TRIZIVIR Drug Patent Profile

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

Trizivir is a drug marketed by Viiv Hlthcare and is included in one NDA.

The generic ingredient in TRIZIVIR is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Summary for TRIZIVIR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	20
Drug Prices:	Drug price information for TRIZIVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIZIVIR
What excipients (inactive ingredients) are in TRIZIVIR?	TRIZIVIR excipients list
DailyMed Link:	TRIZIVIR at DailyMed

See drug prices for TRIZIVIR

Recent Clinical Trials for TRIZIVIR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AIDS Clinical Trials Group	Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3
Ines Perez	Phase 4

See all TRIZIVIR clinical trials

Paragraph IV (Patent) Challenges for TRIZIVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIZIVIR	Tablets	abacavir sulfate; lamivudine; zidovudine	300 mg/150 mg/ 300 mg	021205	1	2011-03-22

US Patents and Regulatory Information for TRIZIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000		DISCN	Yes	No

Expired US Patents for TRIZIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	7,119,202*PED
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	4,837,208
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	4,828,838
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	4,724,232
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	6,294,540*PED
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	4,833,130

International Patents for TRIZIVIR

See the table below for patents covering TRIZIVIR around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	9809126
Indonesia	24910
South Africa	9000943
United Kingdom	9506490
United Kingdom	2340491	Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Mexico	9707316	COMBINACIONES SINERGISTICAS DE ZIDOVUDINA, 1592U89 Y 3TC O FTC. (SYNERGISTIC COMBINATIONS OF ZIDOVUDINE, 1592U89 AND 3TC OR FTC.)

Supplementary Protection Certificates for TRIZIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	SPC016/2005	Ireland		SPC016/2005: 20060407, EXPIRES: 20191216
0434450	33/1999	Austria		PRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628
0382526	SZ 22/1996	Austria		PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE
0434450	990028	Netherlands		PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
0817637	23/2005	Austria		PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
0817637	SPC/GB05/027	United Kingdom		SPC/GB05/027: 20050922, EXPIRES: 20191216

Market Dynamics and Financial Trajectory for Trizivir

Introduction to Trizivir

Trizivir is a fixed-dose combination (FDC) drug used to treat adults infected with the human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS). It contains three active substances: abacavir, lamivudine, and zidovudine, all of which are nucleoside reverse transcriptase inhibitors (NRTIs)[4].

Mechanism of Action

Trizivir works by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to replicate within infected cells. This action reduces the amount of HIV in the blood and helps maintain the immune system, preventing the development of infections and diseases associated with AIDS[4].

Market Overview

The global market for combination drugs, including Trizivir, is experiencing significant growth. This growth is driven by several factors, including the high efficiency of combination drugs, convenience in dosing schedules, and improved patient compliance, particularly in the treatment of chronic diseases like HIV and tuberculosis[1].

Regional Market Insights

North America

North America is expected to dominate the global combination drugs market, including Trizivir, due to ongoing technological advancements in the healthcare sector and the prevalence of chronic diseases in the US. Favorable government policies and the rising prevalence of cardiovascular diseases and diabetes also contribute to market growth in this region[1].

Asia Pacific

The Asia Pacific region is witnessing rapid growth due to an increasing geriatric population, rising awareness, favorable government policies, increased healthcare expenditure, and modernization in medical infrastructure, especially in countries like India, China, and Japan[1].

Competitive Landscape

Trizivir is part of a competitive market where several pharmaceutical companies are active. For instance, Gilead Sciences, the manufacturer of Trizivir, has a significant presence in the antiviral market. The company's strategic mergers and acquisitions, such as the acquisition of Pharmasset, have helped fortify its position by eliminating potential competition and expanding its market share[3].

Financial Performance

While specific financial data for Trizivir alone is not readily available, the overall financial performance of companies like Gilead Sciences, which manufactures Trizivir, can provide insights. Gilead Sciences has historically generated significant revenue from its antiviral drugs, including those used in combination therapies. For example, the acquisition of Pharmasset and the subsequent launch of Sovaldi, another antiviral drug, generated tens of billions of dollars annually[3].

Revenue and Market Share

The revenue generated by combination drugs like Trizivir contributes to the overall financial health of pharmaceutical companies. For instance, Gilead Sciences' market share in the antiviral drug market increased significantly after the acquisition of Pharmasset, indicating the financial impact of such strategic moves[3].

Challenges and Risks

Despite the market growth, there are challenges associated with combination drugs like Trizivir. These include risks related to side effects, difficulties in identifying the specific active ingredient causing harmful or beneficial effects, and the high cost of these products in mid and low-income economies[1].

Regulatory Environment

Trizivir has received marketing authorization in various regions, including the European Union. The European Medicines Agency (EMA) has noted that the benefits of Trizivir, including reduced pill burden and improved patient compliance, outweigh its risks. Continuous monitoring of side effects and necessary actions to protect patients are part of the regulatory oversight[4].

Patient Compliance and Adherence

One of the key benefits of Trizivir is its ability to reduce the number of tablets patients need to take, which can significantly improve treatment adherence. This convenience is a major factor driving the market growth for combination drugs[4].

Future Outlook

The combination drugs diagnostic market, including Trizivir, is expected to grow at a CAGR of 13.2% during the forecast period from 2023 to 2029, reaching a market size of US$ 12.99 billion by 2029. This growth is fueled by ongoing technological advancements, increasing prevalence of chronic diseases, and favorable government policies[1].

Key Takeaways

• Market Growth: The combination drugs market, including Trizivir, is expected to grow significantly due to high efficiency, convenience, and improved patient compliance.
• Regional Dominance: North America and the Asia Pacific are key regions driving market growth.
• Competitive Landscape: Strategic mergers and acquisitions play a crucial role in market dominance.
• Financial Performance: Combination drugs contribute substantially to the revenue of pharmaceutical companies.
• Challenges: Side effects, identification of active ingredients, and high costs are significant challenges.
• Regulatory Environment: Continuous monitoring and regulatory approvals are essential for market presence.

FAQs

Q: What is Trizivir used for?

A: Trizivir is used to treat adults infected with the human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS)[4].

Q: How does Trizivir work?

A: Trizivir works by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to replicate within infected cells[4].

Q: What are the benefits of using Trizivir?

A: The benefits include reducing the number of tablets patients need to take, which improves treatment adherence, and maintaining the immune system by reducing the amount of HIV in the blood[4].

Q: What are the potential risks associated with Trizivir?

A: Risks include side effects, difficulties in identifying the specific active ingredient causing harmful or beneficial effects, and the high cost of the product in mid and low-income economies[1].

Q: What is the expected market growth for combination drugs like Trizivir?

A: The combination drugs diagnostic market is expected to grow at a CAGR of 13.2% during the forecast period from 2023 to 2029, reaching a market size of US$ 12.99 billion by 2029[1].

Cited Sources

1. Maximize Market Research: "Combination Drugs Diagnostic Market: Global Industry Analysis..."
2. Maravai LifeSciences: "Maravai LifeSciences Reports Second Quarter 2024 Financial Results"
3. MPRA: "Mergers with Future Rivals Can Boost Prices, Intensify Market..."
4. European Medicines Agency: "Trizivir | European Medicines Agency (EMA)"
5. TG Therapeutics: "TG Therapeutics Reports Second Quarter 2024 Financial Results..."