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
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	5,616,582

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/004826Gefitinib 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/001016Iressa 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
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)
Croatia	P960204	QUINAZOLINE DERIVATIVES
Norway	974940
Hungary	221622	Kinazolinszármazékok, az ezeket tartalmazó gyógyászati készítmények és eljárás előállításukra (QUINAZOLINE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS COMPRISING SAME AS ACTIVE INGREDIENT AND PROCESS FOR PRODUCING THEM)
Australia	3101093
Germany	69611361
Portugal	823900

Supplementary Protection Certificates for IRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0823900	347	Finland
0823900	91631	Luxembourg		91631, EXPIRES: 20210423
0823900	C300429	Netherlands		PRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
0823900	CA 2009 00051	Denmark
0823900	PA2009009	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
0823900	PA2009009,C0823900	Lithuania		PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
0823900	403	Finland

Market Dynamics and Financial Trajectory for IRESSA (Gefitinib)

Last updated: September 10, 2025

Introduction

IRESSA, the brand name for gefitinib, is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed primarily to treat non-small cell lung cancer (NSCLC). Since its approval, IRESSA has played a critical role in targeted cancer therapy, transforming treatment paradigms for subsets of NSCLC patients with EGFR mutations. Analyzing its market dynamics and financial trajectory offers insights into its current positioning, growth potential, and competitive landscape within the oncology therapeutics sector.

Market Overview

Therapeutic Area and Demand Drivers

Non-small cell lung cancer accounts for approximately 85% of lung cancer cases globally, representing a substantial market for targeted therapies like gefitinib. The demand for IRESSA stems from its efficacy in EGFR-mutant NSCLC, which constitutes around 10-15% of lung adenocarcinomas in Western populations and up to 50% in Asian populations, notably in Japan and South Korea [1]. The increasing prevalence of EGFR mutations, driven by smoking trends and genetic predispositions, directly influences IRESSA's market demand.

Regulatory Approvals and Geographic Penetration

Initially approved by the U.S. Food and Drug Administration (FDA) in 2003 for first-line treatment of locally advanced or metastatic EGFR mutation-positive NSCLC, gefitinib’s regulatory landscape has evolved with multiple approvals worldwide. Japan was among the first markets, given the high prevalence of EGFR mutations, followed by approvals in Europe and other Asian countries. Despite being supplanted in some regions by newer generation TKIs, gefitinib retains a significant market share, especially in Asia and certain European nations.

Market Competition and Launch of Competitors

The oncology market's landscape for EGFR inhibitors is highly competitive, featuring agents like erlotinib (Tarceva), afatinib (Gilotrif), and osimertinib (Tagrisso). Osimertinib's approval in 2015, with superior efficacy and safety profile for T790M mutation-positive cases, has displaced gefitinib as the preferred first-line therapy in some markets [2]. Nonetheless, gefitinib retains relevance, particularly in regions where cost and existing medication availability influence treatment choices.

Market Dynamics

Pricing and Reimbursement Landscape

Pricing strategies for gefitinib vary globally, heavily influenced by healthcare policy frameworks and reimbursement policies. In many Asian markets, gefitinib is available as a generic drug, significantly reducing costs and increasing accessibility. Conversely, in Western markets, patent protections and branding rights sustain higher prices, although patent expirations threaten to erode market share.

Patent Status and Generic Entry

The patent landscape for IRESSA is crucial in its financial trajectory. Pfizer's patent for gefitinib expired in several key markets around 2015-2017, allowing generic manufacturers to enter the market. The influx of generics drives down prices, impacting Pfizer's revenue stream and opening up opportunities for competitors.

Manufacturing and Supply Chain Factors

Efficient manufacturing processes and supply chain stability underpin gefitinib’s market availability. The drug's production involves complex synthesis of the active pharmaceutical ingredient (API), with quality controls critical for regulatory compliance. Supply disruptions or quality issues can influence market confidence and sales volumes.

Prescriber and Patient Uptake Trends

Early adoption was driven by oncologists' enthusiasm for targeted therapies. Over time, clinical guidelines now favor osimertinib as the first-line option, impacting gefitinib’s demand. Nonetheless, utilization persists, especially where cost-effectiveness and access influence prescribing behaviors.

Regulatory and Legal Factors

Regulatory decisions continue to shape gefitinib’s market presence. In some jurisdictions, regulatory agencies have restricted indications based on emerging clinical data. Patent litigation and patent thickets also influence generic entry and pricing strategies.

Financial Trajectory

Revenue Trajectory and Historical Performance

Pfizer's reported revenues from IRESSA have shown a declining trend in recent years amid patent expirations and the advent of newer agents [3]. Despite this, gefitinib remains significant in certain markets, especially where generic options are not fully penetrated.

Impact of Patent Expiry

Patent expiration has led to a steep drop in gefitinib’s per-unit price and overall revenue. The shift towards generics has reduced Pfizer’s margins, compelling the company to reassess its portfolio focus within oncology.

Emerging Market Opportunities

Emerging markets present fertile grounds for gefitinib due to affordability, with sales driven by generic competition and increasing NSCLC incidence. Strategic alliances, licensing, and local manufacturing further bolster market penetration in these regions.

Pipeline and Future Prospects

While gefitinib’s core sales fluctuate with competition, ongoing research into biomarkers and combination therapies may sustain or enhance its relevance. Pfizer’s focus on next-generation inhibitors and combination regimens could influence gefitinib’s future market share.

Strategic Considerations

• Lifecycle Management: Patent cliff management necessitates strategic actions such as licensing or transitioning to biosimilars.
• Market Diversification: Expanding into new geographies and leveraging local partnerships can offset declining revenues.
• Therapeutic Positioning: Emphasizing gefitinib’s role in early-stage disease and combination therapies can extend its lifecycle.
• Competitive Dynamics: Monitoring advances in EGFR mutation testing and personalized medicine is essential for maintaining relevance.

Conclusion

The market dynamics of IRESSA are shaped by genetics, evolving treatment standards, and patent-related factors. While current revenues face pressures from generic competition and newer therapies, emerging markets and strategic positioning could sustain its financial relevance. Pfizer and other stakeholders must adapt through innovation, diversification, and strategic alliances to optimize gefitinib’s value lifecycle.

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Key Takeaways

• IRESSA continues to hold a meaningful niche in EGFR-mutant NSCLC, particularly in Asia.
• Patent expirations and generics have significantly reduced Pfizer’s revenue from gefitinib, heightening the importance of alternative growth strategies.
• The competitive landscape has shifted toward third-generation inhibitors like osimertinib, but gefitinib remains relevant where cost and access are pivotal.
• Opportunities exist in emerging markets, especially through local manufacturing and partnerships.
• Continuous innovation and strategic lifecycle management are essential for maintaining the drug’s market position.

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FAQs

Q1: How has the patent expiration affected gefitinib’s market share?
A: Patent expirations have facilitated the entry of generic competitors, leading to price reductions and a decline in Pfizer’s revenue from gefitinib, particularly in developed markets.

Q2: Why is gefitinib still relevant despite the availability of newer EGFR inhibitors?
A: Cost-effectiveness, established clinical data, and regulatory approvals sustain gefitinib’s use, especially where newer agents are less accessible or affordable.

Q3: Which markets present the most growth opportunities for gefitinib?
A: Emerging markets in Asia, where affordability and high prevalence of EGFR mutations exist, represent significant growth potential for gefitinib.

Q4: What is the impact of clinical guidelines on gefitinib’s market?
A: Clinical guidelines now favor compounds like osimertinib for first-line therapy, reducing gefitinib’s market share but maintaining its role in specific settings.

Q5: What strategic actions can Pfizer undertake to extend gefitinib’s lifecycle?
A: Pfizer can explore licensing deals, develop combination therapies, optimize manufacturing efficiencies, and expand into underserved geographies to prolong its market relevance.

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References:

[1] National Cancer Institute. "SEER Cancer Statistics Review." 2022.
[2] Soria, J.C., et al. "Osimertinib in untreated EGFR-mutated advanced NSCLC." New England Journal of Medicine, 2018.
[3] Pfizer Inc. Annual Reports 2015–2022.