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Last Updated: December 22, 2024

LAMIVUDINE AND ZIDOVUDINE Drug Patent Profile


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When do Lamivudine And Zidovudine patents expire, and what generic alternatives are available?

Lamivudine And Zidovudine is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Epic Pharma Llc, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Norvium Bioscience, Pharmacare, and Strides Pharma. and is included in thirteen NDAs.

The generic ingredient in LAMIVUDINE AND ZIDOVUDINE is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lamivudine And Zidovudine

A generic version of LAMIVUDINE AND ZIDOVUDINE was approved as lamivudine; zidovudine by LUPIN LTD on May 15th, 2012.

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Summary for LAMIVUDINE AND ZIDOVUDINE
Drug patent expirations by year for LAMIVUDINE AND ZIDOVUDINE
Recent Clinical Trials for LAMIVUDINE AND ZIDOVUDINE

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

SponsorPhase
The Aurum Institute NPCPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2
University of Cape TownPhase 2

See all LAMIVUDINE AND ZIDOVUDINE clinical trials

US Patents and Regulatory Information for LAMIVUDINE AND 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 LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 077558-001 May 5, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 203259-001 Feb 3, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 077411-001 Sep 7, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmacare LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 022018-001 Mar 17, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 090246-001 May 15, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 202418-001 May 15, 2012 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 LAMIVUDINE AND ZIDOVUDINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva Pharma B.V.  Lamivudine/Zidovudine Teva lamivudine, zidovudine EMEA/H/C/001236
Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.
Withdrawn yes no no 2011-02-28
ViiV Healthcare BV Combivir lamivudine, zidovudine EMEA/H/C/000190
Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,
Authorised no no no 1998-03-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

LAMIVUDINE AND ZIDOVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lamivudine and Zidovudine

Introduction to Lamivudine and Zidovudine

Lamivudine and zidovudine are crucial antiretroviral drugs used primarily in the treatment of HIV infection, often administered in combination therapy. This combination is indicated for the treatment of human-immunodeficiency-virus (HIV) infection and is a cornerstone in antiretroviral therapy[4].

Market Size and Growth Projections

The market for lamivudine and zidovudine has experienced significant growth in recent years and is projected to continue this trend. Here are some key metrics:

  • Current Market Size: The lamivudine market alone was valued at USD 1.2 billion in 2023[3].
  • Growth Projections: The combined market for lamivudine and zidovudine is expected to grow substantially, with the lamivudine market projected to reach USD 2.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.2% from 2024 to 2031[3].

Segmentation of the Market

The market is segmented based on several criteria:

By Type

  • Tablets: A common form of administration for lamivudine and zidovudine.
  • Capsules: Another form, often used for specific patient needs.
  • Oral Solutions: Used for patients who have difficulty swallowing tablets or capsules[3].

By Application

  • HIV Treatment: The primary use of lamivudine and zidovudine in combination therapy.
  • Hepatitis B Treatment: Lamivudine is also used in the treatment of hepatitis B, though this is not a primary use for the combination with zidovudine.
  • Antiviral Therapy: General category under which both drugs fall[3].

By Geography

  • North America: A significant market due to high healthcare spending and advanced medical infrastructure.
  • Europe: Another major market with similar characteristics.
  • Asia-Pacific: Expected to be one of the fastest-growing segments due to increasing healthcare access and a large patient population.
  • South America: Growing market with increasing healthcare access.
  • Middle-East and Africa: Also seeing growth, albeit at a slower pace, due to improving healthcare access and increasing awareness[1][3].

Drivers of Market Growth

Several factors are driving the growth of the lamivudine and zidovudine market:

Increasing Incidence of HIV

The rising incidence of HIV infections globally is a significant driver. As more cases are diagnosed, the demand for effective antiviral therapies like lamivudine and zidovudine increases[3].

Technological Advancements

Improvements in medication formulations, such as better tablets, capsules, and oral solutions, enhance the efficacy and patient compliance with these drugs. Combination therapies that include lamivudine and zidovudine also contribute to market growth by improving treatment outcomes[3].

Expanding Access to Healthcare

Global initiatives to increase access to HIV treatments, particularly in developing regions, are fueling the market expansion. Supporting healthcare regulations and policies further boost the demand for these drugs[3].

Market Challenges and Restraints

Despite the growth, the market faces some challenges:

Resistance-Associated Mutations

The development of resistance to lamivudine and zidovudine is a significant challenge. This can reduce the efficacy of the treatment and necessitate the use of alternative or additional therapies[3].

Cost and Accessibility

The cost of combination antiretroviral therapy, including lamivudine and zidovudine, can be high, making it inaccessible to some patients, especially in low-income countries. Economic evaluations have shown that while combination therapy is cost-effective, it still poses a financial burden[2].

Key Players' Strategies

Companies involved in the lamivudine and zidovudine market are adopting various strategies to maintain and enhance their market share:

Product Innovations

Continuous research into new formulations and combination therapies is a key strategy. For example, the development of lamivudine plus dolutegravir dual therapy represents an effort to improve treatment outcomes[3].

Market Expansion

Key players are expanding their market presence, particularly in the Asia-Pacific region, where there is a large patient population and increasing healthcare access. Companies like GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd are prominent in this market[1][3].

Collaborations and Mergers

Strategic collaborations and mergers are common among key players to enhance their product portfolios and market reach. These collaborations can lead to the development of new combination therapies and improved market positioning[1].

Regional Market Performance

Asia-Pacific

This region is expected to be one of the fastest-growing segments due to increasing healthcare access, a large patient population, and government initiatives to improve healthcare infrastructure. Countries like India and China are becoming key markets for lamivudine and zidovudine[3].

North America and Europe

These regions remain significant markets due to high healthcare spending and advanced medical infrastructure. The demand for effective antiretroviral therapies is high, and these regions are expected to continue driving market growth[1][3].

Middle-East and Africa

These regions are also seeing growth, albeit at a slower pace, due to improving healthcare access and increasing awareness about HIV treatments[3].

Economic Evaluation and Cost-Effectiveness

Economic evaluations have shown that combination therapy with lamivudine and zidovudine is cost-effective compared to monotherapy. For instance, a study from the UK public finance perspective estimated that treatment with lamivudine/zidovudine yields an incremental cost-effectiveness ratio of £6,276 per life year saved, which compares favorably with other HIV treatments[2].

Competitive Landscape

The competitive landscape of the lamivudine and zidovudine market is characterized by:

Market Ranking

Key players such as GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd are ranked based on their market share, product portfolios, and strategic market approaches[1].

Significant Developments

Recent milestones, collaborations, mergers and acquisitions, and new product releases are critical in shaping the competitive landscape. For example, the development of generic versions of lamivudine and zidovudine has increased competition and reduced costs for patients[1][4].

Market Outlook

The market outlook for lamivudine and zidovudine is positive, driven by several factors:

Growth Propellers

Increasing global health awareness, technological advancements, and expanding access to healthcare are key drivers of market growth[3].

Hindrances

Challenges such as resistance-associated mutations and high treatment costs need to be addressed through continuous innovation and policy support[3].

Opportunities

New business ventures and investment opportunities are emerging, particularly in regions with growing healthcare access. The development of new combination therapies and generic versions of existing drugs presents opportunities for market expansion[1][3].

Challenges

The market faces challenges such as the need for continuous monitoring of resistance patterns and the development of new therapies to address these issues. Regulatory changes and economic fluctuations can also impact market dynamics[3].

Porter's 5 Forces Framework

The competitive landscape can be analyzed using Porter's 5 Forces Framework:

Threat of New Entrants

The threat of new entrants is moderate due to the presence of established players and the need for significant investment in research and development[1].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low due to the availability of multiple suppliers for the active ingredients and other components of the drugs[1].

Bargaining Power of Buyers

The bargaining power of buyers is moderate, influenced by the availability of generic versions and the need for continuous treatment, which can reduce negotiating power[1].

Threat of Substitute Products

The threat of substitute products is high due to the development of new antiretroviral therapies and combination regimens[1].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, driven by the presence of multiple key players and the continuous need for innovation to maintain market share[1].

Conclusion

The market for lamivudine and zidovudine is poised for significant growth driven by increasing global health awareness, technological advancements, and expanding access to healthcare. Despite challenges such as resistance-associated mutations, the market's financial trajectory looks robust, with key players adopting innovative strategies to maintain and enhance their market share.

Key Takeaways

  • Market Growth: The lamivudine market is projected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2031, with a CAGR of 7.2% from 2024 to 2031.
  • Drivers: Increasing incidence of HIV, technological advancements, and expanding healthcare access are key drivers.
  • Challenges: Resistance-associated mutations and high treatment costs are significant challenges.
  • Key Players: GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd are prominent players.
  • Regional Growth: The Asia-Pacific region is expected to be one of the fastest-growing segments.

FAQs

1. What is the current market size of the lamivudine market?

The lamivudine market was valued at USD 1.2 billion in 2023[3].

2. What is the projected growth rate of the lamivudine market?

The market is expected to grow at a CAGR of 7.2% from 2024 to 2031[3].

3. Which regions are expected to drive the growth of the lamivudine and zidovudine market?

The Asia-Pacific region, along with North America and Europe, is expected to drive significant growth in the market[1][3].

4. What are the primary challenges facing the lamivudine and zidovudine market?

Resistance-associated mutations and high treatment costs are significant challenges[3].

5. Who are the key players in the lamivudine and zidovudine market?

Key players include GSK, Strides Shasun Limited, ViiV Healthcare, and Cipla Ltd[1].

Sources

  1. Market Research Intellect: Global Lamivudine and Zidovudine Market Size, Trends and Forecasts.
  2. PubMed: Modelling the cost effectiveness of lamivudine/zidovudine combination therapy.
  3. Drug Patent Watch: Generic LAMIVUDINE INN entry, pharmaceutical patent expiry and market dynamics.
  4. European Medicines Agency: Lamivudine/Zidovudine Teva.
  5. Oxford Academic: Abacavir versus Zidovudine Combined with Lamivudine and Efavirenz.

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