Abacavir sulfate - Generic Drug Details

What are the generic drug sources for abacavir sulfate and what is the scope of freedom to operate?

Abacavir sulfate is the generic ingredient in eight branded drugs marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Viiv Hlthcare, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Norvium Bioscience, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in twenty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for abacavir sulfate. Thirteen suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for abacavir sulfate

US Patents:	2
Tradenames:	8
Applicants:	14
NDAs:	23
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	65
Patent Applications:	4,703
What excipients (inactive ingredients) are in abacavir sulfate?	abacavir sulfate excipients list
DailyMed Link:	abacavir sulfate at DailyMed

Recent Clinical Trials for abacavir sulfate

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

Sponsor	Phase
Cynthia L Gay, MD	N/A
ViiV Healthcare	N/A
University of North Carolina, Chapel Hill	N/A

See all abacavir sulfate clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE

Applicant	Application No.	Strength	Dosage Form
		60MG	TABLET; ORAL
		60MG; 30MG	TABLET; ORAL
		60MG	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

Drug Class	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

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIAGEN	Oral Solution	abacavir sulfate	20 mg/mL	020978	1	2012-12-27
ZIAGEN	Tablets	abacavir sulfate	300 mg	020977	1	2009-01-28

US Patents and Regulatory Information for abacavir sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	ABACAVIR SULFATE	abacavir sulfate	TABLET;ORAL	091294-001	Jun 18, 2012	AB	RX	No	No
Cipla	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	091144-001	Mar 28, 2017	AB	RX	No	Yes
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes
Lupin Ltd	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	202912-001	Dec 5, 2013		RX	No	Yes

Expired US Patents for abacavir sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	6,641,843*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	5,034,394*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998	5,089,500*PED
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998	5,034,394*PED

Abacavir sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abacavir Sulfate

Introduction

Abacavir sulfate, an antiretroviral drug used to treat HIV-1 infection, is a crucial component in the global pharmaceutical market. This article delves into the market dynamics and financial trajectory of abacavir sulfate, highlighting key trends, drivers, and challenges.

Market Size and Growth Projections

The abacavir sulfate market, including both the reagent and API segments, is poised for significant growth. Reports indicate that the market has experienced rapid and substantial growth in recent years and is expected to continue this upward trend from 2023 to 2031[1][4].

Abacavir Sulfate Reagent Market

The reagent market is segmented based on type (min purity less than 98%, min purity 98%-99%, min purity more than 99%) and application (research, medical) across various geographical regions. The positive trend in market dynamics suggests robust growth rates, driven by increasing demand in research and medical applications[1].

Abacavir Sulfate API Market

The API market, similarly segmented by type and application (research, pharmaceutical), also forecasts continued expansion. This growth is attributed to the increasing need for high-purity APIs in pharmaceutical manufacturing and research[4].

Drivers of Market Growth

Several factors drive the growth of the abacavir sulfate market:

Increasing Demand for HIV Treatment

The global need for effective HIV treatments continues to rise, driving demand for antiretroviral drugs like abacavir sulfate. Innovations in treatment regimens and the introduction of new combination therapies further boost market growth[3].

Advancements in Research and Development

Continuous research and development in the pharmaceutical sector, particularly in antiretroviral therapies, contribute to the market's expansion. Clinical trials and studies on the pharmacokinetics and safety of abacavir sulfate in various patient populations support its widespread adoption[3].

Regulatory Support

Regulatory bodies' approval and support for new treatments and formulations of abacavir sulfate facilitate market growth. For instance, the FDA's approval of new combination therapies and generic versions of the drug helps in increasing its accessibility and affordability[3].

Restraints and Challenges

Despite the positive outlook, several challenges affect the market:

Patent Expiries and Generic Competition

The loss of patent exclusivity for branded drugs can lead to significant reductions in spending due to generic competition. For example, the patent expiry of similar drugs has resulted in substantial reductions in spending, a trend that could impact abacavir sulfate if generic versions become widely available[2].

Pricing and Rebates

The pharmaceutical market is heavily influenced by pricing strategies and rebates. High invoice price increases can be offset by off-invoice discounts and rebates, affecting the net price growth of the drug. This dynamic can impact the revenue projections for abacavir sulfate[2].

Regulatory and Compliance Issues

Changing regulatory landscapes, such as new sustainability reporting requirements and ESG disclosures, can pose challenges for pharmaceutical companies. Compliance with these regulations can be costly and time-consuming, potentially affecting market dynamics[5].

Market Segmentation

The abacavir sulfate market is segmented into several key categories:

By Type

• Min Purity Less Than 98%
• Min Purity 98%-99%
• Min Purity More Than 99%

These segments cater to different needs in research and pharmaceutical applications, with higher purity levels typically commanding higher prices[1][4].

By Application

• Research
• Medical (Pharmaceutical)

The research segment drives demand for reagents, while the pharmaceutical segment is crucial for API sales[1][4].

By Geographical Region

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa

Each region has its own market dynamics, influenced by local healthcare policies, economic conditions, and regulatory environments[1][4].

Financial Trajectory

The financial outlook for the abacavir sulfate market is optimistic, with projections indicating significant revenue growth:

Revenue Projections

The market size of both the reagent and API segments is expected to increase substantially from 2023 to 2031, measured in USD million. This growth is driven by increasing demand, new product launches, and expanding geographical reach[1][4].

Key Financial Metrics

• Market Size: Expected to grow significantly over the forecast period.
• Growth Rate: Robust growth rates anticipated due to favorable market dynamics.
• Revenue: Projected to increase across all segments, driven by research, medical, and geographical expansion[1][4].

Industry Expert Insights

Industry experts highlight the importance of continuous innovation and regulatory compliance in driving market growth.

"The pharmaceutical industry is highly regulated, and compliance with evolving ESG and regulatory requirements is crucial for sustained growth. Companies must balance innovation with ethical and responsible practices to maintain market leadership," - [GSK ESG Performance Report 2023][5].

Illustrative Statistics

• The abacavir sulfate reagent market is expected to experience robust growth rates, with the market size projected to increase significantly from 2023 to 2031[1].
• In 2014, spending on new brand medicines, including those for HIV, increased dramatically, totaling $12.3 billion for hepatitis C treatments alone[2].
• Clinical trials have shown that abacavir sulfate, when combined with other antiretroviral drugs, demonstrates favorable pharmacokinetic parameters and safety profiles[3].

Key Takeaways

• The abacavir sulfate market is poised for significant growth driven by increasing demand for HIV treatments and advancements in research and development.
• Market segmentation by type, application, and geographical region highlights diverse growth opportunities.
• Regulatory support and compliance are critical for market expansion.
• Challenges such as patent expiries, pricing dynamics, and regulatory changes must be navigated to sustain growth.

FAQs

What is the primary use of abacavir sulfate?

Abacavir sulfate is primarily used to treat HIV-1 infection in conjunction with other antiretroviral drugs.

What are the key segments of the abacavir sulfate market?

The market is segmented by type (min purity levels), application (research, medical), and geographical regions.

How is the market expected to grow from 2023 to 2031?

The market is expected to experience robust growth rates, driven by increasing demand and favorable market dynamics.

What are the main challenges facing the abacavir sulfate market?

Challenges include patent expiries, generic competition, pricing and rebate dynamics, and regulatory compliance issues.

How does regulatory support impact the abacavir sulfate market?

Regulatory support, such as FDA approvals and compliance with ESG regulations, facilitates market growth by ensuring the drug's safety, efficacy, and accessibility.

Sources

1. Market Research Intellect, "Abacavir Sulfate Reagent Market Size, Scope And Forecast Report"
2. Vermont Legislature, "Medicines Use and Spending Shifts"
3. NCBI Bookshelf, "Abacavir - StatPearls"
4. Market Research Intellect, "Abacavir Sulfate API Market Size, Scope And Forecast Report"
5. GSK, "ESG Performance Report 2023"