ABACAVIR SULFATE; LAMIVUDINE - Generic Drug Details

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

Abacavir sulfate; lamivudine is the generic ingredient in four branded drugs marketed by Norvium Bioscience, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Teva Pharms Usa, Zydus Pharms, Viiv Hlthcare, and Lupin Ltd, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for ABACAVIR SULFATE; LAMIVUDINE

US Patents:	0
Tradenames:	4
Applicants:	10
NDAs:	11
Finished Product Suppliers / Packagers:	6
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABACAVIR SULFATE; LAMIVUDINE
DailyMed Link:	ABACAVIR SULFATE; LAMIVUDINE at DailyMed

Recent Clinical Trials for ABACAVIR SULFATE; LAMIVUDINE

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

Sponsor	Phase
ViiV Healthcare	Phase 4
Gilead Sciences	Phase 3
GlaxoSmithKline	Phase 4

See all ABACAVIR SULFATE; LAMIVUDINE clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE

Applicant	Application No.	Strength	Dosage Form
		60MG; 30MG	TABLET; ORAL
		EQ 300MG BASE; 150MG; 300MG	TABLET; ORAL
		600MG; 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

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

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPZICOM	Tablets	abacavir sulfate; lamivudine	600 mg/300 mg	021652	1	2007-09-27

US Patents and Regulatory Information for ABACAVIR SULFATE; LAMIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	204990-001	Mar 28, 2017	AB	RX	No	No
Cipla	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	091144-001	Mar 28, 2017	AB	RX	No	Yes
Norvium Bioscience	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET, FOR SUSPENSION;ORAL	204311-001	Dec 22, 2023		DISCN	Yes	No

Expired US Patents for ABACAVIR SULFATE; LAMIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	6,180,639
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	5,034,394*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	6,417,191*PED

ABACAVIR SULFATE; LAMIVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abacavir Sulfate and Lamivudine

Introduction

Abacavir sulfate and lamivudine are crucial components in the treatment of HIV-1 infection, often used in combination with other antiretroviral agents. Understanding the market dynamics and financial trajectory of these drugs is essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Indications and Usage

Abacavir sulfate and lamivudine are indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. This combination is particularly important for pediatric patients, as it offers a simplified dosing regimen that enhances adherence to treatment[2][4].

Competitive Landscape

The market for antiretroviral therapies is highly competitive, with multiple players offering various combinations of drugs. However, the combination of abacavir sulfate and lamivudine remains a significant player due to its efficacy and the convenience of a fixed-dose combination. Companies like Viatris have been instrumental in expanding access to these treatments, especially in low- and middle-income countries[2].

Regulatory Approvals and Impact

Recent regulatory approvals have significantly impacted the market dynamics. For instance, the U.S. FDA's tentative approval of a pediatric formulation of abacavir, dolutegravir, and lamivudine has enhanced access to WHO-recommended regimens for children living with HIV. This approval is expected to improve treatment adherence and reduce the pill burden for pediatric patients[2].

Financial Trajectory

The financial trajectory of abacavir sulfate and lamivudine is influenced by several factors, including regulatory approvals, market demand, and competition.

Revenue Projections

Companies like Viatris have set ambitious targets for providing antiretroviral therapy to millions of patients, including children. The approval of new formulations and the expansion of access to these treatments are expected to drive revenue growth. Viatris aims to provide ARV therapy equivalent to a total of 30 million patients, including more than 2 million children, between 2022 and 2025[2].

Cost and Pricing

The cost of abacavir sulfate and lamivudine can vary significantly depending on the region and the specific formulation. Generic versions of these drugs, particularly those produced by companies like Viatris, have made these treatments more affordable in low- and middle-income countries. This affordability is crucial for increasing access and adherence to HIV treatment[2].

Market Expansion

The market for abacavir sulfate and lamivudine is expanding due to the increasing need for effective HIV treatments globally. The introduction of novel heat-stable generic formulations and more convenient packaging options has further boosted market growth. Partnerships with multiple stakeholders to improve access to ARVs, especially for vulnerable populations like children, have also contributed to this expansion[2].

Challenges and Risks

Despite the positive market dynamics, there are several challenges and risks associated with abacavir sulfate and lamivudine.

Adverse Reactions and Safety Concerns

Abacavir sulfate is associated with hypersensitivity reactions, which can be severe and even life-threatening. Monitoring for these reactions and other adverse events such as lactic acidosis, severe hepatomegaly, and hepatic toxicity is crucial[1][2][4].

Regulatory and Legal Impediments

Regulatory changes and legal impediments can affect the ability of companies to bring new products to market. Factors such as actions and decisions of healthcare and pharmaceutical regulators, changes in laws and regulations, and any regulatory or legal barriers can impact the financial trajectory of these drugs[2].

Pharmacokinetics and Efficacy

The pharmacokinetics of abacavir and lamivudine have been studied extensively, particularly in pediatric and malnourished populations. These studies have shown that the WHO weight-band dosing recommendations are appropriate and that the pharmacokinetic variability does not significantly affect the efficacy of the treatment[5].

Clinical Trials and Postmarketing Experience

Clinical trials, such as the ARROW trial, have demonstrated the safety and efficacy of once-daily dosing of abacavir and lamivudine in pediatric patients. Postmarketing experience has also highlighted the importance of monitoring for adverse reactions and ensuring that patients are compliant with the treatment regimen[4].

Global Access and Sustainability

Companies like Viatris are committed to sustainability goals that include providing high-quality HIV/AIDS treatment to millions of patients. The approval of new formulations and the expansion of access to these treatments are aligned with these sustainability goals and support global health initiatives[2].

Key Takeaways

• Regulatory Approvals: Recent FDA approvals have enhanced access to WHO-recommended pediatric regimens.
• Financial Projections: Revenue growth is expected due to increased access and adherence to treatment.
• Market Expansion: The market is expanding due to the introduction of novel formulations and increased affordability.
• Safety Concerns: Monitoring for hypersensitivity reactions and other adverse events is crucial.
• Global Access: Efforts to improve access to ARVs, especially for children, are ongoing.

Frequently Asked Questions

Q: What is the primary indication for abacavir sulfate and lamivudine? A: Abacavir sulfate and lamivudine are indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.

Q: What are the potential adverse reactions associated with abacavir sulfate? A: Abacavir sulfate is associated with hypersensitivity reactions, lactic acidosis, severe hepatomegaly, and hepatic toxicity.

Q: How has the FDA's tentative approval impacted the market? A: The FDA's tentative approval of a pediatric formulation has enhanced access to WHO-recommended regimens and is expected to improve treatment adherence for children living with HIV.

Q: What are the financial targets set by companies like Viatris for ARV therapy? A: Viatris aims to provide ARV therapy equivalent to a total of 30 million patients, including more than 2 million children, between 2022 and 2025.

Q: How do pharmacokinetic studies support the efficacy of abacavir and lamivudine in pediatric patients? A: Pharmacokinetic studies have shown that the WHO weight-band dosing recommendations are appropriate and that the pharmacokinetic variability does not significantly affect the efficacy of the treatment.

Cited Sources

1. Abacavir sulfate and Lamivudine tablets 60/30 mg - FDA.
2. Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir, Dolutegravir, Lamivudine - Viatris Newsroom.
3. Abacavir & Lamivudine Clinical Statistical PREA - FDA.
4. ABACAVIR AND LAMIVUDINE - FDA.
5. Abacavir - StatPearls - NCBI Bookshelf.