Gefitinib - Generic Drug Details

What are the generic sources for gefitinib and what is the scope of patent protection?

Gefitinib is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, Natco, Qilu Pharm Hainan, and Astrazeneca, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for gefitinib. Six suppliers are listed for this compound.

Summary for gefitinib

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	386
Patent Applications:	7,285
Drug Prices:	Drug price trends for gefitinib
What excipients (inactive ingredients) are in gefitinib?	gefitinib excipients list
DailyMed Link:	gefitinib at DailyMed

See drug prices for gefitinib

Recent Clinical Trials for gefitinib

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

Sponsor	Phase
China Medical University Hospital	Phase 1/Phase 2
MedSIR	Phase 2
Daiichi Sankyo, Inc.	Phase 2

See all gefitinib clinical trials

Pharmacology for gefitinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for gefitinib

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for gefitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Qilu Pharm Hainan	GEFITINIB	gefitinib	TABLET;ORAL	211591-001	Feb 13, 2023	AB	RX	No	No
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003		DISCN	No	No
Actavis Labs Fl Inc	GEFITINIB	gefitinib	TABLET;ORAL	208913-001	Apr 26, 2023	AB	RX	No	No
Natco	GEFITINIB	gefitinib	TABLET;ORAL	212827-001	May 31, 2023	AB	RX	No	No
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	AB	RX	Yes	Yes
Apotex	GEFITINIB	gefitinib	TABLET;ORAL	209532-001	Sep 23, 2022	AB	RX	No	No

Expired US Patents for gefitinib

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

EU/EMA Drug Approvals for gefitinib

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

Gefitinib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gefitinib

Introduction to Gefitinib

Gefitinib, a tyrosine kinase inhibitor, is a crucial drug in the treatment of non-small cell lung cancer (NSCLC), particularly in patients with specific epidermal growth factor receptor (EGFR) mutations. Here, we delve into the market dynamics and financial trajectory of gefitinib, highlighting key factors driving its growth and future projections.

Market Size and Growth Projections

The global gefitinib market is experiencing significant growth. As of 2023, the market size was valued at USD 1.91 billion and is expected to reach USD 4.57 billion by 2031, growing at a compound annual growth rate (CAGR) of 11.2% from 2024 to 2031[1].

Another report estimates the global gefitinib market size to be USD 1,541.2 million in 2024, with a projected CAGR of 8.50% from 2024 to 2031, reaching USD 2,728.1 million by 2031[4].

Key Drivers of Market Growth

Increasing Incidence of Cancer

The rising incidence of cancer, especially NSCLC, is a primary driver for the gefitinib market. Regions with high smoking and air pollution rates are seeing an increase in cancer cases, which in turn increases the demand for targeted treatments like gefitinib[1][4].

Advancements in Precision Medicine

Advances in genetic testing have improved patient identification, allowing for more precise treatment plans. This has led to an increased use of gefitinib, as it is highly effective in patients with specific EGFR mutations[1][3].

Regulatory Approvals and Clinical Research

Favorable regulatory approvals, especially in emerging economies, and ongoing clinical research are significant factors contributing to the market expansion. Positive outcomes from clinical trials and the approval of new indications further boost the market[1][3].

Pharmaceutical R&D and Healthcare Infrastructure

Pharmaceutical companies' focus on research and development for better cancer therapeutics, along with improvements in healthcare infrastructure and patient awareness, are also driving the growth of the gefitinib market[1][4].

Geographical Market Segmentation

The gefitinib market is segmented geographically, with different regions showing varying growth rates:

• North America: Held over 40% of the global revenue in 2024, with a market size of USD 616.48 million and a CAGR of 6.7% from 2024 to 2031[4].
• Europe: Accounted for more than 30% of the global revenue in 2024, with a market size of USD 462.36 million and a CAGR of 7.0% from 2024 to 2031[4].
• Asia-Pacific: Held around 23% of the global revenue in 2024, with a market size of USD 354.48 million and a CAGR of 10.5% from 2024 to 2031[4].
• Latin America: Represented more than 5% of the global revenue in 2024, with a market size of USD 77.06 million and a CAGR of 7.9% from 2024 to 2031[4].
• Middle East and Africa: Held around 2% of the global revenue in 2024, with a market size of USD 30.82 million and a CAGR of 8.2% from 2024 to 2031[4].

Competitive Landscape

The EGFR inhibitor market, which includes gefitinib, is highly competitive. Established drugs like gefitinib and erlotinib have long been staples, but newer entrants such as osimertinib have significantly impacted market dynamics. Osimertinib's approval as a first-line treatment for NSCLC patients with EGFR mutations has led to shifts in prescribing patterns and market dominance[3].

Emerging Players and New Therapies

Several leading companies, including Merus, Cullinan Oncology, Taiho Pharma, and Blueprint Medicines Corporation, are developing novel EGFR inhibitors. These include Petosemtamab, MCLA-129, Zipalertinib, Furmonertinib, and BLU-945, among others. The emergence of these new therapies is expected to further expand the market[3].

Impact of Biosimilars and Generics

The entry of biosimilars and generics into the market has added complexity, driving down prices and intensifying competition for market share. This trend is expected to continue, influencing the financial trajectory of gefitinib and other EGFR inhibitors[3].

Financial Performance and Revenue Streams

Revenue Growth

The revenue from gefitinib is expected to increase significantly due to its expanding applications and favorable regulatory approvals. For instance, the market is projected to grow from USD 1.91 billion in 2023 to USD 4.57 billion by 2031, reflecting a robust financial trajectory[1].

Pharmaceutical Company Investments

Pharmaceutical companies are investing heavily in research and development to bring more effective and less toxic inhibitors to market. This investment is driven by the success of drugs like gefitinib and the potential for new therapies to capture significant market share[1][3].

Healthcare Expenditure

The rising healthcare expenditure in developing regions is another factor supporting the financial growth of the gefitinib market. As healthcare systems improve and more patients gain access to targeted cancer medicines, the demand for gefitinib is expected to rise[1][4].

Regulatory and Clinical Trial Impact

Regulatory Approvals

Regulatory approvals play a crucial role in the market dynamics of gefitinib. Positive approvals for new indications and patient populations can significantly boost sales and market dominance. For example, the approval of osimertinib as a first-line treatment has reshaped the market landscape[3].

Clinical Trials and Combination Therapies

Ongoing clinical trials exploring combination therapies and new indications promise to expand the market further. These trials are critical in demonstrating the efficacy and safety of gefitinib in various cancer types, which can lead to additional regulatory approvals and increased market share[3].

Key Takeaways

• The global gefitinib market is expected to grow significantly, driven by the increasing incidence of cancer, advancements in precision medicine, and favorable regulatory approvals.
• Geographical segmentation shows varying growth rates, with Asia-Pacific expected to grow at the highest CAGR.
• The competitive landscape is intense, with both established and emerging players vying for market share.
• Regulatory approvals and ongoing clinical trials are crucial for the financial trajectory of gefitinib.
• Rising healthcare expenditure and improvements in healthcare infrastructure are supporting the market growth.

FAQs

What is the current market size of the gefitinib market?

The global gefitinib market size was valued at USD 1.91 billion in 2023 and is estimated at USD 1,541.2 million in 2024 according to different reports[1][4].

What is the projected growth rate of the gefitinib market?

The market is expected to grow at a CAGR of 11.2% from 2024 to 2031, reaching USD 4.57 billion by 2031, or at a CAGR of 8.50% from 2024 to 2031, reaching USD 2,728.1 million by 2031, depending on the source[1][4].

What are the key drivers of the gefitinib market growth?

Key drivers include the increasing incidence of cancer, advancements in precision medicine, favorable regulatory approvals, and rising healthcare expenditure in developing regions[1][3][4].

Which regions are expected to show the highest growth rates for gefitinib?

The Asia-Pacific region is expected to show the highest CAGR, at 10.5% from 2024 to 2031[4].

How does the competitive landscape impact the gefitinib market?

The competitive landscape is highly competitive, with established drugs like gefitinib and erlotinib, and newer entrants like osimertinib. The emergence of biosimilars and generics also affects market dynamics[3].

Sources

1. Market Research Intellect: "Gefitinib Market Size and Forecast"[1]
2. AstraZeneca: "Full year and Q4 2022 results announcement"[2]
3. GlobeNewswire: "EGFR Inhibitor Market to Accelerate Substantially During the Study Period (2020–2034) - DelveInsight's Analysis"[3]
4. Cognitive Market Research: "Global Gefitinib Market Report 2024"[4]