DOVATO Drug Patent Profile

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

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

This drug has two hundred and ninety-three patent family members in forty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Dovato

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. 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 DOVATO

International Patents:	293
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	7
Patent Applications:	108
Drug Prices:	Drug price information for DOVATO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOVATO
What excipients (inactive ingredients) are in DOVATO?	DOVATO excipients list
DailyMed Link:	DOVATO at DailyMed

See drug prices for DOVATO

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

Constraining patent/regulatory exclusivity:

11,234,985

NDA:

211994

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.

Recent Clinical Trials for DOVATO

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

Sponsor	Phase
ViiV Healthcare	Phase 1
Saint Michael's Medical Center	Phase 4
Societa' Italiana Di Malattie Infettive E Tropicali	Phase 3

See all DOVATO clinical trials

Pharmacology for DOVATO

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

Paragraph IV (Patent) Challenges for DOVATO

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 DOVATO

DOVATO is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,234,985.

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	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
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	9,242,986*PED				Y

International Patents for DOVATO

When does loss-of-exclusivity occur for DOVATO?

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

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

Ukraine

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 DOVATO around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	200803423	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Portugal	3284520
Australia	2011209788	Antiviral therapy
South Korea	20110094336	SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES

Supplementary Protection Certificates for DOVATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	CA 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
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	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

Market Dynamics and Financial Trajectory for DOVATO

Last updated: July 3, 2025

Introduction

In the competitive landscape of HIV treatments, DOVATO—a fixed-dose combination of dolutegravir and lamivudine—stands out as a streamlined option for adults with HIV-1. Developed by ViiV Healthcare, a subsidiary of GSK, DOVATO simplifies regimens while maintaining efficacy, appealing to both patients and healthcare providers. This analysis delves into its market dynamics and financial trajectory, offering insights for business professionals navigating pharmaceutical investments. As HIV treatment demands evolve, understanding DOVATO's position could influence strategic decisions in a market valued at over $25 billion globally.

Overview of DOVATO

DOVATO entered the market in 2019, approved by the FDA as a once-daily, two-drug regimen for HIV-1 treatment in adults with no antiretroviral treatment history and no known resistance mutations. Its formulation combines dolutegravir, an integrase strand transfer inhibitor, with lamivudine, a nucleoside reverse transcriptase inhibitor, reducing pill burden and potential side effects compared to traditional three-drug cocktails.

This drug's appeal lies in its efficacy rates, demonstrated in clinical trials like the GEMINI studies, which showed non-inferiority to three-drug regimens. ViiV Healthcare positions DOVATO as a cost-effective alternative, targeting markets where adherence and accessibility drive demand. With HIV prevalence rising in regions like sub-Saharan Africa and increasing in urban centers worldwide, DOVATO addresses a critical need for simplified therapies.

Current Market Dynamics

The HIV treatment market remains robust, with DOVATO navigating a landscape shaped by regulatory approvals, competitive pressures, and shifting patient demographics. Global HIV drug sales reached approximately $28 billion in 2023, according to IQVIA data, with fixed-dose combinations like DOVATO capturing a growing share due to their convenience.

Regulatory Environment and Approvals

Regulatory bodies play a pivotal role in DOVATO's expansion. The FDA and EMA approvals in 2019 paved the way for its launch in major markets, including the U.S. and Europe. More recently, in 2022, DOVATO gained approval in several emerging economies, such as Brazil and South Africa, through partnerships with generic manufacturers under voluntary licensing agreements. These moves enhance accessibility but introduce pricing pressures, as governments negotiate lower costs for public health programs.

Competition intensifies from rivals like Gilead Sciences' Biktarvy, a three-drug regimen dominating with over 50% market share in the U.S. as of 2023. DOVATO differentiates itself through its two-drug approach, potentially reducing long-term toxicity risks, but faces challenges from biosimilars and generics entering the space post-patent expiration. ViiV's patent on DOVATO's combination extends to 2030 in key markets, providing a window for market consolidation.

Demand Drivers and Patient Access

Patient demand for DOVATO surges in regions with high HIV incidence, driven by factors like treatment adherence and side effect profiles. In the U.S., where over 1.2 million people live with HIV, DOVATO's uptake has grown due to insurance coverage and telemedicine integration. Globally, UNAIDS reports indicate that simplified regimens could improve adherence rates by up to 20%, boosting DOVATO's appeal in low- and middle-income countries.

Supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily hindered distribution in 2021-2022, but ViiV mitigated this through diversified manufacturing. Pricing strategies also influence dynamics: DOVATO's list price in the U.S. hovers around $2,500 per month, yet discounts and rebates bring it closer to competitors, fostering broader adoption.

Financial Trajectory of DOVATO

DOVATO's financial performance reflects ViiV Healthcare's strategic focus on HIV innovation, with revenues climbing amid market growth. Since its launch, the drug has generated steady sales, contributing to ViiV's overall portfolio, which exceeded $7 billion in 2023 revenues.

Revenue Trends and Growth

In 2023, DOVATO's global sales reached approximately $1.8 billion, up 15% from 2022, driven by expanded indications and geographic reach. ViiV's Q3 2023 earnings report highlighted DOVATO as a key growth driver, with U.S. sales alone surging 25% year-over-year. This trajectory stems from increased prescriptions in primary care settings and favorable formulary placements.

Comparatively, DOVATO's revenue growth outpaces some competitors; for instance, while Biktarvy posted $11 billion in sales, its growth rate slowed to 8% in 2023 due to market saturation. DOVATO benefits from ViiV's R&D investments, totaling $1.2 billion in 2023, which fund ongoing studies to expand its use in treatment-naive patients and potentially in pediatric populations.

Profitability and Cost Factors

Profit margins for DOVATO remain strong, with ViiV reporting gross margins above 80% in recent filings. Manufacturing efficiencies and economies of scale contribute to this, as does the drug's simplified production process. However, costs associated with clinical trials and marketing, estimated at $500 million annually for ViiV's HIV portfolio, temper net profits.

Financial risks include patent challenges; a 2024 legal dispute in Europe over dolutegravir patents could erode exclusivity. Despite this, analysts from Evaluate Pharma forecast DOVATO's revenues to hit $2.5 billion by 2026, assuming no major setbacks.

Investment and Forecasting

Investors view DOVATO as a high-potential asset within GSK's broader pipeline. GSK's stock price rose 12% in 2023, partly attributed to ViiV's performance. Forward-looking forecasts from Statista project the HIV market to grow at a 5% CAGR through 2030, positioning DOVATO for sustained gains. Strategic partnerships, such as ViiV's collaboration with Pfizer for distribution in emerging markets, further bolster its financial outlook.

Challenges and Future Outlook

DOVATO faces headwinds from evolving market conditions, including generic competition and shifting healthcare policies. By 2030, patent expirations could introduce biosimilars, potentially halving prices in developed markets. Yet, opportunities abound: Ongoing trials, like the TANGO study extension, explore DOVATO's role in maintenance therapy, which could unlock new revenue streams.

Global health initiatives, such as the WHO's 95-95-95 targets for HIV control, align with DOVATO's profile, potentially increasing demand in underserved areas. Financially, ViiV plans to invest $800 million in HIV R&D by 2025, focusing on long-acting formulations that could differentiate DOVATO further.

Key Takeaways

• DOVATO's market position strengthens through its efficient two-drug regimen, driving sales growth amid rising HIV treatment demands.
• Revenue projections indicate sustained expansion, with potential risks from patent expirations and competition.
• Business professionals should monitor regulatory developments and partnerships to gauge investment opportunities in HIV therapeutics.
• The drug's financial trajectory underscores the value of innovation in pharmaceuticals, balancing profitability with accessibility.
• Strategic decisions in this space require attention to global market dynamics, including pricing pressures and patient access improvements.

FAQs

1. What makes DOVATO different from other HIV treatments?
   DOVATO stands out as a two-drug combination, reducing complexity and side effects compared to standard three-drug regimens, which can improve patient adherence and long-term outcomes.

2. How has DOVATO's sales performance evolved since launch?
   Since 2019, DOVATO's global sales have grown from under $500 million to approximately $1.8 billion in 2023, fueled by expanded approvals and increased prescriptions in key markets.

3. What factors could impact DOVATO's future revenue?
   Patent expirations around 2030 and potential generic entries pose risks, while ongoing clinical trials and partnerships may drive growth through new indications and market access.

4. Is DOVATO accessible in low-income countries?
   Yes, through voluntary licensing agreements, DOVATO is available at reduced prices in many low- and middle-income countries, supporting global HIV control efforts.

5. How does DOVATO fit into ViiV Healthcare's overall strategy?
   DOVATO serves as a cornerstone of ViiV's HIV portfolio, emphasizing simplified therapies to capture market share and sustain revenue growth amid competitive pressures.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Outlook." IQVIA, 2023.
2. UNAIDS. "Global HIV Statistics 2023." UNAIDS, 2023.
3. ViiV Healthcare. "Q3 2023 Earnings Report." ViiV Healthcare, 2023.
4. Evaluate Pharma. "World Preview 2024, Outlook to 2030." Evaluate, 2024.
5. Statista. "HIV Drugs Market Size and Forecast." Statista, 2023.