BIKTARVY Drug Patent Profile

Which patents cover Biktarvy, and what generic alternatives are available?

Biktarvy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and sixty-four patent family members in fifty-five countries.

The generic ingredient in BIKTARVY is bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate. Three suppliers are listed for this compound. Additional details are available on the bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Biktarvy

Biktarvy was eligible for patent challenges on February 7, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 8, 2036. This may change due to patent challenges or generic licensing.

There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BIKTARVY

International Patents:	364
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	38
Drug Prices:	Drug price information for BIKTARVY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIKTARVY
What excipients (inactive ingredients) are in BIKTARVY?	BIKTARVY excipients list
DailyMed Link:	BIKTARVY at DailyMed

See drug prices for BIKTARVY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BIKTARVY

Constraining patent/regulatory exclusivity:

10,548,846

NDA:

210251

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BIKTARVY

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Fenway Community Health	Phase 3
Prism Health North Texas	Phase 3

See all BIKTARVY clinical trials

Pharmacology for BIKTARVY

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 BIKTARVY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BIKTARVY	Tablets	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	30 mg/120 mg/ 15 mg	210251	1	2023-09-28
BIKTARVY	Tablets	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	50 mg/200 mg/ 25 mg	210251	3	2022-02-07

US Patents and Regulatory Information for BIKTARVY

BIKTARVY is protected by nine US patents and five FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,548,846.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	9,296,769*PED				Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	11,744,802		Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No	10,385,067
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No	7,390,791*PED				Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No	9,708,342		Y	Y

Expired US Patents for BIKTARVY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021	7,803,788
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018	6,642,245
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018	7,803,788
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018	6,703,396

International Patents for BIKTARVY

When does loss-of-exclusivity occur for BIKTARVY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Cuba

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BIKTARVY around the world.

Country	Patent Number	Title	Estimated Expiration
China	1037682
Greece	950300024
Hong Kong	1199026	替諾福韋艾拉酚胺 半反丁烯二酸鹽 (TENOFOVIR ALAFENAMIDE HEMIFUMARATE (TENOFOVIRALAFENAMIDE))
Japan	5651275
Mexico	2016016059
Morocco	44221

Supplementary Protection Certificates for BIKTARVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	1690012-8	Sweden		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061/001-002 20151123
0513200	91073	Luxembourg		91073, EXPIRES: 20160131
1301519	CR 2016 00012	Denmark		PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
1301519	PA2016009	Lithuania		PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
0513200	SPC/GB04/016	United Kingdom		PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
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

Market Dynamics and Financial Trajectory of Biktarvy

Introduction

Biktarvy, a groundbreaking single-tablet regimen for HIV-1 treatment, has revolutionized the antiretroviral therapy (ART) landscape since its approval in 2018. Developed by Gilead Sciences, Biktarvy has not only transformed the treatment paradigm but also dominated the market with its exceptional efficacy and safety profile.

Approval and Initial Market Impact

Biktarvy, which combines bictegravir, emtricitabine, and tenofovir alafenamide (TAF), was approved by the US FDA in 2018. Its launch marked a significant shift in the HIV treatment market, as it quickly gained traction due to its once-daily dosing, high efficacy, and favorable safety profile[1].

Market Performance

Since its introduction, Biktarvy has shown remarkable market performance. In its launch year, it generated $1.144 billion in the US, which surged to $6.095 billion by 2020. DelveInsight predicts that Biktarvy will continue to grow, reaching a market size of $10.673 billion by 2024, solidifying its position as the market leader[1].

Sales Growth

The sales of Biktarvy have been consistently strong. For the full year 2022, Biktarvy sales increased by 20% to $10.4 billion, driven by higher demand and favorable pricing dynamics. This trend continued in 2023, with sales increasing by 14% to $11.8 billion compared to the previous year[4][5].

Market Share and Dominance

Gilead Sciences, the manufacturer of Biktarvy, holds over 60% of the US HIV drug market, primarily due to the success of this medication. Biktarvy's dominance has led to a decline in sales of other HIV therapies such as Genvoya, Stribild, and Triumeq[3].

Competitive Landscape

The rise of Biktarvy has significantly altered the competitive landscape of the HIV treatment market. It has outperformed other TAF-based regimens like Genvoya and Odefsey, which saw declining sales after Biktarvy's launch. The drug's superior efficacy and safety, combined with its convenience as a single-tablet regimen, have made it the preferred choice for many patients and healthcare providers[1].

Financial Impact on Gilead Sciences

Biktarvy's success has been a key driver of Gilead Sciences' financial performance. In 2022, HIV product sales, led by Biktarvy, increased by 5% to $17.2 billion. This growth was a significant contributor to Gilead's overall revenue, which remained flat at $27.0 billion for the full year 2022 compared to 2021, despite declines in other product segments like Veklury (remdesivir)[4].

Future Outlook

The future outlook for Biktarvy remains robust. With ongoing research and development, Gilead is expected to maintain its market leadership in the HIV treatment sector. The company's continuous investment in R&D ensures a strong pipeline of new HIV medications and innovations, further solidifying Biktarvy's position in the market[3].

Challenges and Opportunities

Despite its dominance, the HIV treatment market faces challenges such as generic competition, affordability limitations, and stigma. However, these challenges also present opportunities for Gilead to expand access to treatment, particularly in underdeveloped nations. Government initiatives to raise awareness about HIV management and the increasing diagnosis rates are expected to drive the demand for ART medications like Biktarvy[3].

Regulatory and Clinical Updates

Biktarvy has received regulatory approvals and has been involved in various clinical trials, further enhancing its credibility and market position. For instance, the approval of lenacapavir, another HIV agent by Gilead, complements Biktarvy's offerings and strengthens the company's HIV treatment portfolio[4].

Impact on Public Health

The success of Biktarvy has significant implications for public health. By providing an effective and safe treatment option, it helps in managing HIV-1 infection more effectively, improving the quality of life for patients, and reducing the transmission rates of the virus.

Key Takeaways

• Market Dominance: Biktarvy has become the market leader in the HIV treatment sector since its launch in 2018.
• Sales Growth: The drug has shown consistent sales growth, reaching $11.8 billion in 2023.
• Competitive Edge: Biktarvy's superior efficacy, safety, and convenience have led to a decline in sales of other HIV therapies.
• Financial Impact: Biktarvy is a key driver of Gilead Sciences' financial performance, contributing significantly to the company's revenue.
• Future Outlook: The drug is expected to maintain its market leadership with ongoing R&D and expanding access to treatment.

FAQs

What is Biktarvy and how does it work?

Biktarvy is a single-tablet regimen for HIV-1 treatment, combining bictegravir, emtricitabine, and tenofovir alafenamide (TAF). It works by inhibiting the replication of the HIV virus, thereby reducing the viral load in the body.

Who is the primary manufacturer of Biktarvy?

Gilead Sciences is the primary manufacturer of Biktarvy.

What has been the market performance of Biktarvy since its launch?

Since its launch in 2018, Biktarvy has shown remarkable market performance, with sales increasing from $1.144 billion in the launch year to $11.8 billion in 2023.

How does Biktarvy compare to other HIV treatments?

Biktarvy has outperformed other HIV treatments such as Genvoya and Stribild due to its superior efficacy, safety, and convenience as a single-tablet regimen.

What are the future prospects for Biktarvy in the HIV treatment market?

Biktarvy is expected to maintain its market leadership with ongoing R&D and expanding access to treatment, particularly in underdeveloped nations.

Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
2. BusinessWire: Gilead Sciences Announces Second Quarter 2023 Financial Results.
3. Insights10: US HIV Drugs Market Analysis Report 2022 to 2030.
4. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2022 Financial Results.
5. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results.