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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-five 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. Three 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-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 PD

International Patents:	155
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	31
Patent Applications:	43
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
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 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
Israel	225207	נגזרת של קרבאמוילפירידון רב-טבעתי, הרכב רוקחי המכיל אותה, השימוש בה ותהליך להכנתה (Polycyclic carbamoylpyridone derivative, pharmaceutical composition comprising the same, use and process for preparation thereof)
World Intellectual Property Organization (WIPO)	2006088173
Norway	20161315	Polysyklisk karbamoylpyridonderivat som har integrase inhibitorisk aktivitet

Supplementary Protection Certificates for TIVICAY PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
2932970	C201830054	Spain		PRODUCT NAME: COMBINACION QUE COMPRENDE DOLUTEGRAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (DOLUTEGRAVIR SODICO) Y RILPIVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA (RILPIVIRINA HIDROCLORURO); NATIONAL AUTHORISATION NUMBER: EU/1/18/1282; DATE OF AUTHORISATION: 20180516; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1282; DATE OF FIRST AUTHORISATION IN EEA: 20180516

TIVICAY PD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Tivicay PD

Introduction to Tivicay PD

Tivicay PD, developed by ViiV Healthcare, is a formulation of the drug dolutegravir, specifically designed for pediatric patients. It is intended to treat HIV-1 infection in children and infants who are at least 4 weeks old and weigh at least 3 kg, including those who have never been treated for HIV or who have been treated with other HIV medications[4].

Market Position of ViiV Healthcare

ViiV Healthcare holds a significant position in the HIV-1 treatment market, with a market share of approximately 21% in 2020. The company's portfolio includes two blockbuster drugs: Tivicay/Tivicay PD and Triumeq. These drugs have been crucial in maintaining ViiV Healthcare's market presence, although the company has faced competition from Gilead Sciences, which dominates the market with a 68% share[1].

Product Approval and Regulatory Landscape

Tivicay and Tivicay PD received FDA approval in 2020, with Priority Review designation, indicating that these drugs significantly improve the safety or effectiveness of treating HIV in pediatric patients. This approval has been a key factor in the drug's market acceptance and usage[4].

Market Trends in HIV-1 Treatment

The HIV-1 treatment market is undergoing significant changes, with a shift from multi-tablet regimens (MTRs) to single-tablet regimens (STRs). This trend has impacted the sales of various HIV-1 therapies, including those from ViiV Healthcare. The market for MTRs has been declining, while STRs have seen an increase in sales. For instance, the US market for MTRs decreased from $5,918 million in 2018 to $3,867 million in 2020, while the market for STRs increased from $10,305 million to $13,620 million during the same period[1].

Competitive Landscape

Tivicay PD faces competition from other STRs, particularly those from Gilead Sciences. The launch of Biktarvy by Gilead Sciences in 2018 has significantly impacted the market, capturing a substantial share and reducing the sales of older TDF-based and TAF-based regimens. Biktarvy's market size increased from $1,144 million in its launch year to $6,095 million in 2020 and is expected to reach $10,673 million by 2024, making it a market leader[1].

Financial Performance of ViiV Healthcare

While specific financial data for Tivicay PD is not detailed, the overall performance of ViiV Healthcare and its parent companies provides insight into the financial trajectory. ViiV Healthcare is a joint venture between GSK, Pfizer, and Shionogi, with GSK being a significant partner. GSK's financial reports indicate strong performance across Specialty Medicines, including HIV treatments. For example, GSK's sales growth in Specialty Medicines, including HIV, has been robust, contributing to the company's overall financial health[3].

Impact of Patent Expiry

The HIV-1 treatment market is expected to face challenges due to the impending patent expiry of several key products. For instance, patents for drugs like Selzentry, Atripla, Truvada, and others are set to expire in the coming years. This could impact the market share and revenue of Tivicay PD, as generic versions of these drugs may enter the market, increasing competition[1].

Future Outlook

Despite the competitive landscape and patent expiry challenges, Tivicay PD remains a crucial part of ViiV Healthcare's portfolio. The company's focus on innovative treatments, including long-acting HIV therapies, is expected to drive future growth. GSK's strategic report highlights the company's commitment to R&D and business development, which will likely support the continued relevance of Tivicay PD and other HIV treatments in the market[3].

Key Statistics and Market Size

• Market Share: ViiV Healthcare holds a 21% market share in the HIV-1 treatment market as of 2020[1].
• Sales Growth: The US market for STRs, which includes Tivicay PD, grew from $10,305 million in 2018 to $13,620 million in 2020[1].
• Competitive Impact: Biktarvy's market size increased from $1,144 million in 2018 to $6,095 million in 2020 and is projected to reach $10,673 million by 2024[1].

Expert Insights and Quotes

"The faster uptake of Biktarvy is believed to be for many reasons, including its excellent safety and efficacy and the fact that it does not require pharmacokinetic boosting." - DelveInsight[1].

This quote highlights the competitive pressure Tivicay PD faces from newer, more efficient treatments.

Illustrative Statistics

• Tivicay and Tivicay PD: Approved for pediatric use in 2020, these drugs are part of ViiV Healthcare's strategy to maintain market presence in the HIV-1 treatment sector[4].
• Market Shift: The shift from TDF-based to TAF-based regimens and now to newer STRs like Biktarvy has significantly impacted the sales of older therapies, including those from ViiV Healthcare[1].

Key Takeaways

• Tivicay PD is a critical component of ViiV Healthcare's HIV-1 treatment portfolio, especially for pediatric patients.
• Market Trends favor STRs over MTRs, impacting the sales of various HIV-1 therapies.
• Competitive Landscape is dominated by Gilead Sciences, with Biktarvy being a major competitor.
• Financial Performance of ViiV Healthcare and its partners, such as GSK, indicates strong growth in Specialty Medicines.
• Future Outlook is influenced by R&D investments and the impending patent expiry of key products.

FAQs

Q: What is Tivicay PD used for? A: Tivicay PD is used to treat HIV-1 infection in pediatric patients who are at least 4 weeks old and weigh at least 3 kg.

Q: Who developed Tivicay PD? A: Tivicay PD was developed by ViiV Healthcare, a joint venture between GSK, Pfizer, and Shionogi.

Q: How does Tivicay PD fit into the current market trends in HIV-1 treatment? A: Tivicay PD is part of the trend towards single-tablet regimens (STRs), which are preferred over multi-tablet regimens (MTRs) due to their convenience and efficacy.

Q: What are the main competitors to Tivicay PD in the HIV-1 treatment market? A: The main competitors include Biktarvy from Gilead Sciences, which has significantly impacted the market share of older therapies.

Q: How will patent expiry affect the market for Tivicay PD? A: The impending patent expiry of several key HIV-1 treatments could increase competition from generic versions, potentially affecting the market share and revenue of Tivicay PD.

Cited Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market - DelveInsight
2. GSK: Press release - Full-year and fourth quarter 2022 - GSK
3. GSK: Strategic report 2023 | GSK
4. FDA: FDA Approves Drug to Treat Infants and Children with HIV