KRAZATI Drug Patent Profile

When do Krazati patents expire, and what generic alternatives are available?

Krazati is a drug marketed by Bristol and is included in one NDA. There are four patents protecting this drug.

This drug has eighty-nine patent family members in thirty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Krazati

Krazati will be eligible for patent challenges on December 12, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 21, 2043. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KRAZATI

International Patents:	89
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	5
Patent Applications:	786
Drug Prices:	Drug price information for KRAZATI
What excipients (inactive ingredients) are in KRAZATI?	KRAZATI excipients list
DailyMed Link:	KRAZATI at DailyMed

See drug prices for KRAZATI

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

Constraining patent/regulatory exclusivity:

12,383,503

NDA:

216340

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 KRAZATI

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

Sponsor	Phase
China Medical University Hospital	PHASE1
Incyte Corporation	Phase 1
Mirati Therapeutics Inc.	Phase 1

See all KRAZATI clinical trials

US Patents and Regulatory Information for KRAZATI

KRAZATI is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 12,383,503.

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
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes	12,336,995
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes	12,281,113		Y	Y
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes	10,689,377		Y	Y
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes

International Patents for KRAZATI

When does loss-of-exclusivity occur for KRAZATI?

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

Australia

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

Peru

South Korea

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 KRAZATI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018369759
Brazil	112020009818
Canada	3082579
Chile	2020001271
China	111989321

Supplementary Protection Certificates for KRAZATI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3710439	301279	Netherlands		PRODUCT NAME: ADAGRASIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1744 20240109
3710439	CA 2024 00024	Denmark		PRODUCT NAME: ADAGRASIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1744 20240109
3710439	PA2024517	Lithuania		PRODUCT NAME: ADAGRASIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1744 20240105
3710439	LUC00350	Luxembourg		PRODUCT NAME: ADAGRASIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1744 20240109
3710439	2024C/525	Belgium		PRODUCT NAME: ADAGRASIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1744 20240109

Last updated: June 22, 2026

KRAZATI (adagrasib) market dynamics and financial trajectory: pricing, uptake, revenues, and exclusivity-driven risk

KRAZATI (adagrasib) is marketed as a targeted KRAS G12C inhibitor for oncology, with revenue and volume growth driven by (1) label expansion across KRAS G12C–mutant cancers, (2) line-of-therapy adoption in metastatic disease, and (3) combination uptake contingent on clinical results and payer coverage. Financial trajectory is shaped by time-limited exclusivity, competitive pressure from other KRAS G12C inhibitors and subsequent-generation regimens, and manufacturing and contracting terms.

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How is KRAZATI priced and reimbursed in the US market?

Core payer logic

• US reimbursement for targeted oncology drugs is dominated by net price after rebates, PMP/IRA negotiation effects, site of care, and prior authorization tied to biomarker testing and line-of-therapy rules.
• Uptake accelerates when plans treat adagrasib similarly to other oral targeted agents in tier placement and provide pre-authorization pathways for KRAS G12C–positive tumors.

What drives net pricing in practice

• High-cost oral oncology drugs typically face:
  • manufacturer-to-PBM rebates,
  • performance-based contracting tied to response/trajectory endpoints in managed-care arrangements,
  • restrictions that require validated KRAS G12C testing and adherence to evidence-based sequencing.
• KRAZATI’s net price typically tracks the broader market dynamic for oral oncology: gross-to-net compression as formularies tighten and as competitors expand indications.

US competitive pricing environment

• The KRAS G12C class pricing has been increasingly under pressure as more agents, combination options, and biomarker testing adoption expand.
• For adagrasib, payer behavior depends on:
  • whether its outcomes in specific tumor types and combinations match or outperform class peers,
  • whether dosing schedules create adherence advantages that improve perceived value,
  • availability of co-pay support versus plan-level patient cost barriers.

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How fast is KRAZATI uptake growing by line of therapy and tumor type?

Uptake drivers

• Adagrasib’s market expansion is anchored by:
  • growth in the diagnosed population with actionable KRAS G12C mutations,
  • adoption in metastatic settings where oral targeted therapy is preferred,
  • accumulation of evidence that broadens label coverage.

Key segmentation that determines commercial performance

• Tumor-type mix. Revenues tend to concentrate in the highest-volume labeled indications first, then broaden as additional cohorts gain coverage through trial maturity and payer recognition.
• Line-of-therapy. First-line adoption is slower for novel targeted agents unless payers view outcomes as superior to existing standards. Second-line and later usually show faster uptake if efficacy is established and sequencing is aligned with clinical guidelines.

Combination effects

• Combination uptake can improve sustained use, but only when:
  • combination regimens are clinically validated in the relevant biomarker and line setting,
  • payers accept combination pricing without restrictive utilization management.

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What is the financial trajectory for KRAZATI: annual revenue pattern and growth phases?

Trajectory pattern typical for a new targeted oncology agent

• Phase 1: Early launch growth tied to initial label and trial-driven prescriber adoption.
• Phase 2: Expansion after label growth and data readouts drive broader prescribing and formulary wins.
• Phase 3: Maturation and margin pressure as:
  • competitors gain share in the same labeled biomarker,
  • gross-to-net declines accelerate due to plan tightening and broader competition,
  • manufacturing and contracting terms reset.

How to read the financial path

• Revenue growth should be interpreted alongside:
  • net price movement (gross-to-net compression),
  • patient volume growth (eligible diagnosed population and formulary access),
  • persistence (dose interruptions, adherence, discontinuation rates),
  • combination mix (typically increases patient exposure per course).

Investor and commercial watch items

• Revenue timing is sensitive to:
  • FDA label updates and guideline changes,
  • payer coverage policy updates,
  • trial readouts that change physician perception of value,
  • competitive launch cadence within the KRAS G12C class.

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What competitive dynamics affect KRAZATI’s share against other KRAS G12C inhibitors?

Class competition structure

• KRAZATI’s market position is affected by:
  • peer KRAS G12C inhibitors with overlapping labels,
  • sequencing preferences (which agent is used first after standard therapy),
  • combination regimens that can move prescribing away from single-agent use.

Share is determined by

• Clinical positioning: relative efficacy by tumor type and line-of-therapy.
• Real-world use: adherence, tolerability, dose management, and access hurdles.
• Payer formulary position: tier placement, prior authorization criteria, and specialty pharmacy distribution.

Commercial implication

• As competitors expand indications, adagrasib’s growth can shift from “label-driven penetration” to “share movement within the labeled population,” increasing price and access pressure.

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When does KRAZATI lose exclusivity, and how does that change revenue risk?

Exclusivity-based risk

• For high-revenue targeted drugs, exclusivity loss risk typically occurs through:
  • patent expiry,
  • expiration of regulatory exclusivities (if any, depending on labeling and jurisdiction),
  • ANDA entry risk once patents are no longer enforceable.

Revenue impact channels

• If generic entry occurs:
  • rapid share loss is expected at the first approved generic or authorized biosimilar-equivalent analog (for small molecules, generics),
  • net price declines quickly after multiple entrants,
  • payer switching accelerates if the drug becomes a low-cost formulary option.

What matters for KRAZATI timing

• Revenue risk is not only about calendar expiry. It also hinges on:
  • whether patent estate coverage includes formulation, method-of-use, and combination regimens,
  • the settlement and “launch-at-risk” posture in paragraph IV litigation,
  • how many patents remain enforceable in the relevant jurisdiction.

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What patent landscape creates delay risk for generic entry of KRAZATI?

Market relevance of patent estate

• Generic entry timing is governed by enforceable claims listed in Orange Book and any litigation outcomes.
• Settlement agreements can shift launch dates by specifying “agreed entry windows” or negotiated design-workarounds.

Commercial effect of litigation outcomes

• If paragraph IV challenges are unsuccessful, commercial exposure can extend.
• If challengers succeed or settlements permit earlier entry, the revenue curve steepens downward.

Key analytical lens

• For a product like KRAZATI, the patent estate coverage typically includes:
  • active ingredient and core composition claims,
  • formulation claims tied to dosage forms,
  • method-of-use claims tethered to specific tumor types and treatment regimens.

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What is the Orange Book status of KRAZATI for exclusivity and generic exposure?

How Orange Book entries translate to market risk

• A robust Orange Book listing with multiple unexpired patents reduces generic entry risk.
• More patents covering both the molecule and specific uses can delay ANDA approval and launch, especially if at least one relevant claim remains enforceable.

Commercial reading

• The most important Orange Book items are:
  • patents with the earliest effective expiration dates,
  • patents with broad claim scope that are difficult to design around,
  • patents connected to the most commercially relevant indications.

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How do FDA regulatory milestones affect KRAZATI sales timing?

Milestone-driven revenue steps

• FDA label expansions can create step increases in:
  • prescriber addressable patient pool,
  • payer coverage breadth,
  • clinician confidence in earlier-line positioning.
• Manufacturing and supply milestones affect:
  • ability to meet demand,
  • specialty pharmacy channel fill rates,
  • continuity of patient treatment.

Pathway dynamics

• Changes in trial evidence, real-world effectiveness, and safety management can shift:
  • guideline adoption,
  • combination regimen uptake,
  • utilization management intensity.

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How does KRAZATI compare with competing drugs on commercial robustness?

Commercial robustness factors

• Patient volume growth potential: breadth of labeled tumors and line-of-therapy.
• Net price resilience: how quickly gross-to-net compresses with competition.
• Persistence and tolerability: influences repeat prescriptions and second-course continuity.
• Coverage stability: whether payers maintain favorable policies as alternatives enter.

Comparison outcomes that typically decide share

• When peers show stronger outcomes in the highest-volume labeled setting, adagrasib’s market share growth slows and pricing pressure intensifies.
• When adagrasib’s tolerability or combination profile supports adoption, it can maintain share even with broader competition.

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What generic entry scenarios are most likely to hit KRAZATI revenue?

Primary scenarios

1. Single generic entry after key patent barriers clear
   • Revenue declines but may soften with payer brand loyalty and adherence to specialty contracts.
2. Multiple generic entrants following rapid successive approvals
   • Price erosion accelerates, and net revenue can fall sharply.
3. Authorized generic or “design-around” launches
   • Payer switching can begin earlier than expected if alternative pathways reduce enforceability.

Market effect

• Revenue loss rate is typically greatest in the first 6 to 12 months after entry as formularies change and pharmacy networks shift.

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What manufacturing and supply constraints could affect KRAZATI’s financial performance?

Supply determinants

• For oral targeted therapies, financial performance is sensitive to:
  • drug substance procurement and batch release timelines,
  • manufacturing scale-up and stability testing,
  • specialty pharmacy distribution capacity and lead times.

Market effect

• Even short supply interruptions can:
  • force treatment gaps,
  • trigger payer re-authorization complications,
  • reduce refill persistence, translating into lost revenue.

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Key Takeaways

• KRAZATI’s financial trajectory is driven by label expansion, diagnosed population growth, payer coverage and rebate dynamics, and combination adoption.
• Competitive share shifts in the KRAS G12C class can compress net price and slow volume growth even when overall biomarker testing expands.
• The biggest revenue downside comes from generic entry timing tied to the Orange Book patent estate and paragraph IV litigation outcomes.
• Monitoring should focus on: formulary positioning, net price trends, line-of-therapy uptake, label and trial readouts, and patent enforcement timelines that define generic launch windows.

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FAQs

1) What factors most influence KRAZATI net price after rebates?

Formulary placement, PBM rebate levels, prior authorization rules, and negotiated performance contracting based on utilization and patient outcomes.

2) Does combination therapy change KRAZATI revenue stability?

Yes. Combination mix can increase patient exposure per course, but it also increases payer scrutiny and may intensify access restrictions.

3) What indications typically drive the largest share of KRAZATI sales?

The highest-volume labeled metastatic KRAS G12C settings in which evidence supports earlier use and guideline uptake.

4) How does the KRAS G12C competitive landscape affect future KRAZATI growth?

New entrants with overlapping labels can shift sequencing and trigger gross-to-net compression through payer tightening and switching behavior.

5) What is the main operational risk to KRAZATI revenue growth?

Drug supply continuity and specialty pharmacy refill persistence, which directly impact dose adherence and ongoing treatment duration.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Package for KRAZATI (adagrasib). U.S. Food and Drug Administration.
3. U.S. FDA. Drug Labels and Labeling Information for KRAZATI (adagrasib). U.S. Food and Drug Administration.
4. Federal Register and FDA guidance documents related to exclusivity and generic/biosimilar pathways (as applicable).

DrugChatter Q&A for KRAZATI

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