Lamivudine; tenofovir disoproxil fumarate - Generic Drug Details

What are the generic drug sources for lamivudine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Lamivudine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Mylan Labs Ltd, Aurobindo Pharma Ltd, and Chartwell Rx, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound. There are seven tentative approvals for this compound.

Summary for lamivudine; tenofovir disoproxil fumarate

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	81
DailyMed Link:	lamivudine; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for lamivudine; tenofovir disoproxil fumarate

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

Sponsor	Phase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	N/A
Prism Health North Texas	Phase 3
Merck Sharp & Dohme LLC	Phase 3

See all lamivudine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		300MG; 300MG	TABLET; ORAL
		300MG; 300MG; 200MG	TABLET; ORAL
		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; tenofovir disoproxil fumarate

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; tenofovir disoproxil fumarate

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; tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	CIMDUO	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022141-001	Feb 28, 2018		RX	Yes	Yes
Aurobindo Pharma Ltd	LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022344-001	May 15, 2018		DISCN	Yes	No
Chartwell Rx	TEMIXYS	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	211284-001	Nov 16, 2018		DISCN	Yes	No

Lamivudine; tenofovir disoproxil fumarate Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Lamivudine and Tenofovir Disoproxil Fumarate

Introduction to Lamivudine and Tenofovir Disoproxil Fumarate

Lamivudine and tenofovir disoproxil fumarate are crucial antiretroviral and antiviral drugs used primarily in the treatment of HIV and hepatitis B infections. These medications have become cornerstone treatments in the global fight against these diseases.

Market Overview

Lamivudine Market

• Market Size and Growth Projections: The lamivudine market was valued at USD 1.2 billion in 2023 and is projected to grow to USD 2.1 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 7.2% from 2024 to 2031[3].

Tenofovir Disoproxil Fumarate Market

• Market Size and Growth Projections: The tenofovir disoproxil fumarate market is estimated to grow at a CAGR of around 4.5% from 2022 to 2027. This growth is driven by the increasing cases of hepatitis B and HIV/AIDS globally[1].

Drivers of Market Growth

Increasing Incidence of HIV and Hepatitis B

• Both lamivudine and tenofovir disoproxil fumarate markets are driven by the rising incidence of HIV and hepatitis B infections. According to the World Health Organization, in 2020, 680,000 people died from HIV-related causes, and 1.5 million people acquired HIV. Similarly, 296 million people were living with chronic hepatitis B infection in 2019, resulting in an estimated 820,000 deaths[1][3].

Technological Advancements

• Improvements in medication formulations, such as better tablets, capsules, and oral solutions, enhance the efficacy and patient compliance with both lamivudine and tenofovir disoproxil fumarate. Combination therapies, like lamivudine plus dolutegravir or tenofovir disoproxil fumarate with emtricitabine and dolutegravir, also contribute to market growth by improving treatment outcomes[1][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. For instance, generic versions of tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) are now available at a cost of less than $45 per person per year in over 100 low- and middle-income countries under voluntary licenses[2][3].

Market Segmentation

By Application

• Lamivudine:
  • Lamivudine tablets
  • Lamivudine capsules
  • Lamivudine oral solutions[3]
• Tenofovir Disoproxil Fumarate:
  • Tablets (available in different dosages like 150mg, 200mg, 250mg, and 300mg)
  • Combination therapies (e.g., with emtricitabine and dolutegravir)[1].

By Product

• Lamivudine:
  • HIV treatment
  • Hepatitis B treatment
  • Antiviral therapy[3]
• Tenofovir Disoproxil Fumarate:
  • HIV treatment
  • Hepatitis B treatment
  • Prevention of HIV exposure[1].

By Geography

• Lamivudine:
  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa[3]
• Tenofovir Disoproxil Fumarate:
  • North America (dominant region due to major producers like Gilead Sciences Inc.)
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa[1].

Regional Market Performance

Lamivudine

• 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].

Tenofovir Disoproxil Fumarate

• North America is the fastest-growing region, with a CAGR of 5.2% during the forecast period, driven by the presence of major companies like Gilead Sciences Inc. in the US. The increase in HIV and hepatitis B cases in this region has significantly boosted the sales of these drugs[1].

Key Players and Strategies

Lamivudine

• Companies like Gilead Sciences, GSK, and Bristol-Myers Squibb are key players in the lamivudine market. Their strategies include product innovations, such as developing new formulations and combination therapies, and market expansion into regions with growing healthcare access[3].

Tenofovir Disoproxil Fumarate

• Major players include Gilead Sciences Inc., which is a leading producer of tenofovir disoproxil fumarate. These companies focus on strengthening their product portfolios and expanding their business globally. Generic versions of tenofovir disoproxil fumarate are also becoming increasingly available, further driving market growth[1][4].

Market Challenges and Restraints

Side Effects and Resistance

• Both drugs face challenges related to side effects. Tenofovir disoproxil fumarate can cause nausea, rash, diarrhea, headache, pain, and depression, which can restrict its usage. Lamivudine also faces issues related to resistance-associated mutations, although these are less common compared to other antiretroviral drugs[1][3].

Regulatory and Economic Factors

• The cost of these medications, although decreasing with the availability of generics, remains a barrier in some regions. Regulatory approvals and patent expirations also play a crucial role in the market dynamics. For example, the final dolutegravir patents expiring by 2029 will make generic TLD more widely available[2].

Financial Trajectory

Revenue Growth

• The lamivudine 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. The tenofovir disoproxil fumarate market, while growing at a slightly lower CAGR, is also projected to see significant revenue growth driven by increasing demand and expanding access to healthcare[1][3].

Regional Performance

• The Asia-Pacific region is expected to be a key driver for both markets due to its large patient population and improving healthcare infrastructure. North America and Europe will continue to be significant contributors due to their advanced healthcare systems and high spending on antiretroviral therapies[1][3].

Key Takeaways

• Lamivudine:

  • The market is projected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2031.
  • The Asia-Pacific region is expected to be one of the fastest-growing segments.
  • Key drivers include increasing incidence of HIV and hepatitis B, technological advancements, and expanding healthcare access[3].

• Tenofovir Disoproxil Fumarate:

  • The market is estimated to grow at a CAGR of around 4.5% from 2022 to 2027.
  • North America dominates the market due to the presence of major producers.
  • Growing cases of hepatitis B and HIV/AIDS globally are driving the growth of this market[1].

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 primary uses of tenofovir disoproxil fumarate?

Tenofovir disoproxil fumarate is used to treat chronic hepatitis B and to prevent HIV/AIDS. It is also used in combination therapies with other antiretroviral drugs[1].

5. How does the availability of generic versions impact the market for these drugs?

The availability of generic versions, such as generic TLD, significantly reduces the cost and increases access to these medications, particularly in low- and middle-income countries. This has a positive impact on market growth by increasing the demand for these drugs[2].

Sources

1. IndustryARC: Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027.
2. Oxford Academic: Challenges for Novel Antiretroviral Development in an Era of Generic TDF/XTC/DTG.
3. Cognitive Market Research: Lamivudine Market dynamics and financial trajectory.
4. Cognitive Market Research: Tenofovir Disoproxil Fumarate and Its Combination Drugs Market Report.