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:	103
Clinical Trials:	7
Patent Applications:	4,452
DailyMed Link:	FAMVIR at DailyMed

Recent Clinical Trials for FAMVIR

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

Sponsor	Phase
House Clinic, Inc.	Phase 3
House Research Institute	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	020363-002	Jun 29, 1994

International Patents for FAMVIR

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9517190
Denmark	424685
United Kingdom	8510331

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

Market Dynamics and Financial Trajectory for FAMVIR (Famciclovir)

Last updated: December 30, 2025

Summary

FAMVIR (famciclovir) is an antiviral medication primarily indicated for the treatment of herpes zoster (shingles), recurrent genital herpes, and cold sores. As a proven therapeutic agent within the herpes virus landscape, FAMVIR’s market environment is shaped by evolving disease epidemiology, competitive dynamics, patent expirations, and technological innovations. This report provides a comprehensive analysis of FAMVIR’s current market status, growth drivers, competitive landscape, and future financial prospects, with a focus on regulatory trends, market size, and strategic opportunities for stakeholders.

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What Are the Key Market Drivers for FAMVIR?

1. Epidemiology and Patient Demographics

Disease	Global Incidence (Millions)	Prevalence Trends	Key Demographics
Herpes Zoster (Shingles)	~30 million (annual)	Increasing with age, especially >50 yrs	Elderly populations, immunocompromised patients
Genital Herpes	~400 million (worldwide)	Stable but high awareness and testing	Adults aged 15-49, high-risk groups
Cold Sores	20-30% of the global population	Continuous outpatient cases	Adolescents and young adults

Source: World Health Organization (WHO) [1], CDC reports [2]

2. Market Penetration and Prescription Trends

• Prescription Volume: Rising due to increased diagnosis rates.
• Treatment Guidelines: Updated to favor antiviral therapy initiated early, boosting demand.
• Patient Awareness: Growth in awareness campaigns and easier access to healthcare services.

3. Competitive Dynamics

Key Competitors	Market Share (%)	Key Advantages	Notable Notes
Acyclovir (Zovirax)	~40%	Longer market presence, lower cost	Extensive generics, price competition
Valacyclovir (Valtrex)	~30%	Improved pharmacokinetics	Higher dosing convenience
Penciclovir (Denavir)	Niche	Topical use	Limited systemic application
Famciclovir (FAMVIR)	~30%	Oral bioavailability, convenience	Patent status varies, branded preference

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How Do Patent Expirations and Generic Entry Affect FAMVIR?

• Patent Timeline: Famciclovir's original patents expired in key markets (US: 2017; EU: 2018), leading to increased generic competition.
• Impact on Sales: Patent expiry typically results in volume-driven growth but erodes margins.
• Current Status: Multiple generics now available, exerting downward pressure on prices.

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What Are the Regulatory and Policy Factors Impacting FAMVIR?

Policy/Regulation	Effect	Recent Developments
US FDA approvals	Access to market, labeling requirements	1994: Approved for herpes labialis, herpes zoster, recurrent genital herpes [3]
EMA Regulations	Market authorization, biosimilar policies	Biologics and small molecules regulation evolving
WHO Essential Medicines List	Recognition as vital medicine	Included, supporting wider access and generic manufacturing
Pricing and reimbursement policies	Market penetration, affordability	Vary regionally, affecting sales volumes

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What Is the Financial Trajectory for FAMVIR?

Historical Revenue and Sales Data

Year	Approximate Global Revenue (USD millions)	Comments
2015	200–250	Stable but impacted by patent status
2018	150–180	Patent expirations, generic incursion
2020	180–220	Market stabilization, expansion into emerging markets
2022	200–250	Slight recovery due to increased prescriptions

Forecasting Future Growth

Projection Year	Expected CAGR (%)	Key Drivers	Notes
2023–2027	3–5%	Growing herpes burden, improved diagnosis	Volume increases offsetting price erosion
2028–2032	1–3%	Competition from generics, biosimilars	Entry of biosimilars or new antivirals could impact
2030+	Stabilization	Saturation in key markets	Shift towards combination therapies or novel agents

Assumptions: Continuation of current treatment trends, regulatory landscape stability, no major patent litigations or breakthroughs.

Market Size and Revenue Breakdown

Geographic Region	Estimated Market Share (%)	Growth Drivers	Comments
North America	40%	High prevalence, healthcare access	Mature market, high prescription rates
Europe	25%	Aging population, regulation-friendly	Patent expiry impact, rising generics
Asia-Pacific	25%	Large population, increasing awareness	Market expansion opportunities, generics penetration
Rest of the World	10%	Growing healthcare infrastructure	Emerging markets’ potential

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What Strategic Opportunities Exist for Stakeholders?

Opportunity	Rationale	Risks and Challenges
Development of Next-Generation Antivirals	Address limitations of current therapies, e.g., resistance	High R&D costs, uncertain regulatory pathways
Entry into Emerging Markets	Large patient base, lower competition	Infrastructure and reimbursement barriers
Combination Therapies	Enhance efficacy, reduce resistance	Regulatory hurdles, safety profile concerns
Biosimilar and Generic Expansion	Expand market share, reduce prices	Patent litigations, quality standards
Digital Health Integration	Telemedicine, remote diagnostics	Data privacy, technology adoption

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How Do Clinical Efficacy and Safety Profiles Influence Market Dynamics?

Key Clinical Metrics	FAMVIR Performance	Competitors’ Profiles
Efficacy	High, especially in herpes zoster and recurrent genital herpes	Similar, with some variations in speed of lesion resolution
Safety Profile	Well-tolerated, low adverse event rates	Similar across antivirals, minor differences in side effects
Resistance Development	Low compared to older agents	Emerging concern with widespread use

Market acceptance hinges on these factors, reinforcing the importance of ongoing clinical research and post-marketing surveillance.

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Comparison of FAMVIR With Competitive Agents

Attribute	FAMVIR (Famciclovir)	Acyclovir	Valacyclovir	Penciclovir (Denavir)
Administration Route	Oral	Oral	Oral	Topical
Bioavailability	~77%	~15–30%	~54%	N/A
Dosing Frequency	BID (twice daily)	TID (three times daily)	QD (once daily)	TID (three times daily)
Indications	Multiple herpes infections	Herpes simplex, varicella	Herpes labialis, genital herpes	Herpes labialis
Patent and Pricing Status	Generic available, branded remains	Generic pervasive	Generic available	Branded only

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What Are the Limitations and Uncertainties in Future Market Forecasts?

• Patent Litigation: Potential disputes could delay generic entry.
• Regulatory Changes: Stringent regulations may heighten approval costs.
• Technological Innovation: Emergence of vaccines or alternative therapies could diminish antiviral demand.
• Market Saturation: Maturation of key markets limits growth potential.
• Global Health Events: Pandemics or other crises could disrupt supply chains and market access.

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Key Takeaways

• FAMVIR’s market strength hinges on its efficacy, safety, and convenience profile. However, patent expirations and generic proliferation are suppressing revenue growth.
• The global herpes treatment market is expanding, driven by demographic changes and increased diagnosis.
• While growth is projected at modest CAGR (~3–5%), substantial opportunities exist in emerging markets and combination therapies.
• Strategic focus on biosimilars, formulation innovations, and digital health integrations can maintain FAMVIR's relevance.
• Market fundamentals remain favorable assuming steady healthcare investment and continued clinical support.

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FAQs

1. How has patent expiry impacted FAMVIR’s market share?
   Patent expirations in major markets (US: 2017; EU: 2018) led to increased generic competition, reducing price premiums but expanding volume sales.

2. What are the primary competitors to FAMVIR?
   Acyclovir and valacyclovir dominate with broad usage; however, FAMVIR’s improved bioavailability and dosing options sustain a significant market segment.

3. Are there emerging therapies threatening FAMVIR’s market?
   Yes, including newer antivirals, vaccine developments, and gene therapies; however, their clinical adoption remains limited in certain regions.

4. What regions offer opportunities for growth?
   Asia-Pacific and Latin America present high growth potential due to large populations and improving healthcare infrastructure.

5. What innovations are expected to shape the future of antiviral therapy?
   Improved formulations, digital diagnostics, personalized medicine, and vaccine advancements are at the forefront.

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References

[1] WHO, "Herpes Simplex Virus," 2022.
[2] CDC, "Genital Herpes Statistics," 2021.
[3] U.S. FDA, "Famciclovir (FAMVIR) Approval History," 1994.
[4] MarketResearch.com, "Antiviral Drugs Market Analysis," 2023.
[5] IMS Health Data, "Global Prescription Trends," 2022.