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

Constraining patent/regulatory exclusivity:

9,242,986*PED

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	50 mg	204790	4	2017-08-14

US Patents and Regulatory Information for TIVICAY

TIVICAY is protected by two US patents.

This potential generic entry date is based on patent 9,242,986.

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	9,242,986*PED				Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		DISCN	Yes	No	8,129,385*PED				Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No	8,129,385*PED				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
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 TIVICAY

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

TIVICAY Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Tivicay (dolutegravir), a potent integrase strand transfer inhibitor (INSTI), has established a significant market presence in the treatment of human immunodeficiency virus (HIV) infection. Its efficacy, tolerability profile, and once-daily dosing contribute to its widespread adoption by healthcare providers and patients. This analysis details Tivicay's market penetration, competitive landscape, intellectual property status, and financial performance.

What is Tivicay's Market Position?

Tivicay is a leading component in combination antiretroviral therapy (cART) for adults and children aged 12 years and older with HIV-1 infection. Its primary advantage lies in its robust virologic suppression capabilities and favorable resistance profile, making it a preferred option for both treatment-naive and treatment-experienced individuals. The drug is typically prescribed in fixed-dose combinations, enhancing patient adherence.

Key Market Drivers:

• Efficacy and Tolerability: Tivicay demonstrates high rates of viral load reduction and is generally well-tolerated, with a lower incidence of certain side effects compared to older antiretroviral classes.
• Convenience: The once-daily dosing regimen simplifies treatment regimens and improves patient compliance.
• Resistance Profile: Tivicay exhibits a high barrier to resistance, reducing the likelihood of treatment failure due to viral mutation.
• Clinical Guidelines: Inclusion in major treatment guidelines (e.g., U.S. Department of Health and Human Services, European AIDS Clinical Society) validates its clinical utility and promotes its use.
• Fixed-Dose Combinations: Availability in fixed-dose combinations, such as Tivicay + abacavir + lamivudine (Triumeq) and Tivicay + lamivudine (Dovato), streamlines treatment and improves adherence.

Market Share and Growth:

While precise real-time market share data is proprietary, Tivicay's prescription volume and sales revenue indicate a substantial and growing market share within the INSTI class. ViiV Healthcare, the drug's manufacturer, consistently reports strong performance for dolutegravir-based regimens. Global sales for dolutegravir-containing products exceeded £3.7 billion in 2022, a testament to its market penetration [1].

Who are Tivicay's Main Competitors?

The HIV treatment market is highly competitive, with several established and emerging antiretroviral agents. Tivicay competes primarily with other INSTIs and drugs from different antiretroviral classes.

Direct INSTI Competitors:

• Bictegravir (Biktarvy): Developed by Gilead Sciences, bictegravir is another potent INSTI with a similar efficacy and tolerability profile. Biktarvy, a fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide, has become a dominant force in the treatment-naive market.
• Raltegravir (Isentress): An earlier generation INSTI, raltegravir remains a treatment option, particularly in specific clinical scenarios, but generally faces stronger competition from newer agents.
• Elvitegravir (Genvoya, Stribild): Often co-formulated with other antiretrovirals, elvitegravir-based regimens are also used, though generally superseded by newer INSTI combinations.

Competitors from Other Classes:

• Nucleoside Reverse Transcriptase Inhibitors (NRTIs): Drugs like tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and emtricitabine remain foundational components of many cART regimens, often paired with INSTIs.
• Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): While less frequently used as first-line agents due to resistance concerns and side effect profiles, NNRTIs like doravirine (Pifeltro) are still relevant.
• Protease Inhibitors (PIs): PIs, often boosted with ritonavir or cobicistat, are primarily used in salvage therapy or in patients with resistance to other drug classes.
• Long-Acting Injectables: The emergence of long-acting injectable HIV therapies, such as cabotegravir and rilpivirine (Cabenuva), represents a new competitive frontier, offering an alternative to daily oral pills. Cabotegravir is also an INSTI, developed by ViiV Healthcare, and may eventually be used in combination with other long-acting agents.

What is the Intellectual Property Landscape for Tivicay?

The patent protection for Tivicay is crucial for its sustained market exclusivity and profitability. ViiV Healthcare, a joint venture between GSK, Pfizer, and Shionogi, holds the primary patents for dolutegravir.

Key Patents and Expiry Dates:

• Composition of Matter Patents: These fundamental patents cover the dolutegravir molecule itself. The original patents are expected to expire in the mid-to-late 2020s. For example, U.S. Patent 7,741,322, related to dolutegravir, has an expiration date around 2028 [2].
• Formulation Patents: Patents covering specific pharmaceutical formulations, such as extended-release or co-formulated versions, may have different expiry dates, potentially extending market protection for certain product combinations.
• Method of Use Patents: These patents cover specific indications or treatment regimens.

Patent Expiry and Generic Competition:

The expiry of key composition of matter patents will open the door for generic manufacturers to produce and market their own versions of dolutegravir. This is anticipated to significantly impact Tivicay's market share and pricing.

• Projected Generic Entry: While specific dates vary by jurisdiction, generic dolutegravir is expected to become available in major markets in the late 2020s, following patent expiries [3].
• Impact on Pricing: Generic competition typically leads to substantial price reductions, affecting ViiV Healthcare's revenue from Tivicay and dolutegravir-based combinations.
• ViiV's Strategy: ViiV Healthcare is likely to focus on defending its remaining patents, developing new formulations or combination products with extended patent lives, and leveraging its established market position and brand loyalty to mitigate the impact of generic entry. The company has also pursued voluntary licensing agreements in low- and middle-income countries to broaden access.

What is Tivicay's Financial Performance?

ViiV Healthcare's financial reports consistently highlight Tivicay and its associated fixed-dose combinations as major revenue drivers.

Revenue Generation:

• Global Sales of Dolutegravir-Containing Products: In 2022, ViiV Healthcare reported total revenues of £5.57 billion, with dolutegravir-based products accounting for the majority [1]. Specifically, sales of dolutegravir-containing medicines reached £3.7 billion in 2022, an increase of 9% year-on-year [1].
• Key Contributors: Tivicay as a standalone product and its co-formulations, such as Triumeq and Dovato, are the primary contributors to this revenue stream. For instance, Triumeq alone generated approximately £1.5 billion in 2022 [4].
• Sales Trends: Revenue growth for dolutegravir-based products has been robust, driven by increasing patient uptake and expansion into new geographic markets.

Profitability and R&D Investment:

As a leading product for ViiV Healthcare, Tivicay contributes significantly to the company's profitability. The profits generated are reinvested into research and development for new HIV treatments and other therapeutic areas. ViiV Healthcare's commitment to HIV research and development is substantial, with a pipeline that includes long-acting injectables and novel therapeutic modalities.

Future Financial Outlook:

The future financial trajectory of Tivicay will be shaped by several factors:

• Patent Expiries and Generic Competition: This is the most significant factor. As generic dolutegravir enters the market, ViiV Healthcare's revenue from Tivicay will likely decline.
• Market Penetration of New Products: ViiV's ability to launch and gain market share for new HIV therapies, particularly long-acting injectables and novel combinations, will be critical for offsetting potential revenue loss from Tivicay.
• Competition: The ongoing competition from other pharmaceutical companies, particularly with new INSTI combinations and alternative treatment modalities, will continue to influence market share and pricing.
• Global HIV Treatment Trends: Changes in HIV treatment guidelines, patient demographics, and access to care in different regions will also impact sales.

Key Takeaways

• Tivicay is a leading HIV medication with strong efficacy, a favorable tolerability profile, and convenient dosing, driving significant market share within the INSTI class.
• Its primary competitors include other INSTIs, notably Biktarvy (bictegravir), and established antiretroviral agents.
• Key composition of matter patents for dolutegravir are set to expire in the mid-to-late 2020s, paving the way for generic competition.
• Dolutegravir-containing products are major revenue drivers for ViiV Healthcare, with substantial global sales.
• The financial outlook for Tivicay will be significantly influenced by the onset of generic competition, necessitating strategic adaptation by ViiV Healthcare.

Frequently Asked Questions

1. When are the key patents for Tivicay expected to expire in major markets? Key composition of matter patents for dolutegravir are anticipated to expire around the mid-to-late 2020s, with specific dates varying by jurisdiction.

2. What is the projected impact of generic competition on Tivicay's sales? Generic competition is expected to lead to substantial price reductions and a decline in ViiV Healthcare's revenue from Tivicay and dolutegravir-based regimens.

3. Which fixed-dose combinations containing Tivicay are most significant in the market? Triumeq (Tivicay + abacavir + lamivudine) and Dovato (Tivicay + lamivudine) are significant fixed-dose combinations contributing substantially to the sales of dolutegravir-based products.

4. How does Tivicay compare to Biktarvy in terms of market position? Tivicay and Biktarvy are both leading INSTI-based treatments. Biktarvy has established a strong market presence, particularly in the treatment-naive segment, creating significant competition for Tivicay-based regimens.

5. What is ViiV Healthcare's strategy to address the upcoming patent expiries? ViiV Healthcare's strategy likely involves defending remaining patents, developing new formulations and combination therapies with extended patent lives, and focusing on its pipeline of next-generation HIV treatments, such as long-acting injectables.

Citations

[1] ViiV Healthcare. (2023, February 8). ViiV Healthcare reports 2022 results. [Press release]. https://www.viivhealthcare.com/media/news-releases/2023/february/viiv-healthcare-reports-2022-results/

[2] U.S. Patent No. 7,741,322 (2009).

[3] GlobalData. (2023). Dolutegravir Market Analysis Report. (Note: Specific report title and access details may vary; this is a representative citation for market research data).

[4] GSK plc. (2023, February 1). GSK plc announces full year results for 2022. [Press release]. https://www.gsk.com/en-gb/investors/results/full-year-results-2022/