IRESSA Drug Patent Profile

When do Iressa patents expire, and when can generic versions of Iressa launch?

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

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. Six 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 APOTEX on September 23^rd, 2022.

Summary for IRESSA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	233
Drug Prices:	Drug price information for IRESSA
What excipients (inactive ingredients) are in IRESSA?	IRESSA excipients list
DailyMed Link:	IRESSA at DailyMed

See drug prices for IRESSA

Recent Clinical Trials for IRESSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beta Pharma, Inc.	Phase 3
Second Affiliated Hospital of Nanchang University	Phase 2
Nanchang University	Phase 2

See all IRESSA clinical trials

Pharmacology for IRESSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

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

Expired US Patents for IRESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	5,457,105
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	5,770,599
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	5,770,599

EU/EMA Drug Approvals for IRESSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Gefitinib Mylan	gefitinib	EMEA/H/C/004826 Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with activating mutations of EGFR‑TK.	Authorised	yes	no	no	2018-09-27
AstraZeneca AB	Iressa	gefitinib	EMEA/H/C/001016 Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.	Authorised	no	no	no	2009-06-24

International Patents for IRESSA

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

Country	Patent Number	Title	Estimated Expiration
Poland	189182
Finland	930208
China	1182421

Supplementary Protection Certificates for IRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0823900	PA2009009,C0823900	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
0823900	0990043-2.L	Sweden		PRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302
0823900	PA2009009	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624

IRESSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Iressa (Gefitinib)

Introduction

Iressa, also known as gefitinib, is a groundbreaking drug in the oncology sector, particularly for the treatment of non-small cell lung cancer (NSCLC). Developed by AstraZeneca, it was the first epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) to be approved for this indication. Here, we delve into the market dynamics and financial trajectory of Iressa.

Historical Approval and Regulatory Status

Iressa was first approved in 2002 for the treatment of locally advanced or metastatic NSCLC. This approval marked a significant milestone in targeted therapy, especially for patients with EGFR mutations[1].

Mechanism of Action and Clinical Use

Gefitinib works by inhibiting the tyrosine kinase activity of the EGFR, which is often overexpressed in certain types of cancer cells. This inhibition blocks the signal transduction events implicated in the proliferation and survival of cancer cells, making it an effective treatment for NSCLC patients with specific EGFR mutations[1].

Market Performance: Historical Sales Analysis

Annual Sales

Historical annual sales data from 2006 to 2015 show that Iressa had a strong initial market presence. However, the sales trend has been declining due to increasing competition from other EGFR-TKIs and the expiration of its patent in various geographies starting from 2017[1].

Quarterly Sales

Quarterly sales data from Q1-2013 to Q3-2016 indicate a consistent decline, reflecting the impact of generic competition and the introduction of newer, more effective treatments in the NSCLC market[1].

Sales Expectations

Despite its declining sales, the market report anticipates some level of sales for Iressa from 2016 to 2021, although at a significantly reduced rate compared to its peak years. The competition from newer drugs and the loss of patent protection are key factors influencing these expectations[1].

Global Gefitinib Market Overview

The global gefitinib market, which includes Iressa, was valued at USD 1541.2 million in 2024. This market is expected to grow at a compound annual growth rate (CAGR) of 8.5% from 2024 to 2031. Regionally, North America, Europe, and the Asia Pacific are significant markets, with varying growth rates[3].

Regional Market Dynamics

North America

In North America, the gefitinib market was valued at USD 616.48 million in 2024, with the United States being the largest market segment. The CAGR for this region is expected to be around 6.5% to 6.7% from 2024 to 2031[3].

Europe

The European market for gefitinib was valued at USD 462.36 million in 2024, with countries like the UK, Germany, and France contributing significantly. The CAGR for Europe is anticipated to be around 7% during the same period[3].

Asia Pacific

The Asia Pacific region is expected to see a higher CAGR of 10.5% from 2024 to 2031, driven by growing healthcare demands and increasing access to cancer treatments in countries like China and Japan[3].

Competitive Landscape

Iressa faces intense competition from other EGFR-TKIs such as erlotinib, afatinib, and osimertinib. Companies like Roche, Pfizer, and Novartis are key players in this market, offering alternative treatments that have often surpassed Iressa in terms of efficacy and patient preference[1].

Pricing and Affordability

The affordability of Iressa varies significantly across different regions. For instance, in Morocco, gefitinib is priced lower compared to some other cancer drugs, but it still faces challenges related to reimbursement and accessibility[4].

Financial Impact on AstraZeneca

AstraZeneca's overall financial performance has been robust, despite the decline in Iressa sales. The company has seen strong growth in other therapy areas such as oncology, cardiovascular, renal, and metabolism (CVRM), and rare diseases. In 2022, AstraZeneca reported a significant increase in revenue, excluding COVID-19 medicines, with oncology product sales increasing by 19%[2].

Future Outlook

While Iressa's sales are expected to continue declining, AstraZeneca's pipeline is robust with several new medicines in late-stage trials. The company is poised for industry-leading revenue growth through 2025 and beyond, driven by its diverse portfolio and continued investment in research and development[2].

Key Takeaways

• Historical Sales Decline: Iressa's sales have declined due to competition and patent expiration.
• Global Market Growth: The global gefitinib market is expected to grow at a CAGR of 8.5% from 2024 to 2031.
• Regional Dynamics: North America, Europe, and the Asia Pacific are significant markets with varying growth rates.
• Competitive Landscape: Iressa faces competition from other EGFR-TKIs.
• Affordability: Pricing and reimbursement challenges affect accessibility in various regions.
• AstraZeneca's Financial Performance: Strong growth in other therapy areas compensates for the decline in Iressa sales.

FAQs

What is Iressa used for?

Iressa, or gefitinib, is used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), particularly in patients with specific EGFR mutations.

Who developed Iressa?

Iressa was developed by AstraZeneca.

What is the current market size of the global gefitinib market?

The global gefitinib market size was estimated at USD 1541.2 million in 2024[3].

What is the expected growth rate of the global gefitinib market?

The global gefitinib market is expected to grow at a compound annual growth rate (CAGR) of 8.5% from 2024 to 2031[3].

How does Iressa compare to other EGFR-TKIs in terms of market performance?

Iressa faces significant competition from other EGFR-TKIs like erlotinib, afatinib, and osimertinib, which have often surpassed it in terms of efficacy and patient preference[1].

What are the challenges in accessing Iressa in different regions?

Access to Iressa is challenged by regulatory hurdles, importation issues, and pricing disparities, particularly in regions like Morocco[4].

How has the decline in Iressa sales affected AstraZeneca's overall financial performance?

Despite the decline in Iressa sales, AstraZeneca has seen strong growth in other therapy areas, ensuring overall robust financial performance[2].

Sources

1. Research and Markets, "Iressa - Gefitinib - Oncology Drug Report - 2002-2015 Analysis; 2016-2021 Expectations"[1].
2. AstraZeneca, "Full year and Q4 2022 results announcement"[2].
3. Cognitive Market Research, "Global Gefitinib Market Report"[3].
4. PMC, "Investigating the availability, affordability, and market dynamics of innovative oncology drugs in Morocco: an original report"[4].