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Last Updated: December 22, 2024

TENOFOVIR DISOPROXIL FUMARATE Drug Patent Profile


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When do Tenofovir Disoproxil Fumarate patents expire, and when can generic versions of Tenofovir Disoproxil Fumarate launch?

Tenofovir Disoproxil Fumarate is a drug marketed by Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Norvium Bioscience, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa. and is included in twelve NDAs.

The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tenofovir Disoproxil Fumarate

A generic version of TENOFOVIR DISOPROXIL FUMARATE was approved as tenofovir disoproxil fumarate by TEVA PHARMS USA on March 18th, 2015.

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Drug patent expirations by year for TENOFOVIR DISOPROXIL FUMARATE
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Recent Clinical Trials for TENOFOVIR DISOPROXIL FUMARATE

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

SponsorPhase
MRC/UVRI and LSHTM Uganda Research UnitPhase 3
Ministry of Health, UgandaPhase 3
Assistance Publique - Hôpitaux de ParisPhase 3

See all TENOFOVIR DISOPROXIL FUMARATE clinical trials

Paragraph IV (Patent) Challenges for TENOFOVIR DISOPROXIL FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIREAD Tablets tenofovir disoproxil fumarate 150 mg, 200 mg, and 250 mg 021356 1 2012-05-17
VIREAD Tablets tenofovir disoproxil fumarate 300 mg 021356 1 2010-01-26

US Patents and Regulatory Information for 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
Aurobindo Pharma TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-001 Jan 26, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Reyoung TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 211337-001 Mar 2, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 078800-001 Jan 26, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-004 Jan 26, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection Experimental

Tenofovir Disoproxil Fumarate Market Dynamics and Financial Trajectory

Market Overview

Tenofovir disoproxil fumarate, commonly known by the brand name Viread, is a medication used to treat chronic hepatitis B and prevent HIV/AIDS. It is a nucleotide reverse transcriptase inhibitor that prevents the HIV and hepatitis B viruses from multiplying in the human body. The market for this drug is experiencing significant growth driven by several key factors.

Market Size and Growth

The tenofovir disoproxil fumarate market is estimated to grow at a Compound Annual Growth Rate (CAGR) of around 4.5% from 2022 to 2027[1]. By 2032, the market is projected to reach USD 3.41 billion, growing at a CAGR of 6.41%[5].

Key Drivers

Growing Number of Hepatitis B Patients

The increasing cases of hepatitis B globally are a significant driver for the market. According to the World Health Organization, in 2019, 296 million people were living with chronic hepatitis B infection, resulting in an estimated 820,000 deaths. This high number of active cases and deaths will lead to increased usage of tenofovir disoproxil fumarate for treatment[1].

Increase in Number of Female HIV Patients

Women are more vulnerable to HIV infection, and the growing number of female HIV patients is another key driver. The World Health Organization reported that in 2020, 680,000 people died from HIV-related causes, and 1.5 million people acquired HIV, highlighting the need for antiretroviral drugs like tenofovir disoproxil fumarate[1].

Government Initiatives

Various government initiatives aimed at ending the HIV pandemic, such as those in the US, will lead to increased usage of tenofovir disoproxil fumarate in HIV treatment, further expanding the global market[1].

Market Segmentation

By Form

The tablets segment held a significant share in the tenofovir disoproxil fumarate market in 2021 and is projected to grow with a CAGR of 4.7% during the forecast period. These tablets combine multiple antiviral drugs in a single dose and are available in different dosages, making them a preferred treatment option for HIV and hepatitis B patients[1].

By Indication

The market is segmented by indication into HIV pre-exposure prophylaxis (PrEP), HIV treatment, and hepatitis B virus infection. The growing need for effective treatments and preventive measures for these conditions drives the demand for tenofovir disoproxil fumarate[5].

By Patient Population

The market is also segmented by patient population, with a focus on the increasing number of HIV and hepatitis B cases among various demographics. This segmentation helps in understanding the specific needs and trends within different patient groups[5].

Regional Analysis

North America

North America dominates the tenofovir disoproxil fumarate industry, primarily due to the presence of leading producers like Gilead Sciences Inc. in the US. The region is projected to grow with a CAGR of 5.2% during the forecast period, driven by the increasing number of HIV and hepatitis B patients and the availability of generic versions of the drug[1].

Other Regions

Other regions, including Europe, Asia Pacific, Middle East & Africa, and Latin America, also contribute significantly to the market. These regions are expected to experience growth due to increasing awareness and government initiatives to combat HIV/AIDS and hepatitis B[3].

Financial Performance

Gilead Sciences Inc.

Gilead Sciences Inc., a leading producer of tenofovir disoproxil fumarate, reported significant financial performance in recent years. For instance, in Q4 of 2021, HIV product sales in the US increased by 7% to $4.5 billion compared to the same period in 2020. Hepatitis B virus product sales also increased by 9% to $265 million during the same period[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on Gilead's financials. While the launch of Veklury (remdesivir) boosted total revenues, the sales of HIV and hepatitis C virus (HCV) products, including tenofovir disoproxil fumarate, decreased due to the pandemic's effects and the loss of exclusivity for certain products[2].

Competitive Landscape

The market for tenofovir disoproxil fumarate is competitive, with several key players focusing on strategy building and product portfolio expansion. Companies like Gilead Sciences Inc., Alkem Laboratories, and others are significant players in this market. The introduction of combination drugs, such as Biktarvy and Descovy, has also contributed to the market's growth[3].

Challenges and Restraints

Side Effects

The side effects of tenofovir disoproxil fumarate, such as nausea, rash, diarrhea, headache, pain, and depression, can restrict its usage in the medical sector. These side effects are a significant restraint on the market's growth[1].

Loss of Exclusivity

The loss of exclusivity for certain products, such as Truvada and Atripla, has led to a decline in sales for these drugs. This decline is partially offset by the growth of other products like Biktarvy and Descovy[2].

Future Outlook

The future outlook for the tenofovir disoproxil fumarate market is positive, driven by the increasing demand for antiretroviral drugs and treatments for hepatitis B. Government initiatives, growing awareness, and the introduction of new combination drugs are expected to continue driving market growth.

"By 2032, the market is projected to reach USD 3.41 billion, growing at a CAGR of 6.41%," - Market Research Future[5].

Key Takeaways

  • The tenofovir disoproxil fumarate market is driven by the growing number of hepatitis B and HIV/AIDS cases globally.
  • North America, particularly the US, is a dominant region due to the presence of leading producers like Gilead Sciences Inc.
  • Government initiatives and the availability of generic versions of the drug are key factors in market growth.
  • The market faces challenges such as side effects and the loss of exclusivity for certain products.

FAQs

What is tenofovir disoproxil fumarate used for?

Tenofovir disoproxil fumarate is used to treat chronic hepatitis B and to prevent HIV/AIDS. It acts as a nucleotide reverse transcriptase inhibitor to prevent the viruses from multiplying in the body[1].

Which region dominates the tenofovir disoproxil fumarate market?

North America, particularly the US, dominates the tenofovir disoproxil fumarate market due to the presence of leading producers like Gilead Sciences Inc.[1].

What are the key drivers of the tenofovir disoproxil fumarate market?

The key drivers include the growing number of hepatitis B patients, the increase in female HIV patients, and government initiatives aimed at ending the HIV pandemic[1].

What are the side effects of tenofovir disoproxil fumarate?

The side effects include nausea, rash, diarrhea, headache, pain, and depression. These side effects can restrict the drug's usage in the medical sector[1].

How has the COVID-19 pandemic affected the market for tenofovir disoproxil fumarate?

The COVID-19 pandemic had a mixed impact, with increased sales of some products like Veklury but decreased sales of HIV and HCV products due to the pandemic's effects and the loss of exclusivity for certain products[2].

Sources:

  1. IndustryARC, Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027.
  2. Gilead Sciences, Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results.
  3. Cognitive Market Research, Global Tenofovir Disoproxil Fumarate and Its Combination Drugs Market Report 2024.
  4. DrugPatentWatch, DESCOVY Drug Patent Profile.
  5. Market Research Future, Tenofovir Disoproxil Fumarate Market Growth Analysis 2032.

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