Dolutegravir sodium; lamivudine - Generic Drug Details

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

Dolutegravir sodium; lamivudine is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium; lamivudine has two hundred and eighty patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for dolutegravir sodium; lamivudine

International Patents:	280
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium; lamivudine
DailyMed Link:	dolutegravir sodium; lamivudine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium; lamivudine

Constraining patent/regulatory exclusivity:

11,234,985

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for dolutegravir sodium; lamivudine

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dolutegravir sodium; lamivudine

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DOVATO	Tablets	dolutegravir sodium; lamivudine	50 mg/300 mg	211994	1	2019-07-30

US Patents and Regulatory Information for dolutegravir sodium; lamivudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	11,234,985		Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	8,129,385*PED				Y

International Patents for dolutegravir sodium; lamivudine

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1179522	包含 之治療組合 (THERAPEUTIC COMBINATION COMPRISING DOLUTEGRAVIR, ABACAVIR AND LAMIVUDINE DOLUTEGRAVIRABACVIR LAMIVUDINE)
Serbia	54123	TERAPEUTSKA KOMBINACIJA KOJA SADRŽI DOLUTEGRAVIR, ABACAVIR I LAMIVUDINE (THERAPEUTIC COMBINATION COMPRISING DOLUTEGRAVIR, ABACAVIR AND LAMIVUDINE)
Mexico	2011006241	SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Cyprus	1116331
Lithuania	PA2021512
South Korea	101964923

Supplementary Protection Certificates for dolutegravir sodium; lamivudine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3494972	CA 2024 00022	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, INKLUSIV DOLUTEGRAVIRNATRIUM, OG LAMIVUDIN; REG. NO/DATE: EU/1/19/1370 20190703
1874117	30/2014	Austria		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121
3494972	122024000031	Germany		PRODUCT NAME: DOLUTEGRAVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM, MIT LAMIVUDIN; REGISTRATION NO/DATE: EU/1/19/1370 20190701
2932970	CR 2018 00036	Denmark		PRODUCT NAME: KOMBINATION AF DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518
1874117	C 2014 024	Romania		PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121

Dolutegravir sodium; lamivudine Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Dolutegravir and Lamivudine

Introduction

Dolutegravir and lamivudine are pivotal components in the treatment of HIV/AIDS, and their market dynamics are influenced by several key factors. This article delves into the current market size, growth projections, drivers, restraints, and the financial trajectory of these antiretroviral drugs.

Market Size and Growth Projections

The global dolutegravir market was valued at USD 5.2 billion in 2023 and is projected to reach USD 9.99 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Geographical Segmentation

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own set of market dynamics, influenced by local healthcare policies, disease prevalence, and access to antiretroviral therapies.

Drivers of Market Growth

Several factors are driving the growth of the dolutegravir and lamivudine market:

Efficacy and Safety Profile

Dolutegravir has been widely incorporated into HIV treatment regimens due to its exceptional efficacy in inhibiting HIV replication and its favorable safety profile. This has led to its recommendation as a first-line treatment in international guidelines[1][5].

Increasing HIV Diagnoses

The rising number of HIV diagnoses, particularly in regions with high prevalence rates, has created a growing need for efficient treatment options like dolutegravir and lamivudine[1].

Government and NGO Initiatives

Efforts by non-governmental and governmental groups to increase access to antiretroviral medicines in low- and middle-income nations have significantly boosted the market. Programs such as the Global HIV Programme have facilitated the transition to dolutegravir-based antiretroviral therapy (ART) in these regions[5].

Research and Innovation

Ongoing research into new formulations and combination medications, including pediatric formulations like abacavir/lamivudine/dolutegravir, continues to drive market expansion. Partnerships between academic institutions and pharmaceutical corporations are key in this regard[1][3].

Restraints and Challenges

Despite the positive growth trajectory, there are several challenges that the market faces:

Adverse Reactions and Safety Concerns

Dolutegravir and lamivudine can have significant adverse reactions, including post-treatment exacerbations of hepatitis B, embryo-fetal toxicity, and renal impairment. These safety concerns necessitate close monitoring and may impact market growth[2].

Resistance and Efficacy Concerns

Studies have shown that lamivudine plus dolutegravir may be less effective than three-drug regimens in patients with resistance-associated mutations to nucleoside reverse transcriptase inhibitors (NRTIs). This could affect the long-term efficacy and market acceptance of dual therapy regimens[4].

Regulatory and Access Issues

Transitioning to dolutegravir-based ART in low- and middle-income countries faces challenges such as regulatory hurdles, supply chain issues, and the need for continuous monitoring and surveillance[5].

Competitive Landscape

The market for dolutegravir and lamivudine is highly competitive, with several major players:

Key Players

• ViiV Healthcare (GSK)
• Shanghai Desano Pharmaceuticals
• Mylan
• Aurobindo Pharma
• LAURUS Labs
• Adcock Ingram Limited

These companies are involved in various strategies such as product innovation, partnerships, and expanding their distribution networks to capture market share[1].

Market Segments and Distribution

The market is segmented based on the type of formulation and the distribution channels. For instance:

Combination Therapies

Dolutegravir is often used in combination with lamivudine and tenofovir alafenamide (TLD), which is a popular regimen due to its efficacy and convenience. This combination is widely distributed through various channels, including vendor-managed solutions programs[3].

Pediatric Formulations

The introduction of pediatric formulations like abacavir/lamivudine/dolutegravir has expanded the market reach, particularly in regions with high pediatric HIV prevalence[3].

Financial Trajectory

The financial trajectory of dolutegravir and lamivudine is robust, driven by increasing demand and expanding market reach.

Revenue Projections

The projected growth to USD 9.99 billion by 2031 indicates a strong financial outlook. This growth is supported by the increasing adoption of dolutegravir-based regimens in both developed and developing countries[1].

Investment and Research

Continuous investment in research and development, as well as partnerships between pharmaceutical companies and academic institutions, will further fuel the financial growth of this market segment[1].

Porter’s Five Forces Analysis

To understand the competitive landscape better, a Porter’s Five Forces analysis is crucial:

Buyers' Bargaining Power

The bargaining power of buyers is moderate due to the availability of multiple treatment options, although dolutegravir's efficacy gives it a competitive edge[1].

Suppliers' Bargaining Power

Suppliers have significant bargaining power due to the specialized nature of the raw materials and the complexity of the manufacturing process[1].

Threat of New Entrants

The threat of new entrants is low due to high barriers to entry, including regulatory requirements and the need for significant research and development investments[1].

Threat of Substitutes

The threat of substitutes is moderate, as other antiretroviral drugs are available, but dolutegravir's unique profile makes it a preferred choice in many treatment regimens[1].

Degree of Competition

The degree of competition is high, with multiple players vying for market share through innovation, pricing strategies, and distribution networks[1].

Key Takeaways

• The global dolutegravir market is expected to grow significantly, driven by its efficacy and expanding clinical uses.
• Government and NGO initiatives are crucial in increasing access to these medications in low- and middle-income countries.
• Continuous research and innovation are key to addressing safety concerns and improving treatment outcomes.
• The competitive landscape is highly dynamic, with several major players competing for market share.
• Financial projections indicate a robust growth trajectory for the market.

FAQs

Q: What is the projected market size of dolutegravir by 2031? A: The global dolutegravir market is expected to reach USD 9.99 billion by 2031[1].

Q: What are the main drivers of the dolutegravir market? A: The main drivers include its efficacy, increasing HIV diagnoses, government and NGO initiatives, and ongoing research into new formulations[1].

Q: What are the potential safety concerns associated with dolutegravir and lamivudine? A: Potential safety concerns include post-treatment exacerbations of hepatitis B, embryo-fetal toxicity, and renal impairment[2].

Q: Which companies are major players in the dolutegravir market? A: Key players include ViiV Healthcare (GSK), Shanghai Desano Pharmaceuticals, Mylan, Aurobindo Pharma, LAURUS Labs, and Adcock Ingram Limited[1].

Q: How is the transition to dolutegravir-based ART in low- and middle-income countries being facilitated? A: The transition is being facilitated through programs like the Global HIV Programme, which addresses best practices, challenges, and future priorities for HIV programs[5].

Cited Sources:

1. Market Research Intellect: "Dolutegravir Market Size, Trends and Projections"
2. FDA: "DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR ALAFENAMIDE"
3. GHSC: "Fiscal Year 2024 Quarterly Report | Quarter 2 January 1, 2024 to March 31, 2024"
4. Oxford Academic: "Efficacy of Lamivudine Plus Dolutegravir vs Dolutegravir-Based 3-Drug Regimens"
5. WHO: "Update on the transition to dolutegravir-based antiretroviral therapy"