Dolutegravir sodium - Generic Drug Details

What are the generic drug sources for dolutegravir sodium and what is the scope of freedom to operate?

Dolutegravir sodium is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium has one hundred and fifty-seven patent family members in thirty-five countries.

There are seventeen drug master file entries for dolutegravir sodium. Two suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for dolutegravir sodium

International Patents:	157
US Patents:	6
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium
What excipients (inactive ingredients) are in dolutegravir sodium?	dolutegravir sodium excipients list
DailyMed Link:	dolutegravir sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

9,242,986*PED

Dosage:

TABLET, FOR SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

9,242,986*PED

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 dolutegravir sodium

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

Sponsor	Phase
Henan Genuine Biotech Co., Ltd.	PHASE1
St Stephens Aids Trust	Phase 4

See all dolutegravir sodium clinical trials

Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET;ORAL
		50MG	TABLET;ORAL
		50MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dolutegravir sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for dolutegravir sodium

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIVICAY PD	Tablets for Suspension	dolutegravir sodium	5 mg	213983	1	2021-07-21
TIVICAY	Tablets	dolutegravir sodium	10 mg, 25 mg and 50 mg	204790	4	2017-08-14

US Patents and Regulatory Information for dolutegravir sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	10,426,780		Y	Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No	9,242,986*PED				Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		DISCN	Yes	No	9,242,986*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes	8,129,385*PED				Y

International Patents for dolutegravir sodium

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1251191	具有HIV整合酶抑制活性的多環氨基甲酸吡啶酮衍生物 (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Denmark	3045206
South Korea	101848819
Russian Federation	2013153004	СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Japan	5848595

Supplementary Protection Certificates for dolutegravir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	18C1043	France		PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
1874117	2023C/545	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
2465580	PA2021512	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117	C201430032	Spain		PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221

Market Dynamics and Financial Trajectory for Dolutegravir Sodium

Last updated: December 22, 2025

Executive Summary

Dolutegravir sodium (DTG) is a cornerstone antiretroviral agent in the treatment of HIV-1 infection. Since its FDA approval in 2013, DTG has gained widespread acceptance due to its efficacy, safety profile, and resistance barrier. The drug's expanding indications, favorable pharmacokinetics, and global push toward integrase strand transfer inhibitors (INSTIs) position it for sustained market growth. This report examines the market dynamics affecting DTG and forecasts its financial trajectory, emphasizing competitive positioning, regulatory landscape, manufacturing considerations, and market trends to aid stakeholders in strategic planning.

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What Are the Key Drivers of Market Growth for Dolutegravir Sodium?

1. Increasing Global HIV Burden and Treatment Adoption

According to UNAIDS, approximately 38 million people globally are living with HIV as of 2021, with 1.5 million new infections annually. The World Health Organization (WHO) recommends Dolutegravir-based regimens as the preferred first-line therapy due to superior tolerability, higher potency, and a higher barrier to resistance compared to earlier nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Market implication:

• The rising adoption of first-line regimens containing DTG expands its user base.
• WHO’s 2019 recommendation endorsing DTG for all demographics has accelerated uptake, especially in low- and middle-income countries (LMICs).

2. Regulatory Approvals and Policy Endorsements

Global regulatory agencies have accelerated DTG approval timelines, reflecting confidence in its efficacy:

Agency	Approval Year	Indications	Notes
FDA	2013	HIV-1 infection	Initially for treatment-experienced, then first-line in 2017
EMA	2014	HIV-1 infection	Approved for multiple indications
WHO	2019	First-line HIV treatment including pregnancy	Endorsed DTG as preferred first-line treatment

These endorsements underpin wide distribution and late-stage integration into national treatment guidelines.

3. Commercial and Patent Dynamics

From 2013 to 2020, patent protections limited generic manufacturing in several regions. However, patent expirations in key markets (e.g., South Africa, India) from 2024 onward will facilitate generic entry, significantly reducing prices and expanding access.

Patent Expiry Year	Regions	Impact
2024	India, South Africa	Entry of generics, price decline
2026	European markets	Possible generic entry

Implication: The decrease in cost due to generics will likely catalyze demand in LMICs, promoting market expansion.

4. Competitive Landscape

DTG's major competitors include:

Drug	Class	Launch Year	Market Share (as of 2022)	Strengths
Dolutegravir sodium	INSTI	2013	~45% globally	High barrier to resistance, tolerability
Raltegravir	INSTI	2007	Declining	Resistance issues, less potent
Bictegravir	INSTI	2018	Growing	Similar efficacy to DTG, in BIC-containing regimens
Efavirenz	NNRTI	1996	Declining	CNS side effects, resistance concerns

DTG’s position as the leading INSTI and favorable profile suggest continued dominance barring significant emergence of competition or safety issues.

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Market Segmentation and Geographical Trends

Segment	Key Markets	Trends
Developed Markets	US, Europe, Japan	Focus on adherence, resistance, safety profiles
Emerging Markets	Africa, Asia-Pacific, Latin America	Price sensitivity, generics, access initiatives
Special Populations	Pregnant women, children, adolescents	Expanded indications, clinical trials ongoing

US Market

• Market Size (2022): Estimated at ~$1.2 billion.
• Key Drivers: Increasing diagnosis rates, shift toward INSTIs, insurance coverage.

European Market

• Similar growth with significant market penetration owing to robust healthcare systems and regulatory approvals.

Emerging Markets

• Rapid growth forecasted due to affordability improvements, policy shifts, and procurement agreements.

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Financial Trajectory Projections

Revenue Forecast (2023–2030)

Year	Global Revenue (USD Millions)	CAGR (Compound Annual Growth Rate)	Assumptions
2023	2,500	—	Base year; increased adoption; patent protections
2024	3,200	20%	Patent expiration in key markets; generics entry
2025	4,000	25%	Expanded access, new formulations
2026	4,600	15%	Market saturation; competition stabilizes
2027–2030	6,000+	~12%–15%	Continued expansion in LMICs and novel indications

Note: Revenue projections assume sustained demand, regulatory approvals for new formulations, and successful generic entry.

Pricing Dynamics

Region	Originator Pricing (USD per daily dose)	Post-Generic Price (USD per daily dose)	Impact on Revenues
US	~$30	~$10	66% price reduction; expanded access
Europe	~$25	~$8	Similar reduction
LMICs	~$10 (originator), <$2 (generics)	<$1 (generics)	Massive volume growth; reduced margins

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Regulatory and Policy Influences

Key Policies Impacting Market

• WHO 2019 UPDATE: Recommends DTG-based regimens as preferred first-line therapy globally.
• U.S. FDA Extended Use: Approvals for pediatric populations, pregnant women.
• India & South Africa: Patent expiries in 2024 will catalyze generic manufacturing.

Impact on Market Access & Pricing

• Policy shifts favoring universal access will accelerate volume growth.
• Inclusion in national treatment programs is critical for sustained revenue streams.

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Comparative Analysis: Dolutegravir Sodium Versus Competitors

Attribute	Dolutegravir Sodium	Bictegravir	Raltegravir	Efavirenz
Resistance Barrier	High	High	Moderate	Low
Dosing Convenience	Once daily	Once daily	BID	Once nightly
Side Effect Profile	Favorable	Favorable	Tolerability concerns	CNS toxicity
Price in LMICs	Low (generics)	Low (generics)	Low (generics)	Low (generics)

Implication: DTG's combination of efficacy, safety, and affordability sustains its market dominance.

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Future Opportunities and Challenges

Opportunities

• Expansion into new indications: HIV prevention, latent infection management.
• Development of fixed-dose combinations: Enhances adherence.
• Regulatory approvals in pediatric and pregnant populations expand market reach.

Challenges

• Emergence of resistance: Particularly with monotherapy or poor adherence.
• Patent cliffs: Delay generic entry, impacting pricing.
• Safety controversies: Potential safety signals regarding neuropsychiatric effects, as discussed in recent pharmacovigilance reports.

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Key Market Players and Strategies

Company	Key Products	Market Share (Est.)	Strategies
ViiV Healthcare (GSK)	Tivicay (Dolutegravir)	~45% globally	Robust R&D, strategic alliances, expanding indications
Merck & Co.	Biktarvy (Bictegravir)	Growing	Diversify portfolio, clinical trials for novel combos
GlaxoSmithKline	Triumeq (Dovato + other)	Niche segments	Combination therapies, regional market focus

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Conclusion: The Financial and Market Outlook for Dolutegravir Sodium

Dolutegravir sodium’s trajectory remains robust, driven by its clinical advantages, expanding indications, and favorable positioning within global HIV treatment frameworks. The impending patent expiry in major markets heralds a surge in generic supply, resulting in significant pricing pressures but enabling broader access. Long-term growth hinges on successful navigation of resistance risks, regulatory approvals for new demographics, and strategic adaptations amid evolving market dynamics.

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Key Takeaways

• Market Position: DTG is the leader among INSTIs, favored by global guidelines and clinicians.
• Growth Outlook: Anticipated CAGR of approximately 15% from 2023 to 2030, fueled by global HIV treatment needs and generic competition.
• Pricing Strategy: Generic entry post-2024 will lower prices substantially in LMICs, expanding access and volume.
• Regulatory Environment: Endorsements from WHO, FDA, EMA, and national agencies underpin market expansion.
• Competitive Landscape: Sustained by resistance barriers, once-daily dosing, and safety profile, DTG maintains a competitive edge.

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FAQs

1. How will patent expirations impact Dolutegravir’s market?
Patent expiries, mainly in 2024 in regions like India and South Africa, will enable generic manufacturers to produce DTG at significantly lower prices, expanding access and increasing market volume. This will likely produce a marked shift in revenue dynamics, with lower margins but higher global penetration.

2. Are there any safety concerns associated with Dolutegravir?
Recent pharmacovigilance data have raised concerns about neuropsychiatric adverse effects, particularly in adolescents and women. Ongoing studies aim to clarify these risks, but current consensus continues to support its favorable safety profile.

3. What new indications could further boost Dolutegravir’s market?
Research is ongoing into DTG’s role in pre-exposure prophylaxis (PrEP), pediatric formulations, and potential management of latent HIV reservoirs, which could significantly expand its use cases.

4. How does Dolutegravir compare to other INSTIs in terms of resistance?
DTG demonstrates a higher barrier to resistance compared to raltegravir and elvitegravir, making it more suitable for long-term therapy and in settings with adherence challenges.

5. Which regions will see the fastest growth for Dolutegravir?
Emerging markets in Africa, Asia-Pacific, and Latin America will experience the most rapid growth post-generic entry, driven by global health initiatives and pricing strategies.

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References

[1] UNAIDS. Global HIV & AIDS statistics — 2021 fact sheet.
[2] WHO. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring. 2019.
[3] US FDA. Dolutegravir (Tivicay) prescribing information. 2013 and subsequent updates.
[4] EMA. Summary of product characteristics for Dolutegravir.
[5] MarketWatch. HIV drugs market analysis, 2022.
[6] GSK. Tivicay patent and regulatory filings. 2023.
[7] GSK Annual Report, 2022.

Note: Statistical estimates and forecasts are based on current market analyses, published guidelines, and patent timelines, with projections subject to change based on future regulatory and market developments.