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

The generic ingredient in BIKTARVY is bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate. Two 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:	376
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	44
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
Gilead Sciences	NA
Brigham and Women's Hospital	NA
Trutag Technologies	NA

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	210251-002	Oct 7, 2021		RX	Yes	No	10,385,067
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	210251-002	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
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

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
Japan	2019218368
Japan	2022095640	ナトリウム（２Ｒ，５Ｓ，１３ＡＲ）－７，９－ジオキソ－１０－（（２，４，６－トリフルオロベンジル）カルバモイル）－２，３，４，５，７，９，１３，１３Ａ－オクタヒドロ－２，５－メタノピリド［１’，２’：４，５］ピラジノ［２，１－Ｂ］［１，３］オキサゼピン－８－オレート
Japan	H06505725
Peru	20181207	COMPOSICIONES TERAPEUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Hungary	E036928
El Salvador	2018005682	COMPOSICIONES TERAPEUTICAS PARA EL TRATAMIENTO DEL VIRUS DE INMUNODEFICIENCIA HUMANA
Mexico	357940	COMPUESTOS DE CARBAMOILPIRIDONA POLICICLICOS Y SU USO FARMACEUTICO. (POLYCYCLIC-CARBAMOYLPYRIDONE COMPOUNDS AND THEIR PHARMACEUTICAL USE.)

Supplementary Protection Certificates for BIKTARVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	330 16-2018	Slovakia		PRODUCT NAME: BIKTEGRAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
2822954	300947	Netherlands		PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
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	CA 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	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
0513200	300148	Netherlands		300148, 20110131, EXPIRES: 20160130

Market Dynamics and Financial Trajectory for BIKTARVY

Last updated: November 7, 2025

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Introduction

BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) stands as a prominent fixed-dose combination therapy for treating HIV-1 infections. Launched by Gilead Sciences in 2018, BIKTARVY has carved a significant niche within the competitive antiretroviral (ART) landscape. Its market performance hinges on multifaceted factors—drug efficacy, patent lifecycle, competitive pressures, regulatory landscape, and evolving HIV treatment paradigms. Understanding these dynamics is vital for stakeholders seeking to gauge its financial trajectory and long-term profitability.

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Market Landscape and Product Positioning

The global HIV treatment market is projected to reach approximately USD 30 billion by 2028, driven by increasing prevalence, active treatment guidelines, and improvements in drug tolerability and convenience [1]. BIKTARVY’s strategic positioning benefits from its once-daily, co-formulated regimen, which appeals to both clinicians and patients seeking simplified treatment options.

Gilead’s market dominance, especially with prior flagship drugs like Truvada and Descovy, has created a strong foundation for BIKTARVY’s uptake. The drug’s efficacy, a favorable safety profile, and minimal drug-drug interactions bolster its adoption, especially among treatment-naïve populations.

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Market Dynamics Influencing BIKTARVY

1. Competition from Other Regimens

BIKTARVY faces substantial competition from therapies such as Genvoya, Biktarvy’s competitor from Gilead, as well as generic formulations and emerging drugs like cabotegravir or doravirine-based regimens. The competitive edge hinges on efficacy, side-effect profile, dosing convenience, and cost.

2. Patent Life and Generic Entry

Patents for BIKTARVY are expected to last into the mid-2020s, with Gilead actively defending intellectual property rights. Nonetheless, upcoming patent expirations threaten generic proliferation—potentially eroding margins and market share [2]. The entry of generics often leads to significant price reductions, influencing revenue streams.

3. Regulatory Approvals and Off-Label Uses

While primarily approved for HIV-1 treatment, ongoing research and regulatory approvals for new indications could expand BIKTARVY’s market reach. Conversely, regulatory hurdles or withdrawal of approvals in specific regions could hinder growth.

4. Pricing and Reimbursement Policies

Pricing strategies, especially in developed regions like the US and EU, considerably impact sales volume and revenue. Payor dynamics and reimbursement policies favoring cost-effective therapies enhance BIKTARVY’s market penetration.

5. Patient Preference and Treatment Guidelines

Evolving guidelines favor simplified, efficacious regimens with minimal side effects. BIKTARVY’s once-daily dosing and favorable safety profile align with these trends, driving its adoption.

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Financial Trajectory and Revenue Forecasts

Initial Success and Revenue Growth

Post-approval, BIKTARVY experienced rapid uptake, with Gilead reporting USD 960 million in sales in 2020, reflecting strong initial demand [3]. The drug's appeal to both treatment-naïve and switching patients sustains revenue growth.

Projection Amid Patent Protections

Assuming patent protections remain intact through 2025, BIKTARVY could sustain annual revenues in the USD 1.2-1.5 billion range, bolstered by expanding global access programs. Gilead’s focus on expanding into emerging markets, where HIV prevalence is high but treatment options are limited, offers untapped revenue streams.

Impact of Patent Expiry and Generics

From 2026 onward, patent expiry could precipitate a decline in revenue unless Gilead adopts mitigation strategies, such as reformulations or expanding indications. The entry of generic competitors may lead to price erosions of up to 80%, according to industry standards [4].

Pipeline Developments and Line Extensions

Gilead’s pipeline includes long-acting injectable formulations and combination therapies, which could influence BIKTARVY’s financial trajectory through increased market share or cannibalization.

Market Risks and Opportunities

Risks include declining market share due to emerging therapies, regulatory setbacks, or adverse shifts in reimbursement policies. Conversely, the adoption of BIKTARVY in pediatric populations or new geographic markets presents growth opportunities.

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Influencing Factors for Long-Term Financial Performance

• Patent and IP Strategy: Defending patents into the late 2020s is crucial to delay generic competition.

• Product Differentiation: Maintaining a competitive edge through label expansions and combination therapy innovations.

• Market Access Initiatives: Broadening access in low-income regions enhances volume but pressures margins.

• Pipeline Success: Long-acting formulations could extend product lifecycle and revenue streams.

• Global Healthcare Trends: Growing awareness, increased screening, and treatment adherence facilitate sustained demand.

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Conclusion

BIKTARVY’s market dynamics are shaped by intense competition, patent protections, technological innovations, and evolving treatment protocols. Its financial outlook remains favorable amid robust initial performance, provided Gilead strategically manages patent protections and pipeline advancements. Long-term revenue realization will depend heavily on patent exclusivity, competitive responses, and expansion into new markets.

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Key Takeaways

• BIKTARVY’s success hinges on maintaining patent exclusivity and fostering differentiation through new formulations or indications.
• Competitive pressure from generics post-patent expiry underscores the need for pipeline innovation and strategic market expansion.
• The global HIV market’s growth trajectory supports sustained demand, especially in underserved regions, augmenting BIKTARVY’s revenue potential.
• Adaptive pricing and reimbursement strategies are critical to balancing profitability with access.
• Strategic investments in long-acting formulations and pipeline drugs can extend BIKTARVY’s financial viability and market relevance.

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FAQs

1. When is BIKTARVY’s patent set to expire, and what are the implications?
Patent protections for BIKTARVY are expected to expire around 2025–2026, opening the door for generic competition, which could significantly reduce market share and revenues unless Gilead employs strategies such as reformulations or licensing.

2. How does BIKTARVY compare with competitors in terms of efficacy and safety?
BIKTARVY offers comparable or superior efficacy with a favorable safety and tolerability profile, making it a preferred option for treatment-naïve patients, supported by clinical trial data [5].

3. What factors could threaten BIKTARVY’s market position?
Emerging long-acting injectables, shifts in treatment guidelines, patent expiries, and price competition from generics pose potential threats.

4. Are there opportunities for BIKTARVY in emerging markets?
Yes, expanding access and tailoring pricing in low- and middle-income countries may significantly grow revenues, albeit with margin considerations.

5. What role do pipeline developments play in BIKTARVY’s future?
Pipeline innovations like long-acting formulations and broader indications aim to sustain market relevance and extend the product lifecycle.

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References

[1] Fortune Business Insights. The Global HIV Treatment Market Size, Share & Industry Analysis, 2021-2028.

[2] Gilead Sciences Annual Report 2022; patent filings and protection timelines.

[3] Gilead Sciences Q4 Fiscal Year 2020 Financial Results.

[4] IMS Health Data, 2021; analysis of generic entry impacts on HIV pharmaceuticals.

[5] ClinicalTrials.gov. BIKTARVY efficacy and safety trials summary, 2022.

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Note: This analysis is based on publicly available data as of early 2023 and may evolve with new market developments.