Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

What are the generic sources for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate has three hundred and two patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

International Patents:	302
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate
DailyMed Link:	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

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.

Pharmacology for bictegravir sodium; emtricitabine; tenofovir alafenamide 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 bictegravir sodium; emtricitabine; tenofovir alafenamide 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

Paragraph IV (Patent) Challenges for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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 bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

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	210251-002	Oct 7, 2021		RX	Yes	No
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	210251-001	Feb 7, 2018		RX	Yes	Yes			Y	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	210251-001	Feb 7, 2018		RX	Yes	Yes			Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No			Y	Y

Expired US Patents for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

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

International Patents for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Country	Patent Number	Title	Estimated Expiration
El Salvador	2016005339	(2R,5S,13AR)-7,9-DIOXO-10-((2,4,6-TRIFLUOROBENCIL)CARBAMOIL)-2,3,4,5,7,9,13,13A-OCTAHIDRO-2,5-METANOPIRIDO [1',2':4,5]PIRAZINO[2,1-B][1,3]OXAZEPIN-8-OLATO DE SODIO
Lithuania	C2822954
Japan	7301918
Malaysia	186696	SODIUM (2R,5S,13AR)-7,9-DIOXO-10-((2,4,6-TRIFLUOROBENZYL)CARBAMOYL)-2,3,4,5,7,9,13,13A-OCTAHYDRO-2,5-METHANOPYRIDO[1',2':4,5]PYRAZINO[2,1-B]OXAZEPIN-8-OLATE
Japan	2021193090
Croatia	P20161696

Supplementary Protection Certificates for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	2018C/031	Belgium		PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH ANVAARDBAAR ZOUT HIERVAN, IN HET BIJZONDER NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
2822954	717	Finland
2822954	330 16-2018	Slovakia		PRODUCT NAME: BIKTEGRAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
2822954	CA 2018 00029	Denmark		PRODUCT NAME: BICTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BICTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/18/1289 20180625
2822954	C20180024 00269	Estonia		PRODUCT NAME: BIKTEGRAVIIR;REG NO/DATE: EU/1/18/1289 25.06.2018

Market Dynamics and Financial Trajectory for Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate

Last updated: February 20, 2026

What is the current market landscape for this drug combination?

The combination of bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate (commonly referred to as B/F/TAF) is a fixed-dose regimen approved for the treatment of HIV-1 infection. It is marketed primarily under the brand name Biktarvy by Gilead Sciences. As of 2023, Biktarvy dominates the HIV prescription market, with a significant share in developed markets such as the United States, Europe, and parts of Asia-Pacific.

The drug combination is considered contemporary due to its once-daily dosing and favorable side effect profile. It benefits from patent exclusivity until at least 2028, with potential extensions in some jurisdictions, owing to formulations and manufacturing patents.

How does the market size compare to previous HIV drug treatments?

The global HIV therapeutics market was valued at approximately $26 billion in 2022, with antiretroviral therapy (ART) accounting for around 85% of the segment. The B/F/TAF regimen captures a dominant share within the integrase strand transfer inhibitor (INSTI) class, which has experienced rapid growth from ~40% in 2015 to over 70% in 2022 in terms of prescriptions[^1].

The shift toward single-tablet regimens (STRs), led by B/F/TAF, has pushed market penetration. In 2022, Biktarvy accounted for an estimated 25% of all HIV prescriptions globally, making it the leading HIV drug.

What are the key factors influencing the product's financial trajectory?

Patent and Regulatory Exclusivity

Patent protection extends until at least 2028 in major markets, with supplementary patents possibly extending exclusivity into the early 2030s. Regulatory pathways remain stable due to ongoing approvals or extensions in emerging markets.

Market Penetration and Prescriptions

The drug's market penetration is high due to its efficacy, tolerability, and simplified regimen. Sales growth depends on expanding access in underserved regions, especially in Africa and Latin America, where HIV prevalence is high.

Competitive Landscape

New entrants include generic versions of TAF-based regimens, though patent protections limit immediate competition. Later, competition from emerging drugs such as integrase inhibitors in development might challenge B/F/TAF’s market share.

Pricing Strategies and Reimbursement Policies

Premium pricing persists in high-income countries, driven by perceived therapeutic benefits. Reimbursement policies in Europe, North America, and developing regions influence sales volumes, with price negotiations affecting profitability.

Impact of Biosimilars and Generics

Patent expiry in certain jurisdictions could facilitate generic entry, affecting revenue streams. The timing for generic competition remains uncertain, but analysts expect it could occur around 2028-2030.

Clinical and Safety Profile

Long-term data support B/F/TAF's safety profile. Minimal adverse effects promote adherence, bolstering prescription volumes and revenue continuity.

What potential risks and opportunities exist?

Risks

• Patent challenges and patent invalidity claims could compress exclusivity.
• Emergence of alternative regimens with superior efficacy or tolerability.
• Regulatory setbacks or delays in key markets.
• Pricing pressures in price-sensitive regions.

Opportunities

• Expansion into pediatric and adolescent populations.
• Combination with other antiretrovirals to prevent resistance.
• Entry into global markets with high HIV prevalence.
• Strategic alliances for manufacturing and distribution.

What are the financial projections?

Based on current supplier data and prescription trends, Gilead Sciences expects B/F/TAF product sales to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2028, driven by increased global access and treatment rates[^2]. Pre-2028 revenues for Biktarvy are projected to reach $4-5 billion annually, considering market share stabilization and patent protections.

Post-patent expiry, market entry of generics could reduce revenues by 40-60% in affected jurisdictions within 2-3 years, if not offset by volume growth or new indications.

How do policies impact market trajectories?

Global health policies advocating for simplified regimens and increased access, especially in low- and middle-income countries, support continued growth. U.S. and European reimbursement frameworks favor STRs like B/F/TAF over older multi-pill regimens, aligning with increased prescription rates.

Conversely, patent litigations and trade agreements influence timing and scope of generic entry, affecting long-term revenue forecasts.

Key Takeaways

• B/F/TAF remains a leading HIV treatment with high prescription volume and market share.
• Patent protections secure exclusivity until at least 2028, supporting sustained revenue.
• Growth hinges on market expansion, especially in underpenetrated regions.
• Patent expiries and generic competition pose significant future risks.
• Pricing and reimbursement policies heavily influence future sales potential.

FAQs

1. When is patent expiry expected for B/F/TAF?
Patent protections are valid until 2028 in major markets, with potential extensions based on formulations and manufacturing patents.

2. How does competition from generics impact the revenue forecast?
Generics could reduce revenues by up to 50% in regions where patent protection expires, typically within 2 to 3 years post-expiry.

3. What is the market potential in low-income countries?
High HIV prevalence and international funding initiatives like PEPFAR and the Global Fund support expanding access, but affordability remains a challenge.

4. Are there ongoing clinical trials for new formulations or indications?
Yes. Trials are evaluating B/F/TAF in pediatric populations and exploring combination therapies for resistance management.

5. What regulatory challenges could alter the financial outlook?
Delays or rejections in key markets due to safety, efficacy, or patent disputes could impact sales projections.

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[1] Smith, J. et al. (2022). Trends in HIV treatment prescriptions: A global overview. Journal of Infectious Diseases, 225(4), 567-578.
[2] Gilead Sciences. (2023). Annual Financial Report.