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Last Updated: December 25, 2024

Zalcitabine - Generic Drug Details


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What are the generic sources for zalcitabine and what is the scope of patent protection?

Zalcitabine is the generic ingredient in one branded drug marketed by Roche and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for zalcitabine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 116
Clinical Trials: 49
Patent Applications: 6,686
DailyMed Link:zalcitabine at DailyMed
Recent Clinical Trials for zalcitabine

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

SponsorPhase
AvexaPhase 3
PENTA FoundationPhase 2/Phase 3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2/Phase 3

See all zalcitabine clinical trials

Medical Subject Heading (MeSH) Categories for zalcitabine

US Patents and Regulatory Information for zalcitabine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche HIVID zalcitabine TABLET;ORAL 020199-002 Jun 19, 1992 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche HIVID zalcitabine TABLET;ORAL 020199-001 Jun 19, 1992 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

Expired US Patents for zalcitabine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche HIVID zalcitabine TABLET;ORAL 020199-001 Jun 19, 1992 4,879,277 ⤷  Subscribe
Roche HIVID zalcitabine TABLET;ORAL 020199-002 Jun 19, 1992 5,028,595 ⤷  Subscribe
Roche HIVID zalcitabine TABLET;ORAL 020199-001 Jun 19, 1992 5,028,595 ⤷  Subscribe
Roche HIVID zalcitabine TABLET;ORAL 020199-002 Jun 19, 1992 4,879,277 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Zalcitabine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zalcitabine

Introduction

Zalcitabine, also known as ddC (2',3'-dideoxycytidine), is an antiretroviral drug used in the treatment of HIV/AIDS. Understanding the market dynamics and financial trajectory of zalcitabine is crucial for pharmaceutical companies, investors, and healthcare policymakers.

Historical Context of Zalcitabine

Zalcitabine was approved by the FDA in 1992 as part of the early arsenal against HIV/AIDS. Initially, it was used in combination with other antiretroviral drugs to manage the disease. However, its use has declined with the advent of more effective and less toxic antiretroviral therapies[5].

Market Size and Growth

The global zalcitabine market has experienced significant changes over the years. As of 2018, the market size was valued at a certain amount, and it was projected to expand at a compound annual growth rate (CAGR) from 2019 to 2025. However, the growth rate has been modest due to the availability of more advanced treatments[4].

Competitive Landscape

The market for antiretroviral drugs, including zalcitabine, is highly competitive. The entry of generic versions of these drugs has significantly impacted the market dynamics. Generic drug prices fall with the number of competitors, but they remain above long-run marginal costs until there are 8 or more competitors. This competition has driven down the prices of zalcitabine, making it more accessible but also reducing the profit margins for manufacturers[3].

Pricing and Cost Dynamics

The pricing of zalcitabine is influenced by several factors, including the number of generic competitors and regulatory policies. Initially, generic versions of zalcitabine were priced 35% to 50% above long-run marginal costs. However, as more generic competitors entered the market, prices declined. Despite this, the cost of zalcitabine remains relatively high, especially for patients in low-income countries[3].

Regulatory Environment

Regulatory changes have played a crucial role in shaping the market for zalcitabine. For instance, the FDA's increased scrutiny of generic drug applications in the late 1980s raised the cost of obtaining approval, which initially reduced the number of generic entrants. Later, the FDA's policy of approving multiple generic entrants simultaneously for certain drugs led to earlier competition and lower prices, but also reduced expected rents for manufacturers[3].

Public Health Implications

In countries like Thailand, where HIV/AIDS is a significant public health issue, access to cost-effective treatments like zalcitabine is critical. However, the high cost of antiretroviral therapies, including zalcitabine, has been a barrier. Governments and NGOs have had to implement strategies to reduce drug costs and increase affordability, particularly for marginalized groups[2].

Financial Trajectory

The financial trajectory of zalcitabine has been marked by declining revenues due to increased competition from generic versions and newer, more effective antiretroviral therapies. The cost of developing and marketing zalcitabine has been high, and the return on investment has decreased over time. Despite this, zalcitabine remains a part of the treatment regimen in some regions due to its cost-effectiveness compared to newer drugs.

Revenue Trends

  • Peak Revenue: Zalcitabine saw its peak revenue in the mid to late 1990s when it was one of the primary treatments for HIV/AIDS.
  • Decline: With the introduction of more advanced antiretroviral therapies, the revenue from zalcitabine began to decline.
  • Current Status: The revenue from zalcitabine is now significantly lower than its peak, primarily due to generic competition and the preference for newer treatments.

Cost Structure

  • Research and Development: The initial investment in researching and developing zalcitabine was substantial.
  • Manufacturing Costs: The cost of manufacturing zalcitabine has decreased over time due to economies of scale and generic competition.
  • Marketing and Distribution: Marketing and distribution costs have also decreased as the drug has become less prominent in treatment regimens.

Impact of Generic Competition

Generic competition has been a significant factor in the financial trajectory of zalcitabine. As more generic versions entered the market, the prices dropped, making the drug more affordable but reducing the profit margins for the original manufacturer. This competition has also led to a faster decline in the market share of branded zalcitabine.

Future Outlook

The future outlook for zalcitabine is challenging. With the continuous development of more effective and less toxic antiretroviral therapies, the demand for zalcitabine is expected to further decline. However, in regions where access to newer treatments is limited, zalcitabine may still play a role due to its cost-effectiveness.

Potential for Emerging Markets

In some emerging markets, zalcitabine could still be a viable option due to its lower cost compared to newer treatments. Governments and NGOs may continue to support the use of zalcitabine as part of their public health strategies to combat HIV/AIDS.

Technological Advancements

Advancements in antiretroviral therapy have significantly impacted the market for zalcitabine. Newer treatments with better efficacy and safety profiles have become the preferred choice, further reducing the demand for zalcitabine.

Conclusion

The market dynamics and financial trajectory of zalcitabine are characterized by a decline in revenue and market share due to increased competition from generic versions and newer antiretroviral therapies. Despite this, zalcitabine remains relevant in certain regions due to its cost-effectiveness.

Key Takeaways

  • Declining Revenue: Zalcitabine's revenue has declined significantly due to generic competition and the advent of newer treatments.
  • Cost-Effectiveness: Zalcitabine remains a cost-effective option in regions where access to newer treatments is limited.
  • Regulatory Impact: Regulatory changes have influenced the pricing and availability of zalcitabine.
  • Public Health Role: Zalcitabine continues to play a role in public health strategies to combat HIV/AIDS in certain regions.

FAQs

Q: What is zalcitabine used for? A: Zalcitabine is an antiretroviral drug used in the treatment of HIV/AIDS.

Q: Why has the demand for zalcitabine declined? A: The demand for zalcitabine has declined due to the availability of more effective and less toxic antiretroviral therapies.

Q: How has generic competition affected zalcitabine? A: Generic competition has driven down the prices of zalcitabine, making it more affordable but reducing the profit margins for manufacturers.

Q: What is the current market size of zalcitabine? A: The current market size of zalcitabine is smaller than its peak in the late 1990s, with a projected modest growth rate.

Q: Is zalcitabine still relevant in the treatment of HIV/AIDS? A: Yes, zalcitabine remains relevant in regions where access to newer treatments is limited due to its cost-effectiveness.

Sources

  1. Global Zalcitabine Market Size, Scope And Forecast Report - Market Research Intellect
  2. Building on Success: The Evolution of Thailand's AIDS Epidemic and the National Response - The World Bank
  3. Generic Drug Industry Dynamics - Federal Trade Commission
  4. Zalcitabine(DDC) Market Size, Share, Trend and Forecast to 2025 - Prof Research
  5. Long-Term Follow-Up of Infants Exposed to Antiretroviral Drugs - NIH Clinical Info

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