Last Updated: May 16, 2026

IMFINZI Drug Profile


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Summary for Tradename: IMFINZI
High Confidence Patents:7
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for IMFINZI
Recent Clinical Trials for IMFINZI

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University Medical Center GroningenPHASE1
AIM ImmunoTech Inc.Phase 1/Phase 2
Joachim Aerts, MD PhDPhase 1/Phase 2

See all IMFINZI clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for IMFINZI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for IMFINZI Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Astrazeneca Uk Ltd IMFINZI durvalumab Injection 761069 10,001,483 2036-06-24 DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd IMFINZI durvalumab Injection 761069 10,106,546 2037-03-27 DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd IMFINZI durvalumab Injection 761069 10,143,723 2038-06-01 DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd IMFINZI durvalumab Injection 761069 10,172,808 2038-06-01 DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd IMFINZI durvalumab Injection 761069 10,189,833 2037-10-04 DrugPatentWatch analysis and company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for IMFINZI Derived from Patent Text Search

These patents were obtained by searching patent claims

Supplementary Protection Certificates for IMFINZI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2019/002 Ireland ⤷  Start Trial PRODUCT NAME: DURVALUMAB; REGISTRATION NO/DATE: EU/1/18/1322 20180921
19C1001 France ⤷  Start Trial PRODUCT NAME: DURVALUMAB; REGISTRATION NO/DATE: EU/1/18/1322 20180925
C20190001 00261 Estonia ⤷  Start Trial PRODUCT NAME: DURVALUMAB;REG NO/DATE: EU/1/18/1332 25.09.2018
SPC/GB19/019 United Kingdom ⤷  Start Trial PRODUCT NAME: DURVALUMAB; REGISTERED: UK EU/1/18/1322(NI) 20180921; UK PLGB 17901/0327 20180921
2019002 Norway ⤷  Start Trial ; REG. NO/DATE: 20180108
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: April 22, 2026

IMFINZI (durvalumab) Market Dynamics and Financial Trajectory

IMFINZI (durvalumab) is a programmed death-ligand 1 (PD-L1) immune checkpoint inhibitor with a large, expanding oncology footprint across lung and other solid tumors. The market has moved toward combination regimens, line-of-therapy expansions, and rapid adoption in biomarker-defined settings, while manufacturing scale-up and label consolidation have supported sustained revenue generation for AstraZeneca.

How is IMFINZI positioned in PD-(L)1 competition?

IMFINZI competes in the PD-(L)1 class dominated by AstraZeneca/MedImmune and Bristol Myers Squibb (Opdivo), plus Merck (Keytruda). Within lung cancer, PD-L1 selection and regimen sequencing determine share, with durvalumab’s key differentiators anchored in stage-driven disease settings (notably unresectable stage III NSCLC consolidation) and durable response profiles.

Competitive posture by major clinical geography within oncology

  • NSCLC stage III (unresectable) and consolidation: IMFINZI is a category-defining therapy where consolidation after chemoradiation remains a core use case.
  • Metastatic NSCLC (1L and later): Competitive pressure is highest due to multi-agent combinations, PD-L1 testing variability across jurisdictions, and payer-driven regimen selection.
  • Beyond lung (urothelial carcinoma, head and neck, others): Share is tied to label fit, trial-driven evidence depth, and adoption of biomarker-anchored strategies.

Practical implication for market dynamics

  • IMFINZI’s demand profile is structurally tied to whether consolidation and earlier-line settings remain reimbursed and to how fast combination protocols are adopted across hospital formularies.

Which patient segments drive IMFINZI demand?

IMFINZI demand is led by large-burden oncology categories with survivorship and long-duration outcomes that keep patients on treatment schedules sufficient to sustain revenue through cycle-based dosing. The company’s commercial strategy has relied on: 1) lock-in of high-volume lung programs (stage III consolidation and related extensions), 2) sequential uptake in metastatic settings, 3) cross-indication monetization from platform evidence.

Key segment buckets (commercially relevant) Disease/setting Commercial role for IMFINZI Market driver
Unresectable stage III NSCLC consolidation after chemoradiation Anchor revenue engine Clinician standardization and guideline uptake after definitive chemoradiation
Metastatic NSCLC (multiple lines, biomarker-defined) Share gains and offsetting pressure Combination adoption, PD-L1 testing workflows, payer preference
Urothelial carcinoma / other solid tumors Secondary growth vector Label expansions and trial evidence uptake in real-world practice

Pricing and access dynamics

  • PD-(L)1 uptake often moves from clinical adoption to payer-managed protocols. IMFINZI’s trajectory depends on how quickly it becomes formulary standard in high-volume settings, versus remaining restricted to narrow criteria where competitive alternatives are preferred.

How have labels and trial expansions affected market trajectory?

Market trajectory has historically followed a pattern common to checkpoint inhibitors: early establishment in a pivotal setting, then monetization through incremental label expansions into adjacent disease stages or combinations.

IMFINZI’s financial sensitivity to new indication approvals

  • Stage/line expansions create step-changes in addressable patient volume.
  • Combination regimens can shift utilization from monotherapy to fixed-protocol dosing, typically increasing total cycles captured by the index drug.
  • Biomarker refinement can either expand eligibility (broader testing acceptance) or narrow it (tighter PD-L1 cutoffs and companion diagnostics).

Ongoing commercial effect

  • In checkpoint inhibitors, the fastest revenue acceleration typically occurs where a drug becomes a default regimen rather than an option. IMFINZI’s adoption has depended on whether it holds a default position in consolidation and validated combinations.

What is the financial trajectory of IMFINZI?

Financial trajectory is measured through IMFINZI-linked revenue and AstraZeneca’s immuno-oncology growth in key markets. AstraZeneca reports performance for its oncology portfolio and separately tracks product-level revenue in public filings.

AstraZeneca reported revenue basis

  • AstraZeneca annual and quarterly financial statements provide the revenue path for IMFINZI and the company’s oncology portfolio, including growth drivers like new patient starts, dosing persistence, and geography mix. Public reporting also shows how currency and collaboration income affect the reported trajectory.

Reported product-level revenue trend (directional)

  • IMFINZI has sustained meaningful growth over the period of label maturation, with step-ups tied to expanded approvals and broader adoption in lung cancer settings.
  • The longer-term curve is shaped by competitive intensity in metastatic NSCLC and by the persistence of consolidation-driven demand.
What has been driving financial momentum Lever How it impacts IMFINZI revenue
Patient starts in eligible settings Increases topline through the treatment cycle window
Treatment duration/persistence Converts durable response into sustained revenue capture
Regimen mix (mono vs combos) Combination uptake can increase total drug cycles per patient
Pricing and access Payer negotiations and tender outcomes can accelerate or constrain utilization
Competition Share shifts in metastatic NSCLC and line-of-therapy sequencing affect incremental growth

Key financial reality

  • IMFINZI’s trajectory is less exposed to short-cycle churn than many oncology drugs because immunotherapy dosing and response duration can extend beyond initial assessment windows. That said, line-of-therapy re-ranking and consolidation pathway changes remain the major sources of volatility.

How do manufacturing and supply constraints factor into revenue delivery?

A checkpoint inhibitor’s commercial trajectory can be constrained by supply. AstraZeneca has expanded manufacturing for biologics to protect continuity of supply and support global demand.

Supply chain dynamics

  • Scale-up readiness is required to prevent missed patient starts and to avoid regional allocation constraints.
  • Batch consistency and release timing can affect short-term revenue recognition if availability lags demand.

Revenue impact mechanism

  • If supply constrains patient starts, revenue falls quickly. Once supply stabilizes, growth returns as treatment initiation resumes.

What do payer and guideline dynamics imply for future monetization?

Payer adoption and clinical guidelines determine whether IMFINZI becomes a default regimen in large patient pools.

Payer dynamics typical for PD-(L)1 class

  • Formulary access: Institutions often prefer the lowest administrative friction regimen that is clinically acceptable.
  • Evidence thresholds: Payors track progression-free survival and overall survival outcomes by setting.
  • Budget impact: High-cost regimens trigger managed-entry agreements, step edits, or narrower reimbursement criteria.

Guideline dynamics

  • Clinical standardization in unresectable stage III consolidation supports recurring demand.
  • For metastatic NSCLC, guidelines evolve with new combinations, creating churn risk for any single agent.

How does the competitive landscape influence the near-to-mid term revenue outlook?

Competitive pressure is most intense in metastatic NSCLC where:

  • multiple PD-(L)1 options compete,
  • combination protocols continue to expand,
  • sequencing changes can move a drug from first choice to later-line use.
Competitive influence map Competitive dimension Where it hits IMFINZI most Expected effect on revenue path
Line sequencing 1L and subsequent metastatic NSCLC Potential share dilution
Combination preference Regimens where multiple checkpoint options can be paired Mix shift; either supports or dilutes
Biomarker interpretation PD-L1 testing workflows and cutoffs Eligibility swings by jurisdiction

Net effect

  • IMFINZI’s base (stage III consolidation and entrenched solid tumor approvals) tends to stabilize revenue, while metastatic NSCLC determines incremental growth and tactical share shifts.

What financial risks matter most for IMFINZI?

The principal risks to the financial trajectory for IMFINZI are those that change utilization rate or the number of cycles paid for within reimbursed settings.

Revenue risk checklist

  • Loss of default status in large-volume metastatic protocols through updated guidelines or payer edits.
  • Competitive substitution in PD-(L)1 monotherapy and combination regimens.
  • Reimbursement pressure driven by budget impact and outcomes comparisons.
  • Supply disruptions affecting patient starts.
  • Clinical readouts that re-rank regimens or shrink eligible populations.

Key Takeaways

  • IMFINZI’s market dynamics are anchored in large, guideline-incentivized lung cancer settings, with consolidation therapy supporting a durable demand profile.
  • Financial trajectory is structurally driven by patient starts and treatment persistence, both amplified by combination regimen uptake where IMFINZI is positioned.
  • Near-to-mid term revenue growth faces the highest uncertainty in metastatic NSCLC, where competitive sequencing and payer protocol shifts can dilute share.
  • Manufacturing scale and continuity of supply are operational prerequisites to keep utilization aligned with demand, particularly in high-volume settings.

FAQs

1) What is IMFINZI’s primary market engine?
Unresectable stage III NSCLC consolidation after chemoradiation, where clinical guideline adoption supports recurring demand.

2) What drives IMFINZI revenue most directly?
Patient starts in reimbursed indications and treatment persistence across dosing cycles.

3) Where is competitive pressure highest for IMFINZI?
Metastatic NSCLC, where regimen sequencing and PD-(L)1 alternatives compete across multiple lines.

4) How do payer decisions affect IMFINZI growth?
Formulary access and managed-entry conditions determine whether IMFINZI is a default regimen or limited to narrower criteria.

5) What are the main risks to IMFINZI’s financial trajectory?
Loss of preferred protocol status in metastatic settings, reimbursement tightening, competition-driven substitution, and supply constraints.


References

[1] AstraZeneca. Annual Report and Form 20-F / Financial Statements (IMFINZI and oncology segment disclosures). AstraZeneca plc investor relations. (Latest available annual filing within the reporting period).
[2] AstraZeneca. Quarterly results and product performance disclosures (including immuno-oncology revenue drivers). AstraZeneca plc investor relations. (Latest available quarterly filings within the reporting period).
[3] AstraZeneca. Imfinzi (durvalumab) prescribing information. AstraZeneca. (Most recent label available as of publication).
[4] FDA. Prescribing information / label history for Imfinzi (durvalumab). US FDA database.
[5] EMA. Imfinzi (durvalumab) product information and assessment history. European Medicines Agency.

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