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Last Updated: December 27, 2024

ABACAVIR SULFATE AND LAMIVUDINE Drug Patent Profile


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Which patents cover Abacavir Sulfate And Lamivudine, and when can generic versions of Abacavir Sulfate And Lamivudine launch?

Abacavir Sulfate And Lamivudine is a drug marketed by Norvium Bioscience, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Teva Pharms Usa, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Abacavir Sulfate And Lamivudine

A generic version of ABACAVIR SULFATE AND LAMIVUDINE was approved as abacavir sulfate; lamivudine by CHARTWELL RX on March 28th, 2017.

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

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

SponsorPhase
ViiV HealthcarePhase 4
Gilead SciencesPhase 3
GlaxoSmithKlinePhase 4

See all ABACAVIR SULFATE AND LAMIVUDINE clinical trials

US Patents and Regulatory Information for ABACAVIR SULFATE AND LAMIVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Norvium Bioscience ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET, FOR SUSPENSION;ORAL 204311-001 Dec 22, 2023 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246-001 Sep 29, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 204990-001 Mar 28, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 208990-001 Nov 15, 2018 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151-001 Mar 28, 2017 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

ABACAVIR SULFATE AND LAMIVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abacavir Sulfate and Lamivudine

Introduction

Abacavir sulfate and lamivudine, a combination of two nucleoside analogue HIV-1 reverse transcriptase inhibitors, is a crucial medication in the treatment of HIV-1 infection. This article delves into the market dynamics and financial trajectory of this drug, highlighting its sales trends, pricing analysis, and future forecasts.

Market Scope and Coverage

The market for abacavir sulfate and lamivudine spans across various regions, including North America, Europe, Japan, BRIC countries, and Australia. The drug is marketed by several companies under different brand names in these regions[1].

Sales Analysis

Historical sales data indicate that abacavir sulfate and lamivudine have been a significant part of the antiretroviral therapy market. The sales trends show a steady growth pattern, driven by the increasing demand for effective HIV treatments. For instance, a report by Research and Markets provided detailed sales data and forecasts up to 2021, highlighting the drug's performance in different countries[1].

Sales by Countries

The sales of abacavir sulfate and lamivudine vary significantly by country. In the US, Europe, and other developed markets, the drug has seen consistent sales due to its inclusion in standard HIV treatment regimens. In emerging markets like Brazil, India, and China, the sales have been driven by government initiatives and international aid programs aimed at increasing access to antiretroviral therapies[1].

Price Analysis

The unit price of abacavir sulfate and lamivudine varies by country, influenced by factors such as local healthcare policies, competition from generics, and pricing regulations. In general, the prices in developed countries are higher compared to those in emerging markets. The price data is crucial for companies to devise pricing strategies, estimate patient shares, and develop patient forecast models[1].

Sales Forecast

Sales forecasts for abacavir sulfate and lamivudine indicate continued growth, albeit at a slower pace due to the increasing competition from generic and biosimilar alternatives. The forecast up to 2021 showed a positive trend, with the drug expected to maintain its market share despite the entry of generics[1].

Impact of Generic and Biosimilar Competition

The expiration of patents for abacavir and lamivudine has led to the entry of generic versions, which has impacted the market dynamics. Generic medicines, known for their lower prices, have captured a significant share of the market, especially in low- and middle-income countries. The global market for generic medicines is projected to grow substantially, reaching USD 442.3 billion by 2027, which will continue to influence the sales trajectory of abacavir sulfate and lamivudine[5].

Pediatric Formulations and Market Expansion

Recent developments, such as the FDA's tentative approval of a pediatric formulation of abacavir, dolutegravir, and lamivudine, are expected to enhance market access and adherence to HIV treatment in children. This formulation, designed for once-daily dosing, reduces the pill burden and is particularly beneficial for children living with HIV in low- and middle-income countries[2].

Financial Benefits and Strategic Planning

For companies marketing abacavir sulfate and lamivudine, the financial benefits include significant revenues from both developed and emerging markets. The sales and price data are essential for market planning, market assessments, market sizing, and competitive intelligence. Companies like Viatris have leveraged these data to expand access to high-quality HIV/AIDS treatments, aligning with their sustainability goals[2].

Risks and Precautions

Despite the financial and market benefits, the use of abacavir sulfate and lamivudine comes with several risks and precautions. Hypersensitivity reactions, lactic acidosis, severe hepatomegaly, and exacerbations of hepatitis B are among the serious adverse reactions associated with this medication. Monitoring for hepatotoxicity and careful patient selection are critical to mitigate these risks[4].

Competitive Intelligence

The competitive landscape for abacavir sulfate and lamivudine is dynamic, with multiple companies marketing the drug under different brand names. Competitive intelligence involves analyzing the sales trends, pricing strategies, and market shares of these companies to position the product effectively in the market[1].

Market Assessments and Sizing

Market assessments and sizing are crucial for understanding the current and future market potential of abacavir sulfate and lamivudine. These analyses help in determining the drug's market share, identifying growth opportunities, and developing strategic forecasts[1].

Product Positioning and Brand Planning

Effective product positioning and brand planning are essential for maintaining market share. Companies need to consider the drug's efficacy, safety profile, and convenience (such as once-daily dosing) to position it favorably against competitors[1].

Strategic Forecasts

Strategic forecasts involve predicting future sales trends based on historical data, market analysis, and competitive intelligence. For abacavir sulfate and lamivudine, these forecasts must account for the impact of generic competition, regulatory changes, and emerging market trends[1].

Business Development and Licensing (BD&L)

BD&L activities play a significant role in the financial trajectory of abacavir sulfate and lamivudine. Partnerships with other stakeholders, licensing agreements, and the development of novel formulations can enhance market access and revenue growth[1].

Pricing Analysis and Benchmarks

Pricing analysis is vital for setting competitive prices and estimating annual therapy costs. Companies must benchmark their prices against those of competitors and generics to maintain market competitiveness[1].

Patient Forecast Models

Developing patient forecast models helps companies predict the number of patients who will be treated with abacavir sulfate and lamivudine. These models are based on pricing and sales data, as well as epidemiological trends in HIV infection[1].

Conclusion

The market dynamics and financial trajectory of abacavir sulfate and lamivudine are influenced by a complex interplay of factors including sales trends, pricing strategies, competitive intelligence, and regulatory approvals. As the market continues to evolve with the entry of generics and biosimilars, companies must remain agile in their strategic planning to maintain market share and ensure continued access to this critical HIV treatment.

Key Takeaways

  • Sales Trends: Steady growth driven by increasing demand for HIV treatments.
  • Price Analysis: Varies by country, influenced by local healthcare policies and competition.
  • Generic Competition: Significant impact on market share, especially in low- and middle-income countries.
  • Pediatric Formulations: Enhance market access and adherence to HIV treatment in children.
  • Risks and Precautions: Hypersensitivity reactions, lactic acidosis, severe hepatomegaly, and exacerbations of hepatitis B.
  • Competitive Intelligence: Essential for market positioning and strategic forecasts.
  • Market Assessments: Crucial for understanding market potential and identifying growth opportunities.

FAQs

Q1: What are the primary indications for abacavir sulfate and lamivudine? Abacavir sulfate and lamivudine are indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents[4].

Q2: How does the pricing of abacavir sulfate and lamivudine vary by country? The pricing varies significantly by country, influenced by local healthcare policies, competition from generics, and pricing regulations[1].

Q3: What are the risks associated with the use of abacavir sulfate and lamivudine? The risks include hypersensitivity reactions, lactic acidosis, severe hepatomegaly, and exacerbations of hepatitis B[4].

Q4: How has the introduction of generic versions impacted the market for abacavir sulfate and lamivudine? The introduction of generics has significantly impacted the market, capturing a substantial share, especially in low- and middle-income countries[5].

Q5: What is the significance of the FDA's tentative approval of a pediatric formulation of abacavir, dolutegravir, and lamivudine? The approval enhances market access and adherence to HIV treatment in children, particularly in low- and middle-income countries, by reducing the pill burden and improving convenience[2].

Sources

  1. Research and Markets, "Abacavir / Lamivudine Sales, Price Analysis, & Sales Forecast - 2017"
  2. PR Newswire, "Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir/Abc/Dolutegravir/Dtg/Lamivudine/3TC/A Once Daily Treatment for Children Living with HIV"
  3. FDA, "21652 Abacavir & Lamivudine Clinical Statistical PREA"
  4. FDA, "Abacavir sulfate and Lamivudine tablets 60/30 mg"
  5. Access to Medicine Foundation, "Generic & Biosimilar Medicines Programme 2023"

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