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Last Updated: December 22, 2024

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE - Generic Drug Details


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What are the generic sources for lamivudine; nevirapine; zidovudine and what is the scope of patent protection?

Lamivudine; nevirapine; zidovudine is the generic ingredient in one branded drug marketed by Micro Labs and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seven tentative approvals for this compound.

Summary for LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 45
DailyMed Link:LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE at DailyMed
Recent Clinical Trials for LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

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

SponsorPhase
The Aurum Institute NPCPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 4

See all LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE clinical trials

Generic filers with tentative approvals for LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe150MG; 200MG; 300MGTABLET; ORAL
⤷  Subscribe⤷  Subscribe150MG; 200MG; 300MGTABLET; ORAL
⤷  Subscribe⤷  Subscribe30MG; 50MG; 60MGTABLET, FOR SUSPENSION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE lamivudine; nevirapine; zidovudine TABLET;ORAL 205626-001 Aug 13, 2018 DISCN Yes 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

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lamivudine, Nevirapine, and Zidovudine

Introduction to the Drugs

Lamivudine, Nevirapine, and Zidovudine are crucial antiretroviral and antiviral drugs used in the treatment of HIV and other viral infections. Here’s a detailed look at the market dynamics and financial trajectory of these drugs.

Lamivudine

Market Size and Growth Projections

The lamivudine market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.2% from 2024 to 2031[1][4].

Segmentation of the Lamivudine Market

  • By Application: Lamivudine tablets, capsules, and oral solutions.
  • By Product: HIV treatment, hepatitis B treatment, and antiviral therapy.
  • By Geography: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[1][4].

Drivers of Market Growth

  • Increasing Incidence of HIV and Hepatitis B: The rising incidence of these infections globally increases the demand for effective antiviral therapies like lamivudine[1][4].
  • Technological Advancements: Improvements in medication formulations and combination therapies enhance the efficacy and patient compliance with lamivudine[1][4].
  • Expanding Access to Healthcare: Global initiatives to increase access to HIV and hepatitis B treatments, particularly in developing regions, fuel market expansion[1][4].

Market Challenges and Restraints

Despite the growth, the lamivudine market faces challenges such as resistance-associated mutations and the need for continuous innovation to stay ahead of viral resistance[1].

Regional Market Performance

The Asia-Pacific region is expected to be one of the fastest-growing segments due to increasing healthcare access and a large patient population. North America and Europe also remain significant markets due to high healthcare spending and advanced medical infrastructure[1].

Nevirapine

Market Overview

Nevirapine, another key antiretroviral drug, is used primarily in the treatment of HIV. While specific market size and growth projections for nevirapine are not detailed in the sources, its market dynamics are influenced by similar factors as lamivudine.

Drivers of Market Growth

  • Increasing HIV Incidence: The global rise in HIV cases drives the demand for antiretroviral therapies, including nevirapine.
  • Combination Therapies: Nevirapine is often used in combination with other antiretroviral drugs, enhancing treatment outcomes and driving market growth.
  • Global Health Initiatives: Efforts to expand access to HIV treatments in developing regions contribute to the market expansion of nevirapine.

Market Challenges

  • Side Effects and Resistance: Like other antiretroviral drugs, nevirapine faces challenges related to side effects and the development of resistance, necessitating continuous research and innovation[3].

Zidovudine

Market Size and Growth Projections

The zidovudine market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031. While the exact market size is not specified, the market is anticipated to experience significant growth during this period[2].

Segmentation of the Zidovudine Market

  • By Type: Oral and injectable forms.
  • By Application: HIV treatment and HIV prevention.
  • By Geography: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[2].

Drivers of Market Growth

  • Increasing Demand for HIV Treatments: The rising incidence of HIV and the need for effective treatments drive the demand for zidovudine.
  • Technological Advancements: Improvements in medication formulations and the development of combination therapies contribute to market growth.
  • Expanding Healthcare Access: Global initiatives to increase access to HIV treatments, especially in developing regions, fuel the market expansion of zidovudine[2].

Market Challenges and Restraints

  • Resistance and Side Effects: Zidovudine, like other antiretroviral drugs, faces challenges related to the development of resistance and side effects, which can impact market growth[2].

Common Market Dynamics

Increasing Global Health Awareness

The growing global awareness about HIV and hepatitis B infections is a significant driver for all three drugs. As more cases are diagnosed, the demand for effective antiviral therapies increases[1][2][4].

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, nevirapine, and zidovudine also contribute to market growth by improving treatment outcomes[1][2][4].

Expanding Access to Healthcare

Global initiatives to increase access to HIV and hepatitis B treatments, particularly in developing regions, are fueling the market expansion for these drugs. Supporting healthcare regulations and policies further boost the demand[1][2][4].

Regional Market Performance

Asia-Pacific Region

The Asia-Pacific region is expected to be one of the fastest-growing segments for all three drugs due to increasing healthcare access and a large patient population. Countries like India and China are becoming key markets[1][2].

North America and Europe

These regions remain significant markets due to high healthcare spending and advanced medical infrastructure. The high prevalence of HIV and hepatitis B in these regions also contributes to the demand for these drugs[1][2].

Key Players' Strategies

Product Innovations

Companies involved in the market are adopting various strategies to maintain and enhance their market share. 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[1][4].

Market Expansion

Key players are focusing on market expansion, particularly in the Asia-Pacific region, due to its large patient population and government initiatives to improve healthcare infrastructure[1][4].

Financial Trajectory

Revenue Growth

The lamivudine market is expected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2031, indicating a substantial increase in revenue. While specific financial projections for nevirapine and zidovudine are not detailed, they are also expected to experience significant revenue growth driven by the increasing demand for antiviral therapies[1][4].

Conclusion

The markets for lamivudine, nevirapine, and zidovudine are 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 financial trajectory for these drugs 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 and hepatitis B, technological advancements, and expanding healthcare access are key drivers.
  • Regional Performance: The Asia-Pacific region is expected to be one of the fastest-growing segments.
  • Key Players: Companies like Gilead Sciences, GSK, Bristol-Myers Squibb, and others are focusing on product innovations, market expansion, and collaborations.

FAQs

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

The lamivudine market was valued at USD 1.2 billion in 2023[1].

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[1].

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

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

4. What are the main drivers of the zidovudine market?

The main drivers include the increasing demand for HIV treatments, technological advancements, and expanding healthcare access[2].

5. How do technological advancements impact the market for these drugs?

Technological advancements in medication formulations and combination therapies enhance the efficacy and patient compliance, contributing to market growth[1][2][4].

Sources

  1. Drug Patent Watch: "LAMIVUDINE INN entry, pharmaceutical patent expiry and market dynamics"[1].
  2. Market Research Intellect: "Global zidovudine market size and forecast"[2].
  3. PubMed: "Modelling the cost effectiveness of lamivudine/zidovudine combination therapy"[3].
  4. Market Research Intellect: "Global Lamivudine Market Size, Share | Industry Research Report 2031"[4].
  5. Market Research Intellect: "Global Lamivudine and Zidovudine Market Size, Trends and Forecast"[5].

More… ↓

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