Famciclovir - Generic Drug Details

What are the generic drug sources for famciclovir and what is the scope of freedom to operate?

Famciclovir is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd V, Hikma, Macleods Pharms Ltd, Natco Pharma, Teva Pharms, and Novartis, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for famciclovir. Ten suppliers are listed for this compound.

Summary for famciclovir

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	19
Patent Applications:	6,848
Drug Prices:	Drug price trends for famciclovir
What excipients (inactive ingredients) are in famciclovir?	famciclovir excipients list
DailyMed Link:	famciclovir at DailyMed

See drug prices for famciclovir

Recent Clinical Trials for famciclovir

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

Sponsor	Phase
Queen Mary University of London	Phase 2
EMS	Phase 3
House Clinic, Inc.	Phase 3

See all famciclovir clinical trials

Pharmacology for famciclovir

Drug Class	Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for famciclovir

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for FAMCICLOVIR

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 famciclovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	FAMCICLOVIR	famciclovir	TABLET;ORAL	090128-003	Mar 21, 2011		DISCN	No	No
Hikma	FAMCICLOVIR	famciclovir	TABLET;ORAL	090128-002	Mar 21, 2011		DISCN	No	No
Aurobindo Pharma Ltd	FAMCICLOVIR	famciclovir	TABLET;ORAL	091114-001	Mar 21, 2011	AB	RX	No	No
Natco Pharma	FAMCICLOVIR	famciclovir	TABLET;ORAL	201333-003	Mar 24, 2011		DISCN	No	No
Hikma	FAMCICLOVIR	famciclovir	TABLET;ORAL	090128-001	Mar 21, 2011		DISCN	No	No

Expired US Patents for famciclovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996	6,124,304*PED
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994	5,916,893*PED
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995	6,124,304*PED
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996	5,916,893*PED
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995	5,246,937*PED

Famciclovir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Famciclovir

Introduction to Famciclovir

Famciclovir, marketed under the brand name Famvir, is an antiviral medication used to treat various herpes infections, including herpes zoster (shingles), herpes labialis (cold sores), and recurrent episodes of genital herpes. It is prescribed to alleviate symptoms, reduce pain, and accelerate the healing of sores, although it does not cure the underlying infections[5].

Market Size and Growth

The famciclovir API market is anticipated to experience significant growth over the coming years. Here are some key indicators:

• The market is expected to witness exponential growth at a substantial CAGR from 2024 to 2033, driven by the rising prevalence of herpes infections and the increasing adoption of famciclovir due to its favorable safety profile and improved bioavailability[1].
• The global herpes market, which includes famciclovir, is projected to grow from USD 1.24 billion in 2023 to USD 2.06 billion by 2031, with a CAGR of 6.6% during the forecast period[3].

Driving Factors

Several factors are driving the growth of the famciclovir market:

• Increasing Prevalence of Herpes Infections: The rising incidence of herpes zoster and genital herpes is a major driver. This is particularly significant in older populations and in regions with improving healthcare access[1][4].
• Favorable Safety Profile: Famciclovir's better safety profile and higher bioavailability compared to other antivirals make it a preferred treatment option, contributing to its market growth[1].
• Advancements in Manufacturing: Improvements in manufacturing processes and purification techniques enhance product quality, yield, and cost-effectiveness, making famciclovir more competitive[1].
• Expansion into Emerging Markets: Growing healthcare expenditure and increasing access to antiviral therapies in emerging economies present significant growth opportunities[1].

Regional Market Analysis

The famciclovir API market is geographically diverse, with various regions contributing to its growth:

• North America: This region, particularly the United States, is a significant contributor due to its well-established pharmaceutical industry, advanced healthcare systems, and high prevalence of herpes infections[1].
• Europe: Countries like Germany, France, and the UK are major contributors, driven by a focus on drug development, stringent regulatory standards, and access to antiviral therapies[1].
• Asia-Pacific: This region is experiencing rapid growth, driven by increasing healthcare expenditure, rising prevalence of herpes infections, and improving access to antiviral treatments in countries like China, India, and Japan[1].
• Latin America and Middle East & Africa: These regions are emerging markets with growth opportunities fueled by improving healthcare infrastructure and increasing demand for affordable antiviral therapies[1].

Market Opportunities

Several opportunities are poised to further drive the growth of the famciclovir API market:

• Development of Novel Formulations and Delivery Systems: Exploring innovative formulations and delivery systems, such as extended-release or targeted delivery mechanisms, can improve patient compliance, bioavailability, and therapeutic efficacy[1].
• Combination Therapies and Adjunctive Treatments: Investigating the potential of combining famciclovir with other antiviral agents or adjunctive therapies could lead to improved treatment outcomes and address unmet medical needs[1].
• Contract Manufacturing and Outsourcing: Strategic partnerships and collaborations between API manufacturers and pharmaceutical companies can ensure reliable supply and meet specific product requirements[1].

Economic Impact

Famciclovir therapy has a positive economic impact, particularly in the treatment of postherpetic neuralgia (PHN):

• A study showed that famciclovir therapy for PHN resulted in a net savings of $23 per patient, with a reduction in the average cost of PHN by $155 for patients 50 years of age or older[2].

Challenges and Regulatory Considerations

Despite the growth potential, the famciclovir API market faces several challenges:

• Stringent Regulatory Requirements: Adherence to strict quality control measures and regulatory standards is crucial for ensuring the safety and efficacy of famciclovir API products[1].
• Intellectual Property Disputes: Potential intellectual property disputes and competition from alternative antiviral therapies are challenges that need to be addressed through continuous innovation and strategic collaborations[1].

Future Outlook

The famciclovir API market is expected to experience steady growth driven by the increasing prevalence of herpes infections, advancements in manufacturing processes, and the development of novel formulations and delivery systems. However, addressing regulatory challenges and competition will be essential for maintaining market competitiveness.

Key Statistics

• The global herpes market is projected to grow at a CAGR of 6.6% from 2024 to 2031[3].
• The varicella zoster infection treatment market is expected to grow from USD 1.54 billion in 2021 to USD 2.04 billion by 2028, with a CAGR of 4.1%[4].
• The famciclovir API market is anticipated to witness exponential growth at a significant CAGR from 2024 to 2033[1].

Conclusion

The famciclovir API market is poised for significant growth, driven by increasing demand for effective antiviral treatments, advancements in manufacturing, and expansion into emerging markets. Addressing regulatory challenges and leveraging opportunities in novel formulations and combination therapies will be crucial for market success.

Key Takeaways

• The famciclovir API market is expected to grow exponentially due to rising herpes infections and favorable safety profiles.
• Advancements in manufacturing and expansion into emerging markets are key drivers.
• Novel formulations and combination therapies offer significant growth opportunities.
• Regulatory compliance and addressing intellectual property disputes are critical challenges.
• The market is geographically diverse, with North America, Europe, and Asia-Pacific being major contributors.

Frequently Asked Questions (FAQs)

1. What is famciclovir used for?

Famciclovir is used to treat the symptoms of herpes zoster (shingles), herpes labialis (cold sores), and recurrent episodes of genital herpes. It helps relieve pain, discomfort, and accelerates the healing of sores[5].

2. What are the key drivers of the famciclovir API market?

The key drivers include the rising prevalence of herpes infections, the favorable safety profile and bioavailability of famciclovir, advancements in manufacturing processes, and expansion into emerging markets[1].

3. Which regions are significant contributors to the famciclovir API market?

North America, particularly the United States, Europe (Germany, France, UK), and the Asia-Pacific region (China, India, Japan) are significant contributors to the market[1].

4. What are the potential challenges facing the famciclovir API market?

Challenges include stringent regulatory requirements, potential intellectual property disputes, and competition from alternative antiviral therapies[1].

5. How does famciclovir impact the economic burden of herpes infections?

Famciclovir therapy can reduce the economic burden by lowering the cost of treating postherpetic neuralgia (PHN) and other complications associated with herpes infections[2].

Cited Sources:

1. DataHorizon Research: Famciclovir API Market Size, Share & Forecast 2033.
2. PubMed: Economic evaluation of famciclovir in reducing the cost of postherpetic neuralgia.
3. DataBridge Market Research: Global Herpes Market Size, Statistics, Scope & Trends Analysis By 2031.
4. Future Market Insights: Varicella Zoster Infection Treatment Market Trends & Share.
5. Mayo Clinic: Famciclovir (oral route) - Description.