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TRIUMEQ PD Drug Patent Profile

When do Triumeq Pd patents expire, and when can generic versions of Triumeq Pd launch?

Triumeq Pd is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-five patent family members in thirty-five countries.

The generic ingredient in TRIUMEQ PD is abacavir sulfate; dolutegravir sodium; lamivudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; dolutegravir sodium; lamivudine profile page.

DrugPatentWatch^® Generic Entry Outlook for Triumeq Pd

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 8, 2030. This may change due to patent challenges or generic licensing.

There have been twenty-four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRIUMEQ PD

International Patents:	155
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	19
Drug Prices:	Drug price information for TRIUMEQ PD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIUMEQ PD
DailyMed Link:	TRIUMEQ PD at DailyMed

See drug prices for TRIUMEQ PD

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRIUMEQ PD

Constraining patent/regulatory exclusivity:

9,242,986*PED

NDA:

215413

Dosage:

TABLET, FOR SUSPENSION;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.

Recent Clinical Trials for TRIUMEQ PD

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

Sponsor	Phase
Stichting TRICALS Foundation	Phase 3
King's College London	Phase 3
Macquarie University, Australia	Phase 3

See all TRIUMEQ PD clinical trials

Paragraph IV (Patent) Challenges for TRIUMEQ PD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIUMEQ PD	Tablets for Oral Suspension	abacavir sulfate; dolutegravir sodium; lamivudine	60 mg/5 mg/30 mg	215413	1	2023-03-31

US Patents and Regulatory Information for TRIUMEQ PD

TRIUMEQ PD is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,242,986.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes

International Patents for TRIUMEQ PD

When does loss-of-exclusivity occur for TRIUMEQ PD?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

Russian Federation

Singapore

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRIUMEQ PD around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	12007502373	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Japan	5086478
China	101346376	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Slovenia	3187225
Lithuania	C2465580

Supplementary Protection Certificates for TRIUMEQ PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
1874117	C01874117/01	Switzerland		PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
1874117	C20140020 00130	Estonia		PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014

TRIUMEQ PD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Triumeq

Introduction to Triumeq

Triumeq is a fixed-dose combination medication used in the treatment of HIV-1 infection, comprising the active ingredients abacavir, dolutegravir, and lamivudine. This medication has been a significant player in the antiretroviral therapy market, but its dynamics are influenced by various factors.

Global Triumeq Market Size and Forecast

The Triumeq market was valued at USD 34.10 billion in 2023 and is projected to reach USD 66.16 billion by 2031, growing at a CAGR of 6.21% during the forecast period of 2024-2031[1].

Market Drivers

Several factors drive the demand for Triumeq and similar antiretroviral therapies:

Innovations in Drug Formulation and Delivery Systems

Innovations that enhance the effectiveness and tolerability of treatments can expand the market. New formulations and delivery systems can make treatments more appealing to patients and physicians[1].

Generic Competition

The introduction of generic versions of Triumeq or its components can impact pricing and market dynamics, leading to increased access and patient switching. As patents expire, generic versions can enter the market at lower prices, affecting the sales of branded Triumeq[1].

Regional Market Dynamics

Demand for HIV treatments varies by region due to factors such as healthcare infrastructure, insurance coverage, and cultural attitudes toward HIV treatment. Regions like North America and Europe have advanced healthcare systems and high treatment adoption rates, while Asia-Pacific is experiencing rapid growth due to improving healthcare systems and increasing awareness[1].

Side Effect Profiles and Patient Preferences

Favorable side effect profiles compared to other treatments can drive patient and physician preference for Triumeq, influencing prescribing patterns. The medication's safety and efficacy profile is a crucial factor in its market success[1].

Public Health Initiatives

Efforts to reduce stigma surrounding HIV/AIDS and promote treatment as prevention (TasP) can increase the utilization of antiretroviral therapies like Triumeq. Public health initiatives play a significant role in expanding the market[1].

Challenges and Constraints

Regulatory Challenges

Changes in regulations or approval processes in different countries can affect the availability and marketing of Triumeq. The pharmaceutical industry is heavily regulated, and these changes can impact the market significantly[1].

Pricing Pressure

Increasing pressure from health authorities and insurers to reduce drug prices can impact profit margins for pharmaceutical companies. This pressure can lead to reduced revenue for Triumeq[1].

Market Access Issues

Differences in healthcare systems, reimbursement policies, and access to medications in various regions can limit the market for Triumeq. These issues can restrict the medication's reach in certain areas[1].

Evolving Treatment Guidelines

Changes in clinical guidelines and the development of new, more effective, or safer therapies could lead to decreased demand for Triumeq. The emergence of new treatments can shift market preferences[1].

Adverse Side Effects and Safety Concerns

New safety concerns or adverse effects could affect patient and physician preferences, leading to reduced use of Triumeq. Safety is a critical factor in the long-term success of any medication[1].

Global Triumeq Market Segmentation Analysis

The global Triumeq market is segmented based on demographics, type, indication, and geography.

Geographical Segmentation

The market is primarily categorized by geography, with key regions including North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. Each region exhibits distinct trends and dynamics influenced by local healthcare policies, patient demographics, and socio-economic factors[1].

Key Players in the Triumeq Market

Major players in the Triumeq market include:

• ViiV Healthcare
• Gilead Sciences
• Bristol-Myers Squibb
• Merck & Co.
• Johnson & Johnson
• AbbVie
• Mylan[1].

Cost and Affordability of Triumeq

Retail Cost

As of November 2024, the average retail cost of Triumeq is approximately $4,292 per month. This cost varies significantly due to factors such as prescribed dosage, patient location, pharmacy location, and health insurance plan[2].

Patient Assistance Programs

Organizations like The Rx Advocates offer patient assistance programs to make Triumeq more affordable. For example, The Rx Advocates provides a fixed monthly cost of $80 for Triumeq, significantly reducing the financial burden on patients[2].

Impact of Generic and Alternative Therapies

Generic Competition

The introduction of generic versions of Triumeq components can significantly impact the market. Generic competition often leads to lower prices, increasing access but reducing the sales of branded medications[1].

Alternative Therapies

The rise of alternative therapies, such as Biktarvy, has been seen in the decline of various HIV-1 therapies including Triumeq. Biktarvy, approved in 2018, has captured a significant market share, particularly in the US, and is expected to continue growing[4].

Public Health and Access Initiatives

Enhancing Access

Initiatives aimed at enhancing access to HIV treatments, such as the tentative approval of pediatric regimens, support the goal of improved adherence to HIV treatment for children. These efforts align with sustainability goals to provide antiretroviral therapy to millions of patients, including children living with HIV/AIDS[5].

Financial Trajectory

The financial trajectory of Triumeq is influenced by its market size, growth rate, and the various challenges and opportunities it faces.

Revenue Growth

Despite the challenges, Triumeq is expected to continue growing, with a projected market size of USD 66.16 billion by 2031. This growth is driven by increasing demand, public health initiatives, and the medication's established presence in the market[1].

Competitive Landscape

The competitive landscape, including the emergence of new therapies and generic competition, will continue to shape the financial trajectory of Triumeq. The ability of pharmaceutical companies to adapt to these changes will be crucial in maintaining market share[1][4].

Key Takeaways

• Market Growth: Triumeq's market is projected to grow at a CAGR of 6.21% from 2024 to 2031.
• Regional Dynamics: The market is influenced by regional healthcare policies, patient demographics, and socio-economic factors.
• Generic and Alternative Therapies: The introduction of generics and alternative therapies like Biktarvy impacts Triumeq's market share.
• Cost and Affordability: Patient assistance programs and generic competition can make Triumeq more affordable.
• Public Health Initiatives: Efforts to enhance access to HIV treatments support the long-term market growth of Triumeq.

Frequently Asked Questions (FAQs)

1. What is Triumeq used for?

Triumeq is a fixed-dose combination medication used in the treatment of HIV-1 infection, consisting of the active ingredients abacavir, dolutegravir, and lamivudine.

2. How much does Triumeq cost?

The average retail cost of Triumeq is approximately $4,292 per month, but this can vary based on several factors including dosage, location, and insurance coverage. Patient assistance programs can reduce this cost significantly[2].

3. What are the key drivers of the Triumeq market?

Key drivers include innovations in drug formulation, generic competition, regional market dynamics, favorable side effect profiles, and public health initiatives[1].

4. How does generic competition affect Triumeq?

Generic competition can significantly impact the sales of Triumeq by offering lower-priced alternatives, increasing access but reducing the market share of branded Triumeq[1].

5. What are the challenges facing the Triumeq market?

Challenges include regulatory changes, pricing pressure, market access issues, evolving treatment guidelines, and adverse side effects or safety concerns[1].

Sources:

1. Verified Market Research - Triumeq Market Size, Share, Scope, Trends, Growth and Analysis
2. The Rx Advocates - Triumeq Coupon & Patient Assistance Programs
3. GSK Investor Presentation - Attractive market dynamics
4. DelveInsight - Changing Dynamics of HIV-1 Treatment Market
5. Viatris - U.S. FDA Tentative Approval of a Paediatric Regimen