US Patent 11,969,415: Scope, Claims, Expiration Risk, and the Ripretinib Patent Landscape

US Patent 11,969,415 protects a specific once-daily, oral tablet formulation and treatment method for gastrointestinal stromal tumors (GIST), rather than ripretinib as a molecule in all forms. The central limitations are a 50 mg amorphous ripretinib solid dispersion containing hydroxypropyl methylcellulose acetate succinate (HPMCAS), defined impurity limits, and use in treating GIST. The patent is assigned to Deciphera Pharmaceuticals and relates to Qinlock (ripretinib) tablets.

The practical scope is formulation-specific. A generic manufacturer that uses a different solid-state form, polymer, tablet strength, dosing schedule, or impurity profile may avoid literal infringement, although the complete patent estate for ripretinib includes broader active-ingredient and formulation rights.

What drug does US Patent 11,969,415 protect?

US Patent 11,969,415 protects tablet formulations containing ripretinib, the active ingredient in Qinlock. Ripretinib is a switch-control tyrosine kinase inhibitor approved for adults with advanced GIST previously treated with three or more kinase inhibitors, including imatinib.[1]

The claims supplied identify the active compound through Formula (I), while the chemical drawing is omitted from the text. The 50 mg tablet strength, amorphous solid dispersion, HPMCAS carrier and GIST indication correspond to ripretinib/Qinlock.

Item	Patent-related subject
Active ingredient	Ripretinib
Brand	Qinlock
Developer and marketer	Deciphera Pharmaceuticals
Dosage form	Oral tablet
Claimed strength	50 mg per tablet in claims 1 and 9
Solid-state form	Amorphous
Dispersion polymer	HPMCAS
Administration	Once daily
Disease	Gastrointestinal stromal tumors
Main technical issue	Control of specified process or degradation-related impurities

The claims do not cover every ripretinib product. They require a defined formulation architecture and impurity profile.

What are the key limitations in claims 1 through 12?

Claims 1 through 12 divide into two principal claim families.

Claim family	Independent claims	Core limitation
Formula II impurity family	1 and 5	Ripretinib amorphous solid dispersion with HPMCAS and Formula II at no more than 0.40% or 2% by tablet weight
Diphenylurea family	9 and 11	Ripretinib amorphous solid dispersion with HPMCAS and diphenylurea at no more than 0.2% by tablet weight
Aniline limitation	2, 6, 10 and 12	Aniline at no more than 2% by tablet weight
Narrow Formula II limits	3, 4, 7 and 8	Formula II at no more than 0.4% or 2% by tablet weight

Claims 1 and 9 require a tablet containing 50 mg of amorphous Formula I compound. Claims 5 and 11 use broader language requiring an amorphous form of Formula I but do not expressly repeat the 50 mg limitation in the same way.

The essential elements are:

Treatment of GIST.
Oral administration once daily.
One or more pharmaceutically acceptable tablets.
An amorphous solid dispersion.
HPMCAS in the solid dispersion.
Ripretinib or the Formula I compound.
A specified impurity below a numerical threshold.
In dependent claims, aniline below 2% by total tablet weight.

A product must satisfy every limitation of an asserted claim for literal infringement.

How broad are the Formula II impurity limitations?

The Formula II limitations are drafted in two alternative concentration ranges:

No more than approximately 0.40% by total tablet weight.
No more than approximately 2% by total tablet weight.

Claims 3 and 7 separately recite the 0.40% threshold. Claims 4 and 8 separately recite the 2% threshold. The 2% limitation is materially broader because a tablet containing 0.35% Formula II falls within both thresholds, while a tablet containing 1.5% falls only within the 2% limitation.

The claim language creates an apparent hierarchy:

Formula II concentration	0.40% claim	2% claim
0.10%	Yes	Yes
0.40%	Yes	Yes
0.75%	No	Yes
1.50%	No	Yes
2.00%	No, if interpreted strictly above 0.40%	Yes
2.01%	No	No

The use of “about” can create an interpretation issue around the exact boundary. The scope would depend on the specification’s analytical method, rounding rules, assay variability and treatment of “about” in the patent’s examples.

The patent text supplied does not identify the chemical structure of Formula II. That structure is critical to a complete chemical infringement analysis. The claim language nevertheless establishes that Formula II is a separately measured tablet component or impurity, distinct from the active Formula I compound.

What does the diphenylurea limitation protect?

Claims 9 through 12 cover tablets containing diphenylurea at no more than approximately 0.2% by total tablet weight.

This family is narrower in concentration than the Formula II family but may be broader or different chemically if diphenylurea is not identical to the Formula II compound. The claim text should not be treated as establishing that the two terms are synonyms.

The principal independent claim elements are:

GIST treatment;
once-daily oral administration;
an amorphous Formula I solid dispersion;
HPMCAS;
50 mg of the active compound in claims 9 and 11 as drafted through the incorporated formulation language; and
diphenylurea at no more than 0.2% by tablet weight.

Claims 10 and 12 add aniline at no more than 2% by tablet weight.

A competing product with 0.21% diphenylurea would fall outside the literal concentration limitation, subject to analytical uncertainty and any doctrine-of-equivalents argument. A product with no diphenylurea could also avoid this claim family if diphenylurea is a required limitation rather than an optional component.

What formulations are protected by US Patent 11,969,415?

The protected formulation is a tablet containing an amorphous dispersion of ripretinib in HPMCAS. HPMCAS is an enteric or pH-sensitive polymer commonly used to improve dissolution and maintain supersaturation for poorly water-soluble compounds.

The formulation scope is narrower than a generic “ripretinib tablet” claim. A product may potentially avoid the claims by changing one or more of the following:

Design variable	Potential avoidance route
Solid state	Use crystalline ripretinib rather than amorphous ripretinib
Polymer	Use a polymer other than HPMCAS
Dosage form	Use a capsule, granule, suspension or other non-tablet form
Strength	Use a strength other than the claimed 50 mg configuration
Impurities	Maintain Formula II or diphenylurea above or outside the claimed ranges, subject to regulatory acceptability
Dosing	Use a schedule other than once daily
Indication	Avoid a GIST treatment label or method, although induced infringement remains fact-dependent
Manufacturing process	Produce the same final composition by a different process, which generally does not avoid a composition claim if all final product limitations are met

Changing the manufacturing route alone is unlikely to avoid a claim directed to the final tablet composition. Conversely, a different process that produces a crystalline rather than amorphous product could be commercially significant if confirmed by solid-state characterization.

How do claims 1-4 compare with claims 5-8?

Claims 1-4 use a formulation description that expressly states the solid dispersion comprises 50 mg of the Formula I compound in amorphous form. Claims 5-8 recite an amorphous form of Formula I without repeating the same 50 mg language in the independent claim.

Issue	Claims 1-4	Claims 5-8
Active form	Amorphous	Amorphous
Express 50 mg limitation	Yes	Not repeated in the independent claim
HPMCAS	Required	Required
Formula II	Required	Required
Formula II threshold	0.40% or 2%	0.40% or 2%
Aniline dependent claim	Yes	Yes
Commercial relevance	Closely tracks 50 mg Qinlock tablet	Potentially broader with respect to active amount

Claims 5-8 may provide additional coverage against formulations that preserve the same amorphous/HPMCAS architecture but vary the active amount. Claim construction will depend on whether the 50 mg limitation is imported through the specification, claim dependency structure or prosecution history. It cannot be assumed that the omission has no legal effect.

How do claims 9-12 compare with claims 1-8?

Claims 9-12 replace the Formula II limitation with a diphenylurea limitation.

Feature	Claims 1-8	Claims 9-12
Formula II	Required	Not required by text supplied
Diphenylurea	Not expressly required	Required
Threshold	0.40% or 2%	0.2%
Aniline	Added in dependent claims	Added in dependent claims
Amorphous HPMCAS dispersion	Required	Required
Treatment method	GIST, once daily	GIST, once daily

The two groups appear designed to capture different impurity-control profiles. They may reflect separate manufacturing or stability concerns. A product should be tested against both families because avoiding the Formula II threshold does not necessarily avoid the diphenylurea claims.

What is the FDA regulatory status of the protected product?

Qinlock received FDA approval on May 15, 2020, for adults with advanced GIST after prior treatment with imatinib, sunitinib and regorafenib, or with three or more kinase inhibitors including imatinib.[1]

The FDA-approved regimen is 150 mg orally once daily, administered as three 50 mg tablets. The patent claims refer to administering one or more tablets once daily, which is broad enough to encompass the approved three-tablet regimen if each tablet satisfies the formulation and impurity limitations.[1]

FDA milestone	Date
Qinlock approval	May 15, 2020
Approved indication	Advanced GIST after specified prior kinase-inhibitor therapy
Approved dosage	150 mg once daily
Tablet strength	50 mg
FDA pathway	New drug application

Qinlock received five-year new chemical entity exclusivity under the Hatch-Waxman framework, subject to statutory exceptions and any patent-term adjustment or extension. The exclusivity period does not itself determine the expiration date of Patent 11,969,415.[1][2]

What patents protect ripretinib beyond US Patent 11,969,415?

The ripretinib estate includes at least three commercially relevant categories:

Active-ingredient patents covering ripretinib or related chemical compounds.
Solid-state and formulation patents covering amorphous dispersions, excipients and tablet manufacture.
Method-of-treatment patents covering GIST and other kinase-inhibitor-resistant cancers.

US Patent 10,519,175 is a key earlier Deciphera patent associated with ripretinib and the Qinlock product. It is distinct from US Patent 11,969,415 and should be evaluated separately for chemical scope, expiration, terminal disclaimers, patent-term adjustment and Orange Book listing.[3]

The relevant landscape should be organized as follows:

Patent category	Typical claim subject	Risk to a generic
Composition of matter	Ripretinib chemical structure and analogs	High if unexpired and claim reads on product
Solid-state form	Amorphous or crystalline ripretinib	High where the generic uses the same form
Formulation	HPMCAS dispersion and tablet composition	High for Qinlock-like tablets
Impurity control	Formula II, diphenylurea or aniline limits	Product-specific
Method of use	GIST treatment and dosing	Relevant in ANDA Paragraph IV litigation
Manufacturing	Process steps or intermediate controls	Relevant if process claims are practiced
Pediatric or regulatory exclusivity	FDA exclusivity, not patent rights	Delays approval or patent challenge timing

When does ripretinib lose exclusivity?

The earliest practical generic-entry date depends on four separate events:

Expiration of applicable composition-of-matter patents.
Expiration of formulation or method patents listed for Qinlock.
FDA regulatory exclusivity.
Outcome of any Paragraph IV litigation or settlement.

The five-year NCE exclusivity period associated with the 2020 approval generally runs to May 15, 2025, unless an applicable statutory adjustment changes the date.[1] Patent expiration cannot be calculated reliably from the claim text alone because it depends on the earliest effective nonprovisional filing date, patent-term adjustment, patent-term extension and terminal disclaimer status.

For US Patent 11,969,415, the relevant diligence points are:

Term issue	Why it matters
Earliest priority date	Establishes the baseline 20-year term for the patent family
Continuation status	May produce a later grant with the same underlying term
Patent-term adjustment	Can extend the nominal expiration
Patent-term extension	May apply to regulatory delay, subject to statutory limits
Terminal disclaimer	Can tie expiration to an earlier patent
Orange Book listing	Determines whether the patent is directly relevant to an ANDA certification
Claim scope	Determines whether the generic’s final product falls within the claims

A precise expiration date should be taken from USPTO Patent Center and the FDA Orange Book entry for the specific patent family, not inferred from the grant date.

What is the Orange Book status of US Patent 11,969,415?

An Orange Book listing is commercially important because it can require an ANDA applicant to make a patent certification and may trigger a 30-month stay if the NDA holder or patent owner brings timely infringement litigation after a Paragraph IV notice.[2]

The relevant questions for Patent 11,969,415 are:

Whether Deciphera or its NDA partner listed the patent for Qinlock.
Which claims or use codes were submitted.
Whether the listing covers the approved 50 mg tablet.
Whether the patent is listed as a formulation, drug-substance or method-of-use patent.
Whether the listing remains active or has been delisted.

A formulation patent can create substantial ANDA risk even after NCE exclusivity ends. The patent’s method-of-treatment claims may be less effective against a generic that uses a “skinny label” omitting the patented GIST indication, but the formulation claims can remain directly relevant to the product.

Which companies are likely to challenge the ripretinib estate?

The most likely challengers are generic companies with oncology portfolios and experience filing Paragraph IV ANDAs for small-molecule kinase inhibitors. The public claim text does not identify an ANDA filer, a Paragraph IV notice, litigation docket or settlement agreement.

A generic challenger would likely use one or more of these positions:

Noninfringement based on a crystalline rather than amorphous active.
Noninfringement based on use of a polymer other than HPMCAS.
Noninfringement based on impurity levels outside the claimed ranges.
Invalidity for lack of written description or enablement if the claims cover broad impurity ranges without adequate technical support.
Obviousness based on known amorphous dispersions, HPMCAS formulations and routine impurity specifications.
Indefiniteness based on “about,” ambiguous Formula II identification or overlapping alternative thresholds.
Lack of infringement of the method claims through a label that omits the patented use.

The strongest litigation position may depend on product testing rather than the approved label. A generic that uses a Qinlock-like amorphous HPMCAS tablet could face product-by-process and formulation evidence issues even if it avoids the patented indication on its label.

How strong is the patent estate for Qinlock?

The estate is strongest where multiple rights converge on the same commercial product:

Ripretinib as the active ingredient.
The amorphous form.
HPMCAS solid dispersion.
The 50 mg tablet.
Specified impurity limits.
Once-daily GIST treatment.

Its principal vulnerability is claim specificity. US Patent 11,969,415 does not appear, from the supplied claims, to cover every ripretinib dosage form or every method of treating GIST. The patent is most valuable against a generic that reproduces the approved tablet formulation.

Risk dimension	Assessment
Coverage of approved 50 mg tablet	Strong
Coverage of all ripretinib formulations	Limited
Dependence on analytical testing	High
Dependence on HPMCAS	High
Method-of-use breadth	Limited to GIST and once-daily administration
Design-around potential	Meaningful
Regulatory relevance	High if Orange Book listed
Biosimilar risk	None in the conventional sense; ripretinib is a small molecule
Generic risk	Material after applicable exclusivity and patent barriers expire

What generic launch scenarios exist?

Early Paragraph IV launch

A generic may file an ANDA with a Paragraph IV certification against listed patents. The sponsor could challenge validity, enforceability or infringement and seek approval before patent expiration. A successful first filer may receive 180-day exclusivity under the applicable Hatch-Waxman rules.[2]

Section viii or skinny-label launch

If the relevant patent is solely a method-of-use patent, an ANDA applicant may omit the patented indication. This route is less useful if the formulation patent is listed and the generic’s tablet directly practices the claimed composition.

Formulation design-around

A generic could use a different polymer, solid-state form or tablet architecture. This approach could reduce infringement risk but may require separate bioequivalence, dissolution and stability development.

Post-expiration launch

The lowest-risk route is launch after all blocking composition, formulation and method patents expire or are removed from the Orange Book. This route avoids Paragraph IV litigation but may sacrifice early market entry.

What litigation and settlement issues affect Patent 11,969,415?

The patent number and claim text alone do not establish an infringement case, Paragraph IV filing or settlement. A complete litigation review must distinguish:

Patent prosecution history.
FDA Orange Book listing.
ANDA notice letters.
District court complaints.
Federal Circuit appeals.
30-month stays.
Authorized generic arrangements.
Entry dates under settlement agreements.

Settlement terms may include a licensed entry date, supply agreement, royalty, covenant not to sue or authorized-generic commitment. Those terms can materially change the commercial value of the patent estate even where the patent claims remain formally enforceable.

Key Takeaways

US Patent 11,969,415 is a formulation and method-of-treatment patent for ripretinib tablets used once daily to treat GIST.
The core formulation is an amorphous ripretinib solid dispersion containing HPMCAS.
Claims 1-8 target Formula II impurity thresholds of approximately 0.40% or 2% by tablet weight.
Claims 9-12 target diphenylurea at approximately 0.2% or less by tablet weight.
Dependent claims add aniline at approximately 2% or less by tablet weight.
The patent is most relevant to a generic that copies the Qinlock 50 mg tablet architecture.
A product using a different polymer or solid-state form may have a credible design-around position.
Ripretinib is a small molecule, so biosimilar analysis is not applicable; the relevant competitive threat is generic entry.
FDA NCE exclusivity for Qinlock began with the May 15, 2020 approval and generally runs for five years, subject to statutory adjustments.
Patent expiration, Orange Book listing, Paragraph IV filings and settlement terms must be assessed across the full Deciphera patent family, including earlier composition-of-matter patents.

FAQs

Does US Patent 11,969,415 cover the 150 mg Qinlock dose?

It can cover the approved 150 mg daily regimen when administered as three 50 mg tablets, provided each tablet satisfies the claimed amorphous HPMCAS formulation and impurity limitations.

Can a generic avoid the patent by changing only the tablet coating?

Usually not if the final tablet still contains the claimed amorphous ripretinib/HPMCAS dispersion and impurity profile. A coating change does not remove a composition limitation.

Is ripretinib eligible for biosimilar competition?

No. Ripretinib is a chemically synthesized small molecule regulated through the ANDA pathway, not a biologic regulated through the biosimilar pathway.

Can a generic sell ripretinib for an indication not covered by the patent?

Possibly, if the product does not practice other listed formulation claims and the label omits the patented use. The analysis depends on the Orange Book listings, actual product composition and inducement evidence.

What testing is most important for assessing infringement?

The key testing includes solid-state characterization, HPMCAS identification, active amount per tablet, assay of Formula II and diphenylurea, aniline content, impurity analytical methods and dissolution behavior.

References

U.S. Food and Drug Administration. (2020, May 15). FDA approves Qinlock (ripretinib) for advanced gastrointestinal stromal tumor. https://www.fda.gov/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Patent and Trademark Office. (2021). U.S. Patent No. 10,519,175, compounds and methods for treating cancer. https://patents.google.com/
U.S. Patent and Trademark Office. (2024). U.S. Patent No. 11,969,415. https://patents.google.com/

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	⤷ Start Trial	⤷ Start Trial				TREATMENT OF GASTROINTESTINAL STROMAL TUMOR	⤷ 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	122354	⤷ Start Trial
Argentina	122355	⤷ Start Trial
Australia	2020417282	⤷ Start Trial
Australia	2020419197	⤷ Start Trial
Australia	2023241368	⤷ Start Trial
Australia	2023248048	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,969,415

Which drugs does patent 11,969,415 protect, and when does it expire?

Summary for Patent: 11,969,415