PENTAMIDINE ISETHIONATE - Generic Drug Details

What are the generic drug sources for pentamidine isethionate and what is the scope of patent protection?

Pentamidine isethionate is the generic ingredient in four branded drugs marketed by Fresenius Kabi Usa, Seton Pharms, X-gen Pharms Inc, Armour Pharm, Avet Lifesciences, Baxter Hlthcare, Hospira, Watson Labs, and Xgen Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for pentamidine isethionate. Four suppliers are listed for this compound.

Summary for PENTAMIDINE ISETHIONATE

US Patents:	0
Tradenames:	4
Applicants:	9
NDAs:	11
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	23
Patent Applications:	2,614
Drug Prices:	Drug price trends for PENTAMIDINE ISETHIONATE
What excipients (inactive ingredients) are in PENTAMIDINE ISETHIONATE?	PENTAMIDINE ISETHIONATE excipients list
DailyMed Link:	PENTAMIDINE ISETHIONATE at DailyMed

See drug prices for PENTAMIDINE ISETHIONATE

Recent Clinical Trials for PENTAMIDINE ISETHIONATE

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

Sponsor	Phase
Mayo Clinic	Phase 1
University of Texas Southwestern Medical Center	Phase 1
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 1

See all PENTAMIDINE ISETHIONATE clinical trials

Pharmacology for PENTAMIDINE ISETHIONATE

Drug Class

Antiprotozoal

Medical Subject Heading (MeSH) Categories for PENTAMIDINE ISETHIONATE

Antifungal Agents

Antiprotozoal Agents

Trypanocidal Agents

Anatomical Therapeutic Chemical (ATC) Classes for PENTAMIDINE ISETHIONATE

P01CX	Other agents against leishmaniasis and trypanosomiasis
P01C	AGENTS AGAINST LEISHMANIASIS AND TRYPANOSOMIASIS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for PENTAMIDINE ISETHIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
X-gen Pharms Inc	PENTAMIDINE ISETHIONATE	pentamidine isethionate	FOR SOLUTION;INHALATION	206983-001	Jan 20, 2023	AN	RX	No	No
Armour Pharm	PENTACARINAT	pentamidine isethionate	INJECTABLE;INJECTION	073447-001	Apr 28, 1994		DISCN	No	No
Fresenius Kabi Usa	NEBUPENT	pentamidine isethionate	FOR SOLUTION;INHALATION	019887-001	Jun 15, 1989	AN	RX	Yes	Yes
Avet Lifesciences	PENTAMIDINE ISETHIONATE	pentamidine isethionate	INJECTABLE;INJECTION	213806-001	Jan 7, 2021	AP	RX	No	No
Hospira	PENTAMIDINE ISETHIONATE	pentamidine isethionate	INJECTABLE;INJECTION	073479-001	Jun 30, 1992		DISCN	No	No
Xgen Pharms	PENTAMIDINE ISETHIONATE	pentamidine isethionate	INJECTABLE;INJECTION	206982-001	Mar 17, 2022	AP	RX	No	No

PENTAMIDINE ISETHIONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pentamidine Isethionate

Introduction to Pentamidine Isethionate

Pentamidine isethionate is a medication primarily used to prevent and treat Pneumocystis carinii pneumonia (PCP), a serious type of pneumonia, particularly in patients with compromised immune systems such as those with AIDS or undergoing organ transplantation[2][5].

Historical Context and Therapeutic Importance

The therapeutic importance of pentamidine isethionate increased significantly with the advent of the AIDS epidemic. It has been used as a second-line treatment for PCP due to its toxicity and higher cost compared to other treatments like cotrimoxazole (trimethoprim-sulfamethoxazole)[2].

Market Demand and Growth

The demand for pentamidine isethionate is driven by the ongoing need for effective treatments for PCP, especially in populations with immunodeficiencies. Here are some key points regarding market demand:

Growing Need in Immunocompromised Patients

The continuous presence of immunocompromised patients, including those with AIDS and organ transplant recipients, ensures a steady demand for pentamidine isethionate. This demand is further exacerbated by the limitations and side effects associated with first-line treatments[2][5].

Expansion in Downstream Markets

The global pentamidine isethionate reagent market is expected to grow due to increasing demand in downstream markets. This growth is forecasted to continue until 2029, with the market readjusting to a significant size in terms of revenue[4].

Financial Trajectory

Revenue Projections

The global pentamidine isethionate reagent market is projected to see substantial growth, driven by the increasing demand for the drug in various medical applications. While exact revenue figures are not provided, the market is expected to expand significantly by 2029[4].

Cost and Pricing

Pentamidine isethionate is considered a costly medication, which can impact its adoption rates. For instance, a 1-gram quantity of pentamidine isethionate can cost approximately ₹11,500.00 (Indian Rupees), exclusive of domestic taxes[1].

Economic Factors Influencing Market Dynamics

• Cost of Production: The cost of producing pentamidine isethionate, including the raw materials and manufacturing process, contributes to its final pricing.
• Regulatory Environment: Regulatory approvals and compliance requirements can influence the availability and pricing of the drug.
• Competition: The presence of alternative treatments, such as cotrimoxazole, affects the market share and pricing strategy for pentamidine isethionate[2].

Delivery Methods and Their Impact on Market Dynamics

Parenteral Administration

Parenteral administration of pentamidine isethionate has been associated with significant toxicity, including hypoglycemia and nephrotoxicity. This has led to a search for alternative delivery methods[2].

Aerosolized Delivery

Aerosolized pentamidine has emerged as a preferred method for both therapy and prevention of PCP due to its lower toxicity and greater convenience. This method has shown promising results in clinical trials and is likely to drive market growth as it becomes more widely adopted[2][3].

Side Effects and Their Economic Impact

The side effects of pentamidine isethionate, such as metallic taste, low blood pressure, dizziness, and fatigue, can impact patient compliance and overall market demand. However, the severity and frequency of these side effects are generally lower with aerosolized delivery, which could improve the economic viability of the treatment[5].

Distribution and Accessibility

Global Availability

Pentamidine isethionate is available in various regions, with different distribution channels and lead times. For example, stocks in Hyderabad, India, can be dispatched on the same day, while items from the Japan warehouse may take 10-12 working days[1].

Storage and Handling

The drug requires specific storage conditions, such as refrigeration and storage under inert gas, which can affect its distribution and handling costs. These requirements must be carefully managed to ensure the product's efficacy and safety[1].

Regulatory and Safety Considerations

Safety Data Sheet (SDS)

The safety data sheet for pentamidine isethionate highlights several hazard statements, including skin irritation, serious eye irritation, and potential damage to organs through prolonged exposure. These safety concerns must be addressed in the manufacturing, distribution, and use of the drug[1].

Precautionary Statements

Precautionary statements include recommendations for protective clothing, eye protection, and proper disposal of the drug. Compliance with these statements is crucial for maintaining a safe and regulated market environment[1].

Industry Expert Insights

Industry experts emphasize the importance of balancing the therapeutic benefits of pentamidine isethionate with its associated risks and costs. For example:

"Aerosolised pentamidine, on the basis of early clinical results, convenience and low toxicity, may become the drug of choice for prevention of PCP in individuals at high risk."[2]

Market Trends and Future Outlook

Increasing Adoption of Aerosolized Delivery

The trend towards aerosolized delivery is expected to continue, driven by its lower toxicity and greater convenience. This shift is likely to positively impact the market dynamics and financial trajectory of pentamidine isethionate.

Technological Advancements

Advancements in drug delivery technologies and the development of more effective and safer formulations could further enhance the market position of pentamidine isethionate.

Regulatory Support

Regulatory support and approvals for new delivery methods and formulations will be crucial in driving the growth of the pentamidine isethionate market.

Key Takeaways

• Growing Demand: The market for pentamidine isethionate is driven by the ongoing need for effective treatments for PCP in immunocompromised patients.
• Aerosolized Delivery: This method is gaining preference due to its lower toxicity and greater convenience.
• Cost and Pricing: The drug is costly, but its pricing is expected to be influenced by regulatory and competitive factors.
• Regulatory Compliance: Strict adherence to safety and handling guidelines is essential for maintaining market viability.
• Future Outlook: The market is expected to grow, driven by technological advancements and increasing adoption of aerosolized delivery.

FAQs

What is pentamidine isethionate used for?

Pentamidine isethionate is used to prevent and treat Pneumocystis carinii pneumonia (PCP), particularly in patients with compromised immune systems.

What are the common side effects of pentamidine isethionate?

Common side effects include metallic taste, low blood pressure, dizziness, fatigue, and sometimes nausea, vomiting, and skin rash.

Why is aerosolized delivery preferred for pentamidine isethionate?

Aerosolized delivery is preferred due to its lower toxicity and greater convenience compared to parenteral administration.

How is pentamidine isethionate administered?

It can be administered through inhalation using a nebulizer, as a solution, or as an injection.

What are the storage requirements for pentamidine isethionate?

The drug requires refrigeration (0-10°C) and storage under inert gas to maintain its efficacy and safety.

Sources

1. Tokyo Chemical Industry (India) Pvt Ltd. - Pentamidine Isethionate 140-64-7 | Tokyo Chemical Industry (India) Pvt Ltd.
2. PubMed - Pentamidine. A risk-benefit analysis.
3. PubMed - Distribution of pentamidine in patients with AIDS.
4. Market Research Reports - Global Pentamidine Isethionate Reagent Market Growth 2023-2029.
5. Children's Hospital of Pittsburgh - Pentamidine Isethionate Nebulization Solution (NebuPent®, Pentam®) Uses and Side Effects.