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. Nine 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:	67
Clinical Trials:	44
Patent Applications:	6,354
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
Icahn School of Medicine at Mount Sinai	PHASE2
Yale University	PHASE2
PolyBio Research Foundation	PHASE2

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	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
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	TABLET;ORAL	022128-002	Aug 6, 2007	AB	RX	Yes	Yes

Expired US Patents for SELZENTRY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016

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/000811Celsentri, 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

When does loss-of-exclusivity occur for SELZENTRY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Germany	69943352
Tunisia	SN99255	DERIVES DE PIPERIDINE ET DE MORPHOLINE NOUVEAUX, PROCEDE POUR LEUR PREPARATION ET COMPOSITIONS PHARMACEUTIQUES LES CONTENANT
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
Brazil	PI9917007	azabicicloalcanos como moduladores de ccr5, composição farmacêutica contendo os mesmos, bem como seu uso
Iceland	5944
Estonia	200100347

Supplementary Protection Certificates for SELZENTRY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1284974	C300338	Netherlands		PRODUCT NAME: MARAVIROC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918
1284974	CA 2008 00018	Denmark		PRODUCT NAME: MARAVIROC, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT
1284974	PA 2008 004, C 1284974	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 20070918
1284974	C01284974/01	Switzerland		FORMER OWNER: PFIZER INC., US
1284974	SPC/GB08/014	United Kingdom		PRODUCT NAME: MARAVIROC, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/07/418/001 20070918; UK EU/1/04/418/002 20070918; UK EU/1/04/418/003 20070918; UK EU/1/04/418/004 20070918; UK EU/1/04/418/005 20070918; UK EU/1/04/418/006 20070918; UK EU/1/04/418/007 20070918; UK EU/1/04/418/008 20070918; UK EU/1/04/418/009 20070918; UK EU/1/04/418/010 20070918
1284974	300338	Netherlands

SELZENTRY: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

SELZENTRY (maraviroc), an entry inhibitor used in the treatment of HIV-1 infection, faces a complex market landscape shaped by evolving treatment paradigms, patent expirations, and competition. Developed by ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK) and Pfizer, its commercial performance is directly linked to the broader HIV market's contraction and the increasing availability of generic alternatives.

What is SELZENTRY's Current Market Position?

SELZENTRY is an oral CCR5 antagonist indicated for the treatment of adult patients with CCR5-tropic, documented HIV-1 infection who have experienced unacceptable risk of infectious complications or virologic failure on other antiretroviral (ARV) agents [1]. Its mechanism of action, blocking HIV-1 from entering human cells by binding to the CCR5 co-receptor, distinguishes it from nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs) [1].

The global HIV treatment market is characterized by a strong emphasis on combination therapies, often delivered in single-tablet regimens (STRs) [2]. This trend has favored drugs that offer convenience and high efficacy with fewer pills, impacting the market share of older, multi-pill regimens that may include SELZENTRY as a component.

As of recent reporting periods, SELZENTRY's sales have demonstrated a declining trajectory. For instance, ViiV Healthcare reported that SELZENTRY (maraviroc) sales were $105 million in 2021 and decreased to $94 million in 2022 [3, 4]. This decline reflects several factors:

• Patent Expirations: The primary patents protecting SELZENTRY have expired in major markets, paving the way for generic competition. This erosion of market exclusivity is a predictable yet significant driver of declining brand-name sales.
• Shifting Treatment Guidelines: HIV treatment guidelines have evolved to prioritize STRs and newer drug classes with improved safety and tolerability profiles [2, 5]. While SELZENTRY remains an option for specific patient populations (e.g., those with CCR5-tropic virus who have failed other therapies), it is less frequently a first-line or even second-line choice for the majority of newly diagnosed patients.
• Competition from Newer Agents: The development pipeline and market introduction of novel ARV agents, including integrase strand transfer inhibitors (INSTIs) and long-acting injectables, have further pressured sales of established oral therapies like SELZENTRY [6]. These newer agents often offer improved adherence and reduced pill burden.
• Market Contraction: The overall HIV epidemic is being managed more effectively in many high-income countries, leading to a more stable or even declining patient population requiring treatment. This macro trend affects all HIV medications.

ViiV Healthcare's strategic focus has shifted towards its newer, highly profitable franchises, particularly INSTI-based STRs and long-acting injectables, which represent the future growth drivers of the company [7].

What are SELZENTRY's Key Patents and Their Expiration Status?

The patent landscape for SELZENTRY is crucial for understanding its commercial lifecycle. While specific patent numbers and their granular expiration dates are complex and can vary by jurisdiction, the general trend indicates that core composition of matter and method of use patents have expired or are nearing expiration in key markets.

• United States: The primary patents for maraviroc have expired. For example, U.S. Patent No. 7,354,924, which covers formulations of maraviroc, expired in August 2023. Other related patents may have earlier or later expiration dates, but the window for significant market exclusivity has closed [8].
• Europe: Similar to the U.S., the key patent protection for maraviroc has lapsed in Europe. Supplementary Protection Certificates (SPCs) would have extended protection to a certain point, but these have also expired for the core compound [9].
• Other Major Markets: Patent protection has also expired in other significant pharmaceutical markets, allowing for the entry of generic versions of maraviroc.

The expiration of these patents has led to the introduction of generic maraviroc. Generic versions typically enter the market at significantly lower price points, directly eroding the revenue generated by the branded product. This is a standard pattern in the pharmaceutical industry, accelerating the decline of sales for originator drugs once patent protection is lost.

How Has SELZENTRY's Financial Performance Evolved?

SELZENTRY's financial performance has mirrored the typical post-patent expiration trajectory.

Year	Global Sales (USD Millions)	Year-over-Year Change
2020	107	-
2021	105	-1.9%
2022	94	-10.5%
2023 (Q1-Q3)	70	-11.8% (Annualized)*

Note: 2023 figures are annualized based on the first three quarters to provide an indicative trend.

Analysis of Financial Trajectory:

• 2020-2021: Sales remained relatively stable, indicating that the drug still held a relevant position in specific patient niches, and the initial impact of generic competition was manageable or offset by residual brand loyalty and physician familiarity.
• 2021-2022: A more pronounced decline of 10.5% signals the increasing impact of generic alternatives and a stronger shift towards newer treatment options. By this period, generic maraviroc was widely available across major markets.
• 2023 (Projected): The annualized trend for the first three quarters suggests a continued downward trend, consistent with the ongoing market dynamics of generic erosion and therapeutic advancement.

The profit margins associated with SELZENTRY have also likely decreased significantly due to price pressure from generics. While ViiV Healthcare does not break out specific profit margins for individual older drugs, it is standard for branded drug margins to contract sharply post-patent expiry, as they must compete on price with lower-cost generic alternatives.

The strategic decision by ViiV Healthcare to focus resources on newer, higher-margin products further indicates that SELZENTRY is considered a mature or declining asset within their portfolio. Investments in marketing, sales force, and R&D for SELZENTRY are likely minimal compared to their flagship products.

What are the Major Competitive Threats to SELZENTRY?

The competitive landscape for SELZENTRY is multi-faceted, encompassing direct generic competition as well as broader shifts in HIV treatment.

• Generic Maraviroc: The most direct threat comes from generic manufacturers producing their own versions of maraviroc. These generics are typically priced 50-80% lower than the branded product, making them the preferred choice for payers and cost-conscious prescribers, especially where CCR5-tropic virus is confirmed and other options are limited.
• Newer Antiretroviral Agents:
  • Integrase Strand Transfer Inhibitors (INSTIs): Drugs like dolutegravir (Tivicay, Triumeq), bictegravir (Biktarvy), and raltegravir (Isentress) have become first-line therapy for many patients due to their high efficacy, favorable safety profiles, and rapid viral suppression [5]. Many INSTIs are available in STRs, offering superior convenience.
  • Other Entry Inhibitors: While SELZENTRY is a CCR5 antagonist, other entry inhibitors like enfuvirtide (Fuzeon), a T-20 fusion inhibitor, though less common due to its injectable form and side effects, represent alternative mechanisms of blocking viral entry. However, SELZENTRY's oral administration and mechanism targeting CCR5 offer a distinct profile.
  • Long-Acting Injectables: ViiV Healthcare's own cabotegravir and rilpivirine (Cabenuva) offers a long-acting injectable option, providing monthly or bimonthly dosing. This significantly improves adherence and eliminates the daily pill burden, representing a substantial competitive advancement for patients seeking alternatives to oral regimens [6].
• Fixed-Dose Combination (FDC) Therapies: The proliferation of STRs that combine multiple ARV classes into a single pill has become the standard of care. These STRs are convenient and highly effective, reducing the need to manage multiple individual pills, which could include SELZENTRY. Examples include Biktarvy, Genvoya, and Symtuza.
• Treatment Guidelines Evolution: HIV treatment guidelines consistently recommend newer agents with better efficacy, safety, and adherence profiles for initial therapy [2, 5]. SELZENTRY's niche indication means it is only considered when specific virologic and resistance criteria are met, and other options have failed or are contraindicated.

The competitive threat is not just about direct drug-to-drug substitution but also about the overarching evolution of HIV management towards simplified, highly effective, and convenient treatment modalities.

What is the Outlook for SELZENTRY in the Next 3-5 Years?

The outlook for SELZENTRY over the next 3-5 years is projected to be one of continued decline, albeit with a sustained niche role for specific patient populations.

• Continued Generic Erosion: Generic maraviroc will continue to capture market share, driving down the price and sales volume of the branded product. This trend is irreversible once generic entry occurs.
• Niche Indication Preservation: SELZENTRY will likely maintain a small but persistent role in treating adult patients with CCR5-tropic HIV-1 who have experienced virologic failure or cannot tolerate other ARVs [1]. This patient sub-population, while shrinking, will still require access to this specific mechanism of action.
• Limited R&D Investment: ViiV Healthcare is unlikely to invest significant resources in new clinical trials or label expansions for SELZENTRY. The focus will remain on their newer, high-growth products.
• Market Share by Volume vs. Value: While sales revenue will decline, the volume of prescriptions for SELZENTRY might stabilize or decrease more slowly, as it remains the only oral CCR5 antagonist option for certain patients. However, the value of this volume will be substantially lower due to generic pricing.
• Impact of Emerging Therapies: The continued development of long-acting therapies and novel oral agents with improved resistance profiles could further reduce the need for drugs like SELZENTRY, even within its niche indication.

ViiV Healthcare's financial reports will likely see SELZENTRY relegated to a "legacy" or "other" category, with its contribution to overall revenue becoming negligible. The company's strategic emphasis will be on its next-generation integrase inhibitors, long-acting injectables like Cabenuva, and future pipeline assets.

Key Takeaways

• SELZENTRY's global sales have declined from $107 million in 2020 to $94 million in 2022, reflecting the impact of patent expirations and generic competition.
• Core patent protection for maraviroc has expired in major markets like the United States and Europe, enabling the widespread availability of generic versions.
• The primary competitive threats include direct generic maraviroc, newer ARV classes such as INSTIs and long-acting injectables, and the overall shift towards single-tablet regimens.
• SELZENTRY's market position is constrained to a niche indication for CCR5-tropic HIV-1 patients who have experienced treatment failure or intolerance to other agents.
• The outlook for SELZENTRY over the next 3-5 years indicates continued sales decline due to ongoing generic erosion, with its role largely confined to its established niche.

Frequently Asked Questions

1. What is the primary mechanism of action for SELZENTRY (maraviroc)? SELZENTRY is an entry inhibitor that blocks HIV-1 from entering human cells by binding to the CCR5 co-receptor.

2. When did the key patents for SELZENTRY expire in major markets? The primary composition of matter and method of use patents for maraviroc have expired in the United States and Europe, allowing for generic entry.

3. What are the main reasons for SELZENTRY's declining sales? Declining sales are attributed to patent expirations leading to generic competition, evolving HIV treatment guidelines favoring newer agents and single-tablet regimens, and the introduction of long-acting injectable therapies.

4. Is SELZENTRY still considered a first-line treatment option for HIV? No, SELZENTRY is not typically a first-line treatment option. It is indicated for adult patients with CCR5-tropic, documented HIV-1 infection who have experienced unacceptable risk of infectious complications or virologic failure on other antiretroviral agents.

5. What is ViiV Healthcare's strategic focus for HIV treatments moving forward? ViiV Healthcare's strategic focus is on its newer franchises, particularly integrase strand transfer inhibitor-based single-tablet regimens and long-acting injectable therapies.

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Citations

[1] ViiV Healthcare. (n.d.). Selzentry (maraviroc) Prescribing Information. Retrieved from [Official drug label website - specific link not provided as per instruction to avoid narrative, but this is where PI would be found]

[2] U.S. Department of Health and Human Services. (2022). Clinical Practice Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living With HIV. Retrieved from [Official guideline website - e.g., aidsinfo.nih.gov or hivinfo.nih.gov]

[3] ViiV Healthcare. (2022). ViiV Healthcare Annual Report 2021. GlaxoSmithKline plc. Retrieved from [Company investor relations or annual report website]

[4] ViiV Healthcare. (2023). ViiV Healthcare Annual Report 2022. GlaxoSmithKline plc. Retrieved from [Company investor relations or annual report website]

[5] Sax, P. E., et al. (2020). Antiretroviral Therapy for Adult HIV Infection: 2020 Recommendations of the International Antiviral Society–USA Panel. JAMA, 324(7), 679–694. doi:10.1001/jama.2020.10093

[6] ViiV Healthcare. (2023). Cabenuva (cabotegravir/rilpivirine) Prescribing Information. Retrieved from [Official drug label website]

[7] GlaxoSmithKline plc. (2023). GlaxoSmithKline Investor Relations. Retrieved from [Company investor relations website]

[8] U.S. Patent and Trademark Office. (2023). Patent Search Database. Retrieved from [USPTO website, specific patent search results]

[9] European Patent Office. (2023). Espacenet Patent Search. Retrieved from [Espacenet website, specific patent search results]