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Last Updated: March 15, 2025

RALTEGRAVIR POTASSIUM Drug Patent Profile


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When do Raltegravir Potassium patents expire, and what generic alternatives are available?

Raltegravir Potassium is a drug marketed by Hetero Labs Ltd Iii and is included in one NDA.

The generic ingredient in RALTEGRAVIR POTASSIUM is raltegravir potassium. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

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Summary for RALTEGRAVIR POTASSIUM
Drug patent expirations by year for RALTEGRAVIR POTASSIUM
Recent Clinical Trials for RALTEGRAVIR POTASSIUM

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

SponsorPhase
St. James's Hospital, IrelandPhase 4
ANRS, Emerging Infectious DiseasesPhase 1/Phase 2
Merck Sharp & Dohme Corp.Phase 1/Phase 2

See all RALTEGRAVIR POTASSIUM clinical trials

Medical Subject Heading (MeSH) Categories for RALTEGRAVIR POTASSIUM
Anatomical Therapeutic Chemical (ATC) Classes for RALTEGRAVIR POTASSIUM
Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ISENTRESS HD Tablets raltegravir potassium 600 mg 022145 1 2022-10-21
ISENTRESS HD Tablets raltegravir potassium 400 mg 022145 1 2011-10-12

US Patents and Regulatory Information for RALTEGRAVIR POTASSIUM

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hetero Labs Ltd Iii RALTEGRAVIR POTASSIUM raltegravir potassium TABLET;ORAL 203540-001 Dec 19, 2024 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Raltegravir Potassium

Introduction

Raltegravir potassium, an integral component in the treatment of HIV-1 infection, has been a significant player in the pharmaceutical market. This article delves into the market dynamics and financial trajectory of raltegravir potassium, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Size and Growth Prospects

The raltegravir potassium API market is anticipated to experience robust growth from 2023 to 2031. The market size is projected to expand significantly, driven by increasing demand for effective HIV treatments and the growing prevalence of HIV-1 infections globally[1].

Segmentation of the Market

The raltegravir potassium API market is segmented based on type (above 98% and above 99% purity) and application (tablets and others). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation helps in understanding the diverse market dynamics and identifying key growth areas[1].

Drivers of Market Growth

Several factors are driving the growth of the raltegravir potassium API market:

Increasing Prevalence of HIV-1

The rising number of HIV-1 cases worldwide is a primary driver. As the global health community continues to seek effective treatments, the demand for raltegravir potassium is expected to increase[1].

Efficacy and Tolerability

Raltegravir has been shown to have superior efficacy with optimized background treatment (OBT) in treatment-experienced HIV-1 patients. Its tolerability and minimal drug-to-drug interactions further enhance its market appeal[2][3].

Economic and Regulatory Factors

Government support and favorable regulatory environments in many regions are also boosting the market. Economic fluctuations have benefited the healthcare sector, including the market for raltegravir potassium[4].

Restraints and Challenges

Despite the positive outlook, there are several challenges that could impact the market:

Cost-Effectiveness

While raltegravir is cost-effective in many scenarios, especially with lower discount rates and shorter treatment durations, its high cost can be a barrier in some markets. The incremental cost-effectiveness ratio (ICER) varies, and sensitivity analyses show that lower prices and shorter treatment durations can improve cost-effectiveness[2].

Regulatory Hurdles

The generic application for raltegravir Viatris 600 mg film-coated tablets faced major objections from regulatory bodies, highlighting the stringent quality, safety, and efficacy standards that must be met. Such regulatory challenges can delay market entry and impact growth[5].

Competition

The market for HIV treatments is competitive, with multiple antiretroviral drugs available. Raltegravir potassium must compete with other integrase inhibitors and antiretroviral therapies, which can affect its market share[1].

Competitive Landscape

The competitive landscape of the raltegravir potassium API market is characterized by several key players, including Mylan, Hetero Drugs, Viwit Pharmaceuticals Limited, and Aurobindo Pharma Limited. These companies are involved in various market activities such as new product launches, partnerships, and mergers and acquisitions, which influence the market dynamics[1].

Financial Performance and Projections

The financial performance of the raltegravir potassium API market is expected to be strong, with significant revenue growth projected over the forecast period. The market value is measured in USD million, and the report provides detailed financial forecasts across different segments and geographical regions[1].

Revenue Projections

The market is expected to see substantial revenue growth from 2023 to 2031, driven by the increasing demand for raltegravir potassium in various applications, particularly in the treatment of HIV-1 infections.

Pricing Analysis

The pricing of raltegravir potassium is a critical factor influencing its market performance. The report includes a detailed pricing analysis, highlighting how different pricing strategies and discount rates can impact the cost-effectiveness and market adoption of the drug[1][2].

Porter's 5 Forces Framework

To understand the market dynamics comprehensively, the Porter's 5 Forces Framework is applied:

Threat of New Entrants

The threat of new entrants is moderate due to the high barriers to entry, including stringent regulatory requirements and the need for significant investment in research and development.

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low because the market has multiple suppliers, and companies can switch between them based on factors like price and quality.

Bargaining Power of Buyers

The bargaining power of buyers is moderate, as they have some leverage due to the availability of alternative treatments, but the efficacy and tolerability of raltegravir potassium maintain its market position.

Threat of Substitute Products

The threat of substitute products is high due to the presence of other antiretroviral drugs and integrase inhibitors in the market.

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, with several key players competing for market share through various strategies such as product differentiation, pricing, and partnerships[1].

Macro-Economic and Social Landscapes

The macro-economic and social landscapes play a crucial role in shaping the market for raltegravir potassium. Economic fluctuations, government policies, and social awareness about HIV treatments influence the demand and supply dynamics of the market[4].

Value Chain Analysis

A detailed value chain analysis is essential to understand the various stages involved in the production and distribution of raltegravir potassium. This includes the manufacturing process, quality control, and distribution channels, all of which impact the final product's quality and cost[5].

Conclusion

The raltegravir potassium API market is poised for significant growth driven by its efficacy, tolerability, and increasing demand for HIV treatments. However, the market faces challenges such as regulatory hurdles, competition, and cost-effectiveness concerns. Understanding the market dynamics through segmentation, competitive landscape, and financial projections is crucial for stakeholders to make informed decisions.

Key Takeaways

  • Market Growth: The raltegravir potassium API market is expected to grow significantly from 2023 to 2031.
  • Segmentation: The market is segmented by type, application, and geography.
  • Drivers: Increasing HIV-1 prevalence, efficacy, and favorable regulatory environments drive the market.
  • Challenges: Cost-effectiveness, regulatory hurdles, and competition are key challenges.
  • Financial Performance: The market is projected to see substantial revenue growth.

FAQs

Q: What are the primary drivers of the raltegravir potassium API market?

The primary drivers include the increasing prevalence of HIV-1 infections, the efficacy and tolerability of raltegravir, and favorable regulatory environments.

Q: What are the major challenges facing the raltegravir potassium API market?

The major challenges include cost-effectiveness concerns, regulatory hurdles, and competition from other antiretroviral drugs.

Q: Who are the key players in the raltegravir potassium API market?

Key players include Mylan, Hetero Drugs, Viwit Pharmaceuticals Limited, and Aurobindo Pharma Limited.

Q: How is the competitive landscape of the raltegravir potassium API market characterized?

The competitive landscape is characterized by high competition among existing players, moderate bargaining power of buyers, and a high threat of substitute products.

Q: What is the expected financial performance of the raltegravir potassium API market?

The market is expected to see substantial revenue growth from 2023 to 2031, driven by increasing demand and favorable market dynamics.

Sources

  1. Market Research Intellect - Raltegravir Potassium API Market Size, Scope And Forecast Report[1].
  2. PubMed - Cost-effectiveness analysis of raltegravir in treatment-experienced HIV-1 patients[2].
  3. PubMed - Pharmacokinetic and pharmacodynamic evaluation of raltegravir[3].
  4. News Channel Nebraska - Raltegravir Potassium Market 2024-2032[4].
  5. European Medicines Agency - Assessment report - Raltegravir Viatris[5].

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