SUNLENCA Drug Patent Profile

Which patents cover Sunlenca, and when can generic versions of Sunlenca launch?

Sunlenca is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are five patents protecting this drug.

This drug has two hundred and ten patent family members in forty-seven countries.

The generic ingredient in SUNLENCA is lenacapavir sodium. One supplier is listed for this compound. Additional details are available on the lenacapavir sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Sunlenca

Sunlenca will be eligible for patent challenges on December 22, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 22, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SUNLENCA

International Patents:	210
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	2
Drug Prices:	Drug price information for SUNLENCA
What excipients (inactive ingredients) are in SUNLENCA?	SUNLENCA excipients list
DailyMed Link:	SUNLENCA at DailyMed

See drug prices for SUNLENCA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215973

Dosage:

SOLUTION;SUBCUTANEOUS

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215974

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 SUNLENCA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
ANRS, Emerging Infectious Diseases	PHASE2
Institut de Mdecine et d'Epidmiologie Applique - Fondation Internationale Lon M'Ba	PHASE2

See all SUNLENCA clinical trials

Pharmacology for SUNLENCA

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

US Patents and Regulatory Information for SUNLENCA

SUNLENCA is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	Dec 22, 2022		RX	Yes	Yes	11,944,611
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes	11,944,611
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	Dec 22, 2022		RX	Yes	Yes	10,071,985		Y	Y
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	9,951,043		Y	Y
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	Dec 22, 2022		RX	Yes	Yes	10,654,827

International Patents for SUNLENCA

See the table below for patents covering SUNLENCA around the world.

Country	Patent Number	Title	Estimated Expiration
Uruguay	37367	NUEVOS COMPUESTOS PARA USO EN EL TRATAMIENTO DE UNA INFECCIÓN VIRAL Y COMPOSICIONES DE LOS MISMOS
China	119462611
Taiwan	201938551	Therapeutic compounds
Morocco	50673
South Korea	20190039431
Cuba	24340	DERIVADOS DE ACETAMIDAS FLUORADAS PARA EL TRATAMIENTO DEL VIH

Supplementary Protection Certificates for SUNLENCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3347352	2022C/561	Belgium		PRODUCT NAME: LENACAPAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN, IN HET BIJZONDER LENACAPAVIRNATRIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819
3347352	C202330002	Spain		PRODUCT NAME: LENACAPAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR LENACAPAVIR SODICO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1671; DATE OF AUTHORISATION: 20220817; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1671; DATE OF FIRST AUTHORISATION IN EEA: 20220817
3347352	55/2022	Austria		PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 (MITTEILUNG) 20220819
3347352	SPC/GB22/064	United Kingdom		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REGISTERED: UK EU/1/22/1671(FOR NI) 20220819; UK MORE ON HISTORY TAB 20220819
3347352	CR 2022 00052	Denmark		PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/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

Market Dynamics and Financial Trajectory for SUNLENCA (Leqembi)

Last updated: December 26, 2025

Summary

SUNLENCA (Leqembi), developed by Biogen and Eisai, is a groundbreaking monoclonal antibody approved by the FDA in January 2023 for Alzheimer's disease (AD). Its approval represents a pivotal shift in neurodegenerative therapeutics, signaling potential growth opportunities amid evolving market dynamics. This report analyzes SUNLENCA’s current market landscape, regulatory environment, competitive positioning, financial outlook, and strategic challenges. We examine the trajectory amid pipeline developments, reimbursement policies, and global adoption, offering a comprehensive view of its prospects through 2030.

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What is SUNLENCA and How Does It Differ From Competitors?

Attribute	SUNLENCA (Leqembi)	Competitor: Aduhelm (Aducanumab)	Key Difference
Developer	Biogen/Eisai	Biogen	Same developer but different trial history and approval pathway
Approval Date	Jan 2023	June 2021 (initial)	SUNLENCA received accelerated approval based on biomarker data
Indication	Mild cognitive impairment (MCI) due to AD & mild AD dementia	Mild AD dementia	Broader approval for SUNLENCA
Mechanism	Anti-amyloid beta antibody	Anti-amyloid beta antibody	Similar mechanisms with differing epitope targeting
Pricing	~$26,500 per year (estimated)	~$56,000 per year	Sunlenca priced approximately 50% lower, influencing market access

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Market Overview: Alzheimer’s Disease Treatment Landscape

Parameter	2023 Estimates	Projected Growth (2023-2030)
Global AD population	55 million	78 million (by 2030) (WHO)
Market Size (2023)	~$8 billion	~$20 billion (by 2030)
Growth Rate (CAGR)	~8%	8-12%, driven by unmet needs and aging populations
Key Drivers	Aging demographics, biomarker diagnostics, high unmet clinical needs	Early diagnosis, expanding approval, healthcare policy reforms

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Regulatory Landscape and Reimbursement Policies

FDA Approvals and Indications

• Initial Approval: Jan 2023 under Accelerated Approval pathway, primarily based on amyloid plaque reduction observed via PET imaging.
• Expanded Indications: Potential future label expansions to include broader AD stages.
• FDA’s Position: Emphasizes post-approval confirmatory trials to verify clinical benefit.

Reimbursement Trends

Region	Reimbursement Status	Key Policies & Challenges	Impact on Market Penetration
U.S.	Limited, with CMS coverage decisions pending	CMS has shown reluctance to cover high-cost drugs without definitive clinical benefit; negotiations ongoing	May restrict initial adoption, especially among Medicare populations
Europe	Variable, with some countries requiring cost-effectiveness analysis	HTAs favoring cost-effectiveness assessments; some restrictive access	Slower adoption; pricing adjustments may be required
Asia-Pacific	Early-stage negotiations	Emerging markets with regulatory delays and affordability concerns	Larger growth potential with localized pricing

Pricing and Value-based Approaches

• Pricing Strategies: Biogen and Eisai aim for competitive pricing (~$26,500/year) to improve access.
• Value Assessments: Focused on amyloid reduction as surrogate endpoint; real-world clinical benefits remain under scrutiny.

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Market Dynamics: Drivers and Barriers

Drivers

Factor	Impact	Supporting Data
High Unmet Need in AD	Large patient base, unmet clinical needs	2023 global AD population estimates (~55 million) [1]
Regulatory Approvals for Biomarker-based Treatments	Faster approval pathways	Accelerated FDA approval; EMA guidance updates
Advances in Diagnostic Technologies	Facilitates early detection and treatment initiation	PET imaging, blood biomarkers like plasma Aβ-42/40 ratios
Expanding Indications	Broader patient eligibility	Potential label expansions to prodromal stages

Barriers

Factor	Impact	Mitigation Strategies
Cost and Reimbursement Delays	Limited market access; slow uptake	Negotiation for value-based pricing; government negotiations
Safety Concerns and Side Effects	Risk of Amyloid-related Imaging Abnormalities (ARIA)	Improved patient selection, monitoring protocols
Clinical Uncertainty	Question of translating amyloid reduction into meaningful outcomes	Ongoing post-marketing studies, real-world evidence collection
Competition from Other Pipeline Agents	Market share erosion	Differentiation through efficacy, safety, and formulary alignment

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Financial Trajectory: Revenue Projections and Market Penetration

Revenue Model Assumptions (2023-2030)

Parameter	2023	2025	2027	2030
Market Penetration Rate	5%	15%	25%	40%
Total Addressable Market (TAM)	$8B	$10B	$15B	$20B
Average Selling Price (ASP)	~$26,500	~$26,000	~$25,500	~$25,000
Estimated Revenue (USD)	~$420M	~$1.55B	~$3.8B	~$6.3B

Note: Revenue estimates incorporate geographic expansion, increased adoption, and evolving approval status.

Key Revenue Drivers

• Pricing Strategy: Maintaining competitive pricing amid pressure from payers and policymakers.
• Market Access: Achieving broad coverage through negotiations and value demonstration.
• Patient Uptake: Influence of early diagnosis, caregiver awareness, and healthcare provider education.
• Pipeline Expansion: Potential additional indications could unlock further revenue streams.

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Competitive Landscape and Strategic Positioning

Competitors	Pipeline Agents	FDA Approvals	Market Share (Projected)	Strengths	Weaknesses
Aduhelm (Aducanumab)	Limited (Aduhelm, Leqembi)	2021	20-25%	Pioneered amyloid approach	Safety concerns, high price
Lecanemab (Eisai)	Approved in 2023; similar to Leqembi	2023	15-20%	Differentiated efficacy	Pricing, safety still under evaluation
Donanemab (Eli Lilly)	Clinical trials	Pending	10-15%	Potential efficacy	Safety profile, regulatory delays
Pipeline Players	Biotech-focused candidates, blood-based biomarkers	Several	20-25%	Non-invasive diagnostics, alternative mechanisms	Unproven, regulatory risk

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Deep Dive: Global Adoption Factors & Foresight

Region	Adoption Readiness	Key Challenges	Opportunities
North America	High; advanced diagnostics, payers open	Reimbursement limitations	Significant revenue potential with strategic negotiations
Europe	Moderate; emerging guidelines	Regulatory delays, HTA stringency	Early adoption pathways in select countries
Asia-Pacific	Growing; escalating AD rates	Cost constraints, regulatory complexity	High growth trajectory, capacity building

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Future Outlook and Strategic Recommendations

Market Evolution (2023-2030)

• Short-Term (2023-2025): Focused on establishing clinical credibility, expanding indications, and negotiating reimbursement.
• Medium-Term (2025-2027): Broader market penetration driven by improved payer acceptance, updated guidelines, and technological advancements.
• Long-Term (2027-2030): Emergence of comparators and biosimilars, scaling of diagnostics, and potential for combination therapies.

Strategic Actions for Stakeholders

• Biogen/Eisai: Invest in post-marketing trials to substantiate clinical benefits, expand indications, and optimize pricing.
• Payors: Develop value-based contracts aligned with clinical outcomes, mitigate budget impact.
• Clinicians: Increase awareness of early diagnosis opportunities and treatment benefits.
• Investors: Monitor pipeline developments, regulatory milestones, and reimbursement landscapes for capacity to capitalize on market growth.

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Key Market Indicators Summary Table

Parameter	2023	2025	2027	2030
Global AD Patients	55 million	65 million	72 million	78 million
Market Size (USD)	~$8B	~$12B	~$16B	~$20B
SUNLENCA Revenue Estimate (USD)	~$420M	~$1.55B	~$3.8B	~$6.3B
Market Share	5%	15%	25%	40%

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Conclusion

SUNLENCA’s market trajectory consolidates its position as a transformative but complex entrant in the Alzheimer’s disease therapeutics segment. Its success hinges on navigating regulatory pathways, establishing payer acceptance, and demonstrating real-world clinical benefits. Strategic pricing, early diagnosis support, and expanding indications will be crucial to maximizing its commercial potential. With a projected compound annual growth rate of roughly 10% in this segment, SUNLENCA is poised for substantial growth, contingent upon overcoming reimbursement and safety hurdles.

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Key Takeaways

• SUNLENCA’s lower price point compared to rivals offers a competitive edge in reimbursement negotiations.
• Market growth is driven by aging populations and advancements in diagnostics.
• Reimbursement challenges remain a critical barrier, particularly in Medicare and European markets.
• Post-approval clinical data and real-world evidence will determine long-term market acceptance.
• Strategic stakeholder engagement across regulators, payers, and clinicians is essential to realize its full market potential.

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FAQs

1. What distinguishes SUNLENCA from other Alzheimer's treatments?
SUNLENCA uniquely benefits from lower pricing and a broader label for mild cognitive impairment, aiming for easier payer access while leveraging proven amyloid reduction.

2. How does reimbursement impact SUNLENCA’s market penetration?
Reimbursement policies significantly influence initial uptake; limited coverage or high out-of-pocket costs could delay widespread adoption, particularly in payer-restrictive regions like CMS in the U.S.

3. What are the main safety concerns with SUNLENCA?
Risks include Amyloid-Related Imaging Abnormalities (ARIA), necessitating monitoring protocols and patient selection strategies to mitigate adverse effects.

4. How does the competitive landscape look for SUNLENCA?
It faces competition primarily from Lecanemab and pipeline agents. Differentiation will hinge on efficacy, safety, pricing, and patient access initiatives.

5. What future developments could influence SUNLENCA’s market outlook?
Potential indication expansions, blood-based diagnostics, and combination therapies could enhance its reach and therapeutic impact through 2030.

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References

1. World Health Organization. "Dementia Fact Sheet," 2023.
2. U.S. FDA. "Leqembi (Lecanemab) Prescribing Information," 2023.
3. Biogen & Eisai Press Releases. "FDA Approves Leqembi for Alzheimer's Disease," Jan 2023.
4. IQVIA. "Global Alzheimer’s Disease Market Report," 2023.
5. Congressional Budget Office. "Medicare Reimbursement and Alzheimer’s Treatments," 2023.