Lamivudine; zidovudine - Generic Drug Details

What are the generic sources for lamivudine; zidovudine and what is the scope of freedom to operate?

Lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Epic Pharma Llc, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Norvium Bioscience, Pharmacare, and Strides Pharma, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound. There are fourteen tentative approvals for this compound.

Summary for lamivudine; zidovudine

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	188
Patent Applications:	370
DailyMed Link:	lamivudine; zidovudine at DailyMed

Recent Clinical Trials for lamivudine; zidovudine

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

Sponsor	Phase
The Aurum Institute NPC	Phase 1/Phase 2
Johns Hopkins University	Phase 1/Phase 2
Wellcome Trust	Phase 2

See all lamivudine; zidovudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE; ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
		150MG; 300MG; 200MG	TABLET; ORAL
		150MG; 300MG; 600MG	TABLET; ORAL
		150MG; 300MG; 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 lamivudine; zidovudine

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

Anatomical Therapeutic Chemical (ATC) Classes for 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

US Patents and Regulatory Information for lamivudine; zidovudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079128-001	May 13, 2015	AB	RX	No	No
Chartwell Rx	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079081-001	May 25, 2011		DISCN	No	No
Pharmacare	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	022018-001	Mar 17, 2017		DISCN	No	No

Expired US Patents for lamivudine; zidovudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997

EU/EMA Drug Approvals for lamivudine; zidovudine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva Pharma B.V.	Lamivudine/Zidovudine Teva	lamivudine, zidovudine	EMEA/H/C/001236 Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.	Withdrawn	yes	no	no	2011-02-28
ViiV Healthcare BV	Combivir	lamivudine, zidovudine	EMEA/H/C/000190 Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,	Authorised	no	no	no	1998-03-18

Lamivudine; zidovudine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lamivudine and Zidovudine

Introduction

Lamivudine and zidovudine are crucial antiretroviral drugs used in the treatment of HIV infection and, in some cases, hepatitis B. The market for these drugs is complex and influenced by various factors, including clinical efficacy, economic considerations, and regulatory environments.

Market Size and Growth Projections

The lamivudine and zidovudine market is experiencing significant growth, driven by increasing demand for effective antiretroviral therapies. As of 2023, the lamivudine market was valued at USD 1.2 billion and is projected to reach USD 2.1 billion by 2031, growing at a CAGR of 7.2% from 2024 to 2031[3].

Segmentation

The market is segmented based on several factors:

• Type: The market is categorized into tablets and capsules for both lamivudine and zidovudine[1].
• Application: These drugs are used in hospitals, clinics, drug centers, and other healthcare settings[1].
• Geography: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][3].

Drivers of Market Growth

Increasing Incidence of HIV and Hepatitis B

The rising incidence of HIV and hepatitis B infections globally is a primary driver of the market. As more cases are diagnosed, the demand for effective antiretroviral and antiviral therapies increases[3].

Technological Advancements

Improvements in medication formulations and the development of combination therapies have enhanced the efficacy of lamivudine and zidovudine. These advancements have led to better patient outcomes and increased treatment adherence[3].

Regulatory Support

Supportive healthcare regulations and the global focus on expanding access to HIV and hepatitis B treatments are significant drivers. Governments and international organizations are working to increase access to these medications, particularly in underserved regions[3].

Economic Evaluation and Cost-Effectiveness

Combination Therapy vs. Monotherapy

Studies have shown that combination therapy using lamivudine and zidovudine is more cost-effective than zidovudine monotherapy. An economic evaluation in the UK found that the combination therapy yielded an incremental cost-effectiveness ratio of £6,276 per life year saved, which is favorable compared to other HIV treatments[2].

Cost Considerations

The cost of acquiring these drugs is a significant factor. However, the overall cost-effectiveness is improved when considering the extended life expectancy and reduced progression of the disease. This makes combination therapy a viable and economically sound option[2].

Competitive Landscape

Key Players

The market for lamivudine and zidovudine is dominated by several key players, including GlaxoSmithKline (GSK), Strides Shasun Limited, ViiV Healthcare, Cipla Ltd, and Worldprime Export LLP. These companies are profiled based on their product portfolios, financial statements, strategic market approaches, and geographical presence[1].

Market Positioning

The competitive landscape is characterized by the ranking of top companies, significant developments such as mergers and acquisitions, new product releases, and collaborations. Companies are also evaluated based on their strengths, weaknesses, opportunities, and threats (SWOT analysis)[1].

Regulatory Environment

Generic Medicines

Lamivudine and zidovudine are available as generic medicines, which are developed to be the same as the reference medicines. This has increased accessibility and affordability, contributing to market growth. For example, Lamivudine/Zidovudine Teva, a generic version, was indicated for antiretroviral combination therapy, although its marketing authorization has been withdrawn in the EU[4].

Market Outlook and Trends

Growth Propellers

The market is expected to continue its upward trend due to the increasing demand for antiretroviral therapies, advancements in medication formulations, and supportive healthcare regulations. The incorporation of lamivudine and zidovudine into combination therapies and their potential applications in other viral infections also drive growth[1][3].

Challenges and Opportunities

Despite the growth, the market faces challenges such as the high cost of drug development and the need for continuous research to combat drug resistance. However, these challenges also present opportunities for innovation and the development of new treatment strategies[1].

Financial Trajectory

Revenue Projections

The lamivudine market is projected to grow significantly, with revenues expected to reach USD 2.1 billion by 2031. This growth is driven by the increasing demand for antiretroviral and antiviral therapies, as well as the expanding geographical reach of these medications[3].

Investment Opportunities

The market offers several investment opportunities, particularly in the development of new formulations and combination therapies. Companies investing in research and development are likely to benefit from the growing demand for these drugs[1].

Key Takeaways

• The lamivudine and zidovudine market is growing rapidly due to increasing demand for antiretroviral therapies.
• Combination therapy using these drugs is more cost-effective than monotherapy.
• Key players such as GSK and ViiV Healthcare dominate the market.
• The market is driven by technological advancements, regulatory support, and the increasing incidence of HIV and hepatitis B.
• The financial trajectory indicates significant revenue growth, with the lamivudine market expected to reach USD 2.1 billion by 2031.

FAQs

Q: What are the primary drivers of the lamivudine and zidovudine market?

A: The primary drivers include the increasing incidence of HIV and hepatitis B, technological advancements in medication formulations, and supportive healthcare regulations.

Q: How does combination therapy using lamivudine and zidovudine compare to monotherapy in terms of cost-effectiveness?

A: Combination therapy is more cost-effective, yielding an incremental cost-effectiveness ratio of £6,276 per life year saved compared to zidovudine monotherapy[2].

Q: Who are the key players in the lamivudine and zidovudine market?

A: Key players include GlaxoSmithKline (GSK), Strides Shasun Limited, ViiV Healthcare, Cipla Ltd, and Worldprime Export LLP[1].

Q: What is the projected market size for lamivudine by 2031?

A: The lamivudine market is expected to reach USD 2.1 billion by 2031, growing at a CAGR of 7.2% from 2024 to 2031[3].

Q: Why has the marketing authorization for Lamivudine/Zidovudine Teva been withdrawn in the EU?

A: The marketing authorization for Lamivudine/Zidovudine Teva has been withdrawn at the request of the marketing-authorisation holder[4].

Sources

1. Market Research Intellect: Global Lamivudine and Zidovudine Market Size, Trends and Forecasts 2021-2031.
2. PubMed: Modelling the cost effectiveness of lamivudine/zidovudine combination therapy.
3. Market Research Intellect: Lamivudine Market Size, Share | Industry Research Report 2031.
4. European Medicines Agency: Lamivudine/Zidovudine Teva.