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 nine 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 seventy-six patent family members in fifty-five countries.

Two suppliers are listed for this compound.

Summary for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

International Patents:	376
US Patents:	9
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					Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No					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

International Patents for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Country	Patent Number	Title	Estimated Expiration
Chile	2015001756
Turkey	201802179
Slovenia	2822954

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	717	Finland
1301519	132016000035069	Italy		PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
2822954	330 16-2018	Slovakia		PRODUCT NAME: BIKTEGRAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1289 20180625

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Last updated: December 22, 2025

Executive Summary

This report provides a comprehensive analysis of the market dynamics and projected financial trajectory of the pharmaceutical combination comprising bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate. Market factors including product approvals, competitive landscape, regulatory environment, and evolving treatment paradigms in HIV management shape the trajectory. The combination, marketed predominantly as Biktarvy, holds a significant position in antiretroviral therapy (ART). Its financial outlook is optimistic, underpinned by high efficacy, safety profile, and strong patent protection, with potential growth driven by expanding indications, geographic penetration, and competitive innovations.

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Summary of Key Findings

Aspect	Highlights
Market Position	Dominant in global HIV treatment market
Revenue (2022)	Estimated at ~$5 billion globally
CAGR (2023-2028)	Projected at 8-10% annually
Main Drivers	Efficacy, safety, patent exclusivity, expanding indications
Challenges	Generic competition, pricing pressures, regulatory hurdles
Regional Outlook	North America and Europe lead; Asia-Pacific growth expected
Patent Status	Patents valid till 2030-2035 in most jurisdictions

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What Are the Product Components and Their Therapeutic Role?

Ingredient	Function	Indication
Bictegravir Sodium	Integrase strand transfer inhibitor (INSTI)	HIV-1 infection, reduces viral replication
Emtricitabine	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV-1, HIV-2 infections, suppression of viral load
Tenofovir Alafenamide Fumarate	NRTI, prodrug with improved safety profile over TDF	HIV, hepatitis B virus (HBV) co-infection management

Regulatory Approvals:
First approved in the US in 2018 (FDA), Biktarvy has since received approvals across multiple jurisdictions including EMA (Europe) and Japan, cementing its role as a first-line treatment for HIV-1 infection.

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Market Dynamics

1. Market Size and Growth Drivers

Year	Estimated Global Market Size	CAGR (2023-2028)
2022	~$5 billion	N/A
2028	~$8–9 billion	8-10%

The primary revenue driver is the increasing prevalence of HIV globally, projected to reach 38 million infected individuals by 2030 according to UNAIDS[1].

2. Competitive Landscape

Key Players	Core Products	Market Share (2022)	Differentiators
Gilead Sciences	Truvada, Descovy, Biktarvy	~70%	Strong R&D pipeline, broad patent portfolio, extensive distribution network
ViiV Healthcare (GSK, Pfizer)	Juluca, Dovato	~20%	Focused HIV portfolio, combination therapies
Others	Raltegravir, Dolutegravir-based combinations	<10%	Competitive generic entries, regional players

Biktarvy's market dominance stems from its efficacy, safety, and simplified once-daily dosing.

3. Patent and Regulatory Environment

Patent protection extends into the early 2030s, providing exclusivity and pricing power. Regulatory agencies continue to approve the drug for expanded indications, including pediatric formulations and pre-exposure prophylaxis (PrEP), providing growth avenues.

4. Price and Reimbursement Dynamics

Region	Average Wholesale Price (AWP) per Year	Reimbursement Policies
North America	~$30,000–$50,000 per patient/year	Favorable, with insurance coverage and government programs (Medicare/Medicaid)
Europe	Similar pricing, with national reimbursement	Variability, influenced by health technology assessments (HTA)
Asia-Pacific	Lower prices, emerging reimbursement policies	Market access expanding, patents usually less protected over time

Pricing pressures intensify with the introduction of generics post-patent expiry.

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Financial Trajectory Analysis

1. Revenue Forecast

Year	Projected Revenue (USD billions)	Assumptions
2023	~$5.5 billion	Continued uptake, expanding indications, broader access
2024	~$6.2 billion	Increased market penetration, delayed generic competition
2025	~$7 billion	Patent exclusivity maintained, new indications gaining traction
2026-2028	$8–9 billion	Global expansion, emerging markets, pediatric use

2. Cost Structure and Profit Margins

Expense Category	Approximate Share of Revenue	Implication
R&D (including pipeline):	10–15%	Sustains innovation and pipeline development
Manufacturing & Distribution	5–8%	Economies of scale improve margins
Marketing & Sales	10–12%	Drive adoption and market share
Operating Costs & Compliance	5–7%	Regulatory adherence and quality control
Gross Margin	~70%	Strong, supported by patent exclusivity

3. Impact of Competitive Pressure and Patent Expiry

Post-2030, generics are expected to erode the revenue base significantly. The primary manufacturer will need diversification strategies, such as expanding indications or developing novel formulations, to sustain profits.

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Regional Market Penetration and Opportunities

Region	Current Market Share	Growth Drivers	Challenges
North America	High (~70%)	Established healthcare infrastructure, reimbursement policies	Price regulation, patent challenges
Europe	Moderate (~20%)	Similar to North America, slower adoption in some countries	Cost-containment measures
Asia-Pacific	Growing (~10%)	Increasing HIV prevalence, expanding healthcare access	Regulatory complexity, price sensitivity

Opportunities:

• Expansion into pediatric and adolescent populations.
• Use in PrEP, especially with positive trial results.
• Entry into emerging markets with lower pricing.

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Comparison with Competing Treatments

Parameter	Biktarvy (TAs: Bictegravir + Emtricitabine + TAF)	Dovato (Dolutegravir + Lamivudine)	Triumeq (Abacavir + Dolutegravir + Lamivudine)
Efficacy	>95% viral suppression	Similar	Similar
Safety Profile	Excellent, fewer drug interactions	Good, some concerns (e.g., weight gain)	Good, but requires HLA-B*57:01 testing
Dosing Convenience	Once daily, single tablet	Once daily, single tablet	Once daily, single tablet
Price	High (~$50,000/year)	Slightly lower	Similar to Biktarvy
Patent Expiry	~2030s	~2028	Longer (patented until 2035 in some jurisdictions)

Implication:
Biktarvy's combination offers a balanced profile of efficacy, safety, and convenience, cementing its market leadership.

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Key Regulatory and Policy Factors

• US FDA: Fast track and priority review pathways for new indications.
• EMA: Conditional approvals and orphan designations.
• WHO: Inclusion in essential medicines list supports access initiatives.
• Pricing and Patent Policies: Impact post-patent expiry, negotiations for biosimilar entry, and price caps influence revenue potential.

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FAQs

Q1: When are generic versions of Biktarvy expected to enter the market?
A: Patent protections currently extend into the early 2030s. Generic entry is anticipated post-2030, subject to patent litigation and regulatory approvals.

Q2: How does Biktarvy compare with other first-line HIV treatments?
A: It offers high efficacy, once-daily single-tablet dosing, and favorable safety, making it a preferred choice over older regimens like Truvada or Triumeq, with differential cost and indication profiles.

Q3: What are the opportunities for growth beyond HIV treatment?
A: Expanding indications such as PrEP, pediatric formulations, and combination with innovative delivery platforms can drive future growth.

Q4: How does the regulatory environment influence market longevity?
A: Favorable approvals and patent protections facilitate revenue despite competitive threats, whereas regulatory hurdles can delay entry and market expansion.

Q5: What is the impact of pricing reforms on Biktarvy’s financial trajectory?
A: Price reductions driven by policy reforms, especially in Europe and Asia, can reduce revenue margins but may expand access and volume.

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Key Takeaways

• Market Position: Biktarvy dominates the HIV combination therapy segment, with sustained growth driven by efficacy, safety, and convenience.
• Financial Outlook: Expected CAGR of 8-10% through 2028, reaching ~$8-$9 billion worldwide.
• Patent Protection: Critical to maintaining revenue; expiry anticipated in the early 2030s.
• Competitive Landscape: Intensifies post-generic entry; innovation and expanded indications are pivotal for sustained profitability.
• Regulatory Factors: Approval for new indications and regional access are key growth enablers.
• Strategic Recommendations: Focus on expanding indications, geographic reach, and mitigating generic risks post-patent expiry.

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References

[1] UNAIDS Data 2022. Global HIV Estimates. Available at: https://unaids.org/en/resources/documents/2022/UNAIDS_data