ETHYOL Drug Patent Profile

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

Ethyol is a drug marketed by Cosette and is included in one NDA.

The generic ingredient in ETHYOL is amifostine. There are six drug master file entries for this compound. Additional details are available on the amifostine profile page.

Summary for ETHYOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	32
Patent Applications:	4,801
Drug Prices:	Drug price information for ETHYOL
What excipients (inactive ingredients) are in ETHYOL?	ETHYOL excipients list
DailyMed Link:	ETHYOL at DailyMed

See drug prices for ETHYOL

Recent Clinical Trials for ETHYOL

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1
Children's Hospital Medical Center, Cincinnati	Phase 2
AstraZeneca	Phase 2

See all ETHYOL clinical trials

Paragraph IV (Patent) Challenges for ETHYOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ETHYOL	For Injection	amifostine	500 mg/vial	020221	1	2004-04-16

US Patents and Regulatory Information for ETHYOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995		DISCN	Yes	No
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999		DISCN	No	No

Expired US Patents for ETHYOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999

International Patents for ETHYOL

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9813524
China	1161113
Denmark	0655917
Germany	69333453
Singapore	47101	Crystalline amifostine compositions and methods for the preparation and use of same
Spain	2215992

Market Dynamics and Financial Trajectory for Ethyol

Introduction

Ethyol, also known as amifostine, is a drug approved for reducing the cumulative renal toxicity associated with repeated administration of cisplatin, a chemotherapy agent, and for reducing the incidence of moderate to severe xerostomia (dry mouth) in patients undergoing radiotherapy for head and neck cancer[4].

Market Dynamics

Therapeutic Applications

Ethyol is specialized in protecting against the side effects of certain cancer treatments. Its primary use is in the oncology sector, where it helps mitigate the renal toxicity of cisplatin and the xerostomia caused by radiotherapy. This niche application makes it a critical component in the treatment protocols for specific types of cancer.

Market Drivers

• Increasing Cancer Incidence: The rising incidence of cancer globally drives the demand for protective agents like Ethyol. As more patients undergo chemotherapy and radiotherapy, the need for drugs that reduce the side effects of these treatments increases.
• Advancements in Oncology: Continuous advancements in cancer treatment, including the development of new chemotherapy agents and radiotherapy protocols, create opportunities for Ethyol to be integrated into these new treatments.
• Regulatory Approvals: Ethyol has received approvals from regulatory bodies, which supports its market penetration and acceptance by healthcare providers[4].

Market Restraints

• Cost and Accessibility: High therapy costs can be a significant barrier to the widespread adoption of Ethyol. The financial burden on patients and healthcare systems can limit its accessibility.
• Side Effects and Safety Concerns: Like any drug, Ethyol comes with potential side effects, which can impact its adoption rates. Monitoring and managing these side effects are crucial for maintaining patient trust and compliance.
• Regulatory Challenges: Changes in regulatory environments can affect the market dynamics of Ethyol. Patent restrictions and competition from alternative protective agents can also pose challenges[1].

Market Opportunities

• Expanding Therapeutic Uses: Research into broader therapeutic benefits of Ethyol, such as its potential in reducing other types of toxicity associated with cancer treatments, could expand its market.
• Emerging Markets: There is significant potential in emerging economies where cancer treatment options are limited but growing. Expanding market presence in these regions can drive growth.
• Combination Therapies: Developing combination drugs that include Ethyol could enhance its efficacy and market appeal[1].

Financial Trajectory

Revenue Performance

Cumberland Pharmaceuticals, the company associated with Ethyol, has reported mixed financial results over the years. While the company has seen growth in some of its products, the overall financial performance has been influenced by various factors including operating expenses and revenue from other products.

• Quarterly and Annual Revenues: For instance, in the second quarter of 2016, Cumberland Pharmaceuticals reported net revenues of $8.7 million, with specific product revenues including $3.6 million for Kristalose and $0.4 million for Vaprisol, but Ethyol was not specifically highlighted in these reports[2][5].

Operating Expenses

• Research and Development: The company has invested in research and development, which includes preparations for new product launches and ongoing research into existing products like Ethyol. These expenses can impact the net income but are crucial for long-term growth.
• Selling and Marketing: Significant expenditures on selling and marketing efforts are also noted, which are essential for promoting Ethyol and other products to healthcare providers and patients.
• General and Administrative Costs: Managing general and administrative expenses is critical to maintaining profitability. Cumberland Pharmaceuticals has worked to manage these costs in line with revenues[2][5].

Cash Flow and Financing

• Cash and Cash Equivalents: The company's cash flow has seen fluctuations, with net cash provided by or used in operating, investing, and financing activities impacting the overall cash and cash equivalents at the end of each period.
• Borrowings and Share Repurchases: Cumberland Pharmaceuticals has engaged in net borrowings on lines of credit and repurchased common shares, which affect the financial trajectory and liquidity of the company[5].

Competitive Landscape

Ethyol operates in a competitive landscape within the oncology sector, where other protective agents and combination therapies are also available. The competitive assessment includes:

• Market Share: Ethyol's market share is influenced by its specific indications and the presence of alternative protective agents.
• Strategic Approaches: Cumberland Pharmaceuticals' strategic investments in R&D, marketing, and expanding into emerging markets are key to maintaining and growing Ethyol's market position.
• Regulatory Approvals and Patents: The company must navigate regulatory approvals and patent restrictions to ensure Ethyol remains competitive[1].

Key Takeaways

• Specialized Therapeutic Use: Ethyol is critical in reducing the side effects of certain cancer treatments.
• Market Growth Potential: The drug has potential for growth driven by increasing cancer incidence and advancements in oncology.
• Financial Management: Managing operating expenses, R&D investments, and cash flow is crucial for the financial health of the company.
• Competitive Landscape: Ethyol faces competition from other protective agents and combination therapies, necessitating strategic investments and regulatory vigilance.

FAQs

Q: What is Ethyol primarily used for? A: Ethyol is primarily used to reduce the cumulative renal toxicity associated with repeated administration of cisplatin and to reduce the incidence of moderate to severe xerostomia in patients undergoing radiotherapy for head and neck cancer[4].

Q: Which company is associated with Ethyol? A: Cumberland Pharmaceuticals is the company associated with Ethyol.

Q: What are the main market drivers for Ethyol? A: The main market drivers include the increasing incidence of cancer, advancements in oncology, and regulatory approvals.

Q: What are some of the challenges faced by Ethyol in the market? A: High therapy costs, potential side effects, and regulatory challenges are some of the key challenges.

Q: What opportunities exist for Ethyol in emerging markets? A: There is significant potential in emerging economies where cancer treatment options are limited but growing, offering opportunities for market expansion.