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
AstraZeneca BV	Phase 1/Phase 2
AIM ImmunoTech Inc.	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	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

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	10,001,483	2036-06-24	Patent claims search
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069	10,106,546	2037-03-27	Patent claims search
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069	10,143,723	2038-06-01	Patent claims search

International Patents for IMFINZI

Country	Patent Number	Estimated Expiration
Serbia	56469
Slovenia	3215153
Philippines	12017500629

Supplementary Protection Certificates for IMFINZI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2019C/002	Belgium		PRODUCT NAME: IMFINZI-DURVALUMAB; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20180925
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
2/2019	Austria		PRODUCT NAME: DURVALUMAB; REGISTRATION NO/DATE: EU/1/18/1322 (MITTEILUNG) 20180925

IMFINZI: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is the current market position of IMFINZI?

IMFINZI (durvalumab) is a PD-L1 checkpoint inhibitor developed by AstraZeneca. It was approved by the U.S. FDA in May 2017 for locally advanced or metastatic urothelial carcinoma. The drug is approved for multiple indications, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

As of 2022, IMFINZI is marketed in over 120 countries, with core markets including the U.S., European Union, China, and Japan. Its sales have been driven by approvals in first-line NSCLC, SCLC, and bladder cancer.

How has IMFINZI's revenue evolved?

Year	Global Sales (USD millions)	Growth Rate (%)	Key Drivers
2017	69	N/A	Launch in multiple indications
2018	587	750%	Expanded approvals, increased adoption in lung cancer
2019	1,372	134%	Introduction of additional indications
2020	2,211	61%	Rapid growth before COVID-19 impact
2021	3,217	45%	Growth in lung and bladder cancer indications
2022	4,473	39%	Market penetration, label expansions

Sources: AstraZeneca annual reports, Evaluate Pharma[1], IQVIA.

What are the key drivers influencing its market trajectory?

Clinical approvals and label expansions

• Expanded indications have increased addressable patient population.
• In 2020, gained approval for extensive first-line NSCLC treatment based on the PACIFIC trial results, which significantly expanded use.

Competitive landscape

• Competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and other PD-L1 inhibitors.
• IMFINZI's market share remains strong in SCLC and UC but faces stiff competition in NSCLC, where Keytruda commands over 60% market share.

Patent positions and exclusivity

• Patent protections in major markets extend into the late 2020s.
• AstraZeneca has secured several method-of-use patents, delaying biosimilar entry until after patent expiry.

Pricing and reimbursement

• Pricing strategies vary by geography; generally premium priced, with reimbursement levels influencing volume.
• COVID-19 pandemic caused delays in healthcare services, reducing early-year sales in 2020.

How do pipeline developments impact future financial prospects?

Ongoing trials

• Phase III: Trials for IMFINZI in head and neck cancers, gastric cancers, and combination therapies.
• Biomarker development: Efforts to identify predictive indicators to optimize patient selection.

Potential market expansions

• In 2022, AstraZeneca initiated studies for IMFINZI in adjuvant lung cancer, aiming to broaden post-surgical indications.
• Potential for approvals in Europe and Asia as data mature.

Strategic collaborations

• Partnerships with biotech firms for novel combinations, enhancing the drug's efficacy spectrum.
• Licensing agreements to enter emerging markets with less developed oncology ecosystems.

Financial outlook and projections

Revenue forecasts

• By 2025, AstraZeneca projects IMFINZI will generate USD 8-10 billion annually.
• Compound annual growth rate (CAGR) is estimated between 35% and 45% over the next three years, depending on approval timelines and market access.

Risks to growth

• Patent cliffs beginning 2026-2028 may reduce exclusivity.
• Competition from next-generation immunotherapies and biosimilars could pressure pricing.
• Delays or failures in pivotal trials could impede label expansions.

Investment considerations

• The pipeline's success will determine long-term growth.
• The drug's expanding indications and ongoing combination studies support a positive outlook, assuming regulatory approvals.

Key Market Trends and Policy Influences

• Rising cancer prevalence, notably lung and bladder cancers, bolster market demand.
• Governments in Europe and Asia are increasing reimbursement for immunotherapies.
• Competitive innovations, such as bispecific antibodies and personalized therapies, threaten market share.

Summary

IMFINZI maintains a leadership position within AstraZeneca's oncology portfolio, driven by successful label expansions, robust pipeline development, and increasing global access. Revenue growth is solid, with projections indicating potential to reach USD 8-10 billion annually by 2025. Remaining competitive will depend on clinical trial success, market expansion, and navigating patent expiration and biosimilar entry.

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Key Takeaways

• IMFINZI's global sales rose from USD 69 million in 2017 to USD 4.47 billion in 2022.
• Growth relies on approvals for new indications, especially in lung and bladder cancers.
• Competition from pembrolizumab limits market share in NSCLC.
• Future revenue depends on pipeline success and market access in emerging economies.
• Patent expirations expected post-2026 could influence pricing and market positioning.

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FAQs

1. What are the main indications for IMFINZI?
IMFINZI is approved for unresectable stage III NSCLC post chemoradiation, extensive-stage SCLC, and urothelial carcinoma including bladder cancer.

2. How does IMFINZI compare with competitors?
It competes mainly with pembrolizumab and atezolizumab, with market share varying by indication and geography. IMFINZI holds a notable position in SCLC and urothelial carcinoma markets.

3. What potential market expansions could impact revenue growth?
Pending approvals in adjuvant lung cancer, head and neck cancers, and gastric cancers could increase patient populations significantly.

4. When might biosimilar competition impact IMFINZI?
Patent protections extend into the late 2020s, with biosimilar entry likely after 2026, depending on patent litigation and regulatory approvals.

5. What risks could hinder IMFINZI’s future sales?
Clinical trial delays, regulatory setbacks, increased competition, and price pressures due to biosimilar entries present ongoing risks.

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References

[1] Evaluate Pharma. (2023). Oncology drug sales data.