IMFINZI Drug Profile

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

Sponsor	Phase
University Medical Center Groningen	PHASE1
Joachim Aerts, MD PhD	Phase 1/Phase 2
AstraZeneca BV	Phase 1/Phase 2

See all IMFINZI clinical trials

Pharmacology for IMFINZI

Mechanism of Action	Programmed Death Ligand-1 Antagonists Programmed Death Ligand-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Ligand-1 Blocker
Chemical Structure	Antibodies, Monoclonal

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

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.

2. DrugPatentWatch analysis and company disclosures

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.

3. Patents from broad patent text search

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		2036-06-24	DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2037-03-27	DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2038-06-01	DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2038-06-01	DrugPatentWatch analysis and company disclosures
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2037-10-04	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2036-06-24	Patent claims search
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2037-03-27	Patent claims search
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2038-06-01	Patent claims search
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2038-06-01	Patent claims search
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069		2037-10-04	Patent claims search

International Patents for IMFINZI

Country	Patent Number	Estimated Expiration
Australia	2017268397
Spain	2848978
Cyprus	1119743
Israel	219876
Japan	2019147828

Supplementary Protection Certificates for IMFINZI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C201930002	Spain		PRODUCT NAME: DURVALUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1322; DATE OF AUTHORISATION: 20180921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1322; DATE OF FIRST AUTHORISATION IN EEA: 20180921
CA 2019 00002	Denmark		PRODUCT NAME: ET ANTISTOF DER BINDER TIL B7-H1, OMFATTENDE EN HEAVY CHAIN CDR1 MED AMINOSY-RESEKVENS GFTFSRYWMS, EN HEAVY CHAIN CDR2 MED AMINOSYRESEKVENS NIKQDGSEKYYVDSVKS, ... ISAER DURVALUMAB, ELLER EN TERAPEUTISK AEKVIVALENT DERAF, SOM BESKYTTET I GRUNDPATENTET; REG. NO/DATE: EU/1/18/1322 20180925
122019000005	Germany		PRODUCT NAME: EIN ANTIKOERPER, DER AN B7-H1 BINDET, UMFASSEND GFTFSRYWMS ALS CDR1-AMINOSAEURESEQUENZDR3-AMINOSAEURESEQ; REGISTRATION NO/DATE: EU/1/18/1322 20180921 AFDY ALS CDR3- AMINOSAEURESEQUENZEINE EINER SCHWEREN KETTE, RASQRVSSSYLA ALS CDR1- AMINOSAEURESEQUEN EINER SCHWEREN KETTE, NIKQDGSEKYYVDSVKG ALS CDR2- AMINOSAEURESEQUENZ EINER SCHWEREN KETTE, EGGWFGELZ EINER LEICHTEN KETTE, DASSRAT ALS CDR2-AMINOSAEURESEQUENZ EINER LEICHTEN KETTE UND QQYGSLPWT ALS C
19C1001	France		PRODUCT NAME: DURVALUMAB; REGISTRATION NO/DATE: EU/1/18/1322 20180925
LUC00097	Luxembourg		PRODUCT NAME: UN ANTICORPS SE LIANT AU B7-H1 COMPRENANT UNE CHAINE LOURDE CDR1 AYANT LA SEQUENCE D'ACIDES AMINES GFTFSRYWMS, UNE CHAINE LOURDE CDR2 AYANT LA SEQUENCE D'ACIDES AMINES NIKQDGSEKYYVDSVKG, UNE CHAINE LOURDE CDR3 AYANT LA SEQUENCE D'ACIDES AMINES EGGWFGELAFDY, UNE CHAINE LEGERE CDR1 AYANT LA SEQUENCE D'ACIDES AMINES RASQRVSSSYLA, UNE CHAINE LEGERE CDR2 AYANT LA SEQUENCE D'ACIDES AMINES DASSRAT ET UNE CHAINE LEGERE CDR3 AYANT LA SEQUENCE D'ACIDES AMINES QQYGSLPWT, EN PARTICULIER DURVALUMAB, OU UNE DE SES VARIANTES EQUIVALENTES THERAPEUTIQUEMENT TELLE QUE PROTEGEE PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1322 20180925

Market Dynamics and Financial Trajectory for the Biologic Drug: IMFINZI

Last updated: November 10, 2025

Introduction

IMFINZI (durvalumab) is a monoclonal antibody developed by AstraZeneca targeting programmed death-ligand 1 (PD-L1). Approved for multiple oncologic indications, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and bladder cancer, IMFINZI's market trajectory is closely tied to evolving scientific, regulatory, and competitive landscapes within oncology therapeutics. This report analyzes current market dynamics, growth drivers, competitive forces, and projection of IMFINZI’s financial trajectory, providing insights essential for stakeholders evaluating its commercial potency.

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Market Overview and Indication Expansion

IMFINZI has established a strong foothold in several key cancer indications. Initially approved in 2017 for unresectable stage III NSCLC post-chemoradiotherapy, subsequent approvals expanded its use to extensive-stage SCLC (2019) and metastatic bladder cancer (2020). The drug’s approval trajectory reflects a strategic shift toward immunotherapy-centric treatment paradigms, which have gained prominence over chemotherapy alone.

The global oncology immunotherapy market, valued at approximately $59 billion in 2022, is expected to grow at a CAGR of around 12% through 2030 [1]. IMFINZI’s targeted indications position it within top-tier immuno-oncology treatments alongside Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, both of which also target PD-1/PD-L1 pathways. As of 2022, IMFINZI accounted for notable market share within lung and bladder cancer segments, driven by combination regimens and ongoing clinical trials.

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Key Market Drivers

1. Regulatory Approvals and Expanded Labeling

   The evolving landscape of approvals, including the recent acceptance of IMFINZI in combinations for earlier stages of lung cancer, boosts its addressable market. The FDA’s and EMA’s approvals, grounded in positive Phase III trial data (e.g., PACIFIC trial for NSCLC), underpin confidence in its efficacy, encouraging further penetration [2].

2. Combination Therapies and Line Expansion

   Combining IMFINZI with other agents—such as chemotherapy, radiotherapy, or novel immunotherapies—has shown to improve survival outcomes, effectively broadening its use beyond monotherapy. For example, the PACIFIC regimen’s success highlighted the importance of durable disease control, which is extrapolated into trials like CASPIAN for SCLC.

3. Biomarker-Driven Precision Medicine

   PD-L1 expression levels influence patient selection, optimizing therapeutic efficacy. Advances in biomarker testing facilitate more targeted application, enhancing cost-effectiveness and reimbursement prospects.

4. Growing Incidence of Target Cancers

   Rising global cancer incidence, especially NSCLC (the leading cause of cancer mortality globally), sustains high demand for effective therapies. Aging populations and tobacco-related lung cancers support a persistent need for novel immunotherapies.

5. Strategic Collaborations and Market Penetration

   AstraZeneca’s alliances with healthcare providers and payers, combined with market access strategies, foster wider adoption. The inclusion of IMFINZI in national treatment guidelines also enhances its prescriptive trajectory.

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Competitive Landscape

IMFINZI operates within a fiercely competitive immuno-oncology space. Key competitors include:

• Keytruda (pembrolizumab) by Merck
• Opdivo (nivolumab) by Bristol-Myers Squibb
• Atezolizumab (by Roche/Genentech)

While Keytruda leads in volume owing to broader approvals, IMFINZI’s advantage lies in specific indications like unresectable NSCLC and certain bladder cancers, supported by distinct clinical trial data. The potential for combination regimens and new indications will determine relative market share dynamics.

Patent and Intellectual Property

IMFINZI benefits from AstraZeneca’s robust patent portfolio, protecting its core molecule until at least 2030, with supplementary patents for combination regimens extending exclusivity. Patent expirations could introduce generic competition or biosimilars, potentially impacting pricing and revenues.

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Financial Trajectory and Revenue Forecast

AstraZeneca’s financial disclosures showcase IMFINZI’s rapid revenue growth. In 2022, IMFINZI generated approximately $2.0 billion in global sales, representing a 25% increase over prior years [3]. This growth is attributable to increased adoption in existing indications and pipeline expansion.

Projected Growth and Market Share

Analysts project IMFINZI’s revenues to reach $5 billion annually by 2025, assuming sustained approval extensions and strong clinical pipeline uptake. Factors underpinning this forecast include:

• Pipeline Progress: Multiple Phase III trials (e.g., ASCENT for esophageal and gastric cancers) could expand indications, adding revenue streams.
• Market Penetration: Increasing use in combination regimens with other AstraZeneca therapies (e.g., tremelimumab) will likely accelerate sales.
• Geographic Expansion: Entry into emerging markets with high cancer burdens (India, China) could add significant revenue, supported by local partnerships.
• Pricing and Reimbursement Pressures: Oncology drugs command premium pricing; however, payers’ increasing scrutiny necessitates value-based pricing models, potentially moderating growth rates.

Risks to Financial Trajectory

Potential obstacles include biosimilar entry post-patent expiry, reimbursement challenges, and unforeseen safety concerns. Additionally, competition from other immunotherapies could cap market share gains.

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Regulatory and Policy Influences

Regulatory agencies are increasingly emphasizing real-world evidence and cost-effectiveness. AstraZeneca’s success in securing approvals hinges on demonstrating comparative advantages, including survival benefits and manageable safety profiles. Policy shifts favoring personalized medicine and biomarker-driven approaches will further shape IMFINZI’s market success.

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Conclusion

IMFINZI’s market dynamics reflect a complex interplay of scientific innovation, regulatory support, competitive positioning, and strategic market expansion. Its financial trajectory appears promising, contingent on sustained clinical success, pipeline development, and market access strategies. As immunotherapy continues to redefine oncology treatment paradigms, IMFINZI is well-positioned to capitalize on emerging opportunities, provided it navigates competitive, regulatory, and reimbursement challenges effectively.

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Key Takeaways

• IMFINZI benefits from targeted approvals and strong clinical trial data, enabling robust market penetration.
• The expanding landscape of combination therapies and indications is critical to its growth.
• Competition from fellow PD-L1/PD-1 inhibitors will shape long-term market share.
• Generating sustained revenue growth depends on pipeline advancement, geographic expansion, and managing pricing pressures.
• Monitoring regulatory and reimbursement environments is essential for strategic planning.

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FAQs

1. What are the primary indications for IMFINZI, and how are these evolving?
   IMFINZI is primarily approved for unresectable stage III NSCLC, extensive-stage SCLC, and certain bladder cancers. Ongoing trials aim to expand its use to other cancers, including esophageal and colorectal malignancies.

2. How does IMFINZI compare with competitors like Keytruda in the market?
   While Keytruda holds the largest market share due to broader indications, IMFINZI differentiates itself through targeted approvals and promising combination data, especially in specific lung and bladder cancers.

3. What factors could impact IMFINZI’s revenue growth?
   Patent expiries, biosimilar competition, regulatory changes, reimbursement policies, and clinical trial failures are key risks that could temper revenue growth.

4. Are there upcoming clinical trials that could influence IMFINZI’s market presence?
   Yes, AstraZeneca’s pipeline includes multiple Phase III trials assessing IMFINZI for additional indications such as gastric and other solid tumors, which could further expand its market.

5. What is the outlook for IMFINZI in emerging markets?
   High cancer incidence rates and increasing healthcare investments make emerging markets a significant growth opportunity, though price sensitivity and regulatory hurdles may pose challenges.

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References

[1] Grand View Research, "Oncology Immunotherapy Market Size, Share & Trends," 2022.

[2] FDA Press Release, "Approval of IMFINZI for Unresectable Stage III Non-Small Cell Lung Cancer," 2017.

[3] AstraZeneca Annual Report 2022.