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

Constraining patent/regulatory exclusivity:

10,548,846

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	8,754,065*PED				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	9,216,996		Y	Y
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	210251-002	Oct 7, 2021		RX	Yes	No	9,732,092		Y	Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	9,732,092		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	6,703,396
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	7,803,788
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018	6,642,245

International Patents for bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Country	Patent Number	Title	Estimated Expiration
Cuba	20160187	(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
Argentina	103663	COMPUESTOS DEL TIPO DE LAS CARBAMILPIRIDONAS POLICÍCLICAS Y SU USO FARMACÉUTICO
Eurasian Patent Organization	201890236
Mexico	2019013380	(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. (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.)
World Intellectual Property Organization (WIPO)	2013025788
Philippines	12014500349	TENOFOVIR ALAFENAMIDE HEMIFUMARATE

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	122016000024	Germany		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2822954	1890030-8	Sweden		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
1301519	PA2016009	Lithuania		PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
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
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
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 for BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Last updated: July 29, 2025

Introduction

The combination of BICTEGRAVIR SODIUM, EMTRICITABINE, and TENOFOVIR ALAFENAMIDE FUMARATE has gained significant traction in the HIV treatment landscape. Market dynamics—comprising competitive forces, regulatory pathways, and technological advancements—are shaping the drug’s financial trajectory. This analysis provides a comprehensive understanding of current market conditions, forecasted financial growth, and strategic implications for stakeholders investing or operating within this therapeutic segment.

Therapeutic Market Overview

HIV/AIDS Therapeutic Landscape

The global HIV treatment market is projected to reach $38.6 billion by 2027, with a compound annual growth rate (CAGR) of approximately 4.2% from 2020 to 2027. The primary therapeutic paradigm involves antiretroviral therapy (ART), aimed at suppressing viral replication, improving patient quality of life, and preventing transmission.

Role of Fixed-Dose Combinations (FDCs)

Fixed-dose combinations, such as the triplet of Bictegravir, Emtricitabine, and Tenofovir Alafenamide (commonly marketed as Biktarvy), have revolutionized HIV adherence strategies, simplifying regimens and reducing pill burden. The convenience, efficacy, and tolerability of FDCs place them at a competitive advantage, contributing to market expansion.

Product Overview and Regulatory Status

Active Pharmaceutical Ingredients (APIs)

• Bictegravir Sodium: An integrase strand transfer inhibitor (INSTI) with potent antiviral activity.
• Emtricitabine: A nucleoside reverse transcriptase inhibitor (NRTI) used extensively in HIV regimens.
• Tenofovir Alafenamide (TAF): A prodrug of tenofovir with improved safety profile over tenofovir disoproxil fumarate, especially regarding renal and bone toxicity.

Regulatory Approvals and Launches

Originally approved by the FDA in 2018 as part of Biktarvy, the combination has secured approvals in multiple jurisdictions. Its commonality in the market underscores its pivotal role in current HIV treatment protocols. Patent protections extend into the mid-2030s, influencing market exclusivity trajectories.

Market Dynamics Influencing Financial Performance

Competitive Landscape

The emergence of alternative regimens—including Dolutegravir-based FDCs (e.g., Dolutegravir/Lamivudine), Cabotegravir injectables, and novel agents—poses competitive pressures. However, Biktarvy maintains a dominant market share due to its proven efficacy, safety profile, and established brand recognition.

Patent Expirations and Generic Entry

Pending patent expirations may open avenues for generic competition post-2030, potentially impacting revenue streams. Nonetheless, ongoing patent extensions and formulation patents temporarily safeguard market share.

Pricing Strategies and Reimbursement Policies

Pricing remains a critical factor. High-cost branded therapies face scrutiny amid healthcare cost containment efforts. Payer negotiations, especially in Medicaid and Medicare, influence net sales. The strategic deployment of patient assistance programs and tiered pricing further modulate revenue.

Market Penetration and Adoption

Global penetration varies; high-income countries exhibit robust adoption driven by healthcare infrastructure and clinician familiarity. In contrast, low- and middle-income regions are slowly adopting these therapies, influenced by affordability and regulatory approvals.

Technological Innovations

Next-generation delivery systems, such as long-acting injectable formulations, threaten to redefine treatment adherence paradigms, potentially disrupting the current oral tablet market and affecting revenues dynamically.

Financial Trajectory Forecast

Revenue Projections

Revenue for BIC/EMT/TEN combination is projected to grow at a CAGR of approximately 5.0% from 2023 to 2030, aligning with global HIV prevalence and increasing adoption rates (particularly in Africa and Asia). Revenue peaks are anticipated in the late 2020s, driven by expanding patient pools and increased awareness.

Impact of Patent Protections and Competition

Patent protections provide revenue stability until mid-2030s. Post-expiry, switch to generics could erode approximately 30–40% of sales unless mitigated by new formulations or indications.

Regulatory and Market Expansion Opportunities

Subsequent approvals for pediatric or long-acting formulations could serve as revenue catalysts. Additionally, indications for PrEP (pre-exposure prophylaxis) or expansion into co-infection treatments (e.g., HIV/HBV) offer additional growth avenues.

Cost Structure and Investment Trends

Manufacturing efficiencies, owing to advanced synthetic processes, reduce unit costs over time. R&D investments in new delivery mechanisms and resistance management are expected to increase, though with delayed ROI realization.

Strategic Market Considerations

Partnerships and Alliances

Collaborations with public health agencies and nonprofit organizations will facilitate market penetration, especially in resource-constrained settings.

Pricing and Market Access Strategies

Flexible pricing models and value-based reimbursement arrangements will be vital to sustain revenue growth amidst global cost-containment policies.

Pipeline Development and Innovation

Investing in long-acting injectables, dual therapies, and resistance-resistant formulations will be critical to maintaining competitive advantage and driving long-term revenue.

Conclusion

The financial trajectory for the combination of BICTEGRAVIR SODIUM, EMTRICITABINE, and TENOFOVIR ALAFENAMIDE FUMARATE is favorable in the short to mid-term, supported by strong clinical efficacy, regulatory endorsements, and global demand. however, impending patent expirations, evolving competitive dynamics, and technological innovations necessitate proactive strategic planning to mitigate revenue risks and capitalize on new market opportunities.

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Key Takeaways

• The combined drug offers a solid revenue base with anticipated growth driven by increasing global HIV treatment needs.
• Patent protections prolong market exclusivity until the mid-2030s, but impending generics may challenge sustained profitability.
• Innovation in delivery systems and indications (e.g., long-acting injectables, PrEP) offers avenues for revenue expansion.
• Competitive pressures necessitate strategic alliances, flexible pricing, and pipeline investments.
• Expanding into emerging markets and strengthening treatment adherence initiatives are critical to long-term financial success.

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FAQs

1. How will patent expirations affect the financial outlook for this drug combination?
Patent expirations around the mid-2030s could enable generic manufacturers to enter markets, significantly reducing branded sales. Companies are mitigating this risk through formulation patents, evergreening strategies, and pipeline diversification.

2. What technological innovations could disrupt the current market for this combination?
Long-acting injectable formulations, implantable devices, and sustained-release systems are poised to revolutionize adherence and patient preference, potentially displacing traditional oral regimens.

3. In which regions is market penetration for this drug most promising?
High-income countries currently dominate sales; however, emerging markets in Africa, Asia, and Latin America present substantial growth opportunities due to rising HIV prevalence and global health initiatives.

4. How do pricing and reimbursement policies influence revenue streams?
Price sensitivity and reimbursement policies directly impact access and profitability. Negotiations with payers, inclusion in essential medicines lists, and patient assistance programs are central to maximizing revenue.

5. What strategic steps should pharmaceutical companies take to enhance the financial trajectory?
Investing in pipeline innovation, expanding indications, pursuing regulatory approvals in new territories, and forming strategic alliances are essential to sustaining growth amid competitive pressures.

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References

[1] Market Research Future. "HIV Therapeutics Market." 2022.
[2] IQVIA. "Global HIV Market Insights." 2022.
[3] FDA. "Biktarvy (Bictegravir, Emtricitabine, Tenofovir Alafenamide) Approval History." 2018.