DOVATO Drug Patent Profile

Which patents cover Dovato, 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 three hundred and one 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:	301
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	9
Patent Applications:	263
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
Johns Hopkins University	PHASE3
ViiV Healthcare	PHASE3
Saskatchewan Health Authority - Regina Area	PHASE4

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
Denmark	2531027
Lithuania	3127542
Cyprus	1126771
Luxembourg	C00090
Denmark	3187225
Serbia	65183

Supplementary Protection Certificates for DOVATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	132021000000098	Italy		PRODUCT NAME: CABOTEGRAVIR(VOCABRIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1481, 20201221
2465580	CA 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
2932970	CA 2018 00036	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE 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
2932970	300957	Netherlands		PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS DOLUTEGRAVIR NATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS RILPIVIRINE HYDROCHLORIDE); REGISTRATION NO/DATE: EU/1/18/1282 20180518
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
2465580	2190020-4	Sweden		PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221

Market Dynamics and Financial Trajectory for DOVATO

Last updated: November 17, 2025

Introduction

DOVATO (dolutegravir and lamivudine) represents a significant advancement in HIV treatment, offering a once-daily, two-drug regimen designed to simplify therapy and improve patient adherence. Since its FDA approval in 2019, DOVATO has garnered considerable attention within the pharmaceutical landscape—both for its clinical efficacy and its potential to reshape HIV management. This report provides an in-depth analysis of the market dynamics and financial trajectory of DOVATO, illuminating the factors influencing its growth, competitive positioning, revenue prospects, and challenges.

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Market Overview and Clinical Positioning

DOVATO is an integrase strand transfer inhibitor (INSTI)-based single-tablet regimen indicated for HIV-1 infection. Traditional therapies often involve multi-pill combinations with associated complexities and side effects. DOVATO's simplified two-drug approach positions it as an attractive option for initial and maintenance therapy, especially for patients seeking treatments with fewer side effects and lower pill burdens.

The global HIV treatment market was valued at approximately USD 20 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of nearly 6% through 2030 [1]. DOVATO’s role, as the first two-drug regimen with a high barrier to resistance, aligns with the trend towards 'biomarker-driven,' personalized, and simplified HIV therapies.

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Market Dynamics Influencing DOVATO's Growth

1. Competitive Landscape

DOVATO competes directly with other integrase inhibitors and fixed-dose combination therapies. Notable competitors include Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide), and Dolutegravir-based regimens like TRUCCAO (dolutegravir, abacavir, lamivudine).

In recent years, the market has seen rapid adoption of multi-drug regimens with proven durability and fewer side effects. However, DOVATO's favorable safety profile, absence of tenofovir, and simplified regimen make it a compelling choice, especially for treatment-naïve patients and those seeking reduced pill burden [2].

2. Clinical Efficacy and Safety Profile

Clinical trials, including the GEMINI studies, demonstrated DOVATO's non-inferiority to three-drug regimens in viral suppression, with fewer adverse events related to renal and bone toxicity. Such data underpin its expanding prescription and help maintain market demand [3].

3. Patent Life and Generic Competition

DOVATO's patent protection until at least 2031 restricts generic competition, enabling Novartis to maintain premium pricing. However, as patent expiry approaches, generic options could erode revenue margins, especially in low- and middle-income countries where pricing pressures are intense [4].

4. Market Penetration and Adoption

Initial adoption focused on early HIV diagnosis and the treatment-naïve population. Over time, clinical guidelines from bodies like the WHO and CDC increasingly endorse DOVATO, further accelerating adoption. Its flexibility for both initial and switch therapy also supports broader penetration.

5. Pricing Strategies and Reimbursement Policies

Pricing remains a crucial factor. DOVATO is priced at a premium compared to generic options, which could hinder uptake in cost-sensitive markets but benefits from pharmaceutical partnerships and substantial reimbursement coverage in developed nations. Novartis actively negotiates with healthcare payers to secure favorable formulary positions.

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Financial Trajectory and Revenue Outlook

1. Revenue Projections

Since launch, DOVATO has demonstrated strong sales momentum. In Q2 2022, Novartis disclosed that DOVATO achieved approximately USD 800 million in annualized sales, a marked increase from initial launch figures [5]. Growth is driven by uptake in developed markets like the U.S., EU, and Japan.

Analysts forecast that DOVATO could reach USD 1.5–2 billion in annual sales by 2025, assuming continued market penetration and favorable pricing, supported by its clinical advantages and guideline endorsements [6].

2. Market Expansion Potential

Key opportunities lie in expanding into lower-income countries, where government procurement and global health initiatives could facilitate access. Novartis continues to negotiate tiered pricing models to enhance affordability and increase market share.

3. Impact of Patent and Competition

Patent protections provide revenue predictability until at least 2031. Post-patent expiry, generic competition may substantially reduce DOVATO’s market share unless Novartis can sustain differentiation through clinical outcomes and payer contracts.

4. Pricing and Reimbursement Landscape

Premium pricing strategies have reinforced initial revenues but may face scrutiny as biosimilars emerge or in markets with cost containment policies. The potential for differential pricing and patient assistance programs remains vital to sustain growth.

5. R&D and Pipeline Effects

Continued clinical development around DOVATO, including exploring its use in special populations, may further complement its revenue trajectory. Extension of its indications or formulation improvements can also contribute to sustained demand.

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Regulatory Considerations and Market Risks

Regulatory Approvals and Expansions

Further approvals in pediatric populations or for pre-exposure prophylaxis (PrEP) could unlock new revenue streams. Regulatory success relies on robust clinical data and adherence to global standards.

Supply Chain and Manufacturing

Ensuring reliable supply chains is critical. Disruptions, as experienced during global crises, could impact sales and revenue.

Pricing Pressures & Policy Changes

Healthcare policy shifts favoring generics and cost containment could threaten premium pricing for DOVATO, influencing long-term financial performance.

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Conclusion

DOVATO’s market dynamics are shaped by its innovative clinical profile, competitive landscape, patent protections, and strategic positioning within HIV treatment paradigms. The drug is poised for steady growth in the near term, with sales likely to reach USD 1.5–2 billion annually by 2025 in key markets. Long-term prospects hinge on patent expiry, competitive pressures, and expanding access in emerging markets. Novartis's ability to maintain clinical efficacy, optimize pricing, and navigate evolving regulatory environments will be central to DOVATO’s financial trajectory.

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Key Takeaways

• Strong Growth Prospects: DOVATO's initial market success and clinical advantages position it for continued revenue growth, targeting USD 1.5–2 billion annually by 2025.

• Competitive Differentiation: Its simplified two-drug regimen, safety profile, and guideline endorsements serve as key differentiators against multi-drug regimens.

• Patent and Market Risks: Patent protection until at least 2031 shields revenues; imminent generic competition post-expiry could disrupt long-term sales.

• Market Expansion Opportunities: Strategic efforts in emerging markets, coupled with tiered pricing and global health programs, can expand access and revenues.

• Regulatory and Policy Environment: Staying aligned with evolving healthcare policies and expanding indications will be critical to sustaining growth.

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FAQs

1. What distinguishes DOVATO from other HIV therapies?
DOVATO offers a simplified, two-drug regimen with a high barrier to resistance, fewer side effects, and is approved for both initial and maintenance HIV treatment, distinguishing it from multi-drug traditional therapies.

2. How does patent protection impact DOVATO's revenue potential?
Patent protections safeguard DOVATO’s exclusivity until at least 2031, enabling premium pricing, but expiry could lead to increased generic competition and revenue decline.

3. What markets present the greatest growth opportunities for DOVATO?
Developed markets like the U.S. and EU are current leaders, but emerging markets in Africa, Asia, and Latin America offer significant growth potential through tiered pricing and global health initiatives.

4. How might future clinical data influence DOVATO’s market position?
Positive data expanding indications or demonstrating superior long-term safety and efficacy could reinforce prescribing trends, while any adverse findings could challenge its standing.

5. What are the key risks to DOVATO’s financial trajectory?
Patent expiration, intense competition, policy shifts towards generics, and market access issues pose primary risks that could dampen future revenue streams.

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References

[1] Grand View Research. HIV Therapeutics Market Size, Share & Trends Analysis. 2022.
[2] CDC Guidelines for HIV Treatment. 2021.
[3] Sax PE, et al. "GEMINI Study: Efficacy and Safety of Dolutegravir plus Lamivudine." New England Journal of Medicine, 2019.
[4] Novartis Annual Report 2022.
[5] Novartis Q2 2022 Financial Results.
[6] MarketWatch. HIV Drugs Market Forecast. 2023.