Lenacapavir sodium - Generic Drug Details

What are the generic sources for lenacapavir sodium and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for lenacapavir sodium

International Patents:	201
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	2
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

^*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	10,071,985		Y	Y
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	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	11,267,799			Y
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
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	9,951,043		Y	Y

International Patents for lenacapavir sodium

Country	Patent Number	Title	Estimated Expiration
Lithuania	3347352
Japan	2019528280
Brazil	112015021027	compostos terapêuticos
Denmark	3347352
Hong Kong	1260892	用於治療HIV的醯胺化合物 (AMIDE COMPOUNDS FOR THE TREATMENT OF HIV)
Taiwan	202138365	Therapeutic compounds
South Korea	20200131351	HIV 바이러스 감염의 예방적 또는 치유적 치료에 유용한 치료 화합물 (HIV THERAPEUTIC COMPOUNDS USEFUL FOR THE PROPHYLACTIC OR THERAPEUTIC TREATMENT OF AN HIV VIRUS INFECTION)

Supplementary Protection Certificates for lenacapavir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2023501	Lithuania		PRODUCT NAME: LENAKAPAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC LENAKAPAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/22/1671/001-002 20220817
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	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	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	PA2023501,C3347352	Lithuania		PRODUCT NAME: LENAKAPAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC LENAKAPAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/22/1671/001-002 20220817
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

Lenacapavir Sodium: Market Dynamics and Financial Trajectory

Introduction

Lenacapavir, marketed as Sunlenca, is a groundbreaking HIV capsid inhibitor that has revolutionized the treatment of multidrug-resistant HIV-1 infections. Approved by the FDA in December 2022, this drug represents a significant advancement in HIV therapy, but its market dynamics and financial trajectory are complex and multifaceted.

Mechanism of Action and Clinical Significance

Lenacapavir works by binding to the subunits of the HIV capsid protein, interfering with virus assembly, release, and nuclear transport. This unique mechanism offers a new treatment option for heavily treatment-experienced patients who have developed resistance to other antiretrovirals[1][4].

Market Prospects

The approval of Lenacapavir has generated considerable interest in the pharmaceutical market. Gilead anticipates revealing data from Phase III trials by the end of 2024 or early 2025, which could lead to new indications and potentially drive global peak sales to $3 to $4 billion[3].

Pricing and Affordability

One of the most critical aspects of Lenacapavir's market dynamics is its pricing. The wholesale acquisition cost (WAC) for Lenacapavir is significantly high, at $42,250 per person per year, making it an outlier compared to other pre-exposure prophylaxis (PrEP) options[5].

Current Pricing

The current pricing of Lenacapavir is a major barrier to access, particularly in low- and middle-income countries (LMICs). The cost can range from $25,395 to $44,819 per person per year, which is substantially higher than other PrEP drugs like DESCOVY and CABOTAGREVIR[2][5].

Potential for Generic Production

Research suggests that generic Lenacapavir could be produced at a significantly lower cost. Estimates indicate that with mass production, the cost could drop to $63 to $93 per person per year initially and further to $26 to $40 per person per year if production volumes reach 10 million treatment-years[2][5].

Patent Strategy and Access

Gilead's patent strategy for Lenacapavir involves filing multiple patents globally, including in many LMICs. This strategy, known as "evergreening," aims to extend the patent monopoly until 2037, which could block access to generic formulations and keep prices high[5].

Patent Filings and Oppositions

Patent applications for Lenacapavir have been filed in several countries, including India, Thailand, Brazil, and South Africa. However, these applications are under examination or have been opposed in some countries, which could potentially allow for generic access if the patents are rejected[5].

Financial Projections

The financial trajectory of Lenacapavir is promising but heavily dependent on several factors, including the outcome of ongoing trials, market competition, and the ability to secure voluntary licenses for generic production.

Projected Sales

With potential global peak sales ranging from $3 to $4 billion, Lenacapavir is poised to become a significant player in the HIV treatment and prevention market. This projection is based on its unique mechanism of action, long-acting properties, and the potential for new indications[3].

Cost-Benefit Analysis

While the high price of Lenacapavir is a significant concern, the drug's long-acting nature and the convenience of six-monthly injections could offer cost savings in the long term. However, this benefit is largely mitigated by the current pricing strategy, which makes it inaccessible to many potential users[2][5].

Impact on Public Health

Lenacapavir has the potential to radically improve HIV/AIDS prevention strategies, particularly with its twice-yearly injectable format. However, the affordability issue remains a critical barrier to its widespread adoption, especially in regions with high HIV burdens[5].

Industry and Market Reaction

The approval of Lenacapavir has triggered significant reactions in the stock market and the broader pharmaceutical industry. Gilead's stock price rose following the breakthrough therapy designation in 2019, and other HIV drug markets were impacted as well[3].

Regulatory and Policy Implications

The regulatory environment and policy decisions will play a crucial role in determining the accessibility of Lenacapavir. Efforts to secure voluntary licenses and reduce patent barriers could significantly lower the cost and increase access to this critical drug[2][5].

Conclusion

Lenacapavir represents a groundbreaking advancement in HIV treatment, but its market dynamics are complex. The high pricing, patent strategy, and regulatory environment all impact its accessibility and financial trajectory. As the pharmaceutical industry and global health community navigate these challenges, the potential for Lenacapavir to transform HIV treatment and prevention remains significant.

Key Takeaways

• Lenacapavir is a first-in-class HIV capsid inhibitor approved for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.
• The drug has a unique mechanism of action and long-acting properties, administered via oral tablets and subcutaneous injections.
• High pricing is a significant barrier to access, with costs ranging from $25,395 to $44,819 per person per year.
• Generic production could reduce costs to $26 to $40 per person per year with large-scale production.
• Gilead's patent strategy aims to extend the patent monopoly until 2037, affecting generic access.
• Projected global peak sales range from $3 to $4 billion, contingent on trial outcomes and market factors.

FAQs

Q: What is Lenacapavir, and how does it work?

Lenacapavir, marketed as Sunlenca, is an HIV capsid inhibitor that works by binding to the subunits of the HIV capsid protein, interfering with virus assembly, release, and nuclear transport.

Q: When was Lenacapavir approved, and for what indications?

Lenacapavir was approved by the FDA in December 2022 for the treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.

Q: What are the common side effects of Lenacapavir?

The most common side effects of Lenacapavir include injection site reactions and nausea[1].

Q: How is Lenacapavir administered?

Lenacapavir is initially administered with a combination of oral tablets and a subcutaneous injection, followed by maintenance subcutaneous injections every six months[1][4].

Q: Why is Lenacapavir so expensive, and what are the potential cost savings?

Lenacapavir is expensive due to its current pricing strategy and patent barriers. However, generic production could reduce costs significantly, and its long-acting nature may offer cost savings in the long term[2][5].

Sources

1. U.S. Pharmacist: "Pioneer HIV Capsid Inhibitor" - October 18, 2023.
2. PubMed: "Lenacapavir to prevent HIV infection: current prices versus ..." - November 4, 2024.
3. Synapse: "Unveiling the Development History and Market Prospects of Lenacapavir" - September 11, 2024.
4. Medicines Patent Pool: "Lenacapavir (LEN) - LAPaL" - November 29, 2024.
5. Third World Network: "High Cost of Lenacapavir Sparks Debate over Affordable Access" - October 1, 2024.

Last updated: 2024-12-16