FAMVIR Drug Patent Profile

When do Famvir patents expire, and when can generic versions of Famvir launch?

Famvir is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in FAMVIR is famciclovir. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Famvir

A generic version of FAMVIR was approved as famciclovir by TEVA PHARMS on August 24^th, 2007.

Summary for FAMVIR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	7
Patent Applications:	5,141
DailyMed Link:	FAMVIR at DailyMed

Recent Clinical Trials for FAMVIR

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

Sponsor	Phase
House Research Institute	Phase 3
House Clinic, Inc.	Phase 3
Novartis	Phase 2

See all FAMVIR clinical trials

Paragraph IV (Patent) Challenges for FAMVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FAMVIR	Tablets	famciclovir	125 mg, 250 mg and 500 mg	020363	1	2004-12-28

US Patents and Regulatory Information for FAMVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995		DISCN	Yes	No
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996		DISCN	Yes	No
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994		DISCN	Yes	No

Expired US Patents for FAMVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996

International Patents for FAMVIR

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9510482
Czech Republic	283721	Purinové deriváty a jejich farmaceutické použití (2-AMINO-9-/4-ACETOXY-3-ACETOXYMETHYLBUT-1-YL/PURINE ITS USE FOR PREPARING PHARMACEUTICAL PREPARATIONS AND THE PHARMACEUTICAL PREPARATIONS CONTAINING THEREOF)
Cyprus	2375	Use of penciclorin for the treatment of post-therapeutic neuralgia.
Spain	2166834
Norway	874764
Mexico	160431	UN PROCEDIMIENTO PARA PREPARAR DERIVADOS DE LA GUANINA
European Patent Office	0804199	UTILISATION DE LA PENCICLOVIR DANS LE TRAITEMENT DE NEVRALGIES POST HERPETIQUES (USE OF PENCICLOVIR FOR THE TREATMENT OF POST HERPETIC NEURALGIA)

Supplementary Protection Certificates for FAMVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0182024	SPC/GB94/002	United Kingdom		SPC/GB94/002: 20050910, EXPIRES: 20081209
0053902	96C0036	Belgium		PRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
0141927	97C0033	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228
0141927	SPC/GB96/014	United Kingdom		SPC/GB96/014: 20040810, EXPIRES: 20090809

FAMVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FAMVIR

Introduction to FAMVIR

FAMVIR, also known as famciclovir, is an antiviral drug used primarily for the treatment of herpes zoster (shingles) and recurrent episodes of genital herpes. It is a prodrug of penciclovir, which is the active metabolite that inhibits viral DNA synthesis and replication.

Market Size and Growth

The market for antiviral drugs, including FAMVIR, is part of a broader landscape that includes treatments for various viral infections.

• Global Antiviral Drugs Market: The global antiviral drugs market was valued at USD 72.84 billion in 2022 and is expected to decline at a CAGR of -1.99% from 2023 to 2030, primarily due to the post-COVID-19 market adjustments[1].
• Specific Market Segments: While the overall antiviral market may be declining, specific segments like the genital herpes market are expected to grow. For example, the genital herpes market is projected to grow at a CAGR of 5.3% from 2024 to 2034, reaching USD 3.7 billion by 2034[3].

FAMVIR's Market Position

• Indications: FAMVIR is indicated for the treatment of herpes zoster, recurrent episodes of genital herpes, and recurrent orolabial or genital herpes in HIV-infected adults. This broad range of indications helps it maintain a significant market presence[5].
• Dosage and Efficacy: The efficacy of FAMVIR is well-established, with specific dosing recommendations for different conditions. For instance, for herpes zoster, the recommended dosage is 500 mg every 8 hours for 7 days, initiated as soon as the diagnosis is made[5].

Competitive Landscape

• Key Players: The antiviral market is dominated by several major pharmaceutical companies, including Novartis AG, Pfizer Inc., Abbott Laboratories, and GlaxoSmithKline plc. FAMVIR, being a product of Novartis (though it may be marketed by other companies in different regions), competes within this landscape[4].
• Market Share: While FAMVIR does not dominate the entire antiviral market, it holds a significant share in the treatment of herpes zoster and genital herpes. For example, acyclovir and valacyclovir are other prominent drugs in this space, but FAMVIR's unique indications and efficacy profile help it maintain market relevance[4].

Financial Performance

• Revenue Contribution: The financial performance of FAMVIR is tied to the overall sales of antiviral drugs. Given that the global antiviral market is expected to decline slightly, the revenue from FAMVIR might also see a corresponding adjustment. However, its niche in treating specific viral infections ensures a steady revenue stream.
• Cost and Pricing: The cost of FAMVIR can vary based on region, distribution channel, and insurance coverage. Generally, antiviral drugs like FAMVIR are priced competitively, with hospital pharmacies and retail pharmacies playing a significant role in their distribution[1].

Distribution Channels

• Hospital Pharmacies: Hospital pharmacies held the largest share of the antiviral drugs market in 2022, with 47.64% of the overall revenue. This segment is crucial for FAMVIR, especially in treating acute cases of herpes zoster and other severe viral infections[1].
• Retail Pharmacies: Retail pharmacies also play a vital role in the distribution of FAMVIR, particularly for patients requiring chronic suppressive therapy for recurrent genital herpes.

Geographical Performance

• North America: This region accounts for a significant share of the antiviral market, driven by the launch of effective products and advanced production facilities. FAMVIR benefits from this strong market presence in North America[1].
• Asia Pacific: The Asia Pacific region is expected to grow at the fastest rate during the forecast period, driven by an increasing geriatric population and improving healthcare infrastructure. This growth could positively impact FAMVIR sales in this region[1].

Research and Development

• Continuous Innovation: Companies like Novartis and other market players are continuously involved in research and development to improve antiviral therapies. This includes exploring new indications and enhancing the efficacy of existing drugs like FAMVIR.
• Strategic Partnerships: Strategic partnerships among manufacturers, such as those seen with Virios Therapeutics, are crucial for advancing novel antiviral therapies. These partnerships can lead to new treatment options and potentially boost the market for existing drugs like FAMVIR[2].

Challenges and Opportunities

• Generic Competition: The introduction of generic versions of antiviral medicines can pose a challenge to branded drugs like FAMVIR. However, the growing awareness about the availability of various vaccines and treatments for viral infections can also drive market growth[1].
• Increasing Prevalence of Viral Diseases: The increasing prevalence of viral diseases, such as hepatitis and genital herpes, presents an opportunity for FAMVIR to maintain its market relevance and potentially grow in specific segments.

Key Takeaways

• Market Position: FAMVIR holds a significant position in the antiviral market, particularly for treating herpes zoster and genital herpes.
• Financial Trajectory: While the overall antiviral market may decline slightly, FAMVIR's revenue is expected to remain stable due to its niche indications and competitive pricing.
• Distribution and Geography: Hospital and retail pharmacies are crucial distribution channels, with North America and the Asia Pacific region being key geographical markets.
• Research and Development: Continuous innovation and strategic partnerships are essential for maintaining and growing FAMVIR's market presence.

FAQs

Q: What are the primary indications for FAMVIR? A: FAMVIR is indicated for the treatment of herpes zoster (shingles), recurrent episodes of genital herpes, and recurrent orolabial or genital herpes in HIV-infected adults.

Q: How does FAMVIR compare to other antiviral drugs in the market? A: FAMVIR competes with other antiviral drugs like acyclovir and valacyclovir but holds a significant share due to its specific indications and efficacy profile.

Q: What is the expected market growth for antiviral drugs like FAMVIR? A: The global antiviral market is expected to decline slightly, but specific segments like the genital herpes market are projected to grow.

Q: Which distribution channels are most important for FAMVIR? A: Hospital pharmacies and retail pharmacies are the most important distribution channels for FAMVIR.

Q: How does the geographical performance impact FAMVIR sales? A: North America and the Asia Pacific region are key geographical markets for FAMVIR, driven by advanced healthcare infrastructure and an increasing geriatric population.

Cited Sources

1. Grand View Research: Antiviral Drugs Market Size, Share & Growth Report, 2030
2. Stock Titan: Virios Therapeutics Announces First Quarter 2024 Financial Results
3. Globe Newswire: Genital Herpes Market Size & Share to Exceed USD 3.7 Billion by 2034
4. Future Market Insights: Varicella Zoster Infection Treatment Market Trends & Share
5. FDA: Famvir (famciclovir) tablets label