Durvalumab - Biologic Drug Details

Summary for durvalumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for durvalumab

Recent Clinical Trials for durvalumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
City of Hope Medical Center	PHASE2
BioNTech SE	PHASE3
Bristol-Myers Squibb	PHASE3

See all durvalumab clinical trials

Pharmacology for durvalumab

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 brand-side disclosures

These patents were identified from searching 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 durvalumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for durvalumab 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 durvalumab 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 durvalumab

Country	Patent Number	Estimated Expiration
Serbia	56469
Slovenia	3215153
Philippines	12017500629
European Patent Office	3394093
Portugal	3394093

Supplementary Protection Certificates for durvalumab

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
CR 2019 00002	Denmark		PRODUCT NAME: DURVALUMAB; REG. NO/DATE: EU/1/18/1322 20180925
PA2019002	Lithuania		PRODUCT NAME: ANTIKUNAS, KURIS JUNGIASI PRIE B7-Y1, APIMANTIS SUNKIOSIOS GRANDINES CDR1, CDR2 IR CDR3 SEKAS, LENGVOSIOS GRANDINES CDR1, CDR2 IR CDR3 SEKAS, YPATINGAI DURVALUMABAS ARBA JO TERAPISKAI EKVIVALENTINIS VARIANTAS, KAIP APSAUGOTA PAGRINDINIAME PATENTE; REGISTRATION NO/DATE: EU/1/18/1322 20180921

Durvalumab: Market Dynamics and Financial Trajectory

Last updated: February 24, 2026

What is Durvalumab and its approved indications?

Durvalumab (brand name Imfinzi) is a monoclonal antibody targeting PD-L1. It is approved by the FDA and EMA primarily for:

• Unresectable Stage III non-small cell lung cancer (NSCLC) post-chemoradiation (FDA, 2018)
• Extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy (FDA, 2019)
• Bladder cancer patients with locally advanced or metastatic disease after platinum-based chemotherapy (FDA, 2018)

Its mechanism involves preventing PD-L1 from binding to PD-1, thereby enhancing T-cell immune response.

How does durvalumab compare economically and commercially to competitors?

Durvalumab competes with other PD-1/PD-L1 inhibitors, including pembrolizumab, nivolumab, and atezolizumab. The key points are:

Drug	Approval Year	Main Indications	Price (USD per dose)	Market share (2022)
Durvalumab	2017-2018	Lung, bladder, head & neck cancers	$11,000	12%
Pembrolizumab	2014	Broad range of cancers including lung, melanoma, others	$13,000	29%
Nivolumab	2014	Similar to pembrolizumab	$13,000	28%
Atezolizumab	2016	Lung, bladder, breast	$12,500	10%

Market share varies geographically, with the U.S. accounting for approximately 60% of its sales, and Europe making up 20%. The rest is split across Asia-Pacific, Middle East, and Latin America.

What are the revenue trends and projections?

In 2022, durvalumab generated approximately $2.4 billion globally, positioned as the third leading PD-L1 inhibitor after pembrolizumab and nivolumab.

Year	Revenue (USD billion)	CAGR (2018–2022)	Key driver
2018	0.8	-	Initial approvals
2019	1.2	37.5%	Expanded indications
2020	1.8	33.3%	Market penetration
2021	2.2	22.2%	New geographic markets
2022	2.4	9.1%	Competition intensifies

Projections indicate a compound annual growth rate (CAGR) of approximately 8% through 2027, reaching about $3.5 billion. Growth will be sustained by expanding indications, including early-stage cancers and combination therapies.

What are the factors influencing the market?

Several factors drive durvalumab’s market success:

• Clinical trial data: Demonstrating non-inferiority or superiority to competitors influences off-label uses and formulary inclusion.
• Regulatory approvals: Expanded approvals for indications like head & neck cancers and mesothelioma improve sales opportunities.
• Pricing strategies: Maintaining competitive pricing relative to peers remains critical; discounts and patient assistance programs are common.
• Pipeline developments: Ongoing trials assessing combinations with chemotherapy, targeted agents, and other immunotherapies could broaden use cases.
• Manufacturing capacity: Scaling production to meet rising demand affects the ability to penetrate new markets.

What challenges does durvalumab face?

• Market saturation: Established competitors like pembrolizumab and nivolumab have higher market share and broader approved indications.
• Pricing pressures: Payers push for cost containment, limiting reimbursement and leading to formulary restrictions.
• Clinical trial failures: Negative results in certain indications could hamper expansion efforts and investor confidence.
• Emergence of biosimilars: Pending patent expirations could introduce generics, reducing prices.

Key regulatory milestones and pipeline prospects

Year	Milestone	Impact
2018	FDA approval for NSCLC	Boosted sales in lung cancer segment
2019	FDA approval for ES-SCLC	Extended indications, increasing revenue stream
2021	Ongoing trials for head & neck, mesothelioma	Potential future indications, diversifying revenue sources

Pipeline includes combination trials with chemotherapy, targeted agents, and novel immunotherapies, which may enhance durability and broaden indications.

Investment implications

Durvalumab's financial trajectory is driven by a combination of expanding indications, competitive positioning, and pipeline advancements. The drug's revenue growth is projected to remain steady but faces headwinds from patent expirations and competitive dynamics. Strategic partnerships and pipeline success are vital for long-term growth.

Key takeaways

• Durvalumab revenue stood at ~$2.4 billion in 2022, with a forecasted CAGR of 8% through 2027.
• Market share lags behind pembrolizumab and nivolumab but benefits from regulatory expansion and pipeline trials.
• Pricing strategies and market access significantly influence its financial performance.
• Competitive pressures and biosimilar threats could impact future profitability.
• Ongoing trials and new indications are critical for sustaining long-term growth.

FAQs

Q1: What are durvalumab's primary therapeutic areas?

A1: Lung cancer (NSCLC and SCLC), bladder cancer, head & neck squamous cell carcinoma, mesothelioma.

Q2: How does durvalumab’s pricing compare to competitors?

A2: It is slightly less expensive; $11,000 per dose versus $13,000 for pembrolizumab and nivolumab.

Q3: What are the main challenges in expanding durvalumab’s market?

A3: Market saturation by competitors, reimbursement restrictions, and clinical trial setbacks.

Q4: Are there biosimilars for durvalumab?

A4: No biosimilars are currently approved; patent expiration expected around 2028, which could open the market to generics.

Q5: Which pipeline developments could boost durvalumab’s future sales?

A5: FDA trials for combination therapies in earlier-stage cancers, new indication approvals for head & neck cancers, and mesothelioma.

References

1. U.S. Food and Drug Administration. (2018). FDA approves Imfinzi for bladder cancer.
2. U.S. Food and Drug Administration. (2018). FDA approves Imfinzi for lung cancer.
3. U.S. Food and Drug Administration. (2019). FDA expands approval of Imfinzi for SCLC.
4. MarketWatch. (2023). Durvalumab market analysis 2023–2027.