Abacavir sulfate; lamivudine; zidovudine - Generic Drug Details

What are the generic drug sources for abacavir sulfate; lamivudine; zidovudine and what is the scope of patent protection?

Abacavir sulfate; lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Lupin Ltd and Viiv Hlthcare, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one tentative approval for this compound.

Summary for abacavir sulfate; lamivudine; zidovudine

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for abacavir sulfate; lamivudine; zidovudine
DailyMed Link:	abacavir sulfate; lamivudine; zidovudine at DailyMed

Recent Clinical Trials for abacavir sulfate; lamivudine; zidovudine

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

Sponsor	Phase
Gilead Sciences	Phase 3
Harvard School of Public Health (HSPH)	Phase 2
Harvard School of Public Health	Phase 2

See all abacavir sulfate; lamivudine; zidovudine clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
		EQ 300MG BASE; 150MG; 300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for abacavir sulfate; lamivudine; zidovudine

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for abacavir sulfate; lamivudine; zidovudine

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

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 abacavir sulfate; lamivudine; zidovudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	202912-001	Dec 5, 2013		RX	No	Yes
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000		DISCN	Yes	No

Expired US Patents for abacavir sulfate; lamivudine; zidovudine

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	6,180,639*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	5,905,082*PED
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	5,047,407*PED
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	6,294,540*PED

Abacavir sulfate; lamivudine; zidovudine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abacavir Sulfate, Lamivudine, and Zidovudine

Introduction

Abacavir sulfate, lamivudine, and zidovudine are crucial antiretroviral drugs used in the treatment of HIV-1 infection. Understanding the market dynamics and financial trajectory of these drugs is essential for pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global HIV drugs market, which includes these antiretroviral medications, has been experiencing significant growth. As of 2023, the market size was $34.13 billion and is projected to grow to $58.24 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period of 2024-2032[3].

Impact of COVID-19

The COVID-19 pandemic had a temporary adverse impact on the HIV drugs market. The disruption in supply chains and reduced new patient prescriptions in COVID-affected regions led to a decrease in sales for major antiretroviral drug companies like Gilead Sciences Inc. and Theratechnologies Inc.[3]. However, with the return to pre-pandemic prescription volumes, the market has seen a strong recovery.

Role of Generics

Generics play a significant role in the antiviral market, particularly for HIV medications. By 2010, generics already accounted for 18.9% of the global antivirals market, and this share was forecast to increase to 29.2% by 2018. The expiration of patents for key antiretroviral drugs such as zidovudine, didanosine, stavudine, and lamivudine has driven the growth of generics in this sector[4].

Patent Expiries and Generic Competition

The patent expiries of branded antiretroviral drugs have opened up opportunities for generic manufacturers. For example, the patent expiry of Sustiva (efavirenz) and Kaletra (lopinavir + ritonavir) in 2013, and major NRTIs like Trizivir (abacavir sulphate/lamivudine/zidovudine) in 2016, have led to a surge in generic competition. This shift is expected to continue, with generics forecast to grow at a CAGR of 10.5% during the 2010-2018 period[4].

Regional Market Dynamics

The Asia Pacific region is anticipated to be the fastest-growing market for HIV drugs, driven by highly populated countries like China and India. Increasing treatment programs and funding from both the public and private sectors are driving this growth. For instance, Gilead Sciences Inc. launched the ‘Gilead Asia Pacific Rainbow Grant Program’ in 2020, aiming to improve public-private partnerships in the region[3].

Pharmacokinetics and Efficacy

Abacavir, when combined with lamivudine and efavirenz, has been shown to provide an effective and durable antiretroviral response that is noninferior to zidovudine. Clinical trials have demonstrated that abacavir maintains plasma HIV-1 RNA levels of ≤50 copies/mL in a significant proportion of patients, with a favorable safety profile[1].

Pharmacokinetic Studies

Studies on the pharmacokinetics of abacavir and lamivudine, particularly in severely malnourished children, have shown that the World Health Organization (WHO) weight-band dosing recommendations are appropriate. These studies indicate that the pharmacokinetic variability of abacavir and lamivudine does not significantly affect their efficacy[2].

Safety and Adverse Reactions

The safety profiles of abacavir, lamivudine, and zidovudine are well-documented. Treatment-emergent adverse reactions are generally manageable, with common side effects including gastrointestinal issues, fatigue, and headache. The combination of these drugs has been shown to have a favorable safety profile compared to other antiretroviral regimens[5].

Financial Implications

The financial trajectory of these drugs is influenced by several factors, including generic competition, patent expiries, and market demand. The launch of generic versions of these drugs has reduced the revenue of branded products but has also made treatment more accessible and affordable for a larger patient population.

Revenue Impact

The revenue from branded antiretroviral drugs has decreased due to the rise of generics. For example, the launch of generic Combivir (a combination of lamivudine and zidovudine) in the US market in 2011 significantly impacted the sales of the branded version, which had annual sales of approximately $556 million in 2010[4].

Government Policies and Awareness Programs

Government policies and awareness programs play a crucial role in driving the market for HIV drugs. Policies that promote the use of generic drugs, such as prior authorization requirements for branded drugs with generic alternatives, have been instrumental in increasing the market share of generics. Additionally, government-run awareness programs have helped in increasing the patient population seeking treatment, thereby driving market growth[4].

Research and Development

Increasing research and development initiatives, particularly for long-acting suppression antiretroviral therapy, are a vital trend in the market. These initiatives are expected to drive innovation and growth in the HIV drugs market over the forecast period[3].

Key Takeaways

• The global HIV drugs market is expected to grow significantly, driven by increasing patient populations and new product launches.
• Generics are taking over a substantial share of the antiviral market, especially for HIV medications.
• Patent expiries and government policies favoring generics are key drivers of market growth.
• The Asia Pacific region is expected to be the fastest-growing market due to large patient populations and increasing treatment programs.
• Abacavir, lamivudine, and zidovudine have proven efficacy and safety profiles, making them crucial components of antiretroviral therapy.

FAQs

What is the current market size of the global HIV drugs market?

The global HIV drugs market size was $34.13 billion in 2023 and is expected to grow to $58.24 billion by 2032[3].

How has the COVID-19 pandemic impacted the HIV drugs market?

The COVID-19 pandemic temporarily reduced the sales of HIV drugs due to supply chain disruptions and lower new patient prescriptions, but the market has since recovered[3].

What role do generics play in the HIV drugs market?

Generics account for a significant share of the HIV drugs market, with a forecasted growth rate of 10.5% during certain periods. They have become a major driver of market growth due to patent expiries and favorable government policies[4].

Which region is expected to be the fastest-growing market for HIV drugs?

The Asia Pacific region is anticipated to be the fastest-growing market, driven by highly populated countries like China and India, and increasing treatment programs and funding[3].

What are the key factors driving the growth of the HIV drugs market?

Key factors include increasing patient populations, new product launches, research and development initiatives, and government policies promoting the use of generic drugs[3][4].

How do abacavir, lamivudine, and zidovudine compare in terms of efficacy and safety?

Abacavir, when combined with lamivudine and efavirenz, provides an effective and durable antiretroviral response that is noninferior to zidovudine, with a favorable safety profile[1].