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SUNLENCA Drug Patent Profile

When do Sunlenca patents expire, and what generic alternatives are available?

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 one hundred and eighty-eight patent family members in forty-six 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:	188
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
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.

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

International Patents for SUNLENCA

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

Country	Patent Number	Title	Estimated Expiration
Singapore	10201912535V	THERAPEUTIC COMPOUNDS USEFUL FOR THE PROPHYLACTIC OR THERAPEUTIC TREATMENT OF AN HIV VIRUS INFECTION
South Korea	102497602
Japan	2020111592
Moldova, Republic of	20150092	Derivate ale amidelor pentru tratamentul infecţiei cu HIV (Amide derivatives for the treatment of HIV infection)
Costa Rica	20190084
Israel	264644	תרכובות רפואיות שימושיות לטיפול מניעתי או רפואי של הדבקה בוירוס hiv (Therapeutic compounds useful for the prophylactic or therapeutic treatment of an hiv virus infection)

Supplementary Protection Certificates for SUNLENCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122022000082	Germany		PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 20220817
3347352	C03347352/01	Switzerland		PRODUCT NAME: LENACAPAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68386 07.07.2023
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	CA 2022 00052	Denmark		PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/DATE: EU/1/22/1671 20220819
3347352	22C1063	France		PRODUCT NAME: LENACAPAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LENACAPAVIR SODIQUE; REGISTRATION NO/DATE: EU/1/22/1671 20220819

SUNLENCA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sunlenca

Introduction to Sunlenca

Sunlenca, also known as lenacapavir, is a groundbreaking drug that marks the beginning of a new class of HIV treatments called capsid inhibitors. Approved by the FDA on December 22, 2022, Sunlenca is designed to treat HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant (MDR) HIV-1 infection[1][4].

Mechanism of Action and Clinical Significance

Sunlenca works by blocking the HIV-1 virus's protein shell, known as the capsid, interfering with multiple essential steps of the viral lifecycle. This multi-stage mechanism of action is unique compared to other antiretrovirals, which typically target only one stage of viral replication. This innovation offers a renewed chance for virologic suppression in patients who have limited treatment options due to resistance to other drugs[1].

Approval and Clinical Trials

The FDA approval of Sunlenca was supported by data from the Phase II/III CAPELLA trial, which evaluated lenacapavir in combination with an optimized background regimen in adults with MDR HIV-1. The trial demonstrated the efficacy and safety of Sunlenca, making it a critical addition to the treatment arsenal for HIV[1].

Administration and Dosage

Sunlenca is administered through a unique dosing regimen, involving initial pharmacologic loading with tablets followed by injections every six months. This twice-yearly dosing schedule is the first of its kind in HIV treatment, offering significant convenience and compliance benefits for patients[1].

Market Impact and Demand

The global HIV drugs market is projected to grow at a CAGR of 4.5% from 2023 to 2032, reaching $51.1 billion by 2032. This growth is driven by increasing demand for HIV drugs, government initiatives to raise awareness, and the rising number of HIV cases. Sunlenca, with its novel mechanism and targeted patient population, is poised to capture a significant share of this growing market[4].

Financial Trajectory

Initial Sales and Projections

In the first quarter of 2023, Sunlenca generated $4 million in sales, which was in line with Gilead's expectations. Given its unique position and the unmet needs it addresses, Sunlenca is expected to contribute significantly to Gilead's HIV product sales, which grew 6% year-over-year in FY2023[3].

Pricing Strategy

Gilead has priced Sunlenca to ensure access for patients with high unmet needs. The wholesale acquisition cost (WAC) for Sunlenca injections and tablets is $42,250 per year in the initial year and $39,000 per year in maintenance years. This pricing strategy, along with financial support programs like Gilead Advancing Access®, aims to make the treatment more accessible[1].

Revenue Contribution

While Sunlenca's initial sales were modest, its long-term potential is substantial. Gilead's overall HIV product sales reached $18.2 billion in FY2023, and the company expects HIV sales to grow 4% year-over-year in FY2024. Sunlenca is anticipated to be a key contributor to this growth, especially as it expands its reach and becomes a preferred option for patients with MDR HIV-1[3][5].

Competitive Landscape

Sunlenca enters a market dominated by established players such as Merck & Co., GlaxoSmithKline, and Bristol-Myers Squibb. However, its unique mechanism of action and lack of known cross-resistance to other antiretrovirals position it as a distinct and valuable option. Gilead's strong presence in the HIV market, coupled with its efforts to ensure equitable access, will help Sunlenca navigate this competitive landscape effectively[4].

Regulatory and Access Initiatives

Gilead has a long history of working with payers and providers to enable more equitable access to HIV treatments. The Gilead Advancing Access® program is designed to assist individuals prescribed Sunlenca by helping them understand their coverage and providing financial support options. These initiatives are crucial in ensuring that Sunlenca reaches the patients who need it most[1].

Future Outlook

As the HIV drugs market continues to grow, Sunlenca is well-positioned to become a leading treatment option for patients with MDR HIV-1. Its unique dosing regimen, lack of cross-resistance, and the comprehensive support programs offered by Gilead will drive its adoption and contribute to the company's financial performance.

Key Takeaways

• Innovative Mechanism: Sunlenca is the first capsid inhibitor, offering a multi-stage mechanism of action against HIV-1.
• Clinical Significance: Approved for treating MDR HIV-1 in heavily treatment-experienced adults.
• Unique Dosing: Twice-yearly injections after initial tablet loading.
• Market Growth: Part of a growing HIV drugs market projected to reach $51.1 billion by 2032.
• Financial Projections: Expected to contribute significantly to Gilead's HIV product sales.
• Access Initiatives: Supported by Gilead Advancing Access® program to ensure equitable access.

FAQs

Q: What is Sunlenca, and how does it work? A: Sunlenca, or lenacapavir, is a capsid inhibitor that works by blocking the HIV-1 virus's protein shell, interfering with multiple stages of the viral lifecycle.

Q: Who is Sunlenca approved for? A: Sunlenca is approved for heavily treatment-experienced adults with multi-drug resistant (MDR) HIV-1 infection.

Q: How is Sunlenca administered? A: Sunlenca is administered through initial pharmacologic loading with tablets followed by injections every six months.

Q: What is the pricing strategy for Sunlenca? A: The wholesale acquisition cost (WAC) for Sunlenca is $42,250 in the initial year and $39,000 in maintenance years, with support from the Gilead Advancing Access® program.

Q: How does Sunlenca fit into the broader HIV drugs market? A: Sunlenca is part of a growing HIV drugs market projected to reach $51.1 billion by 2032, driven by increasing demand and government initiatives.

Sources

1. Pharmaceutical Executive: "New Beginnings: Sunlenca"
2. Gilead Sciences: "Q224 Yr/Yr Qtr/Qtr Management Commentary"
3. Gilead Sciences: "GILEAD SCIENCES FIRST QUARTER 2023 EARNINGS"
4. Allied Market Research: "HIV Drugs Market Size, Share and Growth Analysis | Report, 2032"
5. Gilead Sciences: "Q4 & FY23 Financial Results"