Tenofovir disoproxil fumarate - Generic Drug Details

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

Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, 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 fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for tenofovir disoproxil fumarate. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for tenofovir disoproxil fumarate

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	14
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	394
Patent Applications:	6,768
Drug Prices:	Drug price trends for tenofovir disoproxil fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tenofovir disoproxil fumarate
What excipients (inactive ingredients) are in tenofovir disoproxil fumarate?	tenofovir disoproxil fumarate excipients list
DailyMed Link:	tenofovir disoproxil fumarate at DailyMed

See drug prices for tenofovir disoproxil fumarate

Recent Clinical Trials for tenofovir disoproxil fumarate

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

Sponsor	Phase
Wits Health Consortium (Pty) Ltd	Phase 3
London School of Hygiene and Tropical Medicine	Phase 3
Africa Health Research Institute	Phase 3

See all tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET;ORAL
		250MG	TABLET;ORAL
		200MG	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 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 tenofovir disoproxil fumarate

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 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
Teva Pharms Usa	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	091612-002	Jan 26, 2018	AB	RX	No	No
Strides Pharma	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090742-001	Jan 26, 2018	AB	RX	No	No
Reyoung	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	211337-001	Mar 2, 2023	AB	RX	No	No
Qilu	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	209498-003	Mar 2, 2018	AB	RX	No	No

Expired US Patents for tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001

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.