VIREAD Drug Patent Profile

When do Viread patents expire, and when can generic versions of Viread launch?

Viread is a drug marketed by Gilead Sciences Inc and is included in two NDAs.

The generic ingredient in VIREAD 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 Viread

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

Summary for VIREAD

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	91
Patent Applications:	4,617
Drug Prices:	Drug price information for VIREAD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIREAD
What excipients (inactive ingredients) are in VIREAD?	VIREAD excipients list
DailyMed Link:	VIREAD at DailyMed

See drug prices for VIREAD

Recent Clinical Trials for VIREAD

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

Sponsor	Phase
Doris Duke Charitable Foundation	Phase 4
Albert Einstein College of Medicine	Phase 4
Université Protestant au Congo	Phase 4

See all VIREAD clinical trials

Pharmacology for VIREAD

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

Paragraph IV (Patent) Challenges for VIREAD

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 VIREAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012		RX	Yes	Yes
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	AB	RX	Yes	Yes

Expired US Patents for VIREAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	5,935,946*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	4,808,716
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	6,057,305
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	5,935,946*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	5,922,695*PED
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	5,922,695*PED

International Patents for VIREAD

See the table below for patents covering VIREAD around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	3030754
Denmark	0915894
Taiwan	I242561
South Korea	20060038451
Taiwan	200510438
European Patent Office	1243593	Composition d'analogues de nucléotides et procédé de synthèse (Nucleotide analog composition and synthesis method)

Supplementary Protection Certificates for VIREAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0915894	SPC021/2005	Ireland		SPC021/2005: 20090811, EXPIRES: 20200220
2924034	2019/021	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122
1301519	SPC/GB16/015	United Kingdom		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123
1632232	93385	Luxembourg		PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
2487166	1790001-0	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ALAFENAMIDE FUMARATE; FIRST MARKETING AITHORIZATION NUMBER SE: EU/1/15/1061, 2015-11-23
2924034	1990024-0	Sweden		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126

VIREAD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Viread (Tenofovir Disoproxil Fumarate)

Market Overview

Viread, also known as tenofovir disoproxil fumarate, 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.

Growing Demand and Market Size

The global market for tenofovir disoproxil fumarate is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4.5% from 2022 to 2027. This growth is driven by increasing cases of hepatitis B, a rise in the number of female HIV patients, and global efforts to achieve viral suppression against HIV[1].

Regional Performance

North America, particularly the United States, is the fastest-growing region for the tenofovir disoproxil fumarate market, with a CAGR of 5.2% during the forecast period. This is largely due to the presence of major pharmaceutical companies like Gilead Sciences Inc., which is a leading producer of Viread[1].

Financial Performance

Historical Financials

In the early 2000s, Viread played a significant role in Gilead Sciences' financial success. For instance, in the second quarter of 2002, sales of Viread were $44.7 million, contributing 48% of Gilead's product sales. This strong revenue helped Gilead achieve profitability for the first time, with net revenues exceeding $100 million for the quarter[2].

Recent Trends

In recent years, the financial performance of Viread has been influenced by several factors, including the COVID-19 pandemic. During the pandemic, there was a temporary decline in sales due to production and supply chain disruptions. For example, in Q4 of 2020, HIV product sales decreased by 7% compared to the same period in 2019, and hepatitis B product sales dropped by 47% in Q2 of 2020[1].

However, the market has shown resilience. By Q4 of 2021, HIV product sales in the US had increased by 7% to $4.5 billion, and hepatitis B product sales rose by 9% to $265 million compared to the same period in 2020[1].

Competitive Landscape

Market Share and Dominance

Gilead Sciences dominates the HIV-1 treatment market, with approximately 68% of the total market share in the US in 2020. Viread, along with other Gilead products like Truvada, Descovy, Biktarvy, Odefsey, and Genvoya, contributes significantly to this market share[4].

Shift to New Regimens

The market is witnessing a shift from multi-tablet regimens (MTRs) to single-tablet regimens (STRs). The launch of Biktarvy, an integrase-based regimen, has significantly impacted the sales of older TDF-based regimens like Viread. Biktarvy's market size in the US grew from $1.144 billion in its launch year to $6.095 billion in 2020 and is expected to reach $10.673 billion by 2024[4].

Challenges and Opportunities

Side Effects and Litigation

One of the challenges facing Viread is the potential side effects, such as nausea, rash, diarrhea, headache, pain, and depression. These side effects can restrict its usage and have led to product liability lawsuits against Gilead Sciences. Patients who used TDF drugs like Viread and Truvada are now filing lawsuits, which could impact the drug's market trajectory[5].

Generic Availability

Viread is available as a generic medication, which can increase its accessibility but may also reduce the revenue generated by the branded version. The availability of generics is a double-edged sword, as it expands the drug's reach but can erode the market share of the original product[1].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the production and supply of Viread due to lockdowns, lack of raw materials, and workforce availability. This led to a decrease in sales volumes for HIV and hepatitis products in 2020 and 2021. However, the market has been recovering, with sales volumes increasing as the pandemic's impact subsides[1].

Future Outlook

Growth Projections

Despite the challenges, the tenofovir disoproxil fumarate market is expected to grow, driven by increasing demand for HIV and hepatitis B treatments. Gilead Sciences anticipates that its HIV treatment sales will grow approximately 4% in 2024, driven by annual treatment demand growth, market share gains for Biktarvy, and continued growth in demand for HIV prevention[3].

Competitive Dynamics

The rise of new therapies, particularly single-tablet regimens like Biktarvy, will continue to shape the market. Gilead's strong portfolio and ongoing clinical developments position the company to maintain its market dominance, despite the emergence of new competitors and therapies[4].

Key Takeaways

• The tenofovir disoproxil fumarate market is projected to grow at a CAGR of around 4.5% from 2022 to 2027.
• North America, particularly the US, is the fastest-growing region for this market.
• Viread has been a significant contributor to Gilead Sciences' financial success but faces challenges from side effects and litigation.
• The market is shifting towards single-tablet regimens like Biktarvy.
• The COVID-19 pandemic had a temporary negative impact on sales but is recovering.
• Gilead Sciences anticipates continued growth in HIV treatment sales driven by demand and market share gains.

FAQs

What is Viread used for?

Viread, or tenofovir disoproxil fumarate, is used to treat chronic hepatitis B and prevent HIV/AIDS.

How is the market for Viread expected to grow?

The market for tenofovir disoproxil fumarate is expected to grow at a CAGR of around 4.5% from 2022 to 2027.

Which region is the fastest-growing for Viread?

North America, particularly the United States, is the fastest-growing region for the tenofovir disoproxil fumarate market.

What are the main challenges facing Viread?

The main challenges include potential side effects, litigation, and the shift towards new single-tablet regimens like Biktarvy.

How has COVID-19 impacted the sales of Viread?

The COVID-19 pandemic had a negative impact on the production and supply of Viread, leading to a temporary decline in sales volumes.

What is the future outlook for Gilead Sciences' HIV treatment sales?

Gilead Sciences anticipates that its HIV treatment sales will grow approximately 4% in 2024, driven by annual treatment demand growth, market share gains for Biktarvy, and continued growth in demand for HIV prevention.

Sources

1. IndustryARC: Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027.
2. Gilead Sciences: Gilead Sciences Announces Second Quarter 2002 Financial Results.
3. Gilead Sciences: GILEAD SCIENCES FOURTH QUARTER AND FULL YEAR 2023.
4. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
5. Lawsuit-Information-Center: Truvada Lawsuit | Projected Settlement Amounts | February 2024.