Raltegravir potassium - Generic Drug Details

What are the generic sources for raltegravir potassium and what is the scope of freedom to operate?

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

International Patents:	109
US Patents:	5
Tradenames:	3
Applicants:	2
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	5
Patent Applications:	218
DailyMed Link:	raltegravir potassium at DailyMed

Recent Clinical Trials for raltegravir potassium

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

Sponsor	Phase
St. James's Hospital, Ireland	Phase 4
ANRS, Emerging Infectious Diseases	Phase 1/Phase 2
Merck Sharp & Dohme Corp.	Phase 1/Phase 2

See all raltegravir potassium clinical trials

Pharmacology for raltegravir potassium

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors

Medical Subject Heading (MeSH) Categories for raltegravir potassium

Anti-HIV Agents

HIV Integrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for raltegravir potassium

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes			Y	Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007		RX	Yes	Yes			Y	Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes					Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007		RX	Yes	Yes					Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes					Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011		RX	Yes	No					Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		RX	Yes	Yes					Y

Expired US Patents for raltegravir potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011

International Patents for raltegravir potassium

Country	Patent Number	Title	Estimated Expiration
Canada	2588398	SELS DE POTASSIUM D'UN INHIBITEUR D'INTEGRASE HIV (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Japan	2013508395
Japan	6122639
European Patent Office	3165220	COMPOSITION PHARMACEUTIQUE CONTENANT UN AGENT D'ANTI-NUCLÉATION (PHARMACEUTICAL COMPOSITION CONTAINING AN ANTI-NUCLEATING AGENT)
European Patent Office	2586444	Formulation pharmaceutique d'inhibiteurs de l'intégrase du VIH de type carboxamide contenant une composition de contrôle de vitesse de libération (Pharmaceutical formulation of carboxamide HIV integrase inhibitors containing a release rate control composition)
Cyprus	1112859
Japan	2008521932

Supplementary Protection Certificates for raltegravir potassium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436 (MITTEILUNG) 20071220
1441735	PA2008 007, C1441735	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735	SZ 30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735	C200800017	Spain		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	67 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102
1441735	DO 67; 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
1441735	300340	Netherlands		PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102

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].

Last updated: 2024-12-16