QINLOCK Drug Patent Profile

Which patents cover Qinlock, and what generic alternatives are available?

Qinlock is a drug marketed by Deciphera Pharms and is included in one NDA. There are forty-one patents protecting this drug.

This drug has one hundred and thirty-one patent family members in twenty-five countries.

The generic ingredient in QINLOCK is ripretinib. One supplier is listed for this compound. Additional details are available on the ripretinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Qinlock

Qinlock was eligible for patent challenges on May 15, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2040. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for QINLOCK

International Patents:	131
US Patents:	41
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
Patent Applications:	344
Drug Prices:	Drug price information for QINLOCK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QINLOCK
What excipients (inactive ingredients) are in QINLOCK?	QINLOCK excipients list
DailyMed Link:	QINLOCK at DailyMed

See drug prices for QINLOCK

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QINLOCK

Constraining patent/regulatory exclusivity:

11,185,535

NDA:

213973

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for QINLOCK

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Deciphera Pharmaceuticals LLC	Phase 1

See all QINLOCK clinical trials

Pharmacology for QINLOCK

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors P-Glycoprotein Inhibitors Platelet-derived Growth Factor alpha Receptor Inhibitors Stem Cell Factor (KIT) Receptor Inhibitors

US Patents and Regulatory Information for QINLOCK

QINLOCK is protected by forty-one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,185,535.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,911,370		Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	8,188,113		Y	Y
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,576,903		Y

EU/EMA Drug Approvals for QINLOCK

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Deciphera Pharmaceuticals (Netherlands) B.V.	Qinlock	ripretinib	EMEA/H/C/005614Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.	Authorised	no	no	yes	2021-11-18

International Patents for QINLOCK

When does loss-of-exclusivity occur for QINLOCK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QINLOCK around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	122301
Australia	2020328538
Australia	2020329956

Qinlock (ripretinib) Market Dynamics and Financial Trajectory: exclusivity, pricing pressure, formulary positioning, and revenue outlook

Last updated: July 27, 2026

Executive summary

• Qinlock (ripretinib, Deciphera) launched in the US in 2020 and remains a branded, oncology-market specialty asset with a shrinking pool of eligible patients as line-of-therapy sequencing stabilizes and competitors broaden access.
• The financial trajectory is shaped by (1) dose and adherence realities in chronic dosing, (2) payer controls (prior authorization and step edits), (3) biosurvival versus switching behavior after TKIs, (4) geographic and label-driven penetration, and (5) patent and exclusivity timelines governing durable price protection.
• Commercial headwinds are most likely to come from: increased use of alternative KIT/PDGFRA strategies, tighter pharmacy benefit manager (PBM) management, and additional market share capture by newer TKIs where guideline inclusion expands.
• Upside depends on durable clinical differentiation in post-line settings, continued formulary access, and maintaining reimbursement pathways as the product ages into later lifecycle stages.

What is Qinlock (ripretinib) and who is the target market?

Qinlock is a targeted oral tyrosine kinase inhibitor for gastrointestinal stromal tumor (GIST), positioned for adults with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.

Which GIST patients drive sales volume?

• Core population is adult patients with advanced GIST after multiple prior TKIs.
• Market access typically concentrates on patients who fail earlier lines, where oncologists need an additional mechanism and tolerability profile.
• Demand is therefore line-of-therapy dependent. As patients are treated earlier or switched sooner, the “pool” for later-line therapies can contract.

What competitors compete for the same later-line GIST prescribers?

• The competitive set includes established TKIs used in multi-line GIST (and any label expansions or guideline uptake that pull patients into adjacent sequencing).
• In late-line GIST, prescriber behavior can be influenced by:
  • prior intolerance or resistance patterns,
  • access barriers to branded therapies,
  • insurer preference for step-through ordering.

How did Qinlock pricing and reimbursement evolve, and what does that imply for revenue?

Branded oncology economics are dominated by net price after PBM concessions, rebates, and patient assistance structures.

What payer mechanisms usually pressure net price for later-line oncology?

• Prior authorization and clinical criteria restrict use to label-concordant cases.
• Step edits or formulary placement can shift patients toward preferred TKIs or “preferred within class” brands.
• Quantity management and dose-limiting editing can create effective reductions in usage beyond headline dosing.

What drives net revenue trajectory for an oral oncology TKI?

• The product is taken continuously, so treatment duration is revenue-relevant.
• Net revenue depends on maintaining patient persistence:
  • dose interruptions for adverse events,
  • discontinuations due to progression,
  • switching patterns following new access or guideline shifts.

When does Qinlock lose exclusivity, and what is the impact on the financial outlook?

Exclusivity and patent coverage determine how long Qinlock can defend premium net pricing against generics and authorized entrants. The economic effect is typically non-linear: value holds until a major infringement/entry event, then compresses quickly post-launch.

What exclusivity typically matters for small-molecule branded oncology drugs?

• US regulatory exclusivities and patent term coverage govern:
  • composition-of-matter protection,
  • formulation and salt/crystal form claims,
  • method-of-use claims for GIST indication(s),
  • potential late-life follow-on patents.

How does pipeline timing change market dynamics near expiration?

• In the years immediately before key patent cliffs, the market often experiences:
  • greater payer willingness to negotiate net price downward,
  • earlier launch planning by generics and “at-risk” entrants,
  • increased patient support costs as retention becomes harder.

(Patent expiration and Orange Book status are not provided in the current prompt, so a date-specific exclusivity timeline cannot be produced here.)

What patents protect Qinlock, and how strong is the patent estate for ripretinib?

Patent strength is evaluated by claim breadth around:

• the core chemical entity,
• polymorphs/crystal forms,
• specific dosing regimens and method-of-use,
• intermediate or manufacturing process.

Which patent categories determine generic risk for Qinlock?

• Composition-of-matter: strongest barrier for all dosage forms.
• Formulation: can restrict generic switching to certain dosage forms if claims are narrow.
• Method-of-use: can delay label competition even if the core molecule is challenged successfully.

How patent strength affects commercial strategy

• If composition claims dominate, the commercial strategy prioritizes maximizing net price durability until the cliff.
• If method-of-use claims are central, the strategy includes maintaining narrow payer criteria and label-concordant prescribing.

(A claim-by-claim patent map cannot be generated because patent numbers and cited references are not included in the prompt.)

What patent litigation affects Qinlock, including Paragraph IV challenges or settlements?

For branded small-molecules, the major inflection points are Paragraph IV filings, district court rulings, and any settlement agreements that trigger “carve-out” entry dates.

What litigation events most change financial trajectory?

• An at-risk generic launch drives immediate pricing compression.
• A delayed-launch settlement can extend branded value but may signal risk to late-cycle revenue planning.
• Adverse rulings can change payer strategy rapidly due to increased expected competition.

(No litigation docket or settlement details are included in the prompt, so litigation-specific impact cannot be asserted.)

What is the Orange Book status of Qinlock, and what does it mean for biosimilar and generic competition?

Orange Book listing controls:

• which patents are asserted for regulatory listing,
• which can be litigated via Paragraph IV,
• and how quickly generics can enter by triggering carve-outs.

What Orange Book status typically does to market share

• A dense set of listed patents often delays entry and supports continued premium pricing.
• When fewer patents remain or key patents expire, competition accelerates and net price declines quickly.

(Orange Book listings and the patent-by-patent status are not provided in the prompt, so a precise Orange Book table cannot be created.)

How does Qinlock compare with other later-line GIST therapies on market positioning and access?

In later-line oncology, “therapeutic differentiation” matters, but payer acceptance determines realized revenue.

What factors drive formulary placement versus clinical rationale alone?

• Evidence supporting treatment benefit in the specific later-line population.
• Real-world tolerability and persistence (dose holds and discontinuations).
• Hospital and office buying behavior for oral therapies, including specialty pharmacy distribution economics.
• PBM contracting terms and rebate structures.

Which competitive dynamics compress net price even without immediate generic entry

• Even with no generic, manufacturers can face:
  • rebating escalations to maintain access,
  • preferred-position bids by competitors,
  • payer switching to lower-cost alternatives within class.

What generic entry risks exist for Qinlock, and when could pricing compress?

Generic entry risk is the product of:

1. patent cliff proximity,
2. likelihood of successful infringement defenses,
3. regulatory pathway timing,
4. payer readiness to switch.

Typical at-risk launch timing logic for small molecules

• If a Paragraph IV is filed early enough and litigation delays are exhausted, generics can enter soon after an adverse decision.
• If settlement occurs, entry can be delayed but still tends to trigger payer renegotiations.

(No filing dates or court timelines are supplied, so generic entry timing cannot be calculated here.)

How does Qinlock manufacturing and supply risk affect revenue stability?

Oral oncology revenues can drop abruptly if supply disruptions occur, even temporarily, due to:

• specialty pharmacy inventory cycles,
• patient adherence interruption,
• and clinical scheduling.

What manufacturing variables matter for net sales

• capacity expansion readiness around demand surges,
• raw material supply continuity,
• quality events that force hold times or redistribution.

(No manufacturing or supply events are provided in the prompt.)

What are the major commercial drivers behind Qinlock financial performance?

The revenue curve for an oral kinase inhibitor in oncology usually follows a pattern:

• launch uptake and early formulary conversion,
• mid-life stabilization as prescribers learn place-in-therapy,
• late-life pressure from competition within class and payer tightening.

Key drivers

• Net price trajectory (headline list vs rebates and concessions).
• Patient persistence: continuous dosing favors ongoing revenue but can be eroded by toxicity.
• Disease progression and switching: once progression occurs, switching to the next line ends Qinlock’s contribution.
• Access breadth: proportion of eligible patients who can start within coverage constraints.

What FDA label status and regulatory pathway considerations affect sales?

Label constraints are often the gating factor for insurer coverage.

What label breadth tends to do to sales

• Broader indication language can expand the eligible patient pool.
• Tight label language can limit insurers’ authorization approvals and reduce use.

(No label line details beyond the general GIST positioning are included in the prompt.)

Qinlock revenue trajectory: market sizing and scenario analysis

A credible revenue trajectory requires quantitative inputs (US sales history, ex-US sales, net-to-gross evolution, and payer mix). Those figures are not included in the prompt, so a numeric forecast cannot be produced.

Qualitative scenario map

• Base case: gradual net price erosion driven by payer contracting and class competition; volume growth slows as later-line pool stabilizes.
• Bear case: faster payer restrictions plus increased competitor share lead to declining treated patients, with additional net price pressure ahead of key patent cliffs.
• Bull case: sustained differentiation yields stable persistence and maintains formulary inclusion; patient access expands through improved reimbursement terms.

(No numeric data is supplied, so only qualitative scenarios can be stated.)

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Key Takeaways

• Qinlock’s commercial trajectory is primarily a function of late-line GIST patient pool dynamics, payer reimbursement control, and persistence under chronic dosing.
• Even without generic entry, net price can erode as PBMs tighten access and competitors bid for preferred status.
• The largest single-step downside risk is generic or label-competing entry triggered by Orange Book/patent events; the largest upside comes from sustained payer access and durable differentiated positioning.
• A date-specific exclusivity and patent cliff timeline cannot be stated because patent and Orange Book data were not included in the prompt.

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FAQs

1) How does Qinlock’s later-line GIST positioning affect treated-patient volume over time?
Later-line volume depends on line-of-therapy sequencing, switching behavior after earlier TKIs, and payer eligibility criteria.

2) What reimbursement barriers most commonly limit Qinlock starts?
Prior authorization, step edits within class, and documentation requirements for prior kinase inhibitor exposure.

3) What factors drive persistence for oral TKIs like ripretinib in real-world settings?
Adverse event management, dose interruption frequency, tolerability, and progression timing.

4) How would an Orange Book patent cliff change payer behavior before generic entry?
It typically accelerates net price negotiations and preferred formulary switching, even before first generic shipments.

5) What competitive signals indicate Qinlock market share pressure?
Rising competitor contracting wins, increased preferred placement by PBMs, and shifts in guideline or practice patterns that re-order later-line TKIs.

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References (APA)

1. Not provided in the prompt.

DrugChatter Q&A for QINLOCK

How does qinlock treat gist?