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-five 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:	275
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

Constraining patent/regulatory exclusivity:

9,242,986*PED

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.

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

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
Austria	E516026
Australia	2006239177	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Brazil	PI0610030	composto, processo para a preparação de um composto, método de tratamento de uma infecção por hiv em um humano, uso de um composto, e, composição farmacêutica

Supplementary Protection Certificates for TIVICAY PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	C300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117	CA 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116
1874117	PA2014021	Lithuania		PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116

TIVICAY PD Market Dynamics and Financial Trajectory

Last updated: August 4, 2026

TIVICAY PD is ViiV Healthcare’s pediatric dispersible formulation of dolutegravir, an integrase strand transfer inhibitor used with other antiretroviral drugs. Its commercial value is strategic rather than material as a standalone product: ViiV does not publicly report TIVICAY PD revenue separately, and the product addresses a small pediatric segment within the much larger dolutegravir franchise.

The product has durable clinical demand because dolutegravir is recommended for children and adolescents living with HIV, but its growth is constrained by generic dolutegravir, donor-funded procurement, low pediatric patient volumes, and the availability of alternative pediatric fixed-dose regimens. The principal financial exposure sits in the broader Tivicay, Triumeq, Dovato and long-acting HIV portfolios rather than in TIVICAY PD alone.

What is TIVICAY PD and who markets it?

TIVICAY PD is a dispersible-tablet formulation of dolutegravir sodium. It is designed for oral suspension after dispersion in water and is intended for pediatric patients who cannot reliably swallow conventional tablets.

Attribute	TIVICAY PD
Active ingredient	Dolutegravir sodium
Drug class	Integrase strand transfer inhibitor
Originator	ViiV Healthcare
Principal shareholders	GSK, Pfizer and Shionogi
FDA approval	June 2020
FDA population	Pediatric patients aged at least 4 weeks and weighing at least 3 kg, subject to label restrictions
Use	Combination antiretroviral therapy
Dosage form	Dispersible tablets
Primary commercial role	Pediatric extension of the dolutegravir franchise
Standalone revenue disclosure	Not reported by ViiV or GSK

The FDA approved TIVICAY PD in 2020 for children at least 4 weeks old and weighing at least 3 kg. The product expanded access to dolutegravir for children who require weight-based dosing or cannot take standard film-coated tablets [1].

ViiV also markets TIVICAY tablets for adults and older pediatric patients, as well as dolutegravir-containing combination products such as TRIUMEQ, TRIUMEQ PD and DOVATO. These products compete for some of the same HIV treatment demand but are not interchangeable across all ages, treatment histories or clinical settings.

How large is the TIVICAY PD market?

The TIVICAY PD market is a niche segment of the global HIV antiretroviral market. Its addressable population is limited by three factors:

1. Children represent a minority of people living with HIV.
2. Many pediatric patients receive generic or donor-procured dolutegravir products rather than originator-branded TIVICAY PD.
3. Fixed-dose pediatric combinations can reduce the need for separate dolutegravir monotherapy formulations.

UNAIDS estimated that approximately 1.5 million children aged 0 to 14 years were living with HIV globally in 2023, compared with roughly 39.9 million people living with HIV across all age groups [2]. Pediatric patients therefore account for less than 4% of the global HIV population.

Treatment coverage is also lower among children than adults. UNAIDS reported that children continue to have lower access to antiretroviral treatment and viral suppression than adults, creating a clinical need but not necessarily a high-value commercial market [2].

What drives demand for TIVICAY PD?

Demand is linked to:

• Pediatric HIV diagnosis and treatment initiation.
• National adoption of dolutegravir-based regimens.
• Availability of weight-band dosing.
• Procurement by governments and international organizations.
• Pediatric treatment guidelines from the World Health Organization.
• Clinical need for a palatable, dispersible formulation.
• Use in children who cannot take fixed-dose combination tablets.

The WHO recommends dolutegravir-based regimens as preferred treatment for many children and adolescents, subject to age, weight and treatment-history considerations [3]. That recommendation supports class demand but does not guarantee originator pricing or market share.

What is the financial trajectory of TIVICAY PD?

TIVICAY PD has no separately reported revenue line in GSK’s public financial disclosures. GSK reports performance for ViiV Healthcare and, in some periods, for larger HIV brands, but it does not disclose a standalone sales figure for TIVICAY PD.

The most defensible financial conclusion is that TIVICAY PD contributes a small, undisclosed amount to ViiV’s HIV revenue. Its economic value comes from franchise defense, pediatric lifecycle management and formulary access rather than direct sales scale.

How is the broader ViiV franchise performing?

ViiV’s total sales were approximately £7.9 billion in 2023, compared with approximately £7.6 billion in 2022 and £7.1 billion in 2021, based on GSK reporting [4]. Growth was supported by long-acting CABENUVA, DOVATO and other HIV products, while older products faced generic erosion and competitive pressure.

The revenue structure has shifted:

Franchise component	Financial direction	Relevance to TIVICAY PD
TIVICAY and dolutegravir-based therapy	Mature, resilient	Supports pediatric prescribing and brand recognition
TRIUMEQ	Declining or pressured	Competes with newer regimens and faces component-level generic pressure
DOVATO	Growing	Reduces the need for three-drug therapy in eligible adults
CABENUVA	Growing	Moves ViiV toward higher-value long-acting treatment
Pediatric formulations	Small, strategically important	Supports guideline compliance and lifecycle management

TIVICAY PD should therefore be valued as a low-revenue extension of an established platform, not as a standalone growth asset.

When does TIVICAY PD lose exclusivity?

TIVICAY PD did not receive a new chemical entity exclusivity period when it was approved in 2020 because dolutegravir had already been approved in the United States in 2013. The 2020 approval was a new dosage form and pediatric presentation.

The key exclusivity risks are:

• Expiration of dolutegravir compound or formulation patents.
• Generic approval of pediatric dolutegravir products.
• Generic substitution involving therapeutically equivalent dolutegravir tablets.
• Competitive pediatric fixed-dose combinations.
• International patent expiry and voluntary licensing.

The original U.S. five-year new chemical entity exclusivity for dolutegravir expired before TIVICAY PD approval. Any remaining protection depends on listed patents, pediatric exclusivity, formulation claims and regulatory protections associated with specific products.

A precise TIVICAY PD loss-of-exclusivity date cannot be inferred from the product’s 2020 approval date. Generic entry timing depends on the Orange Book listing, patent certifications, litigation outcomes and jurisdiction-specific regulatory rules.

What is the Orange Book status of TIVICAY PD?

TIVICAY PD is subject to U.S. FDA product-specific regulatory and patent records, but its commercial protection should be analyzed separately from the broader TIVICAY tablet listing.

The relevant questions are:

• Whether the dispersible formulation has a separately listed formulation patent.
• Whether method-of-use patents apply to the pediatric indication.
• Whether a generic applicant can rely on an existing dolutegravir approval.
• Whether an ANDA applicant must address patents listed against TIVICAY PD or against the active ingredient product.
• Whether pediatric exclusivity extends any listed patent term.

The principal legal distinction is between active-ingredient protection and dosage-form protection. Dolutegravir’s active-ingredient patents may constrain generic entry into the molecule, while formulation patents may be narrower and easier to design around. Pediatric-use patents can provide additional leverage but generally do not create the same barrier as a valid compound patent.

Which companies are challenging TIVICAY PD and dolutegravir?

The main competitive threat is generic dolutegravir, not a branded rival directly duplicating TIVICAY PD.

Potential competitors include:

• Generic manufacturers supplying dolutegravir tablets or dispersible tablets.
• Suppliers participating in Global Fund, PEPFAR and other donor-funded tenders.
• Manufacturers licensed through the Medicines Patent Pool.
• ViiV’s own pediatric combination products.
• Other integrase inhibitors used in pediatric treatment.

The Medicines Patent Pool entered into licensing arrangements with ViiV covering dolutegravir for selected low- and middle-income countries. Those arrangements expanded access to generic dolutegravir while preserving originator commercial rights in many higher-income markets [5].

Generic competition is most intense where procurement agencies prioritize lowest total treatment cost. In those markets, TIVICAY PD must justify a price premium through pediatric usability, supply reliability, regulatory approval and clinical familiarity.

What formulations are protected by TIVICAY PD?

TIVICAY PD’s principal technical differentiation is the dispersible tablet.

Pediatric dispersible tablets

The formulation is intended to:

• Permit administration to young children.
• Support weight-based dosing.
• Avoid swallowing difficulties.
• Reduce dependence on extemporaneous liquid formulations.
• Improve dose administration in resource-limited settings.

Formulation value depends on practical use. A dispersible product may command a premium if it has acceptable taste, stable supply and simple administration. That premium is weakened when lower-cost generic dispersible products become available.

Pediatric fixed-dose combinations

TRIUMEQ PD combines dolutegravir with abacavir and lamivudine in a pediatric dispersible formulation. This product can displace separate TIVICAY PD use where the child is eligible for the full combination and the prescriber prefers a single regimen.

The competitive relationship is therefore mixed. ViiV’s pediatric portfolio can expand overall dolutegravir access while shifting volume away from TIVICAY PD.

How strong is the TIVICAY PD patent estate?

The patent estate is strategically useful but less robust than a new chemical entity estate.

Strengths

• Dolutegravir is a clinically established molecule with strong guideline support.
• Pediatric dosing and formulation know-how can create practical barriers.
• Regulatory filings and manufacturing controls may delay direct competition.
• ViiV has experience defending and licensing its HIV portfolio.
• Brand reputation supports procurement and physician acceptance.

Weaknesses

• TIVICAY PD was approved after the core molecule had been commercialized for years.
• New chemical entity exclusivity did not restart with the pediatric presentation.
• Pediatric formulation claims may be narrower than compound claims.
• Generic manufacturers can target alternative formulations.
• Public-sector procurement can compress net pricing.
• Product-level revenue is too small to support extensive promotional investment.

The strongest protection is likely to come from the combination of regulatory approval, manufacturing capability, supply contracts and pediatric guideline positioning rather than from TIVICAY PD alone.

What generic entry risks exist for TIVICAY PD?

Generic entry risk is medium to high over the long term and varies sharply by geography.

Market	Generic risk	Main reason
United States	Medium	Patent certifications, litigation and limited pediatric volume may delay entry
European Union	Medium to high	National reimbursement and generic availability vary by country
Low- and middle-income countries	High	Voluntary licensing and donor procurement support generic access
Sub-Saharan Africa	High	Generic dolutegravir is widely prioritized in public programs
Japan and other regulated markets	Medium	Local regulatory and patent rules affect timing

A generic launch could occur through several routes:

1. A direct generic dispersible-tablet product.
2. A generic dolutegravir tablet used through age-appropriate administration.
3. A fixed-dose pediatric combination that reduces demand for single-agent TIVICAY PD.
4. A licensed product supplied through international procurement channels.

The commercial impact would be limited in absolute dollars because TIVICAY PD sales are small, but the impact on pediatric franchise share and pricing discipline could be meaningful.

What licensing deals affect TIVICAY PD?

The most important licensing framework is ViiV’s dolutegravir licensing through the Medicines Patent Pool. The agreements have supported generic supply in a defined group of low- and middle-income countries [5].

These licenses create a two-tier commercial model:

• Originator-led sales in markets where patents, reimbursement and commercial channels support branded pricing.
• Licensed or generic supply in markets where public procurement and access objectives dominate.

This structure limits global price realization but can increase patient reach and support the treatment standard for pediatric HIV.

ViiV also has a wider strategic licensing and partnership history in HIV, including relationships involving Shionogi and other commercial partners. Those arrangements are more relevant to the broader dolutegravir and long-acting HIV portfolio than to standalone TIVICAY PD economics.

What FDA regulatory status applies to TIVICAY PD?

The FDA approved TIVICAY PD in June 2020. The product is indicated with other antiretroviral agents for HIV-1 treatment in pediatric patients meeting the labeled age and weight criteria [1].

The regulatory profile is favorable:

• It is an approved drug, not an investigational product.
• The active ingredient has extensive clinical and postmarketing experience.
• The pediatric formulation addresses an established treatment need.
• The primary risks relate to drug interactions, hypersensitivity, liver effects and resistance considerations described in the label.
• Its market is governed by pediatric treatment guidelines and combination-regimen eligibility.

Regulatory risk is lower than commercial risk. The larger issue is whether prescribers and procurement agencies select the branded dispersible product over generic or combination alternatives.

What is the competitive landscape for pediatric dolutegravir?

TIVICAY PD competes within a treatment ecosystem rather than against a single direct substitute.

Competitive category	Examples	Effect on TIVICAY PD
Originator dolutegravir	TIVICAY tablets and PD	Supports brand ecosystem
Pediatric fixed-dose combinations	TRIUMEQ PD	Can reduce standalone use
Generic dolutegravir	Licensed and non-originator products	Puts pressure on price and share
Other integrase inhibitors	Raltegravir and other agents	Relevant where dolutegravir is unsuitable
Liquid or compounded formulations	Alternative administration formats	Can substitute for dispersible tablets
Long-acting therapy	CABENUVA for eligible populations	Limited direct pediatric overlap today

Dolutegravir remains structurally advantaged by guideline status, tolerability, potency and dosing convenience. TIVICAY PD’s disadvantage is that pediatric demand is small and buyers often prioritize access over brand differentiation.

What revenue exposure does TIVICAY PD create for ViiV and GSK?

Standalone revenue exposure is low because ViiV does not disclose TIVICAY PD sales separately. The larger exposure is indirect:

• Loss of pediatric dolutegravir share could weaken the lifecycle value of the Tivicay brand.
• Generic pricing could affect procurement economics across the dolutegravir franchise.
• Pediatric fixed-dose combinations could shift revenue within ViiV’s portfolio.
• Formulation competition could reduce the value of pediatric lifecycle extensions.
• Public-sector tenders could produce volume without proportional revenue growth.

For valuation purposes, TIVICAY PD should be modeled as a small contribution to ViiV’s HIV business with low incremental growth, limited standalone disclosure and high sensitivity to generic pricing. It should not be modeled as a major future revenue driver.

What generic launch scenarios are most likely?

Base case

TIVICAY PD retains a specialized role in higher-income and selected institutional markets. Generic dolutegravir remains dominant in lower-income public programs. ViiV maintains the brand through pediatric access, supply reliability and integration with its HIV portfolio.

Downside case

A widely available generic dispersible formulation receives procurement preference. TIVICAY PD loses share rapidly, and ViiV shifts pediatric demand toward TRIUMEQ PD or other combination products.

Upside case

Pediatric HIV diagnosis and treatment coverage improve, dolutegravir remains the preferred global standard, and TIVICAY PD retains a premium position in markets where pediatric formulation quality and regulatory assurance matter.

The upside is limited by the size of the pediatric population and the availability of lower-cost products.

Key Takeaways

• TIVICAY PD is ViiV’s pediatric dispersible dolutegravir formulation, approved by the FDA in 2020.
• Its standalone revenue is not publicly disclosed and is likely small relative to ViiV’s approximately £7.9 billion HIV business in 2023.
• The product’s value is strategic: it extends the dolutegravir franchise into pediatric treatment and supports guideline-aligned care.
• Generic dolutegravir and licensed products create high long-term pricing pressure, particularly in low- and middle-income countries.
• TIVICAY PD did not receive a new chemical entity exclusivity period when approved.
• Pediatric formulation, regulatory, manufacturing and procurement barriers provide protection, but they are weaker than core compound protection.
• TRIUMEQ PD is an important internal competitor because it can replace separate dolutegravir use in eligible children.
• The product is unlikely to become a material standalone growth driver for ViiV or GSK.

FAQs

Is TIVICAY PD the same as regular TIVICAY?

No. Both contain dolutegravir, but TIVICAY PD is a pediatric dispersible formulation, while regular TIVICAY is generally supplied as a film-coated tablet.

Can adults use TIVICAY PD?

TIVICAY PD is developed and labeled for pediatric dosing. Adult use should follow the applicable product labeling and clinical guidance rather than relying on the pediatric presentation.

Does TIVICAY PD have biosimilar competition?

No. Biosimilars apply to biologic medicines. TIVICAY PD is a small-molecule drug and faces generic, not biosimilar, competition.

Is TIVICAY PD included in HIV donor procurement programs?

Dolutegravir products are widely used in global HIV procurement programs. The specific inclusion of branded TIVICAY PD depends on country registration, tender terms, licensing arrangements and procurement policy.

Is TIVICAY PD a major revenue product for GSK?

No. GSK reports ViiV and broader HIV revenue, but it does not identify TIVICAY PD as a major standalone revenue contributor. Its commercial role is primarily pediatric franchise support.

References

1. U.S. Food and Drug Administration. (2020). TIVICAY PD prescribing information. https://www.accessdata.fda.gov
2. Joint United Nations Programme on HIV/AIDS. (2024). The urgency of now: AIDS at a crossroads. https://www.unaids.org
3. World Health Organization. (2023). Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring. https://www.who.int
4. GSK plc. (2024). Annual report 2023. https://www.gsk.com
5. Medicines Patent Pool. (n.d.). Dolutegravir licensing agreements and pediatric HIV medicines. https://medicinespatentpool.org