SELZENTRY Drug Patent Profile

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

Selzentry is a drug marketed by Viiv Hlthcare and is included in two NDAs.

The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the maraviroc profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Selzentry

A generic version of SELZENTRY was approved as maraviroc by HETERO LABS LTD III on February 7^th, 2022.

Summary for SELZENTRY

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	43
Patent Applications:	6,035
Drug Prices:	Drug price information for SELZENTRY
What excipients (inactive ingredients) are in SELZENTRY?	SELZENTRY excipients list
DailyMed Link:	SELZENTRY at DailyMed

See drug prices for SELZENTRY

Recent Clinical Trials for SELZENTRY

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

Sponsor	Phase
Hospital Universitario Infanta Leonor	Phase 2
Hospital Clinic of Barcelona	Phase 2
Hospital Clínic de Barcelona	Phase 2

See all SELZENTRY clinical trials

Pharmacology for SELZENTRY

Drug Class	CCR5 Co-receptor Antagonist
Mechanism of Action	Chemokine Co-receptor 5 Antagonists

Paragraph IV (Patent) Challenges for SELZENTRY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SELZENTRY	Tablets	maraviroc	150 mg and 300 mg	022128	2	2011-08-08

US Patents and Regulatory Information for SELZENTRY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007	AB	RX	Yes	No
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		DISCN	Yes	No
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016		DISCN	Yes	No
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes

Expired US Patents for SELZENTRY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016	6,586,430
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007	6,586,430
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016	6,586,430
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007	6,586,430

EU/EMA Drug Approvals for SELZENTRY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ViiV Healthcare B.V.	Celsentri	maraviroc	EMEA/H/C/000811 Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable,	Authorised	no	no	no	2007-09-18

International Patents for SELZENTRY

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	004988	АЗАБИЦИКЛОАЛКАНЫ КАК МОДУЛЯТОРЫ РЕЦЕПТОРА ХЕМОКИНОВ CCR5 (AZABICYCLOALKANES AS CCRS MODULATORS)
Hungary	225810	THERAPEUTICALLY EFFECTIVE TROPANE DERIVATIVES, PROCESS FOR THEIR PREPARATION PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE
Peru	20011371	DERIVADOS DE 3-(3-ISOPROPIL-5-METIL-4H-1,2,4-TRIAZOL-4-IL)-EXO-8-AZABICICLO[3.2.1]OCTANO COMO ANTAGONISTAS DE LOS RECEPTORES DE QUIMIOCINA CCR5
Peru	13412000

Supplementary Protection Certificates for SELZENTRY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1284974	08C0007	France		PRODUCT NAME: MARAVIROC; REGISTRATION NO/DATE: EU/1/07/418/001 20070918
1284974	6/2008	Austria		PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974	91417	Luxembourg		91417, EXPIRES: 20220918
1284974	PA 2008 004, C 1284974	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918

Market Dynamics and Financial Trajectory of Selzentry

Introduction

Selzentry, also known as Celsentri in the EU, is a groundbreaking antiretroviral drug developed by Pfizer. It is designed to prevent HIV from entering uninfected cells by blocking the CCR5 receptor, making it a crucial option for HIV-infected patients, particularly those with CCR5-tropic virus.

Mechanism of Action

Selzentry is the first in a new class of drugs targeting the CCR5 receptor, which is involved in the entry of HIV into host cells. This mechanism provides an alternative treatment for patients who have failed other therapies, making it a significant addition to the antiretroviral treatment arsenal[1].

Market Position

Selzentry was approved for use in treatment-experienced patients, a segment that includes roughly half of all extensively treatment-experienced patients. However, its position as an option of last resort could limit its commercial potential. Despite this, Pfizer has been submitting marketing applications globally and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the EU[1].

Competitive Landscape

The antiretroviral market is highly competitive, with several other drugs vying for market share. Merck’s integrase inhibitor, Isentress (raltegravir), approved after Selzentry, is expected to provide stiff competition. Isentress has been successful in treating treatment-experienced patients, which could impact Selzentry’s market penetration[1].

Sales Projections and Performance

Initial projections indicated that Selzentry could achieve sales of $500 million by 2011. However, the actual performance and long-term sales figures have been influenced by various market dynamics, including competition from other antiretroviral drugs and the evolving treatment landscape.

Impact of Patent Expiry

The HIV-1 treatment market is expected to face challenges due to the wave of patent expiries of several key products, including Selzentry. The patent for Selzentry expired in 2021 in the US, which could lead to the entry of generic versions and further reduce its market share[4].

Financial Performance of Pfizer

While specific financial data for Selzentry alone is not readily available, Pfizer's overall financial performance provides context. Pfizer has seen fluctuations in its revenue and profitability over the years, influenced by the performance of its various drug portfolios. However, the company's diversified product line helps mitigate the impact of any single drug's performance[2].

Market Trends in Antiretroviral Therapies

The antiretroviral market has seen significant changes with the introduction of new therapies. For example, Gilead’s Biktarvy, an integrase-based regimen, has captured a substantial market share since its launch in 2018. Biktarvy’s success has led to a decline in sales of other HIV-1 therapies, including those that were previously market leaders[4].

Sales Data for Antiretroviral Market

Historical sales data for the antiretroviral market shows steady growth but also highlights the competitive nature of the sector. In 2007, top-selling antiretrovirals included VALTREX, TRUVADA, ATRIPLA, REYATAZ, and KALETRA, with significant sales figures and growth rates[1].

Future Outlook

The future of Selzentry is likely to be influenced by the emergence of new therapies and the expiration of its patent. As generic versions enter the market, the drug's sales are expected to decline. The HIV-1 treatment market, however, is expected to show steady growth driven by new and innovative therapies that offer better safety and patient compliance[4].

Key Takeaways

• Mechanism of Action: Selzentry blocks the CCR5 receptor to prevent HIV entry into uninfected cells.
• Market Position: Approved for treatment-experienced patients, but faces competition from other antiretrovirals.
• Sales Projections: Initial projections were $500 million by 2011, but actual performance was impacted by market dynamics.
• Patent Expiry: Patent expired in 2021, potentially leading to generic versions.
• Market Trends: New therapies like Biktarvy have significantly impacted the antiretroviral market.
• Future Outlook: Expected decline in sales due to generic competition and emergence of new therapies.

FAQs

What is the mechanism of action of Selzentry?

Selzentry works by blocking the CCR5 receptor, preventing HIV from entering uninfected cells.

Who is the target patient population for Selzentry?

Selzentry is designed for treatment-experienced patients, particularly those with CCR5-tropic virus.

What are the competitive challenges faced by Selzentry?

Selzentry faces competition from other antiretroviral drugs, notably Merck’s Isentress and Gilead’s Biktarvy.

What was the projected sales figure for Selzentry by 2011?

The projected sales figure for Selzentry by 2011 was $500 million.

How has the patent expiry affected Selzentry?

The patent expiry in 2021 has opened the door for generic versions, which is expected to reduce Selzentry’s market share.

Sources

1. MM+M - Medical Marketing and Media: "Selzentry - MM+M - Medical Marketing and Media"
2. Merck: "Merck Announces Fourth-Quarter and Full-Year 2022 Financial Results"
3. GSK: "Annual Report 2018 | GSK"
4. DelveInsight: "Changing Dynamics of HIV-1 Treatment Market - DelveInsight"