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-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

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:	1,973
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

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 and 25 mg	204790	1	2017-08-14

US Patents and Regulatory Information for TIVICAY

TIVICAY is protected by two US patents.

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					Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		DISCN	Yes	No					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
Austria	E516026
Australia	2006239177	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase

Supplementary Protection Certificates for TIVICAY

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

TIVICAY (dolutegravir) Market Dynamics and Financial Trajectory: Patent/Exclusivity Endpoints, Competitive Timeline, and Revenue Exposure

Last updated: July 23, 2026

Executive summary

• TIVICAY (dolutegravir, DTG) is a high-value anchor for ViiV Healthcare and has maintained commercial durability through line extensions (including fixed-dose combinations) and broad global adoption.
• Near-term market dynamics are driven by (1) patent and exclusivity milestones for dolutegravir across major geographies, (2) competitive intensity from generic dolutegravir and fixed-dose combinations (FDCs), and (3) payer and tender behavior that increasingly rewards lowest net price and reliable supply.
• Financial trajectory is characterized by sustained brand cash flows followed by margin compression as generic entry expands in parallel with continued DTG adoption in treatment-naïve regimens.
• Key revenue risk is not “brand substitution” alone, but replacement of FDC and single-entity offerings in formularies as generic penetration scales.

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What is TIVICAY (dolutegravir) used for and how does that shape market demand?

TIVICAY is an integrase strand transfer inhibitor (INSTI) indicated for HIV treatment. Its demand drivers map to HIV treatment guideline positioning and regimen durability.

Key demand levers

• First-line regimen adoption: DTG-based regimens are widely used in treatment-naïve patients because of strong efficacy and tolerability.
• Switching and intensification: DTG is used for switching from older INSTIs and regimens where viral suppression or tolerability is a key decision.
• Public-sector procurement: Large-volume demand is influenced by global tenders (notably in PEPFAR-supported markets and national HIV programs), where price and supplier reliability dominate.

Where FDCs matter to unit economics

• Dolutegravir is also sold as part of FDCs (for example, DTG/lamivudine and DTG-based triple combinations). These products often retain payer preference even as single-entity branding erodes, shifting revenue mix rather than collapsing demand.

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How fast is generic dolutegravir replacing brand TIVICAY, and where does brand hold up?

Generic replacement typically proceeds by geography and by formulation channel, not uniformly. For DTG, brand resilience has depended on patent boundaries, tender conditions, and patient switching dynamics.

Brand vs generic penetration pattern

• Initial erosion occurs in markets where patent coverage is narrow, already expired, or successfully designed around.
• Brands often retain share in higher-income settings through tender requirements for continuity of supply, pharmacovigilance, and payer contracting.
• In public procurement, generic uptake accelerates when procurers accept lower-cost suppliers without losing regimen performance requirements.

Mechanisms that slow brand decline

• Tender design that favors established suppliers or requires stability of supply for fixed-dose regimens.
• Formulary lock-in and physician practice in specialty care.
• Competitive switching costs, including drug availability constraints and patient stability.

Mechanisms that accelerate brand decline

• Contracting models that reset pricing at each tender cycle.
• Rapid scale-up of generic manufacturing capacity for DTG and DTG-containing FDCs.
• Increased competition among multiple generic manufacturers compressing net prices.

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What competitive landscape defines TIVICAY’s pricing power and market share?

DTG’s competitive set includes:

• Other INSTIs and HIV regimen classes
• Generic dolutegravir and competing FDCs
• Brands and incumbents in specific markets with local tender advantages

INSTI-class competition

• INSTI competitors can limit switching away from DTG but often do not displace DTG rapidly when payer guidance and procurement already favor DTG-based regimens.
• Where alternative INSTIs have favorable tender economics or local approvals, share can shift at the margin.

Generic competitors

• Competition is most intense at the first point where generics are approved and deliverable in scale.
• Fixed-dose combinations reduce “brand-only” leakage because prescribers and formularies prefer simplified regimens.

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How does TIVICAY’s revenue trajectory typically evolve across patent and tender cycles?

DTG revenue behavior in pharmaceuticals is usually cyclical around:

1. patent/exclusivity changes,
2. tender frequency, and
3. competitor pricing resets.

Observed trajectory profile (industry-consistent)

• Phase 1: Brand growth and consolidation post-launch and early guideline adoption.
• Phase 2: Slow-down in growth but sustained high revenue as DTG becomes a standard regimen and FDC mix expands.
• Phase 3: Margin compression as generic share grows; revenue declines depending on tender reset cadence.
• Phase 4: Stabilization driven by remaining protected markets and ongoing uptake via FDCs where generic entry is slower.

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When does TIVICAY lose exclusivity, and which endpoints matter most?

This analysis requires a specific jurisdiction-by-jurisdiction Orange Book and patent expiration map. The question is inherently legal and regulatory. Without the underlying patent lists and expiration dates, producing a complete endpoint timeline would be speculative.

What endpoints typically drive “loss of exclusivity” for DTG products

• Composition-of-matter patent expirations for dolutegravir
• Formulation and process patents that can delay generic launch
• Regulatory exclusivity (including pediatric and marketing exclusivity frameworks where applicable)
• Patent-life extensions tied to specific filings

Because the prompt does not include the patent inventory, FDA Orange Book record identifiers, or jurisdiction scope, a complete exclusivity timeline cannot be produced without inventing dates.

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What is the Orange Book status of TIVICAY, and how does that affect generic entry risk?

The Orange Book status is the controlling dataset for Hatch-Waxman paragraph IV and Section viii carve-outs for small molecules. Generating “Orange Book status” requires the official Orange Book listing and associated patent numbers.

Generic entry risk depends on

• Whether listed patents are expiring vs still in force
• Whether patents are weak (high probability of non-infringement or invalidity)
• Whether generics face formulation-specific barriers

Without the Orange Book listing details for TIVICAY, this section would require ungrounded assertions.

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What patent estate protects dolutegravir (TIVICAY), and how strong is it for commercial leverage?

A strong commercial patent estate typically includes:

• Multiple composition/process families
• Formulation patents (for specific salt forms, dosage forms, and stability)
• Method-of-use and regimen-selection patents (where permitted)
• Geographically diverse filings

Strength is measured by:

• Remaining life by jurisdiction
• Litigation history
• Claim breadth and design-around feasibility
• Coverage of core doses and FDC variants

The prompt provides no patent family list, remaining life, or litigation outcomes. A rigorous “how strong” assessment cannot be completed.

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What patent litigation affects TIVICAY generic launches, and what are the settlement outcomes?

Hatch-Waxman litigation outcomes and settlement terms often dictate:

• Design-around pathways
• Launch dates
• Carve-outs by strength or dosage form
• Co-existence agreements affecting market share

This requires:

• Court docket records
• Paragraph IV filings tied to TIVICAY’s Orange Book patents
• Settlement agreement dates and terms

No litigation dossier is provided, so a factual litigation section cannot be produced.

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How do biosimilar or biologics dynamics matter for TIVICAY?

Biosimilars are a biologics construct. TIVICAY is a small-molecule drug, so biosimilar risk is not applicable in the conventional sense.

What is applicable instead

• Generic small-molecule entry
• FDC generic entry
• Manufacturing process and formulation design-arounds

A biosimilar-focused framework would not match the product’s regulatory pathway.

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What FDA regulatory milestones shape TIVICAY’s ability to expand or defend market position?

For small molecules, regulatory milestones typically include:

• Initial NDA approval and label updates
• Supplemental indications and dose changes
• Approval of FDCs and alternative dosage strengths

These milestones can increase market addressable volume and strengthen payer inclusion.

Without FDA submission identifiers and approval dates, a milestone timeline cannot be stated with precision.

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How does TIVICAY’s financial performance compare with other HIV franchises and INSTI incumbents?

A cross-drug financial comparison requires:

• Company-level sales disclosures by product,
• Segment and geography,
• Time-matched revenue data,
• Net sales vs gross-to-net differences.

No financial statements, consensus estimates, or product-level revenue dataset is provided, so a comparative analysis cannot be completed without fabricating numbers.

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What generic entry scenarios exist for TIVICAY, and which are most likely to hit revenue?

Generic entry scenarios typically segment into:

• Entry by single-entity dolutegravir vs FDCs
• Entry by strength/dosage form
• Entry by geography (ANDA approvals aligned with tender-ready supply)

The revenue impact is largest when:

• Generics gain formulary share quickly through tender resets
• FDCs enter in parallel, capturing simplified regimen demand

This scenario mapping requires knowledge of where and when generics have regulatory approval and where patents block entry. Those facts are not present in the prompt.

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How does tender pricing and reimbursement pressure translate into margin compression for TIVICAY?

For HIV drugs in many markets:

• Net price declines as generic competition increases.
• Margin erosion shows up earlier in gross-to-net due to rebates and contracting pressure.
• Supply reliability becomes a key buying constraint, shaping which generic suppliers scale.

This is directionally true, but mapping to specific TIVICAY financial outcomes needs product revenue figures and gross-to-net disclosures.

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Key Takeaways

• TIVICAY demand is structurally supported by DTG’s role in widely used HIV regimens and by uptake through fixed-dose combinations.
• Competitive dynamics increasingly center on generic and FDC competition through tender economics rather than therapeutic switching away from DTG.
• The revenue trajectory is best modeled as brand durability followed by margin compression as generics scale, with FDCs acting as a mix-stabilizer.
• A precise exclusivity timeline, Orange Book status, patent strength, and litigation-driven generic risk map cannot be produced from the information provided.

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FAQs

1. When do dolutegravir generics typically start winning tenders after patent expiry?
2. How do fixed-dose combinations change the net revenue impact of generic entry for dolutegravir?
3. What factors influence whether brand dolutegravir retains share in high-income formularies after generics launch?
4. How do process and formulation patents affect ANDA approval timing for small-molecule HIV drugs like dolutegravir?
5. What is the usual relationship between HIV drug procurement cycles and quarterly revenue volatility for incumbents?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Database accessed 2026-07-24).

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