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Last Updated: December 24, 2024

STAVUDINE Drug Patent Profile


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Summary for STAVUDINE
Drug patent expirations by year for STAVUDINE
Recent Clinical Trials for STAVUDINE

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SponsorPhase
Christian Medical College, Vellore, IndiaPhase 4
Tufts UniversityPhase 4
ViiV HealthcarePhase 2/Phase 3

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Medical Subject Heading (MeSH) Categories for STAVUDINE

US Patents and Regulatory Information for STAVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma STAVUDINE stavudine CAPSULE;ORAL 077672-003 Dec 29, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd Iii STAVUDINE stavudine CAPSULE;ORAL 078957-003 Dec 29, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma STAVUDINE stavudine CAPSULE;ORAL 077672-002 Dec 29, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience STAVUDINE stavudine CAPSULE;ORAL 079069-003 Dec 29, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd Iii STAVUDINE stavudine CAPSULE;ORAL 078957-004 Dec 29, 2008 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

EU/EMA Drug Approvals for STAVUDINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Zerit stavudine EMEA/H/C/000110
Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.
Withdrawn no no no 1996-05-08
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

STAVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Stavudine

Introduction to Stavudine

Stavudine, also known as d4T, is a small molecule drug primarily used for the treatment of HIV infections. It targets the HIV-1 reverse transcriptase (RT) enzyme, a crucial component in the replication of the HIV virus. First approved in the United States in June 1994 by Bristol Myers Squibb Co., stavudine has since gained global recognition and approval in various countries, including China[4].

Global Pharmaceutical Market Context

The global pharmaceutical market, which includes both chemical and biological drugs, was valued at $1,475 billion in 2022 and is expected to grow at a CAGR of 5% over the next six years. The chemical drug market, where stavudine is categorized, was estimated to be $1,094 billion in 2022, up from $1,005 billion in 2018[1].

Market Size and Forecast for Stavudine

The global stavudine market is projected to reach $431.9 million by 2030, growing at a CAGR of 4.8% from 2024 to 2030. This growth is driven by several factors, including increasing demand for HIV treatments, technological advancements, and the rising prevalence of chronic diseases[1].

Market Segmentation

The stavudine market is segmented by type, application, and region.

By Type

  • The market is segmented into various dosages such as 15mg, 20mg, 30mg, and 40mg. Each dosage has its specific market share and growth trajectory[1].

By Application

  • Stavudine is primarily used in hospitals and drug stores. The demand from these sectors is expected to drive the market growth, with hospitals being the major consumers due to the need for antiretroviral therapy (ART) in patient care[1].

By Region

  • The market is geographically segmented into North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Asia Pacific, particularly countries like China, India, and Japan, is expected to show significant growth due to the large patient population and increasing healthcare expenditure[1].

Driving Factors

Several factors are driving the growth of the stavudine market:

Increasing Demand for HIV Treatments

  • The rapid scale-up of antiretroviral therapy (ART) in resource-limited settings has increased the demand for antiretroviral medicines, including stavudine. This demand is expected to continue as more people receive ART[2].

Technological Advancements

  • Advances in pharmaceutical technology and the development of new antiretroviral drugs have improved treatment outcomes and patient adherence, contributing to the market growth[1].

Rising Prevalence of Chronic Diseases

  • The increasing prevalence of chronic diseases, including HIV, has led to a higher demand for effective treatments like stavudine[1].

Restrictive Factors

Despite the growth drivers, the stavudine market faces several challenges:

Stringent Regulations

  • Pharmaceutical companies must navigate stringent regulatory environments, which can delay the approval and launch of new drugs or formulations[1].

High R&D Costs

  • The high costs associated with research and development (R&D) can be a significant barrier for companies, especially for drugs like stavudine that require continuous innovation to stay competitive[1].

Patent Expirations

  • The expiration of patents can lead to increased competition from generic drugs, potentially reducing the market share of branded stavudine products[1].

Phase-Out Scenarios

There are ongoing efforts to phase out stavudine due to its toxicity and the availability of newer, less toxic antiretroviral drugs. Studies have projected demand under fast and slower phase-out scenarios of stavudine, indicating a shift towards drugs like tenofovir, emtricitabine, and efavirenz[2].

Competitive Landscape

The stavudine market is competitive, with key players including Aurobindo Pharma, Bristol Myers Squibb, Hetero Drugs, Matrix Laboratories, Mylan Pharmaceuticals, and Cipla. These companies are involved in continuous R&D to improve their products and maintain market share[1].

Regional Market Dynamics

Asia Pacific

  • This region is expected to be a significant growth driver due to the large patient population and increasing healthcare expenditure. Countries like China, India, and Japan are key markets for stavudine[1].

North America and Europe

  • These regions have established healthcare systems and high demand for antiretroviral drugs. However, the market growth here may be slower compared to the Asia Pacific region due to market saturation and the availability of newer drugs[1].

Latin America and Middle East & Africa

  • These regions also present growth opportunities, particularly as healthcare infrastructure improves and access to antiretroviral therapy increases[1].

Financial Trajectory

The financial trajectory of the stavudine market is influenced by several factors:

Revenue and Sales Volume

  • The market is expected to generate $431.9 million in revenue by 2030, with a CAGR of 4.8% from 2024 to 2030. The sales volume is also projected to increase, driven by the growing demand for HIV treatments[1].

Average Price

  • The average price of stavudine is expected to stabilize or slightly decrease due to competition from generic drugs and the phase-out of branded products[1].

Regional Revenue Growth

  • The revenue growth rate varies by region, with Asia Pacific showing the highest growth potential. For example, countries like China and India are expected to see significant revenue growth rates due to their large patient populations and increasing healthcare spending[1].

Impact of COVID-19

The COVID-19 pandemic has highlighted the importance of vaccine development and supply chain management in the pharmaceutical industry. While stavudine is not directly related to COVID-19 treatments, the pandemic has emphasized the need for pharmaceutical companies to be agile and responsive to emerging public health needs, which could indirectly influence the market dynamics of antiretroviral drugs[1].

Regulatory Status

Stavudine has been granted accelerated approval and orphan drug designation, which are regulatory pathways that expedite the approval of drugs addressing unmet medical needs. These designations underscore the significance of stavudine in managing HIV infections and provide it with certain market protections[4].

Conclusion

The stavudine market is driven by increasing demand for HIV treatments, technological advancements, and the rising prevalence of chronic diseases. However, it faces challenges such as stringent regulations, high R&D costs, and patent expirations. As the market evolves, there is a shift towards newer, less toxic antiretroviral drugs, but stavudine remains a valuable tool in the management of HIV infections.

Key Takeaways

  • Market Growth: The global stavudine market is projected to reach $431.9 million by 2030, growing at a CAGR of 4.8%.
  • Segmentation: The market is segmented by type (dosage), application (hospitals and drug stores), and region.
  • Driving Factors: Increasing demand for HIV treatments, technological advancements, and rising prevalence of chronic diseases.
  • Restrictive Factors: Stringent regulations, high R&D costs, and patent expirations.
  • Regional Dynamics: Asia Pacific is expected to be a significant growth driver.

FAQs

Q: What is the primary use of stavudine?

  • Stavudine is primarily used for the treatment of HIV infections by targeting the HIV-1 reverse transcriptase (RT) enzyme.

Q: Which regions are expected to drive the growth of the stavudine market?

  • The Asia Pacific region, particularly countries like China, India, and Japan, is expected to drive the growth of the stavudine market.

Q: What are the key challenges facing the stavudine market?

  • The key challenges include stringent regulations, high R&D costs, and patent expirations.

Q: How has the COVID-19 pandemic impacted the pharmaceutical market?

  • The COVID-19 pandemic has highlighted the importance of vaccine development and supply chain management, emphasizing the need for pharmaceutical companies to be agile and responsive to emerging public health needs.

Q: What regulatory designations has stavudine received?

  • Stavudine has been granted accelerated approval and orphan drug designation, which expedite its approval and provide certain market protections.

References

  1. Global Stavudine Market Research Report 2024 - QYResearch
  2. Utilization Patterns and Projected Demand of Antiretroviral Drugs in Low- and Middle-Income Countries - Wiley Online Library
  3. HIV Drugs and Injectables Market Report 2024-2034 - Visiongain
  4. Stavudine: Detailed Review of its Transformative R&D Success - Synapse
  5. Final 192-Week Efficacy and Safety Results of the ADVANCE Trial - Open Forum Infectious Diseases

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