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Last Updated: December 22, 2024

FAMCICLOVIR Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Famciclovir

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

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Recent Clinical Trials for FAMCICLOVIR

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

SponsorPhase
Queen Mary University of LondonPhase 2
EMSPhase 3
House Clinic, Inc.Phase 3

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Pharmacology for FAMCICLOVIR
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
Apotex FAMCICLOVIR famciclovir TABLET;ORAL 091480-001 Jul 22, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd FAMCICLOVIR famciclovir TABLET;ORAL 201022-003 Jan 12, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms FAMCICLOVIR famciclovir TABLET;ORAL 077487-003 Aug 24, 2007 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla FAMCICLOVIR famciclovir TABLET;ORAL 078278-001 Mar 21, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd FAMCICLOVIR famciclovir TABLET;ORAL 091114-001 Mar 21, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V FAMCICLOVIR famciclovir TABLET;ORAL 202438-003 Sep 10, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma FAMCICLOVIR famciclovir TABLET;ORAL 201333-002 Mar 24, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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