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Last Updated: December 22, 2024

ZIDOVUDINE Drug Patent Profile


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When do Zidovudine patents expire, and when can generic versions of Zidovudine launch?

Zidovudine is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, and Ranbaxy Labs Ltd. and is included in fifteen NDAs.

The generic ingredient in ZIDOVUDINE is zidovudine. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Zidovudine

A generic version of ZIDOVUDINE was approved as zidovudine by AUROBINDO on September 19th, 2005.

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Drug patent expirations by year for ZIDOVUDINE
Drug Prices for ZIDOVUDINE

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Recent Clinical Trials for ZIDOVUDINE

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

SponsorPhase
Michelle Abou-JaoudePhase 1
Inflammasome TherapeuticsPhase 1
Johns Hopkins UniversityPhase 1/Phase 2

See all ZIDOVUDINE clinical trials

Medical Subject Heading (MeSH) Categories for ZIDOVUDINE

US Patents and Regulatory Information for ZIDOVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd ZIDOVUDINE zidovudine CAPSULE;ORAL 078128-001 Mar 27, 2006 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo ZIDOVUDINE zidovudine TABLET;ORAL 077267-001 Sep 19, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Liaoning Chengda ZIDOVUDINE zidovudine INJECTABLE;INJECTION 204538-001 Nov 26, 2013 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma ZIDOVUDINE zidovudine TABLET;ORAL 076844-001 Sep 19, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma ZIDOVUDINE zidovudine TABLET;ORAL 022294-001 Jul 23, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience ZIDOVUDINE zidovudine TABLET;ORAL 078922-001 Feb 14, 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

ZIDOVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zidovudine

Introduction

Zidovudine, also known as AZT, is a nucleoside reverse transcriptase inhibitor (NRTI) widely used in the treatment of HIV/AIDS. The market for zidovudine, often co-formulated with other antiretroviral drugs like lamivudine, has seen significant growth and evolution. Here, we delve into the market dynamics and financial trajectory of zidovudine.

Market Size and Growth

The global zidovudine market has experienced substantial growth in recent years. As of 2023, the market size was valued at approximately $1.1 billion, with projections indicating it will reach $1.68 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of around 4-5%[4].

Market Segmentation

The zidovudine market is segmented based on several key factors:

  • Type: Zidovudine is available in various forms, including tablets and capsules. Each form has its own market share and growth prospects[1].
  • Application: The drug is used in hospitals, clinics, drug centers, and other healthcare facilities. The demand from these segments varies geographically and is influenced by healthcare infrastructure and patient access[1].
  • Geography: The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its own market dynamics, driven by local healthcare policies, patient population, and economic conditions[1].

Drivers of Market Growth

Several factors drive the growth of the zidovudine market:

  • Increasing Prevalence of HIV/AIDS: The ongoing global effort to combat HIV/AIDS has led to an increased demand for antiretroviral therapies, including zidovudine[3].
  • Advancements in Treatment Regimens: The development of combination therapies, such as the co-formulation of zidovudine with lamivudine and other antiretrovirals, has improved treatment outcomes and patient compliance[5].
  • Government Initiatives and Funding: Many governments and international organizations have initiated programs to provide access to antiretroviral drugs, including zidovudine, especially in developing countries[1].

Restraints and Challenges

Despite the growth, the zidovudine market faces several challenges:

  • Side Effects and Toxicity: Zidovudine is associated with significant side effects, including bone marrow cytotoxicities, anemia, and neutropenia. These adverse effects can limit its use and impact patient adherence[3].
  • Resistance and Mutations: The emergence of drug-resistant HIV strains, such as the K65R mutation, poses a challenge to the efficacy of zidovudine. This has led to the development of new dosing regimens and combination therapies[3].
  • Competition from Alternative Therapies: The availability of other NRTIs, such as abacavir, and newer antiretroviral agents can compete with zidovudine in the market[5].

Competitive Landscape

The zidovudine market is characterized by a competitive landscape involving several key players:

  • GSK: One of the major manufacturers of zidovudine, known for its extensive product portfolio and global reach[1].
  • Strides Shasun Limited: A significant player in the generic pharmaceutical market, offering affordable zidovudine formulations[1].
  • ViiV Healthcare: A leader in HIV treatment, offering a range of antiretroviral therapies, including those that include zidovudine[1].
  • Cipla Ltd: A prominent generic pharmaceutical company with a strong presence in emerging markets[1].

Financial Performance

The financial performance of the zidovudine market is robust, driven by consistent demand and expanding market reach:

  • Revenue Growth: The market is expected to grow from $1.1 billion in 2023 to $1.68 billion by 2032, indicating a steady revenue stream[4].
  • Product Pricing: The pricing of zidovudine varies by region and formulation. Generic versions are generally more affordable, contributing to higher sales volumes in price-sensitive markets[1].
  • Investment and Funding: Significant investments are being made in research and development to improve the efficacy and safety of zidovudine, as well as to develop new combination therapies[3].

Market Outlook

The market outlook for zidovudine remains positive, driven by several factors:

  • Porter's 5 Forces Analysis: The market is influenced by factors such as the bargaining power of buyers, the threat of new entrants, and the competitive rivalry among existing players. These forces shape the market dynamics and influence strategic decisions[1].
  • Value Chain Analysis: The value chain for zidovudine involves various stages from manufacturing to distribution. Efficient management of this chain is crucial for maintaining market competitiveness[1].
  • Pricing Analysis: Pricing strategies play a critical role in the zidovudine market. Companies must balance profitability with affordability to ensure widespread access to the drug[1].

Regulatory Environment

The regulatory environment significantly impacts the zidovudine market:

  • Approval Processes: Regulatory approvals are essential for the launch of new formulations or combination therapies. Stringent regulatory standards ensure the safety and efficacy of zidovudine products[1].
  • Patent Expirations: The expiration of patents for branded zidovudine products has led to the entry of generic versions, increasing market competition and reducing prices[1].

Emerging Trends

Several emerging trends are shaping the future of the zidovudine market:

  • Personalized Medicine: There is a growing interest in personalized treatment regimens that take into account individual patient characteristics and genetic profiles[3].
  • Combination Therapies: The development of combination therapies that include zidovudine with other antiretrovirals is a key trend. These combinations offer improved efficacy and reduced side effects[5].

Conclusion

The zidovudine market is characterized by robust growth, driven by increasing demand for antiretroviral therapies and advancements in treatment regimens. Despite challenges such as side effects and resistance, the market is expected to continue growing, driven by a competitive landscape and favorable market dynamics.

Key Takeaways

  • The global zidovudine market is projected to grow from $1.1 billion in 2023 to $1.68 billion by 2032.
  • The market is segmented by type, application, and geography.
  • Key drivers include the increasing prevalence of HIV/AIDS and advancements in treatment regimens.
  • Challenges include side effects, resistance, and competition from alternative therapies.
  • Major players include GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd.
  • The market outlook is positive, driven by favorable market dynamics and emerging trends.

FAQs

Q: What is the current market size of the zidovudine market? A: As of 2023, the global zidovudine market size is approximately $1.1 billion[4].

Q: What is the projected growth rate of the zidovudine market? A: The market is expected to grow at a CAGR of around 4-5% from 2023 to 2032[4].

Q: What are the main side effects associated with zidovudine? A: Zidovudine is associated with side effects such as bone marrow cytotoxicities, anemia, and neutropenia[3].

Q: Which companies are major players in the zidovudine market? A: Key players include GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd[1].

Q: What are the emerging trends in the zidovudine market? A: Emerging trends include personalized medicine and the development of combination therapies that include zidovudine with other antiretrovirals[3][5].

Sources

  1. Market Research Intellect - Global Lamivudine and Zidovudine Market Size, Trends and Forecasts Report.
  2. PMC - Development of an Optimized Dose for Coformulation of Zidovudine.
  3. IMARC Group - Zidovudine Prices, News, Chart, Analysis and Demand.
  4. Oxford Academic - Abacavir versus Zidovudine Combined with Lamivudine and Efavirenz.
  5. Market Research Intellect - Global Lamivudine and Zidovudine Market Report.

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