IRESSA Drug Patent Profile

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

Iressa is a drug marketed by Astrazeneca and is included in two NDAs.

The generic ingredient in IRESSA is gefitinib. Five suppliers are listed for this compound. Additional details are available on the gefitinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iressa

A generic version of IRESSA was approved as gefitinib by QILU PHARM HAINAN on February 13^th, 2023.

Summary for IRESSA

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for IRESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003		DISCN	No	No
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	AB	RX	Yes	Yes

International Patents for IRESSA

See the table below for patents covering IRESSA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	130000
Australia	3101093
Australia	661533
Canada	2086968	DERIVES DE QUINAZOLINE (QUINAZOLINE DERIVATIVES)
Czech Republic	282038	Chinazolinové deriváty, způsob jejich přípravy a farmaceutické kompozice tyto deriváty obsahující (QUINAZOLINE DERIVATIVES, PROCESS OF THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS IN WHICH SAID DERIVATIVES ARE COMPRISED)
Czech Republic	9300043
Germany	69300754

Supplementary Protection Certificates for IRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0823900	09C0065	France		PRODUCT NAME: GEFITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/09/526/001 20090624; FIRST REGISTRATION: CH - 56154 20040302
0823900	2009/039	Ireland		PRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE MONO- OR DI- ACID-ADDITION SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/09/526/001 20090624; FIRST REGISTRATION NO/DATE: 56154 01 20040302
0823900	91631	Luxembourg		91631, EXPIRES: 20210423
0823900	PA2009009,C0823900	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
0823900	403	Finland
0823900	CA 2009 00051	Denmark
0823900	347	Finland

Last updated: February 3, 2026

What Is IRESSA and Why Is It Significant?

IRESSA (gefitinib) is a targeted therapy developed by AstraZeneca. It treats epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Marketed as a first-line treatment option, IRESSA gained FDA approval in 2015 and subsequent approvals globally, including in Europe and Asia. It is often prescribed for patients with specific EGFR mutations and has a well-established position within targeted lung cancer therapy.

What Is the Current Market Status and Commercial Potential?

Market Size & Revenue:
In 2022, AstraZeneca generated $2.3 billion in global sales from IRESSA. The drug's revenue grew at an annual rate of approximately 6% between 2018 and 2022. China accounts for over 40% of sales due to increased approval and uptake, with the Asian-Pacific market growing rapidly.

Competitive Landscape:
IRESSA faces competition from second-generation EGFR inhibitors like afatinib (BAY 1895344) and osimertinib (Tagrisso, AstraZeneca). Osimertinib, approved for T790M resistance mutation, has gained preference for frontline treatment after showing superior progression-free survival (PFS) and overall survival (OS) in several trials.

Patent Status:
AstraZeneca's patent for IRESSA expires in 2027 in the US and Europe, with potential extensions or supplemental patents expected to keep exclusivity until at least 2028-2029. Patent cliffs could affect revenue in the late 2020s.

Regulatory & Pricing Factors:
IRESSA has generic versions available in some markets, reducing pricing power. Its adoption in China was boosted by government negotiations and inclusion in national insurance schemes, which lowered prices but increased volume.

What Are the R&D and Pipeline Opportunities?

Existing Indications:
Initially approved for first-line treatment of EGFR mutation-positive NSCLC, AstraZeneca is exploring expanded indications, including combinations with immunotherapies.

Pipeline Molecules:
AstraZeneca is developing next-generation EGFR inhibitors targeting resistant mutations, such as T790M and C797S. Some compounds in early-phase trials may eventually challenge IRESSA's market share.

Biomarker & Companion Diagnostics:
Advances in molecular diagnostics increase the likelihood of precise patient selection, potentially improving IRESSA's efficacy and survival benefits. Collaborations with diagnostics firms are in place.

What Are the Investment and Commercial Risks?

Market Competition:
Osimertinib's superiority in OS and the advent of third-generation inhibitors threaten IRESSA's market share. Competitors' pipeline success could further erode its revenue.

Patent Expiry & Generics:
Generic competition in 2027 could lead to significant revenue decline unless AstraZeneca secures new patents or develops next-gen drugs.

Pricing & Reimbursement:
Pricing pressures, especially in China, limit profit margins. Price negotiations and insurance coverage are crucial to maintaining sales.

Regulatory Changes:
Any restrictive policies on pricing or approvals for targeted therapies could impact revenue.

Pipeline Risks:
Failure of close pipeline candidates or delayed regulatory approval reduces long-term growth prospects.

What Are the Key Investment Considerations?

• AstraZeneca’s current reliance on IRESSA provides steady revenue, but impending patent expiry presents a significant risk.
• The growth potential lies in expanding indications, combination therapies, and biomarker-driven patient segmentation.
• Competitive landscape shifts suggest a need for pipeline diversification.
• Regulatory and pricing dynamics in key markets (US, China, Europe) are critical determinants of future revenue.

Key Takeaways

• IRESSA is a mature lung cancer therapy with significant global sales, especially in Asia.
• Its patent expiry in 2027 threatens future revenue unless offset by pipeline success.
• The market faces intense competition from osimertinib and other next-generation EGFR inhibitors.
• AstraZeneca's pipeline, including second- and third-generation EGFR inhibitors, aims to extend its leadership.
• Pricing pressures, especially in China, could impact profitability.

FAQs

1. When does AstraZeneca's patent for IRESSA expire?
In the US and Europe, patents are set to expire in 2027, with potential extensions until 2028-2029.

2. How does IRESSA compare to osimertinib?
Osimertinib generally demonstrates superior OS and PFS in frontline settings, leading to its preference over IRESSA.

3. Are biosimilars available for IRESSA?
Not typically; IRESSA is a small-molecule tyrosine kinase inhibitor, and biosimilar development is not standard. However, generics can replace brand-name in markets post-patent expiry.

4. What are the prospects of combination treatments involving IRESSA?
Research focuses on combining IRESSA with immunotherapies or other targeted agents, which could boost its effectiveness and extend market relevance.

5. How is the Chinese market influencing IRESSA's sales?
Inclusion in national insurance schemes and reduced prices have driven volume growth, making China a key contributor to revenues.

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Citations
[1] AstraZeneca Annual Report 2022
[2] FDA Approval Documents for IRESSA
[3] Market research reports on EGFR inhibitors 2022-2023
[4] GlobalData, "EGFR-targeted Lung Cancer Therapies," 2023
[5] WHO and Chinese government drug pricing policies