dose reduction, and, in claim 2, dose re-escalation.

References

United States Patent and Trademark Office. (2022). U.S. Patent No. 11,529,336, methods of treating gastrointestinal stromal tumors.
United States Patent and Trademark Office. (n.d.). Patent term adjustment and patent term calculation resources.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2024). Qinlock (ripretinib) prescribing information.
U.S. Code, 21 U.S.C. § 355(j); 35 U.S.C. § 271(e)(2).

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	11,529,336	⤷ Start Trial				TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS SUFFERING FROM A GRADE 3 ADVERSE REACTION WHILE BEING ADMINISTERED RIPRETINIB DAILY	⤷ 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
Argentina	122301	⤷ Start Trial
Australia	2020328538	⤷ Start Trial
Australia	2020329956	⤷ Start Trial
Australia	2023286024	⤷ Start Trial
Australia	2024259651	⤷ Start Trial
Brazil	112022002609	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,529,336

Which drugs does patent 11,529,336 protect, and when does it expire?

Summary for Patent: 11,529,336