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-six 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:	156
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	31
Patent Applications:	822
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
Chelsea and Westminster NHS Foundation Trust	Phase 1
Chelsea and Westminster NHS Foundation Trust	Phase 3
Frederick National Laboratory for Cancer Research	Phase 4

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.

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	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No					Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	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 PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					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
China	101212903	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Cyprus	1120345
Japan	2012131791	SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES
Japan	5131689
Lithuania	PA2021512

Supplementary Protection Certificates for TIVICAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	2018C/041	Belgium		PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD DOLUTEGRAVIRNATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD RILPIVIRINEHYDROCHLORIDE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
2465580	2190020-4	Sweden		PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
1874117	300676	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
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
3494972	PA2024516	Lithuania		PRODUCT NAME: DOLUTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA IR LAMIVUDINA; REGISTRATION NO/DATE: EU/1/19/1370 20190701

Market Dynamics and Financial Trajectory of Tivicay

Introduction

Tivicay, known generically as dolutegravir, is a significant player in the HIV treatment market, developed by Shionogi and marketed by ViiV Healthcare, a joint venture between GlaxoSmithKline, Pfizer, and Shionogi. Here, we delve into the market dynamics and financial trajectory of Tivicay, highlighting its impact, challenges, and future prospects.

FDA Approval and Market Entry

Tivicay received FDA approval in 2013 as a once-daily drug, positioning itself as a crucial addition to the standard HIV treatment regimens. It is used as an integrase strand transfer inhibitor (INSTI) and is often combined with other antiretroviral drugs like Ziagen and Zeffix, which are available as generics[3].

Pricing Strategy

Upon its launch, Tivicay was priced at $1,175 per month, or $14,105 per year, which is within the range of other third agents used in combination antiretroviral therapy. This pricing drew comparisons with other HIV treatments like Complera and Stribild from Gilead Sciences, which were also criticized for their high costs[3].

Market Reception and Growth

Despite the initial cost concerns, Tivicay has been well-received due to its efficacy and tolerability. Analysts predicted significant growth, estimating that Tivicay could reach $900 million in sales by 2017 and potentially up to $5 billion in peak sales. The drug's high barrier to resistance and its effectiveness in stopping the HIV virus have been key factors in its market success[3].

Competitive Landscape

The HIV treatment market is highly competitive, with several key players. Tivicay has had to compete with established treatments like Gilead's Stribild and Complera, as well as newer entrants like Biktarvy. However, Tivicay's unique profile and ViiV's access programs have helped it carve out a significant market share. The rise of Biktarvy, an integrase-based regimen from Gilead, has impacted the sales of older TDF-based and TAF-based regimens but has not significantly derailed Tivicay's growth[1][3].

Access Programs and Global Reach

ViiV Healthcare has implemented access programs to ensure Tivicay reaches patients in developing countries. The company has partnered with generic manufacturers to produce a low-cost version of the drug, subject to regulatory approvals. This strategy aims to address concerns from organizations like Médecins Sans Frontières (MSF) about the drug's affordability in poorer regions[3].

Financial Performance

Since its launch, Tivicay has contributed significantly to ViiV Healthcare's revenue. While specific financial figures for Tivicay alone are not always detailed, the drug's impact on ViiV's overall financial performance is evident. For instance, ViiV's portfolio, which includes Tivicay, has seen steady growth, driven by the drug's strong market performance and the company's strategic initiatives[3].

Market Size and Growth Projections

The global HIV drugs market, which includes Tivicay, is expected to grow from $33.82 billion in 2023 to $35.33 billion in 2024, with a compound annual growth rate (CAGR) of 4.5%. By 2028, the market is projected to reach $41.2 billion, driven by increased government support, healthcare expenditure, and research and development spending[4].

Trends and Innovations

The HIV treatment market is witnessing several trends that could influence Tivicay's future. These include investments in 3D bioprinting technology, new product innovations, and the development of multi-class combination products. Strategic collaborations and agreements are also becoming more prevalent, which could further enhance Tivicay's market position[4].

Challenges and Criticisms

Despite its success, Tivicay faces challenges related to pricing and accessibility. Organizations like MSF have expressed concerns that the drug's price could limit its availability in developing countries. However, ViiV's efforts to make the drug more accessible through generic licensing agreements are steps in the right direction[3].

Key Takeaways

• Market Reception: Tivicay has been well-received due to its efficacy and tolerability.
• Pricing Strategy: Priced competitively at $14,105 per year, with access programs for developing countries.
• Competitive Landscape: Competes with other HIV treatments but maintains a strong market position.
• Financial Performance: Contributes significantly to ViiV Healthcare's revenue.
• Market Growth: Part of a growing global HIV drugs market expected to reach $41.2 billion by 2028.
• Access Programs: ViiV has implemented programs to ensure affordability in developing countries.

FAQs

What is Tivicay, and how is it used in HIV treatment?

Tivicay, known generically as dolutegravir, is an integrase strand transfer inhibitor (INSTI) used in combination with other antiretroviral drugs to treat HIV. It is taken once daily and is often combined with drugs like Ziagen and Zeffix.

How much does Tivicay cost, and what are the concerns about its pricing?

Tivicay is priced at $1,175 per month, or $14,105 per year. There have been concerns about its affordability, particularly in developing countries, but ViiV Healthcare has implemented access programs to address these issues.

How does Tivicay compare to other HIV treatments in the market?

Tivicay competes with other treatments like Gilead's Stribild and Complera, as well as newer treatments like Biktarvy. However, its unique profile and access programs have helped it maintain a strong market position.

What are the future growth projections for Tivicay and the HIV drugs market?

The global HIV drugs market, which includes Tivicay, is expected to grow from $33.82 billion in 2023 to $41.2 billion by 2028, driven by increased government support, healthcare expenditure, and research and development spending.

How is ViiV Healthcare addressing accessibility concerns for Tivicay in developing countries?

ViiV Healthcare has partnered with generic manufacturers to produce a low-cost version of Tivicay for developing countries, subject to regulatory approvals, to ensure broader access to the drug.

Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
2. Shionogi: 1st Half (Interim period) of Fiscal 2024 Financial Results.
3. FiercePharma: ViiV's newly minted HIV fighter Tivicay to cost $14K per year.
4. The Business Research Company: HIV Drugs Global Market Report 2024.