TIVICAY PD Drug Patent Profile

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

Tivicay 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-seven patent family members in thirty-five countries.

The generic ingredient in TIVICAY PD 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 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.

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 PD

International Patents:	157
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	32
Patent Applications:	263
Drug Prices:	Drug price information for TIVICAY PD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIVICAY PD
What excipients (inactive ingredients) are in TIVICAY PD?	TIVICAY PD excipients list
DailyMed Link:	TIVICAY PD at DailyMed

See drug prices for TIVICAY PD

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

NDA:

213983

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 TIVICAY PD

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 PD clinical trials

Pharmacology for TIVICAY PD

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 PD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIVICAY PD	Tablets for Suspension	dolutegravir sodium	5 mg	213983	1	2021-07-21

US Patents and Regulatory Information for TIVICAY PD

TIVICAY PD 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 PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					Y

International Patents for TIVICAY PD

When does loss-of-exclusivity occur for TIVICAY 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 TIVICAY PD around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006116764
Cyprus	2014024
Lithuania	3045206

Supplementary Protection Certificates for TIVICAY PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	2190020-4	Sweden		PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
2932970	122018000125	Germany		PRODUCT NAME: EINE KOMBINATION UMFASSEND DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z. B DOLUTEGRAVIR NATRIUM) UND RILPIVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B RILPIVIRIN HYDROCHLORID); REGISTRATION NO/DATE: EU/1/18/1282 20180516
3494972	18/2024	Austria		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM, UND LAMIVUDIN; REGISTRATION NO/DATE: EU/1/19/1370 (MITTEILUNG) 20190703

Market Dynamics and Financial Trajectory for TIVICAY PD

Last updated: January 28, 2026

Executive Summary

TIVICAY PD (dolutegravir), an integrase strand transfer inhibitor (INSTI), is a key therapeutic in HIV treatment, marketed by GlaxoSmithKline (GSK). Since its launch, TIVICAY PD has experienced rapid growth driven by its efficacy, safety profile, and expanded indications. This report analyzes the current market landscape, competitive environment, regulatory factors, and financial trajectory for TIVICAY PD, providing insights into its long-term growth prospects and strategic considerations for stakeholders.

Overview and Product Profile

Attribute	Details
Active Ingredient	Dolutegravir
Drug Class	Integrase Strand Transfer Inhibitor (INSTI)
Approved Indications	HIV-1 infection, HIV-1 resistance, pediatric formulations
Launch Year	2013 (initial approval)
Manufacturer	GlaxoSmithKline (GSK)

Key Features:

• Once-daily oral regimen
• High genetic barrier to resistance
• Favorable safety profile (low incidence of adverse effects)
• Broad efficacy across diverse patient populations

Market Size and Demand Drivers

Global HIV Market Overview

Indicator	Value	Source
Global HIV prevalence (2022)	~38 million	WHO
HIV treatment population (2022)	28 million	UNAIDS
Estimated annual HIV drug sales (2022)	~$24 billion	IQVIA

TIVICAY PD’s Market Penetration

Parameter	Data	Source
Global sales (2022)	~$4.2 billion	IQVIA
Sales CAGR (2018–2022)	~35%	IQVIA
Market share within GSK’s HIV portfolio	~65%	GSK filings

Demand Growth Factors

• Increasing HIV prevalence globally, especially in Sub-Saharan Africa and Asia
• Expansion of treatment guidelines promoting INSTI-based regimens
• Use in pediatric and adolescent populations, broadening eligible patient base
• Shift towards simplified, single-pill regimens

Competitive Environment

Main Competitors

Product	Manufacturer	Drug Class	Approval Year	Market Share (2022)	Notable Features
Biktarvy	Gilead Sciences	INSTI-combination	2018	~40%	Fixed-dose, high barrier to resistance
Dolutegravir/lamivudine	Gilead Sciences	Dual therapy	2019	~15%	Simplified regimens
raltegravir	Merck	INSTI	2007	~7%	First-in-class, earlier generation
Bictegravir	Gilead Sciences	INSTI	2018	~5%	Next-generation INSTI

Differentiators

• TIVICAY’s higher barrier to resistance versus earlier INSTIs
• It can be combined with nucleoside reverse transcriptase inhibitors (NRTIs) for potent regimens
• Extended formulations for pediatric use (e.g., TIVICAY for children)

Competitive Advantages and Limitations

Advantages	Limitations
Strong efficacy profile	Increasing competition from combination pills
Favorable tolerability	Patent expiry risk (2029 for key patents)
Extensive clinical data	High-cost perception in some markets
Well-established worldwide	Competitive pricing pressures

Regulatory and Policy Considerations

Aspect	Details
Approvals	Regulatory bodies in US (FDA), EU (EMA), WHO prequalification
Pricing and Reimbursement	Varies by country; policies favoring generics post-patent expiry
Patent Status	Patents expiring around 2029; patent litigation ongoing in some jurisdictions
WHO Guidelines (2022)	Recommends INSTI-based regimens as first-line therapy

Financial Trajectory Analysis

Revenue Forecast

Year	Projected Global Sales	Growth Rate	Comments
2022	~$4.2 billion	—	Baseline
2023	~$5.1 billion	+21%	Market expansion, new indications
2024	~$6.2 billion	+21%	Increased uptake in pediatric populations
2025	~$7.4 billion	+20%	Entry into emerging markets, new formulations
2026	~$8.8 billion	+19%	Saturation in mature markets

Factors Influencing Financial Growth

• Market saturation in developed countries approaching near-peak sales
• Emerging markets adoption boosted by affordability initiatives
• Pipeline development for fixed-dose combination therapies
• Patent cliffs in late 2020s impacting sales unless extended or made available generically
• Pricing strategies balancing access and profitability

Cost Structure and Profitability

Cost Component	Estimated % of Sales	Notes
R&D	10–15%	Continues for pipeline and new formulations
Marketing & Sales	20–25%	Focus on emerging markets
Manufacturing	15–20%	Scale efficiencies improve margins
Distribution & Logistics	10%	Varies by region

Profitability is expected to remain high due to GSK’s established manufacturing and distribution, offsetting costs related to pipeline expansion.

Strategic Outlook

Growth Opportunities

• Expanding pediatric formulations and dosing options
• Combination regimens leveraging TIVICAY’s efficacy
• Market expansion in low- and middle-income countries (LMICs)
• Pipeline innovations: Long-acting injectables, implantables
• Regulatory exclusivity extensions via patent filings and new indications

Challenges

• Patent expiry approaching in 2029, risking generic competition
• Price erosion in mature markets with generic entry
• Global supply chain disruptions impacting manufacturing and distribution
• Emerging competition from next-generation INSTIs (e.g., cabotegravir long-acting)

Comparative Analysis

Feature	TIVICAY (Dolutegravir)	Biktarvy	Raltegravir	Bictegravir
Year of Approval	2013	2018	2007	2018
Formulations	Oral, pediatric	Oral, fixed combo	Oral	Oral, fixed combo
Resistance Barrier	High	Very high	Moderate	Very high
Market Share (2022)	~65% (GSK)	~40%	~7%	~5%
Price (per treatment course)	~$1,200	~$1,800	~$900	~$1,600

(Prices are indicative and vary by geography)

Key Performance Indicators (KPIs)

KPI	Targets	Data Source	Notes
Annual Sales	Growth >20% (2023–2025)	IQVIA	Driven by market expansion and uptake
Market Share	Maintain dominant position	IQVIA	Through continued clinical data and marketing
Patent Litigation Success	80%	GSK reports	Protects exclusivity for targeted period
Pediatric Formulation Adoption	>50% pediatric treatment	GSK clinical data	Critical for long-term market dominance

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Conclusion and Recommendations

TIVICAY PD maintains a robust growth trajectory within the global HIV therapeutics market, driven by its high efficacy, safety, and expanding indications. The upcoming patent expiries necessitate proactive pipeline development, such as long-acting formulations, to sustain revenue streams. Stakeholders should consider strategic investments in emerging markets, pipeline innovation, and potential licensing agreements.

Key Takeaways

• Market Expansion: Emerging markets are pivotal for maintaining growth post-patent expiry.
• Pipeline Innovation: Long-acting injectables and combination therapies can extend product lifecycle.
• Pricing Strategies: Balancing premium pricing in developed markets with affordability in LMICs is essential.
• Patent Management: Effective patent protection through litigation and new indications is vital.
• Competitive Positioning: Differentiation based on resistance barrier and safety profile sustains market leadership.

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FAQs

1. What is the projected impact of patent expiration on TIVICAY’s revenue?
Patent expiry around 2029 could lead to significant revenue erosion due to generic competition, potentially reducing sales by up to 70–80% unless offset by new formulations or indications.

2. How is GSK planning to counter generic entry?
GSK is investing in pipeline development, including long-acting formulations, pediatric versions, and expanding indications to maintain market share and extend patent protections.

3. What are the primary growth markets for TIVICAY PD?
Emerging markets in Africa, Asia, and Latin America are primary targets due to increasing HIV prevalence and affordability initiatives.

4. How does TIVICAY compare to its key competitor Biktarvy?
TIVICAY has a slightly lower price point and extensive clinical data supporting high resistance barrier, but Biktarvy leads in market share due to its fixed-dose combination advantages.

5. What regulatory challenges could influence TIVICAY’s market trajectory?
Changes in national policies on drug pricing, patent laws, and treatment guidelines could impact sales. Regulatory approval of long-acting formulations can also accelerate growth if favorable.

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References

1. WHO. Global AIDS Update 2022.
2. UNAIDS. Global HIV & AIDS Statistics — 2022.
3. IQVIA. HIV Market Insights — 2022.
4. GSK. TIVICAY Clinical and Regulatory Data, 2022.
5. FDA, EMA approval summaries.
6. GSK Annual Reports and Investor Presentations.