FOSCAVIR Drug Patent Profile

Which patents cover Foscavir, and when can generic versions of Foscavir launch?

Foscavir is a drug marketed by Clinigen Hlthcare and is included in one NDA.

The generic ingredient in FOSCAVIR is foscarnet sodium. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the foscarnet sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Foscavir

A generic version of FOSCAVIR was approved as foscarnet sodium by FRESENIUS KABI USA on January 29^th, 2021.

Summary for FOSCAVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	9
Patent Applications:	3,107
Drug Prices:	Drug price information for FOSCAVIR
What excipients (inactive ingredients) are in FOSCAVIR?	FOSCAVIR excipients list
DailyMed Link:	FOSCAVIR at DailyMed

See drug prices for FOSCAVIR

Recent Clinical Trials for FOSCAVIR

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

Sponsor	Phase
Biotest	Phase 2
University Hospital, Lille	Phase 2
City of Hope Medical Center

See all FOSCAVIR clinical trials

Pharmacology for FOSCAVIR

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

US Patents and Regulatory Information for FOSCAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991	AP	RX	Yes	Yes

Expired US Patents for FOSCAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	INJECTABLE;INJECTION	020068-001	Sep 27, 1991

International Patents for FOSCAVIR

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1585615
Australia	510809
Luxembourg	77666

FOSCAVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FOSCAVIR

Introduction to FOSCAVIR

FOSCAVIR, also known as foscarnet sodium, is an antiviral drug used primarily for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) and for acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients[2][4].

Market Size and Growth

The cytomegalovirus treatment market, within which FOSCAVIR operates, is projected to experience significant growth. As of 2023, the global CMV treatment market was valued at USD 590.29 million, and it is anticipated to grow to USD 1,035.16 million by 2032, exhibiting a compound annual growth rate (CAGR) of 6.5% during the forecast period[3].

Key Drivers of Market Growth

Several factors are driving the growth of the CMV treatment market, including:

Increasing Incidence of CMV Infections

The rising incidence of CMV infections, particularly among immunocompromised populations such as organ transplant recipients and individuals with HIV/AIDS, is a major driver. Improved diagnostics have enhanced detection rates, necessitating effective antiviral treatments like FOSCAVIR[3].

Rising Transplantation Activities

An increase in organ and stem cell transplants has led to a higher incidence of CMV infections among recipients, fueling the demand for effective CMV treatment options. Antiviral drugs like FOSCAVIR and ganciclovir play a crucial role in managing these infections[3].

Global Health Initiatives

Global initiatives to combat infectious diseases are fueling the growth of the CMV treatment market. Increased focus on public health and rising healthcare expenditure, especially for infectious diseases, are driving the demand for effective treatments[3].

Financial Performance of FOSCAVIR

Recent Launch and Market Impact

Hikma Pharmaceuticals PLC recently launched FOSCAVIR Sodium Injection in the US, which is expected to contribute to the company's revenue. According to IQVIA, US sales of Foscarnet Sodium Injection were approximately $19 million in the 12 months ending July 2024[1].

Market Share and Competition

FOSCAVIR competes with other antiviral drugs like ganciclovir and valganciclovir. The combination therapy of FOSCAVIR and ganciclovir has shown promising results in clinical trials, indicating a potential for increased market share as healthcare providers opt for combination therapies to manage CMV retinitis effectively[2][4].

Challenges and Limitations

High Cost of Treatment

One of the significant challenges facing the CMV treatment market, including FOSCAVIR, is the high cost of treatment. Expenses related to antiviral medications, diagnostics, and supportive care create a financial burden, restricting access to effective CMV treatments. This economic challenge particularly affects vulnerable populations and healthcare systems with budget constraints[3].

Viral Resistance

Strains of both HSV and CMV that are resistant to FOSCAVIR can be readily selected in vitro. The possibility of viral resistance should be considered in patients who show poor clinical response or experience persistent viral excretion during therapy. This necessitates continuous monitoring and potential adjustments in treatment strategies[2][4].

Clinical Efficacy and Safety

Clinical Trials and Outcomes

Clinical trials have shown that FOSCAVIR can significantly delay the progression of CMV retinitis. For example, in the CMV Retinitis Retreatment Trial (ACTG 228/SOCA CRRT), the combination of FOSCAVIR and ganciclovir demonstrated a median time to retinitis progression or death of 105 days, compared to 39 days for FOSCAVIR monotherapy and 61 days for ganciclovir monotherapy[4].

Safety Profile

FOSCAVIR treatment is associated with several adverse effects, including changes in serum electrolytes such as hypocalcemia, hypophosphatemia, and hypomagnesemia. Seizures have also been reported in patients with impaired baseline renal function or underlying CNS conditions[2][4].

Conclusion

The market dynamics for FOSCAVIR are driven by the increasing incidence of CMV infections, rising transplantation activities, and global health initiatives. Despite the high cost of treatment and the risk of viral resistance, FOSCAVIR remains a crucial antiviral drug in the management of CMV retinitis and acyclovir-resistant HSV infections.

Key Takeaways

• The CMV treatment market is expected to grow to USD 1,035.16 million by 2032.
• FOSCAVIR is indicated for CMV retinitis in AIDS patients and acyclovir-resistant HSV infections.
• Combination therapy with FOSCAVIR and ganciclovir shows promising results.
• High treatment costs and viral resistance are significant challenges.
• Clinical trials highlight the efficacy of FOSCAVIR in delaying CMV retinitis progression.

FAQs

What is FOSCAVIR used for?

FOSCAVIR is used for the treatment of CMV retinitis in patients with AIDS and for acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients[2].

What are the key drivers of the CMV treatment market?

The key drivers include the increasing incidence of CMV infections, rising transplantation activities, and global health initiatives to combat infectious diseases[3].

What are the common adverse effects associated with FOSCAVIR?

Common adverse effects include changes in serum electrolytes such as hypocalcemia, hypophosphatemia, and hypomagnesemia, as well as seizures in certain patients[2][4].

How does FOSCAVIR compare to other antiviral drugs?

FOSCAVIR is often used in combination with ganciclovir, and this combination has shown better outcomes in clinical trials compared to monotherapy with either drug[4].

What is the projected market size for the CMV treatment market by 2032?

The CMV treatment market is projected to reach USD 1,035.16 million by 2032, growing at a CAGR of 6.5% during the forecast period[3].

Cited Sources:

1. Hikma Pharmaceuticals PLC. "Hikma launches Foscarnet Sodium Injection, in the US." September 23, 2024.
2. FDA. "FOSCAVIR® (foscarnet sodium)." September 2012.
3. Polaris Market Research. "Cytomegalovirus Treatment Market Size, Share, Global Analysis."
4. FDA. "FOSCAVIR." July 2007.