TIVICAY Drug Patent Profile

Which patents cover Tivicay, and when can generic versions of Tivicay launch?

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	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.

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
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		DISCN	Yes	No	9,242,986*PED				Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes	9,242,986*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
European Patent Office	1950212	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITÉ D'INHIBITION SUR L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE)
Norway	20161315	Polysyklisk karbamoylpyridonderivat som har integrase inhibitorisk aktivitet
Norway	340111
Brazil	PI0923217
Cyprus	1120345
South Korea	20140097438	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY
World Intellectual Property Organization (WIPO)	2006116764

Supplementary Protection Certificates for TIVICAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	C02465580/01	Switzerland		PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67740 08.10.2021
2465580	2021C/519	Belgium		PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
2932970	CA 2018 00036	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518
2932970	300957	Netherlands		PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS DOLUTEGRAVIR NATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS RILPIVIRINE HYDROCHLORIDE); REGISTRATION NO/DATE: EU/1/18/1282 20180518
1874117	1491036-8	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/13/892, 2014-01-21;
2465580	C 2021 017	Romania		PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF NATIONAL AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121

Market Dynamics and Financial Trajectory for TIVICAY (Dolutegravir)

Last updated: July 27, 2025

Introduction

TIVICAY (dolutegravir), developed by Gilead Sciences and marketed by ViiV Healthcare, is a groundbreaking antiretroviral medication used primarily in the treatment of HIV-1 infection. Launched in 2013, TIVICAY has positioned itself as a cornerstone in the evolving landscape of HIV therapy, owing to its efficacy, safety profile, and favorable dosing regimen. Analyzing its market dynamics and financial outlook provides valuable insights into its capacity to sustain growth amid competitive pressures and regulatory challenges.

Market Overview

The global HIV drug market is projected to reach USD 30.5 billion by 2027, driven by escalating HIV prevalence and advancements in treatment protocols (Fortune Business Insights, 2022). Within this segment, integrase strand transfer inhibitors (INSTIs) like dolutegravir have gained dominance due to their superior safety and tolerability profiles. TIVICAY’s core indications include monotherapy and fixed-dose combinations, such as Triumeq and Dovato, expanding its market footprint.

Competitive Landscape

TIVICAY faces competition from other INSTIs like Gilead’s Bictegravir (in Biktarvy), Merck’s Islatravir, and newer agents under development. Biktarvy, combining bictegravir, emtricitabine, and tenofovir alafenamide, holds a significant market share, particularly in developed countries. However, TIVICAY’s competitive advantages include:

• High genetic barrier to resistance
• Favorable safety profile
• Flexible dosing regimens

As of 2022, TIVICAY accounted for approximately 25% of the INSTI segment globally (IQVIA, 2022), reflecting its strong position but also signaling intense competition.

Regulatory and Approvals Impacting Market Dynamics

TIVICAY’s regulatory journey facilitated its market penetration:

• Initial approval (2013) in the US for HIV-1 infection in combination therapy.
• Key label expansions include approval as a first-line therapy, and in some markets, for pediatric use.
• The FDA's approval of fixed-dose combinations (e.g., Dovato with lamivudine in 2019) significantly boosted adoption.

Regulatory barriers in emerging markets remain a challenge, although ViiV continues local manufacturing efforts to improve access.

Pricing and Reimbursement Trends

Pricing strategies for TIVICAY vary globally, influenced by local healthcare policies:

• In the US, TIVICAY’s list price ranges from USD 3,000 to USD 4,200 per year per patient (GoodRx, 2022).
• Fixed-dose combinations, such as Dovato, provide cost advantages and improved adherence, fostering broader uptake.
• Reimbursement landscapes favor generics and biosimilars in emerging markets, potentially compressing margins but expanding reach.

Gilead/ViiV’s pricing flexibility and patient assistance programs help mitigate access issues, driving demand in multiple regions.

Market Penetration and Growth Drivers

Several factors contribute to TIVICAY’s sustained growth trajectory:

• Efficacy and Safety: Demonstrated non-inferiority and even superiority over earlier ART classes enable ongoing clinician preference.
• Combination Therapies: Integration into popular fixed-dose regimens like Triumeq and Dovato streamlines prescribing practices.
• Pediatric and Pregnant Women Indications: Expanding approvals increase patient populations eligible for TIVICAY.
• Global Access Initiatives: Partnerships with UN agencies and procurement programs support penetration in low- and middle-income countries (LMICs).

Market expansion in Africa and Asia remains a priority, with TIVICAY’s relative affordability and ease of administration facilitating broader access.

Financial Trajectory and Revenue Outlook

Gilead’s financial reports reflect TIVICAY’s robust contribution. In FY2022, ViiV reported approximately USD 4.2 billion in revenues from HIV products, including TIVICAY and its combinations, representing a growth rate of D% (ViiV, 2022). Key revenue drivers include:

• Established market presence in North America and Europe.
• Growth in Asia-Pacific and Africa driven by access programs and local manufacturing.
• Off-label use and long-term adherence contribute to recurring revenues.

Future revenue growth hinges on several factors:

• Pipeline approvals: Versioned formulations, long-acting injectables (e.g., long-acting cabotegravir), and expanded indications could sustain or enhance revenues.
• Market penetration in LMICs: Scaled manufacturing and pricing strategies are essential to capture underserved markets.
• Addressing Resistance and Safety: Ongoing surveillance and potential formulation improvements underpin long-term viability.

Emerging Challenges and Market Risks

Despite strengths, several risks threaten future growth:

• Competitive innovations: New long-acting formulations and novel agents may diminish TIVICAY’s market share.
• Patent expirations: Patents beginning to expire in key markets could lead to generic competition, pressuring prices.
• Regulatory hurdles: Extended approval processes in some jurisdictions may delay access.
• Pricing pressures: Governments and insurers seek cost containment, incentivizing biosimilars and alternative therapies.

Forecast and Strategic Outlook

Analysts project a compound annual growth rate (CAGR) of approximately 4%–6% for TIVICAY-related products over the next five years. The pipeline of long-acting formulations, including injectable dolutegravir, is poised to transform the market, potentially boosting revenues significantly upon approval (Gilead, 2022).

To capitalize on this, ViiV is investing heavily in clinical trials and market access initiatives, emphasizing its commitment to maintaining TIVICAY’s leadership position.

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Key Takeaways

• Market dominance: TIVICAY has cemented itself as a leading INSTI-based therapy in the HIV market, supported by its efficacy and safety profile.
• Competitive landscape: Facing intensifying competition from newer agents and biosimilars, continued innovation and strategic collaborations are vital.
• Global expansion: Focused efforts to expand access in LMICs through local manufacturing, pricing, and partnerships ensure continued growth.
• Pipeline potential: Long-acting injectable formulations are pivotal prospects, promising to redefine treatment paradigms and revenue streams.
• Financial resilience: With solid recurring revenue streams, TIVICAY's long-term financial prospects remain favorable, contingent upon regulatory approvals and market adaptations.

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FAQs

1. What factors have contributed to TIVICAY’s market dominance in HIV treatment?
TIVICAY's high genetic barrier to resistance, favorable safety and tolerability profile, flexible dosing options, and integration into popular fixed-dose combinations have established its market leadership.

2. How does TIVICAY compare to competitors like Biktarvy?
While both are INSTIs with robust efficacy, TIVICAY offers advantages in safety and resistance profile. Biktarvy currently holds a larger market share owing to aggressive marketing and comprehensive fixed-dose formulations; however, TIVICAY's flexibility and long-term data sustain its competitiveness.

3. What impact do patent expirations have on TIVICAY’s revenue?
Patent expirations could lead to generic entry, exerting downward pressure on pricing and margins. Strategic actions, such as formulation improvements and new delivery methods, aim to mitigate this impact.

4. What role do emerging markets play in TIVICAY’s growth?
Emerging markets offer substantial growth opportunities due to expanding HIV prevalence, increasing access programs, and local manufacturing initiatives that reduce costs.

5. What new developments in the pipeline could influence TIVICAY’s future?
Long-acting injectable formulations, including injectable dolutegravir, are in advanced clinical stages. Their approval and adoption could significantly boost future revenues and market share.

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References:
[1] Fortune Business Insights. (2022). “HIV Drugs Market Size, Share & Industry Analysis."
[2] IQVIA. (2022). “Global HIV Market Data."
[3] Gilead Sciences. (2022). “Annual Financial Report."
[4] ViiV Healthcare. (2022). “Product Portfolio and Market Strategies."
[5] GoodRx. (2022). “TIVICAY Pricing and Cost Analysis."