FOSCARNET SODIUM - Generic Drug Details

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

Foscarnet sodium is the generic ingredient in two branded drugs marketed by Amneal, Avet Lifesciences, Beijing, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, and Clinigen Hlthcare, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for foscarnet sodium. Eight suppliers are listed for this compound.

Summary for FOSCARNET SODIUM

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	24
Patent Applications:	6
What excipients (inactive ingredients) are in FOSCARNET SODIUM?	FOSCARNET SODIUM excipients list
DailyMed Link:	FOSCARNET SODIUM at DailyMed

Recent Clinical Trials for FOSCARNET SODIUM

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

Sponsor	Phase
Cttq	Phase 4
Peking University People's Hospital	Phase 4
City of Hope Medical Center

See all FOSCARNET SODIUM clinical trials

Pharmacology for FOSCARNET SODIUM

Drug Class	Pyrophosphate Analog DNA Polymerase Inhibitor
Mechanism of Action	Chelating Activity DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for FOSCARNET SODIUM

Antiviral Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FOSCARNET SODIUM

J05AD	Phosphonic acid derivatives
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for FOSCARNET SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	FOSCARNET SODIUM	foscarnet sodium	INJECTABLE;INJECTION	212483-001	Jan 29, 2021	AP	RX	No	No
Gland Pharma Ltd	FOSCARNET SODIUM	foscarnet sodium	INJECTABLE;INJECTION	213001-001	Apr 21, 2021	AP	RX	No	No
Amneal	FOSCARNET SODIUM	foscarnet sodium	INJECTABLE;INJECTION	216602-001	Mar 1, 2024	AP	RX	No	No
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	AP	RX	Yes	Yes
Beijing	FOSCARNET SODIUM	foscarnet sodium	INJECTABLE;INJECTION	213987-001	Nov 29, 2023	AP	RX	No	No
Hospira	FOSCARNET SODIUM	foscarnet sodium	INJECTABLE;INJECTION	077174-001	May 31, 2005		DISCN	No	No

Expired US Patents for FOSCARNET SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	4,215,113
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	4,771,041
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	4,665,062
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	4,339,445

FOSCARNET SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Foscarnet Sodium

Introduction

Foscarnet sodium, a potent antiviral drug, has been a crucial component in the treatment of various viral infections, particularly in immunocompromised patients. This article delves into the market dynamics and financial trajectory of foscarnet sodium, highlighting its current market position, usage, and future prospects.

Market Overview

Foscarnet sodium is used primarily for the treatment of CMV retinitis in patients with AIDS and for acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients[1].

Current Market Size and Sales

As of the 12 months ending July 2024, the US sales of Foscarnet Sodium Injection (6000mg/250mL) were approximately $19 million, according to IQVIA[1]. This figure indicates a stable demand for the drug within the US market.

Key Players and Market Share

Hikma Pharmaceuticals PLC, a multinational pharmaceutical company, is one of the major players in the market for foscarnet sodium. Hikma recently launched Foscarnet Sodium Injection in the US, expanding its portfolio of essential medicines[1].

Other notable manufacturers include Hospira Inc., Clinigen Healthcare Ltd., and AstraZeneca Inc.[3].

Dosage Forms and Pricing

Foscarnet sodium is available in various dosage forms, including intravenous solutions of 24 mg/mL and 6000 mg/250mL. The pricing varies by dosage form, with the 24 mg/mL infusion bottle costing approximately $0.43 per mL[3].

Pharmacoeconomics and Cost Considerations

The cost of foscarnet sodium can be significant, especially given the need for prolonged treatment in many cases. For instance, the sodium phosphonoformate powder form of foscarnet costs around $286.3 per gram[3].

Impact on Healthcare Costs

The high cost of foscarnet sodium, along with its specific administration requirements (intravenous infusion using an infusion pump), contributes to overall healthcare expenditure. However, its effectiveness in treating severe viral infections justifies the investment for many patients.

Clinical Trials and Efficacy

Foscarnet sodium has been evaluated in several clinical trials, including the FOS-03 trial, which demonstrated its efficacy in treating CMV retinitis. These trials have established the drug's role in managing viral infections in immunocompromised patients[5].

Safety and Adverse Events

While foscarnet sodium is effective, it comes with several potential adverse events, including seizures, QT prolongation, torsades de pointes, and hematopoietic system effects such as anemia and granulocytopenia. These risks necessitate careful patient monitoring and dose adjustment, particularly in patients with renal impairment[1][4].

Market Growth Drivers

Several factors drive the market for foscarnet sodium:

Increasing Prevalence of Viral Infections

The rise in immunocompromised patients, particularly those with HIV/AIDS, increases the demand for antiviral drugs like foscarnet sodium.

Advancements in Healthcare

Improvements in healthcare infrastructure and the availability of advanced medical treatments contribute to the growing market for specialized antiviral medications.

Generic Market Expansion

Hikma's launch of a generic version of foscarnet sodium in the US expands access to this essential medicine, potentially increasing market share and sales volume[1].

Challenges and Limitations

Despite its efficacy, the market for foscarnet sodium faces several challenges:

Renal Impairment Considerations

The drug's pharmacokinetics are significantly affected by renal function, requiring careful dose adjustments in patients with impaired renal function. This complexity can limit its use in certain patient populations[5].

Drug Interactions and Compatibility Issues

Foscarnet sodium has specific compatibility issues, particularly with calcium-containing solutions, which can limit its use in certain clinical settings[4].

Future Prospects

The market for foscarnet sodium is expected to remain stable due to its established role in treating specific viral infections.

Expanding Patient Base

The growing number of immunocompromised patients, including those undergoing organ transplants and those with chronic diseases, will continue to drive demand for foscarnet sodium.

Generic Competition

The entry of more generic versions could increase competition, potentially affecting pricing and market dynamics. However, this competition can also lead to better accessibility and affordability for patients.

Financial Trajectory

Given the stable demand and the recent launch by Hikma, the financial trajectory for foscarnet sodium is expected to be positive.

Revenue Projections

While exact revenue projections are not available, the $19 million in US sales for the 12 months ending July 2024 indicates a solid financial foundation. As the market expands and more generic versions become available, revenues are likely to grow, albeit at a moderate pace.

Key Takeaways

• Established Market Presence: Foscarnet sodium has a well-established role in treating CMV retinitis and acyclovir-resistant HSV infections.
• Stable Demand: The drug sees stable demand, particularly in the US market.
• Generic Expansion: The launch of generic versions by companies like Hikma is expected to increase accessibility and potentially drive market growth.
• Clinical Efficacy: Foscarnet sodium has demonstrated efficacy in clinical trials, solidifying its position in antiviral treatment protocols.
• Safety Considerations: The drug comes with significant safety considerations, including potential adverse events and drug interactions.

Frequently Asked Questions (FAQs)

Q1: What is foscarnet sodium used for? Foscarnet sodium is used for the treatment of CMV retinitis in patients with AIDS and for acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients[1].

Q2: Who are the key manufacturers of foscarnet sodium? Key manufacturers include Hikma Pharmaceuticals PLC, Hospira Inc., Clinigen Healthcare Ltd., and AstraZeneca Inc.[1][3].

Q3: What are the potential adverse events associated with foscarnet sodium? Potential adverse events include seizures, QT prolongation, torsades de pointes, and hematopoietic system effects such as anemia and granulocytopenia[1][4].

Q4: How is foscarnet sodium administered? Foscarnet sodium is administered by intravenous infusion using an infusion pump to prevent rapid infusion and ensure adequate blood flow[4].

Q5: What are the compatibility issues with foscarnet sodium? Foscarnet sodium is chemically incompatible with calcium-containing solutions, such as Ringer’s injection and lactated Ringer’s solution[4].

Sources Cited

1. Hikma Pharmaceuticals PLC, "Hikma launches Foscarnet Sodium Injection in the US," September 23, 2024.
2. Synapse, "Apria Healthcare Group LLC - Drug pipelines, Patents, Clinical trials."
3. DrugBank, "Foscarnet: Uses, Interactions, Mechanism of Action."
4. ASHP Publications, "Foscarnet Sodium - ASHP Publications."
5. FDA, "FOSCAVIR® (foscarnet sodium) - accessdata.fda.gov."