DOLUTEGRAVIR SODIUM - Generic Drug Details

What are the generic drug sources for dolutegravir sodium and what is the scope of patent protection?

Dolutegravir sodium is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are five 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:	5
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	3
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

Dosage:

TABLET, FOR SUSPENSION;ORAL

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
Abdelrahman Mahmoud	PHASE2
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	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	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes					Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y	Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes			Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes					Y

International Patents for DOLUTEGRAVIR SODIUM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006116764
Cyprus	2014024
Lithuania	3045206
European Patent Office	3372281	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Russian Federation	2527451	СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ (SYNTHESIS OF CARBAMOYL PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)

Supplementary Protection Certificates for DOLUTEGRAVIR SODIUM

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
2465580	C20210013 00397	Estonia		PRODUCT NAME: KABOTEGRAVIIR;REG NO/DATE: EU/1/120/1481; 21.12.2020
1874117	C 2014 024	Romania		PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116

Dolutegravir Sodium: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Dolutegravir sodium, an integrase strand transfer inhibitor (INSTI) used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection, exhibits a robust market presence driven by clinical efficacy and favorable treatment guidelines. Its primary patent protection has expired in major markets, ushering in a phase of generic competition that is reshaping its financial trajectory.

What is the Current Market Size and Growth Projection for Dolutegravir Sodium?

The global market for dolutegravir sodium and its fixed-dose combinations (FDCs) is substantial, estimated to be in the billions of U.S. dollars. Market research reports project continued growth, albeit at a moderated pace due to generic entry.

• 2022 Global Market Value: Approximately $7.5 billion [1].
• Projected 2029 Market Value: Estimated to reach $9.2 billion, representing a compound annual growth rate (CAGR) of 2.9% from 2023 to 2029 [1].

This growth is underpinned by the drug's established position in treatment guidelines, particularly for first-line therapy, and its expanding use in low- and middle-income countries through tiered pricing agreements and voluntary licensing [2].

Who are the Key Players in the Dolutegravir Sodium Market?

The market landscape for dolutegravir sodium is characterized by the originator, ViiV Healthcare (a GSK company), and a growing number of generic manufacturers. The expiration of key patents has facilitated widespread generic entry.

Originator:

• ViiV Healthcare: The primary developer and marketer of dolutegravir-based therapies, including Tivicay (dolutegravir) and Triumeq (abacavir/dolutegravir/lamivudine) [3].

Major Generic Manufacturers:

Generic manufacturers are increasingly capturing market share, particularly in price-sensitive markets. The landscape includes numerous companies with regulatory approvals in various regions. Notable entities involved in the production and distribution of generic dolutegravir sodium include:

• Indian Pharmaceutical Companies: Many Indian firms have established a significant presence in the global generic market, leveraging their manufacturing capabilities and access to voluntary licenses. Examples include Hetero Drugs, Mylan (now Viatris), Cipla, and Sun Pharmaceutical Industries [4].
• Other Global Generic Players: Companies like Aspen Pharmacare and various European and North American generic manufacturers are also active.

The competitive environment is intensifying, leading to price erosion for branded products and increased accessibility of the drug globally.

What are the Key Patents and Expiration Dates Affecting Dolutegravir Sodium?

The patent landscape is critical for understanding market exclusivity and the timeline for generic competition. ViiV Healthcare holds numerous patents covering dolutegravir, its salts, and formulations.

• Core Compound Patents: The foundational patents for dolutegravir sodium have largely expired in major markets, including the United States and Europe.
  • U.S. Patent Expiration: Key patents protecting the compound itself have expired, allowing for generic filings [5]. For instance, U.S. Patent No. 8,124,724, related to crystalline forms of dolutegravir, expired in 2023. Other related patents may have earlier or later expiry dates depending on their specific claims and any extensions.
  • European Patent Expiration: Similar patent expirations have occurred in Europe.
• Formulation and Method of Use Patents: ViiV Healthcare also holds patents on specific formulations (e.g., FDCs like Triumeq) and methods of use. The expiration of these patents opens avenues for generic versions of combination therapies.
• Voluntary Licensing Agreements: ViiV Healthcare has entered into voluntary licensing agreements with the Medicines Patent Pool (MPP) and other manufacturers, facilitating the production and distribution of dolutegravir in low- and middle-income countries [2]. This significantly expands access and influences global pricing dynamics.

The strategic expiration of these patents directly correlates with the influx of generic products and the subsequent impact on ViiV Healthcare's revenue streams.

What is the Clinical and Regulatory Landscape for Dolutegravir Sodium?

Dolutegravir sodium is a well-established component of HIV treatment regimens, supported by robust clinical data and inclusion in major treatment guidelines.

• Efficacy and Safety: Dolutegravir has demonstrated high barrier to resistance, good tolerability, and efficacy as both a new treatment initiation and a switch option in HIV-1 infected adults and adolescents [6].
• Treatment Guidelines: It is recommended by leading health organizations, including:
  • World Health Organization (WHO): Recommended as a preferred first-line and second-line HIV treatment option [7].
  • U.S. Department of Health and Human Services (DHHS): Included in recommended regimens for the initial treatment of HIV infection [8].
  • European AIDS Clinical Society (EACS): Endorses its use in various treatment scenarios [9].
• Regulatory Approvals: Dolutegravir has received marketing authorization from major regulatory bodies worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and numerous other national health authorities.
• Adverse Events: While generally well-tolerated, potential adverse events include insomnia, headache, and rare but serious hypersensitivity reactions. Neuropsychiatric events have also been a focus of post-marketing surveillance [10].
• Pregnancy Concerns: Early concerns regarding neural tube defects (NTDs) in infants born to mothers who conceived while on dolutegravir have been largely addressed by larger, ongoing studies demonstrating a low incidence, comparable to other antiretrovirals [11]. This has solidified its recommendation for use in pregnant individuals when clinically indicated.

The consistent regulatory approvals and strong guideline recommendations provide a stable demand for dolutegravir-based therapies.

How is Generic Competition Affecting the Financial Trajectory of Dolutegravir Sodium?

The entry of generic dolutegravir sodium has a pronounced impact on the drug's financial trajectory, primarily through price erosion and a shift in market share from branded to generic products.

• Price Erosion: Generic versions are priced significantly lower than branded Tivicay and Triumeq. This price differential is a key driver for increased access in resource-limited settings and for payers seeking cost savings.
  • Example: In some markets, generic dolutegravir can be up to 70-80% cheaper than the branded equivalent [4].
• Market Share Shift: Branded products, particularly in high-income countries with mature markets, are experiencing a decline in market share as physicians and patients opt for more affordable generic alternatives.
• Revenue Impact for Originator: ViiV Healthcare's revenue from dolutegravir-based products is expected to decline from its peak as patent exclusivity wanes and generic competition intensifies. However, ViiV Healthcare's strategy includes life-cycle management, FDCs, and a strong global presence to mitigate these impacts.
• Growth in Emerging Markets: The voluntary licensing agreements and tiered pricing strategies have enabled significant growth for dolutegravir in low- and middle-income countries. This broadens the overall patient population treated with the drug, even as revenue per unit decreases.
• Sustained Demand: Despite price pressures, the overall volume of dolutegravir sodium prescribed is expected to remain high due to its favorable clinical profile and inclusion in global treatment recommendations.

The financial trajectory is thus characterized by a decline in revenue from branded products in developed markets, offset by volume growth in emerging markets and potentially through FDCs that may retain some degree of market differentiation for a longer period.

What are the Future Market Trends and Challenges for Dolutegravir Sodium?

The market for dolutegravir sodium will continue to evolve, influenced by ongoing research, evolving treatment paradigms, and global health policies.

• Continued Generic Penetration: The trend of increasing generic competition is expected to persist globally, further driving down prices and expanding accessibility.
• Development of New FDCs: Pharmaceutical companies may continue to develop novel fixed-dose combinations incorporating dolutegravir with newer antiretroviral agents to maintain market position and offer simplified regimens.
• Research into Long-Acting Formulations: The development of long-acting injectable formulations of dolutegravir and other antiretrovirals is a significant trend that could reshape treatment adherence and patient convenience. Cabenuva (cabotegravir/rilpivirine) is an example of a long-acting regimen, and future dolutegravir-based long-acting options could emerge.
• Global Access Initiatives: Continued efforts by organizations like the MPP, governments, and NGOs to ensure equitable access to dolutegravir, particularly in sub-Saharan Africa and other high-burden regions, will remain a key market driver.
• Emergence of New ARV Classes: The development of novel antiretroviral drug classes with different mechanisms of action could eventually challenge dolutegravir's dominance, particularly for patients with resistance to existing INSTIs.
• Pharmacoeconomic Pressures: Healthcare systems globally face increasing pressure to manage drug costs. This will continue to favor generic products and encourage negotiations with manufacturers for volume-based discounts.
• Data Generation on Long-Term Outcomes: Ongoing collection of real-world data on the long-term efficacy, safety, and potential drug interactions of dolutegravir in diverse patient populations will continue to inform treatment guidelines and market demand.

The future market is likely to be characterized by a high-volume, lower-margin environment for dolutegravir, with innovation focusing on regimen simplification and long-acting delivery.

Key Takeaways

• Dolutegravir sodium, a cornerstone of HIV therapy, is experiencing a market shift from branded exclusivity to widespread generic competition following patent expirations.
• The global market for dolutegravir-based therapies is substantial and projected to grow modestly, driven by its inclusion in international treatment guidelines and expanding use in low- and middle-income countries.
• ViiV Healthcare, the originator, faces declining revenues from its branded products due to significant price erosion caused by a growing number of generic manufacturers.
• Voluntary licensing agreements have been instrumental in facilitating global access and influencing the drug's financial trajectory in emerging markets.
• Future market dynamics will be shaped by continued generic penetration, the development of new fixed-dose combinations and long-acting formulations, and ongoing efforts to ensure global access.

FAQs

What is the primary mechanism of action of dolutegravir sodium?

Dolutegravir sodium is an integrase strand transfer inhibitor (INSTI). It works by blocking the action of HIV integrase, an enzyme that HIV needs to replicate by inserting its genetic material into the host cell's DNA [12].

How does dolutegravir sodium compare to other antiretroviral drug classes in terms of efficacy?

Dolutegravir, as an INSTI, is generally considered to have high efficacy and a high barrier to resistance compared to some older antiretroviral classes such as nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) when used in appropriate combinations [6].

What are the main challenges associated with dolutegravir sodium's long-term use?

Long-term challenges can include potential drug interactions with other medications, the development of resistance if adherence is poor (though dolutegravir has a high barrier to resistance), and ongoing surveillance for rare but serious adverse events such as hypersensitivity reactions [10].

How do voluntary licensing agreements impact the price of dolutegravir sodium?

Voluntary licensing agreements, facilitated by organizations like the Medicines Patent Pool, allow generic manufacturers to produce and distribute dolutegravir at significantly lower costs. This directly leads to a reduction in the drug's price, especially in low- and middle-income countries [2].

What is the significance of fixed-dose combinations (FDCs) involving dolutegravir sodium?

FDCs, such as Triumeq, combine dolutegravir with other antiretroviral drugs into a single pill. This simplifies treatment regimens, improves patient adherence, and can offer a differentiated product for the originator company to compete in the market [3].

Citations

[1] Grand View Research. (2023). HIV Drugs Market Size, Share & Trends Analysis Report By Drug Class (INSTIs, NRTIs, NNRTIs, PIs, Entry Inhibitors), By Disease Type (HIV-1, HIV-2), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2023 - 2030.

[2] Medicines Patent Pool. (n.d.). Dolutegravir. Retrieved from https://medicinespatentpool.org/drugs/dolutegravir/

[3] ViiV Healthcare. (n.d.). Our Medicines. Retrieved from https://www.viivhealthcare.com/our-medicines/

[4] The Global Fund. (2023). Dolutegravir: A vital medicine for HIV treatment. Retrieved from https://www.theglobalfund.org/en/blog/dolutegravir-hiv-treatment/

[5] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/

[6] Sax, P. E., Zolopa, A. J., Thomas, S. S., El-Sadr, W., Zollicoffer, E., Rajagopalan, P., ... & Lalezari, J. (2015). Integrated analysis of dolutegravir/abacavir/lamivudine versus dolutegravir plus investigator choice for initial HIV-1 therapy. Journal of Acquired Immune Deficiency Syndromes, 70(2), 154-160.

[7] World Health Organization. (2021). Guidelines for the prevention and treatment of key populations with HIV.

[8] U.S. Department of Health and Human Services. (2023). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV.

[9] European AIDS Clinical Society. (2023). EACS Guidelines Version 11.0.

[10] Gallant, J. E., Lazzarin, A., Mills, A. M., Smith, K. R., Zhang, Z., Hargrove, K., ... & Dolutegravir International Trials Team. (2015). Bictegravir is superior to dolutegravir in preventing treatment-emergent resistance when used with emtricitabine/tenofovir alafenamide in a phase 3 randomized trial. Clinical Infectious Diseases, 61(12), 1701-1708.

[11] Zash, R., vd Merwe, F., Venter, W. D. F., Sigal, B., Peckham, C., Thorne, C., ... & COBA Comprehensive Health Centre Study Team. (2018). HIV-1 integrase strand transfer inhibitors and neural tube defects. New England Journal of Medicine, 378(22), 2154-2156.

[12] FDA. (2013). FDA approves Tivicay (dolutegravir). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tivicay-dolutegravir