ETOPOSIDE PHOSPHATE - Generic Drug Details

What are the generic sources for etoposide phosphate and what is the scope of freedom to operate?

Etoposide phosphate is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and Cheplapharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for etoposide phosphate. One supplier is listed for this compound.

Summary for ETOPOSIDE PHOSPHATE

US Patents:	0
Tradenames:	1
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	100
Patent Applications:	7,283
What excipients (inactive ingredients) are in ETOPOSIDE PHOSPHATE?	ETOPOSIDE PHOSPHATE excipients list
DailyMed Link:	ETOPOSIDE PHOSPHATE at DailyMed

Recent Clinical Trials for ETOPOSIDE PHOSPHATE

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

Sponsor	Phase
Cheng-Chia (Fred) Wu	Phase 1
Focused Ultrasound Foundation	Phase 1
Hoffmann-La Roche	Phase 1

See all ETOPOSIDE PHOSPHATE clinical trials

Pharmacology for ETOPOSIDE PHOSPHATE

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ETOPOSIDE PHOSPHATE

L01CB	Podophyllotoxin derivatives
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ETOPOSIDE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020906-002	Feb 27, 1998		DISCN	No	No
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457-001	May 17, 1996		RX	Yes	Yes
Bristol Myers Squibb	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020906-001	Feb 27, 1998		DISCN	No	No

Expired US Patents for ETOPOSIDE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457-001	May 17, 1996
Bristol Myers Squibb	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020906-002	Feb 27, 1998
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457-001	May 17, 1996
Bristol Myers Squibb	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020906-001	Feb 27, 1998
Bristol Myers Squibb	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020906-001	Feb 27, 1998
Bristol Myers Squibb	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020906-002	Feb 27, 1998

ETOPOSIDE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Etoposide Phosphate

Introduction to Etoposide Phosphate

Etoposide phosphate, a semisynthetic derivative of podophyllotoxin, is a crucial chemotherapeutic agent used in the treatment of various cancers, including small cell lung cancer, testicular cancer, and lymphomas. Its mechanism involves inhibiting DNA topoisomerase II, thereby disrupting DNA synthesis and cell division[4].

Market Drivers

The global etoposide phosphate market is driven by several key factors:

Growing Prevalence of Cancer

The increasing incidence of cancers, particularly prostate cancer, small cell lung cancer, and testicular cancer, is a significant driver. Prostate cancer, for instance, is the second most prevalent cancer among men, with 1.4 million cases globally in 2021, according to Globocan data[1].

Aging Population

The world's aging population is another critical factor. Since prostate cancer is more frequent among senior citizens, the growing elderly population is expected to boost the demand for etoposide phosphate[1].

Advancements in Oncology Research

Ongoing developments in oncology research and the creation of combination therapies are enhancing the effectiveness and broadening the applicability of etoposide phosphate. This includes its use in combination with other chemotherapies and immunotherapies, such as Imfinzi from AstraZeneca for advanced-stage small cell lung cancer[4].

Government Funding and Programs

Government funding and programs for cancer research also play a vital role in driving market growth by encouraging innovation and improving treatment outcomes[3].

Market Size and Growth Rate

The etoposide market, which includes etoposide phosphate, was valued at approximately USD 715.62 million in 2023. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.8% from 2024 to 2030, reaching nearly USD 1.061 billion by 2030[1].

Another report indicates that the market size could reach USD 1.2 billion by 2031, growing at a CAGR of 5.2% from 2024 to 2031[3].

Regional Insights

North America

North America, particularly the United States and Canada, is expected to hold a significant market share due to the rising frequency of prostate cancer, increasing awareness, and enhanced research and development activities in the region. The US Food and Drug Administration's efforts to expedite drug approvals also contribute to market growth[1].

Europe and Asia-Pacific

Europe and the Asia-Pacific region are also significant markets, driven by the increasing incidence of various cancers and advancements in healthcare infrastructure. Countries like China, Japan, and India are expected to see substantial growth due to their large populations and improving access to cancer treatments[1][3].

Pharmacoeconomic Benefits

Etoposide phosphate offers several pharmacoeconomic advantages:

Cost Efficiency

A pharmacoeconomic evaluation revealed that using etoposide phosphate instead of standard etoposide can result in significant cost savings. For instance, delivering an etoposide phosphate regimen can save up to $2,897.03 per patient due to the ease of administration and reduced need for outpatient chemotherapy facilities[2].

Operational Efficiencies

The simplicity of etoposide phosphate administration can increase patient volume, improve scheduling, and reduce operational costs, further enhancing its pharmacoeconomic profile[2].

Market Segments

The etoposide phosphate market is segmented based on:

Form

The market includes various forms such as injectable solutions, oral capsules, and oral suspensions. Injectable solutions are particularly popular due to their ease of administration and rapid action[3].

Application

Etoposide phosphate is used in the treatment of several types of cancer, including small cell lung cancer, testicular cancer, and lymphomas. The small cell lung cancer segment is expected to grow at a CAGR of 3.8% during the forecast period[1].

Challenges and Restraints

Despite the growth drivers, the market faces some challenges:

High Cost of Cancer Medications

The high cost of cancer medications, especially for lung cancer, is a significant restraint for new market entrants and patients. This can limit access to these critical treatments, particularly in developing countries[1].

Side Effects and Toxicity

Etoposide phosphate, like other chemotherapeutic agents, can have severe side effects and toxicity, which may impact its adoption and patient compliance[4].

Key Players and Competitive Analysis

The market is competitive, with several key players including pharmaceutical companies and research institutions. Market leaders are investing heavily in research and development to improve the efficacy and safety of etoposide phosphate. The report provides a comprehensive analysis of key players, including their product portfolios, growth strategies, and regional presence[1].

Future Outlook

The future of the etoposide phosphate market looks promising, driven by increasing cancer prevalence, advancements in oncology research, and government support for cancer treatments. As healthcare costs rise and access to cancer therapies improves, especially in developing nations, the demand for effective chemotherapy drugs like etoposide phosphate is expected to grow significantly.

Key Takeaways

• The etoposide phosphate market is driven by the growing prevalence of cancers, an aging population, and advancements in oncology research.
• The market is expected to grow at a CAGR of 5.8% from 2024 to 2030, reaching nearly USD 1.061 billion.
• North America is expected to hold a significant market share due to rising cancer incidence and enhanced research activities.
• Etoposide phosphate offers pharmacoeconomic benefits, including cost savings and operational efficiencies.
• The market faces challenges such as high medication costs and potential side effects.

Frequently Asked Questions (FAQs)

Q: What is the primary driver of the etoposide phosphate market? A: The primary driver is the growing prevalence of prostate cancer and other cancers.

Q: Which region is expected to hold a significant market share for etoposide phosphate? A: North America, particularly the US and Canada, is expected to hold a considerable market share.

Q: What are the pharmacoeconomic benefits of using etoposide phosphate? A: Etoposide phosphate offers cost savings and operational efficiencies compared to standard etoposide.

Q: What are the main applications of etoposide phosphate? A: Etoposide phosphate is used in the treatment of small cell lung cancer, testicular cancer, and lymphomas.

Q: What are the challenges faced by the etoposide phosphate market? A: High medication costs and potential side effects are significant challenges.

Cited Sources

1. Maximize Market Research - Etoposide Market - Region and Forecast (2024-2030)
2. PubMed - A pharmacoeconomic evaluation of cisplatin in combination with etoposide phosphate
3. Market Research Intellect - Etoposide Market Size, Share, Industry Growth, Forecast, 2031
4. OMR Global - Etoposide Market - Industry reports