Lamivudine - Generic Drug Details

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

Lamivudine is the generic ingredient in ten branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Annora, Apotex, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan Labs Ltd, Natco, Strides Pharma, Upsher Smith Labs, Micro Labs, Merck Sharp Dohme, Chartwell Rx, Epic Pharma Llc, Norvium Bioscience, and Pharmacare, and is included in forty-two NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for lamivudine. Fifteen suppliers are listed for this compound. There are forty-four tentative approvals for this compound.

Summary for lamivudine

US Patents:	2
Tradenames:	10
Applicants:	24
NDAs:	42
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	641
Patent Applications:	6,536
Drug Prices:	Drug price trends for lamivudine
What excipients (inactive ingredients) are in lamivudine?	lamivudine excipients list
DailyMed Link:	lamivudine at DailyMed

See drug prices for lamivudine

Recent Clinical Trials for lamivudine

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

Sponsor	Phase
University of Wisconsin, Madison	Early Phase 1
Johns Hopkins University	Phase 1/Phase 2
The Aurum Institute NPC	Phase 1/Phase 2

See all lamivudine clinical trials

Generic filers with tentative approvals for LAMIVUDINE

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

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

Medical Subject Heading (MeSH) Categories for lamivudine

Anti-HIV Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lamivudine

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998		DISCN	Yes	No
Hetero Labs Ltd V	LAMIVUDINE	lamivudine	TABLET;ORAL	203277-002	Jan 6, 2014	AB	RX	No	No
Pharmacare	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	022018-001	Mar 17, 2017		DISCN	No	No
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No	7,169,780*PED
Chartwell Rx	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	079081-001	May 25, 2011		DISCN	No	No
Aurobindo Pharma	LAMIVUDINE	lamivudine	TABLET;ORAL	077464-002	Nov 21, 2016	AB	RX	No	No

Expired US Patents for lamivudine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	RE39155*PED
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	6,180,639*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	7,119,202*PED
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	7,119,202*PED
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	7,119,202*PED
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	7,119,202*PED

EU/EMA Drug Approvals for lamivudine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Lamivudine Teva Pharma B.V.	lamivudine	EMEA/H/C/001111 Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.	Authorised	yes	no	no	2009-12-10
Teva B.V.	Lamivudine Teva	lamivudine	EMEA/H/C/001113 Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).	Authorised	yes	no	no	2009-10-23
GlaxoSmithKline (Ireland) Limited	Zeffix	lamivudine	EMEA/H/C/000242 Zeffix is indicated for the treatment of chronic hepatitis B in adults with:, , , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine., ,	Authorised	no	no	no	1999-07-29
ViiV Healthcare BV	Epivir	lamivudine	EMEA/H/C/000107 Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.,	Authorised	no	no	no	1996-08-08

Lamivudine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lamivudine

Introduction to Lamivudine

Lamivudine is a crucial antiretroviral and antiviral drug used primarily in the treatment of HIV and hepatitis B infections. Its market dynamics are influenced by several key factors, including increasing global health awareness, advancements in medication formulations, and expanding access to healthcare.

Market Size and Growth Projections

The lamivudine market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.2% from 2024 to 2031[3][4].

Segmentation of the Lamivudine Market

The market is segmented based on several criteria:

By Application

• Lamivudine Tablets
• Lamivudine Capsules
• Lamivudine Oral Solutions

By Product

• HIV Treatment
• Hepatitis B Treatment
• Antiviral Therapy

By Geography

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

This segmentation helps in understanding the market's various segments and identifying the most profitable areas for investment[3][4].

Drivers of Market Growth

Several factors are driving the growth of the lamivudine market:

Increasing Incidence of HIV and Hepatitis B

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

Technological Advancements

Improvements in medication formulations, such as better tablets, capsules, and oral solutions, enhance the efficacy and patient compliance with lamivudine. Combination therapies that include lamivudine also contribute to market growth by improving treatment outcomes[3].

Expanding Access to Healthcare

Global initiatives to increase access to HIV and hepatitis B treatments, particularly in developing regions, are fueling the market expansion. Supporting healthcare regulations and policies further boost the demand for lamivudine[3].

Market Challenges and Restraints

Despite the growth, the lamivudine market faces some challenges:

Resistance-Associated Mutations

Studies have shown that lamivudine plus dolutegravir maintenance dual therapy may be less effective than three-drug therapy in the context of resistance-associated mutations, which could impact its long-term efficacy[5].

Competition from Alternative Therapies

The presence of other antiviral and antiretroviral drugs can pose a competitive threat to lamivudine. However, its broad acceptance and continuous research into its applications help maintain its market position[3].

Competitive Landscape

The lamivudine market is highly competitive, with several key players:

Major Market Players

• Gilead Sciences
• GlaxoSmithKline (GSK)
• Bristol-Myers Squibb
• Merck
• Roche
• AbbVie
• Cipla
• Mylan
• Teva
• Lupin

These companies are profiled based on their product portfolios, financial statements, key developments, and market strategies. The report also includes a SWOT analysis and competitive landscape analysis to help understand the market positioning and strategies of these players[3].

Financial Performance and Projections

The financial trajectory of the lamivudine market is robust, with significant growth projected over the forecast period.

Revenue Growth

The market is expected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2031, indicating a substantial increase in revenue[3][4].

Regional Market Performance

The Asia-Pacific region is expected to be one of the fastest-growing segments due to increasing healthcare access and a large patient population. North America and Europe also remain significant markets due to high healthcare spending and advanced medical infrastructure[3].

Key Players' Strategies

Companies involved in the lamivudine market are adopting various strategies to maintain and enhance their market share:

Product Innovations

Continuous research into new formulations and combination therapies is a key strategy. For example, the development of lamivudine plus dolutegravir dual therapy, although facing some challenges, represents an effort to improve treatment outcomes[3][5].

Market Expansion

Expanding into new geographical regions, particularly in emerging markets, is another strategy. Companies like GSK and Cipla are focusing on increasing their presence in these areas to capitalize on growing healthcare demands[1][3].

Collaborations and Acquisitions

Collaborations with other pharmaceutical companies and acquisitions of smaller firms are common strategies to enhance product portfolios and market reach. For instance, Aurobindo Pharma's investments in biosimilars and injectable generics are expected to drive significant growth[2].

Regional Market Dynamics

The market dynamics vary significantly across different regions:

North America and Europe

These regions have well-established healthcare systems and high spending on pharmaceuticals, making them significant markets for lamivudine. Regulatory support and advanced medical infrastructure also contribute to the market growth in these areas[3].

Asia-Pacific

The Asia-Pacific region is expected to experience rapid growth due to increasing healthcare access, a large patient population, and government initiatives to improve healthcare infrastructure. Countries like India and China are becoming key markets for lamivudine[3].

Middle-East and Africa

These regions are also seeing growth, albeit at a slower pace, due to improving healthcare access and increasing awareness about HIV and hepatitis B treatments[3].

Conclusion

The lamivudine market is poised for significant growth driven by increasing global health awareness, technological advancements, and expanding access to healthcare. Despite challenges such as resistance-associated mutations, the market's financial trajectory looks robust, with key players adopting innovative strategies to maintain and enhance their market share.

Key Takeaways

• The lamivudine market is projected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2031.
• The market is driven by the increasing incidence of HIV and hepatitis B, technological advancements, and expanding healthcare access.
• Key players include Gilead Sciences, GSK, Bristol-Myers Squibb, and others, with strategies focusing on product innovations, market expansion, and collaborations.
• The Asia-Pacific region is expected to be one of the fastest-growing segments.

FAQs

1. What is the current market size of the lamivudine market?

The lamivudine market was valued at USD 1.2 billion in 2023[3].

2. What is the projected growth rate of the lamivudine market?

The market is expected to grow at a CAGR of 7.2% from 2024 to 2031[3].

3. Which regions are expected to drive the growth of the lamivudine market?

The Asia-Pacific region, along with North America and Europe, is expected to drive significant growth in the lamivudine market[3].

4. What are the key drivers of the lamivudine market?

Key drivers include the increasing incidence of HIV and hepatitis B, technological advancements in medication formulations, and expanding access to healthcare[3].

5. Who are the major players in the lamivudine market?

Major players include Gilead Sciences, GlaxoSmithKline, Bristol-Myers Squibb, Merck, and others[3].

Cited Sources

1. Market Research Intellect, "Global Lamivudine and Zidovudine Market Size, Trends and Forecasts 2021-2031"[1].
2. JM Financial, "Aurobindo Pharma - Analyst Report"[2].
3. Market Research Intellect, "Lamivudine Market Size, Share | Industry Research Report 2031"[3].
4. Market Research Intellect, "Lamivudine Market Size, Share | Industry Research Report 2031"[4].
5. Oxford University Press, "Efficacy of Lamivudine Plus Dolutegravir vs Dolutegravir-Based 3-Drug Therapy"[5].