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Last Updated: March 13, 2025

Raltegravir potassium - Generic Drug Details


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What are the generic drug sources for raltegravir potassium and what is the scope of patent protection?

Raltegravir potassium is the generic ingredient in three branded drugs marketed by Msd Sub Merck and Hetero Labs Ltd Iii, and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Raltegravir potassium has one hundred and nine patent family members in forty-one countries.

There are five drug master file entries for raltegravir potassium. Seven suppliers are listed for this compound.

Summary for raltegravir potassium
Recent Clinical Trials for raltegravir potassium

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

SponsorPhase
St. James's Hospital, IrelandPhase 4
Merck Sharp & Dohme Corp.Phase 1/Phase 2
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 1/Phase 2

See all raltegravir potassium clinical trials

Pharmacology for raltegravir potassium
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
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  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 5 of 5 entries

Expired US Patents for raltegravir potassium

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 ⤷  Try for Free ⤷  Try for Free
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 ⤷  Try for Free ⤷  Try for Free
Msd Sub Merck ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 ⤷  Try for Free ⤷  Try for Free
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 ⤷  Try for Free ⤷  Try for Free
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries

International Patents for raltegravir potassium

CountryPatent NumberTitleEstimated Expiration
Eurasian Patent Organization 200701204 КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ ⤷  Try for Free
Spain 2755273 ⤷  Try for Free
Taiwan I344463 ⤷  Try for Free
Turkey 201907729 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2011053504 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

Supplementary Protection Certificates for raltegravir potassium

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1441735 122008000016 Germany ⤷  Try for Free PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 30/2008 Austria ⤷  Try for Free PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436 (MITTEILUNG) 20071220
1441735 67 3-2008 Slovakia ⤷  Try for Free PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102
1441735 C200800017 Spain ⤷  Try for Free PRODUCT NAME: RALTEGRAVIR; NATIONAL AUTHORISATION NUMBER: UE/1/07/436/001-002; DATE OF AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UE/1/07/436/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735 PA2008 007, C1441735 Lithuania ⤷  Try for Free PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.