LENACAPAVIR SODIUM - Generic Drug Details

What are the generic drug sources for lenacapavir sodium and what is the scope of freedom to operate?

Lenacapavir sodium is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and is included in four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lenacapavir sodium has two hundred and twenty-two patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for LENACAPAVIR SODIUM

International Patents:	222
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in LENACAPAVIR SODIUM?	LENACAPAVIR SODIUM excipients list
DailyMed Link:	LENACAPAVIR SODIUM at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SOLUTION;SUBCUTANEOUS

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SOLUTION;SUBCUTANEOUS

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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 LENACAPAVIR SODIUM

Drug Class	Human Immunodeficiency Virus 1 Capsid Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A Inhibitors HIV Capsid Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LENACAPAVIR SODIUM

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for LENACAPAVIR SODIUM

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	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes
Gilead Sciences Inc	YEZTUGO	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	220018-001	Jun 18, 2025		RX	Yes	Yes
Gilead Sciences Inc	YEZTUGO	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	220018-001	Jun 18, 2025		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	Dec 22, 2022		RX	Yes	Yes

International Patents for LENACAPAVIR SODIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3823621
South Korea	20200131351
Japan	6716785
South Korea	20150121720	HIV의 치료를 위한 아미드 화합물 (AMIDE COMPOUNDS FOR THE TREATMENT OF HIV)
Chile	2015002445	Compuestos amida para el tratamiento del vih

Supplementary Protection Certificates for LENACAPAVIR SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3347352	C20220045 00443	Estonia		PRODUCT NAME: LENAKAPAVIIR;REG NO/DATE: EU/1/22/1671 19.08.2022
3347352	LUC00292	Luxembourg		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819
3347352	2290051-8	Sweden		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
3347352	C03347352/01	Switzerland		PRODUCT NAME: LENACAPAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68386 07.07.2023
3347352	CA 2022 00052	Denmark		PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/DATE: EU/1/22/1671 20220819

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Lenacapavir Sodium

Last updated: July 28, 2025

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Introduction

Lenacapavir sodium, a pioneering antiviral agent developed by Gilead Sciences, represents a significant advancement in the treatment of HIV/AIDS. As a first-in-class, long-acting capsid inhibitor, it introduces a new approach to HIV management, catering to both treatment-naïve and multi-drug resistant populations. Understanding the evolving market dynamics and the financial trajectory for lenacapavir sodium is essential for stakeholders including investors, healthcare providers, and pharmaceutical strategists.

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Pharmacological Profile and Clinical Landscape

Lenacapavir's unique mechanism targets the HIV capsid, inhibiting multiple stages of the viral lifecycle.[1] Its long-acting formulation enabling monthly or bi-annual dosing addresses adherence barriers associated with daily oral regimens. Clinical trials demonstrate promising efficacy across diverse patient populations, including those with multi-drug resistant HIV strains.[2] The drug's flexible dosing and potent antiviral activity position it to fill substantial gaps in current HIV therapeutics.

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Market Landscape and Competitive Positioning

The global HIV treatment market is projected to surpass $35 billion by 2027, driven by expanding access and evolving treatment paradigms.[3] Currently dominated by combination antiretroviral therapy (cART), the market sees increasing demand for drugs that improve adherence, reduce pill burden, and combat resistance.

Key competitors include traditional drugs such as tenofovir and integrase inhibitors. However, lenacapavir’s long-acting profile differentiates it, targeting unmet needs for patients requiring less frequent dosing or facing adherence challenges. It aligns with market shifts favoring injectable and sustained-release formulations.

Additionally, the potential for combination therapy expands lenacapavir's applicability, either as monotherapy or in fixed-dose combinations, further enhancing its competitive footprint.

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Regulatory Status and Adoption Potential

Gilead Sciences filed for accelerated FDA approval in 2022, supported by promising Phase 2/3 trial data showing significant viral suppression.[4] As of mid-2023, the drug awaits FDA decision, expected within the upcoming year. Pending approval will likely catalyze early market penetration, especially among treatment-experienced patients with limited options.

The European Medicines Agency (EMA) and other global regulators are monitoring trial outcomes, with possibilities for concurrent approval in key markets. This regulatory momentum will crucially influence the drug’s revenue generation trajectory.

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Market Entry Strategies and Revenue Drivers

Gilead’s strategic focus hinges on targeting niche segments: patients with multi-drug resistance, those struggling with adherence, and treatment-naïve populations seeking simplified regimens. Partnering with healthcare providers and payers for favorable reimbursement pathways will be vital for maximizing adoption.

Key revenue drivers include:

• Pricing Strategy: Premium pricing reflecting the drug’s innovative nature and adherence benefits. Pricing will competitively reflect the value of reduced dosing frequency and improved patient outcomes.
• Market Penetration: Rapid adoption in specialized clinics, followed by expansion into broader HIV treatment settings.
• Combination Therapy Potential: Collaborations to develop fixed-dose combinations with other antiretrovirals can expand market size.
• Global Access Programs: Deployment in low- and middle-income countries (LMICs) under differential pricing strategies, aligned with global HIV initiatives.

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Financial Forecast and Revenue Trajectory

Initial Revenue Outlook (2023–2025):
Forecasts anticipate modest revenues, primarily driven by initial adoption among high-need populations and early access programs. Gilead’s existing sales infrastructure and global presence will facilitate swift rollout.

Mid-term Growth (2025–2030):
As regulatory approvals expand and clinical confidence increases, revenue streams are expected to accelerate. Adoption will expand beyond specialized centers into broader treatment settings, supported by evidence of ease of use and efficacy.

Long-term Projections (2030+):
Multiple factors, including patent exclusivity (expected to last through the late 2030s), emerging competitors, and pipeline developments, will influence long-term revenue stability. Market share gains will be sustained if combination therapies and new indications materialize.

Revenue Estimates:
Based on comparable long-acting injectable agents like cabotegravir (sold by ViiV Healthcare), initial sales estimates hover in the $200-$300 million range in the first year post-approval, with potential growth to over $1 billion annually within five years, contingent on market acceptance and global access strategies.[5]

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Market Risks and Challenges

• Regulatory Hurdles: Delays or restrictions could blunt revenue prospects.
• Pricing and Reimbursement: Payer resistance may hinder uptake among certain populations.
• Emerging Competitors: The landscape for long-acting antivirals is competitive, with new agents under development.
• Adherence and Resistance: Patient adherence to long-acting formulations and potential for resistance development could impact long-term efficacy.

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Key Opportunities

• Expanding use in pre-exposure prophylaxis (PrEP), given its long-acting profile.
• Developing combination formulations with other antiretrovirals.
• Gaining entry into LMIC markets through tiered pricing and partnerships with global health initiatives.
• Leveraging real-world evidence to support label extensions and broader indications.

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Conclusion

Lenacapavir sodium’s market potential is underscored by its innovative mechanism and corresponding clinical benefits. While initial commercialization will focus on high-need patient groups, its long-term financial trajectory depends on regulatory progress, competitive dynamics, and strategic market positioning. As the HIV treatment landscape evolves toward tailored, adherence-friendly options, lenacapavir is poised to carve a significant niche and generate sustainable revenue streams.

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Key Takeaways

• Innovative Mechanism: As a capsid inhibitor, lenacapavir introduces a novel approach, promising improved adherence and effectiveness.
• Market Potential: Growing demand for long-acting HIV therapies supports substantial revenue prospects, with forecasts reaching over $1 billion annually within five years.
• Regulatory Timing: Pending FDA and global approvals are pivotal; early approval could accelerate revenue growth.
• Competitive Differentiation: Its extended dosing schedule offers a competitive edge over traditional daily regimens.
• Strategic Opportunities: Partnerships, combination therapies, and engagement in LMIC markets will be critical to maximizing its financial impact.

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FAQs

1. When is lenacapavir sodium expected to receive regulatory approval?
Gilead Sciences submitted for FDA approval in 2022, with decisions anticipated in 2023. Similar reviews are ongoing globally, with approval timelines dependent on regulatory agencies' evaluation of clinical data.

2. How does lenacapavir compare to existing long-acting HIV treatments?
Unlike injectable cabotegravir, which requires bi-weekly or monthly administration, lenacapavir offers a longer dosing interval—potentially bi-annual injections—reducing clinic visits and enhancing adherence.

3. What are the primary market segments for lenacapavir?
High-need patients, including those with multi-drug resistant HIV, treatment non-adherent populations, and treatment-naïve patients seeking simplified regimens, are the main targets.

4. What are the major challenges facing lenacapavir’s commercial success?
Regulatory delays, payer resistance, competition from emerging therapies, and resistance development pose significant risks to market penetration.

5. Can lenacapavir be formulated as part of combination therapy?
Yes. Its versatile mechanism supports development in fixed-dose combinations, which can further expand its market reach and improve patient outcomes.

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References

[1] Gilead Sciences. (2022). Lenacapavir Pharmacology and Clinical Data.
[2] ClinicalTrials.gov. (2022). Lenacapavir Clinical Trials.
[3] Grand View Research. (2022). HIV Treatment Market Analysis and Forecast.
[4] Gilead Sciences. (2022). New Drug Application and Clinical Trial Results.
[5] EvaluatePharma. (2022). Long-Acting Injectables in HIV Treatment: Market Forecasts.