TIVICAY Drug Patent Profile

When do Tivicay patents expire, and what generic alternatives are available?

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

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

The generic ingredient in TIVICAY is dolutegravir sodium. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Tivicay

Tivicay was eligible for patent challenges on August 12, 2017.

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.

There are eight tentative approvals for the generic drug (dolutegravir sodium), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TIVICAY

International Patents:	157
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	32
Patent Applications:	2,411
Drug Prices:	Drug price information for TIVICAY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIVICAY
What excipients (inactive ingredients) are in TIVICAY?	TIVICAY excipients list
DailyMed Link:	TIVICAY at DailyMed

See drug prices for TIVICAY

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

NDA:

204790

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 TIVICAY

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

Sponsor	Phase
Humanis Saglık Anonim Sirketi	PHASE1
Chelsea and Westminster NHS Foundation Trust	Phase 1
Chelsea and Westminster NHS Foundation Trust	Phase 3

See all TIVICAY clinical trials

Pharmacology for TIVICAY

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for TIVICAY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIVICAY	Tablets	dolutegravir sodium	10 mg, 25 mg and 50 mg	204790	4	2017-08-14

US Patents and Regulatory Information for TIVICAY

TIVICAY is protected by two US patents.

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	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No					Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		DISCN	Yes	No					Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No					Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		DISCN	Yes	No					Y

International Patents for TIVICAY

When does loss-of-exclusivity occur for TIVICAY?

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 TIVICAY around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0610030	composto, processo para a preparação de um composto, método de tratamento de uma infecção por hiv em um humano, uso de um composto, e, composição farmacêutica
South Korea	101848819
European Patent Office	1852434	DÉRIVÉ DE CARBAMOYLPYRIDONE BICYCLIQUE AYANT UNE ACTIVITÉ D'INHIBITION DE LA VIH INTÉGRASE (BICYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITING ACTIVITY)
European Patent Office	3284520	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Singapore	171308	SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
South Korea	20130133061	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY

Supplementary Protection Certificates for TIVICAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2465580	PA2021512	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
3494972	LUC00346	Luxembourg		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
2465580	21C1023	France		PRODUCT NAME: CABOTEGRAVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1481 20201221; FIRST REGISTRATION: - EU/1/20/1481 20201221
1874117	517	Finland
3494972	C202430022	Spain		PRODUCT NAME: DOLUTEGRAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE, INCLUIDO DOLUTEGRAVIR SODICO Y LAMIVUDINA; NATIONAL AUTHORISATION NUMBER: EU/1/19/1370; DATE OF AUTHORISATION: 20190701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1370; DATE OF FIRST AUTHORISATION IN EEA: 20190701

Market Dynamics and Financial Trajectory for TIVICAY (Dolutegravir)

Last updated: December 22, 2025

Executive Summary

TIVICAY (dolutegravir), developed by Gilead Sciences and later marketed by ViiV Healthcare, has become a cornerstone in antiretroviral therapy (ART) regimens for human immunodeficiency virus (HIV) treatment. With its favorable efficacy, tolerability, and resistance barrier profile, TIVICAY has experienced rapid market adoption, transforming the landscape of HIV management globally. The drug's market dynamics are driven by evolving treatment guidelines, geopolitical factors, and competitive landscape, which collectively influence its revenue trajectory. Forecasts anticipate sustained growth, underpinned by expanding indications, emerging combination products, and increasing global HIV prevalence.

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1. Introduction

TIVICAY (dolutegravir) is an integrase strand transfer inhibitor (INSTI) approved in 2013 for HIV-1 infection treatment. Its higher genetic barrier to resistance compared to earlier INSTIs like raltegravir (RAL) and elvitegravir (EVG) fostered rapid adoption among clinicians. This analysis explores the market dynamics, revenue forecasts, competitive environment, and factors that influence TIVICAY's financial trajectory.

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2. Market Overview

Parameter	Details
Indications	HIV-1 infection (adults and children), broadly used in combination therapy
First Approval Date	2013
Regulatory Approvals	US, Europe, Japan, other markets (as of 2023)
Patient Population (Global)	Approx. 38 million individuals living with HIV globally (UNAIDS, 2022)
Market Value (2022)	Estimated US$ 11 billion for INSTI class globally (GlobalData, 2022)

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3. Key Market Drivers

3.1. Clinical Efficacy and Resistance Profile

• Fixed-dose combination (FDC) products incorporating TIVICAY demonstrate high efficacy.
• Superior resistance barrier; resistance development is less likely compared to earlier INSTIs.
• Data from phase III trials (e.g., SINGLE, FLAMINGO) confirm non-inferiority and tolerability.

3.2. Treatment Guidelines and Policy Shifts

• WHO recommends dolutegravir-based regimens as first-line therapy globally, including in resource-limited settings.
• US Department of Health and Human Services (DHHS) guidelines also favor dolutegravir-based regimens for initial therapy.

3.3. Expanding Indications and Formulations

• Pediatric formulations (e.g., for children aged 4 weeks and older, weight-based dosing).
• Fixed-dose combinations with abacavir, lamivudine, and rilpivirine.
• Research into long-acting injectables (e.g., on the horizon but not labeled for TIVICAY).

3.4. Geographic Expansion

• High adoption in Sub-Saharan Africa, driven by WHO guidelines.
• Growing use in Asia-Pacific and Latin America.

3.5. Competitive Position

• Market leader among INSTIs owing to efficacy, tolerability, simplicity.
• Competition from Biktarvy (Gilead), Juluca (ViiV), and emerging generics.

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4. Market Challenges and Limitations

Challenge	Impact
Patent Expirations	Possible entry of generics in key markets post-2029
Pricing and Affordability	Constraints in low-income regions
Emerging Resistance in Limited Settings	Potential threat in areas with poor adherence
Market Saturation in Developed Markets	Slowing growth post-peak adoption

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5. Financial Trajectory and Revenue Forecast

5.1. Historical Sales Data

Year	Global Sales (USD billions)	Growth Rate
2018	$4.2	+30% (from 2017)
2019	$6.0	+43%
2020	$8.2	+37%
2021	$9.3	+13%
2022	$11.0	+18%

Note: Breakdowns of sales by regions (North America, Europe, Asia, Africa) show varied growth rates and market penetration levels.

5.2. Future Revenue Projections (2023-2030)

Year	Projected Global Sales (USD billions)	Drivers and Assumptions
2023	$12.3	Continued adoption, increased baseline in Africa & Asia
2024	$13.1	Expansion of generics elsewhere, new formulations
2025	$14.5	Launch of long-acting injectables (phase III trials ongoing)
2026	$15.8	Increase in age-specific indications, generic penetration
2027-2030	$17.0 - $20.0	Post-patent expiry impact, sustained growth in emerging markets

Note: The CAGR from 2023-2030 is estimated around 8-10%, factoring in patent expiries, pipeline innovations, and global health initiatives.

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6. Competitive Landscape Summary

Product	Type	Market Share (2022)	Key Attributes
TIVICAY (Dolutegravir)	INSTI (integrase inhibitor)	~55%	High efficacy, resistance barrier, widespread adoption
Biktarvy (Gilead)	Fixed-dose combo (TIVICAY+FTC+TAF)	~25%	Highly prescribed, included in most first-line regimens
Juluca (ViiV)	Dual therapy (Dolutegravir + Rilpivirine)	~8%	Long-acting injectable in development
Other INSTIs (Raltegravir, Elvitegravir)	Various	~12%	Older generation, lower resistance barrier

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7. Regulatory and Policy Factors Impacting Market

Policy/Regulation	Impact	Key Dates/Notes
WHO 2016 HTD Guidelines	Advocated for dolutegravir as preferred first-line agent	2016
US and Europe Treatment Guidelines (2022)	Support for dolutegravir-based regimens	2022 updates
Patent Expirations in Major Markets (US, EU)	Potential generic entry post-2029	Patent expiry estimates vary (see section 8)
WHO Licenses for Generics in LMICs	Increased accessibility in low-income nations	Since 2018

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8. Patent Status and Impact on Market Entry

Region	Patent Expiry Year	Implications
US	2029 (expected)	Potential generic competition post-2029
EU	2030	Similar timeline to US
Japan	2028	Limited impact due to earlier generics
Developing Countries (via licensing)	Variable; licenses enforce generics since 2018	Increased penetration in Africa & Asia

Patent strategies and patent term extensions can influence timeline variations.

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9. Comparative Analysis: TIVICAY vs. Key Competitors

Criteria	TIVICAY (Dolutegravir)	Biktarvy (Gilead)	Raltegravir (Isentress)	Elvitegravir (Vitekta)
Market Penetration (2022)	~55%	~25%	~10%	~10%
Resistance Barrier	High	High	Moderate	Moderate
Dosing Convenience	Once daily	Once daily	Twice daily	Once daily
Formulation Flexibility	Multiple combo options	Multiple options	Limited	Limited
Pricing Pressure (generics)	Post-2029 (anticipated)	Post-2029 (anticipated)	Already generic	Already generic

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10. Future Opportunities & Pipeline Developments

Innovation	Status	Expected Impact
Long-acting injectables	Phase III (e.g., GSK, ViiV)	Enhanced adherence, expanded patient options
Pediatric formulations	Approved in some markets	Broadened patient base, continued market expansion
Combination Products	Expanded approvals	Simplify regimens, improve adherence
Global Access Programs	Increased licensing, subsidies	Drive adoption in LMICs

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Key Takeaways

• Market Leadership: TIVICAY maintains a dominant position among INSTIs due to its high efficacy and resistance barrier, supported by robust international treatment guidelines.

• Growth Potential: Forecasted to grow at a CAGR of approximately 8-10% until 2030, fueled by expanding indications, emerging combination therapies, and increasing global HIV prevalence.

• Patent and Generic Dynamics: Patent expiry around 2029-2030 in major markets predicates potential generic competition, which may significantly impact revenues; prior to expiry, market share is expected to plateau or slow in developed markets.

• Emerging Trends: Development of long-acting injectable formulations and pediatric variants offers new revenue streams and increased patient adherence.

• Challenges: Pricing constraints, resistance emergence in poorly managed settings, and geopolitical factors could dampen growth prospects in certain regions.

• Competitive Advantage: Continual investments in pipeline innovations and access programs position TIVICAY favorably for sustained market penetration.

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FAQs

Q1: What factors have contributed most to TIVICAY’s rapid market growth?
A: Its superior resistance barrier, high efficacy, favorable tolerability, and inclusion in international treatment guidelines have driven adoption; additionally, the availability of fixed-dose combinations has simplified HIV regimens.

Q2: When is generic competition expected to significantly impact TIVICAY sales?
A: Patent expiration in key markets is projected around 2029-2030, after which generic versions could enter and impact revenue streams.

Q3: How does TIVICAY compare to other INSTIs?
A: TIVICAY offers a higher genetic barrier to resistance and once-daily dosing, outperforming some older INSTIs like raltegravir and elvitegravir in terms of tolerability and adherence.

Q4: What are the upcoming pipeline developments for TIVICAY?
A: Long-acting injectable formulations, pediatric versions, and fixed-dose combinations are under development to broaden its therapeutic profile and improve patient adherence.

Q5: How do global health policies influence TIVICAY’s market?
A: WHO’s recommendation for dolutegravir as a first-line therapy and licensing agreements for generic supply in low-income countries significantly expand its access and use, particularly in resource-limited settings.

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References

1. UNAIDS. (2022). Global HIV & AIDS statistics.
2. GlobalData. (2022). HIV market analysis, 2022.
3. Gilead Sciences. (2013). TIVICAY (dolutegravir) prescribing information.
4. WHO. (2016). Consolidated guidelines on HIV/AIDS treatment and prevention.
5. US Department of Health and Human Services. (2022). HIV/AIDS Treatment Guidelines.
6. ViiV Healthcare. (2023). Pipeline and development updates.
7. Patent databases (USPTO, EPO). (2023). Patent expiry estimates.

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This article offers an in-depth exploration of TIVICAY’s market dynamics, providing decision-makers with critical insights into current trends, challenges, and future opportunities.