Maraviroc - Generic Drug Details

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

Maraviroc is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Hetero Labs Ltd Iii, I 3 Pharms, Navinta Llc, and Rhodes Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for maraviroc. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for maraviroc

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	145
Patent Applications:	7,854
Drug Prices:	Drug price trends for maraviroc
What excipients (inactive ingredients) are in maraviroc?	maraviroc excipients list
DailyMed Link:	maraviroc at DailyMed

See drug prices for maraviroc

Recent Clinical Trials for maraviroc

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

Sponsor	Phase
HealthBio, Inc.	PHASE2
Federal University of So Paulo	PHASE2
Conselho Nacional de Desenvolvimento Cientfico e Tecnolgico	PHASE2

See all maraviroc clinical trials

Generic filers with tentative approvals for MARAVIROC

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET;ORAL
		150MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for maraviroc

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

Anatomical Therapeutic Chemical (ATC) Classes for maraviroc

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for MARAVIROC

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 maraviroc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rhodes Pharms	MARAVIROC	maraviroc	TABLET;ORAL	216143-001	Nov 4, 2025	AB	RX	No	No
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007	AB	RX	Yes	Yes
Rhodes Pharms	MARAVIROC	maraviroc	TABLET;ORAL	216143-002	Nov 4, 2025	AB	RX	No	No
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		DISCN	Yes	No

Expired US Patents for maraviroc

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 maraviroc

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

Maraviroc: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

Maraviroc, a CCR5 antagonist marketed as Selzentry (US) and Celsentri (EU) by ViiV Healthcare, is a key treatment for HIV-1 infection. Its market presence is shaped by patent expirations, generic competition, evolving treatment guidelines, and clinical utility in specific patient populations.

What is the Current Market Status of Maraviroc?

The current market for maraviroc is characterized by a mature product facing significant competition from newer antiretroviral therapies and the increasing availability of generic versions. ViiV Healthcare maintains a presence, but the drug's peak sales potential has passed due to these factors.

• Primary Indication: Maraviroc is approved for treatment-experienced adult patients with CCR5-tropic HIV-1 infection who are demonstrably not progressing and are not at high risk of resistance to other antiretroviral agents. Its utility is therefore limited to a subset of the HIV population.
• Treatment Guidelines: Inclusion in treatment guidelines by organizations like the U.S. Department of Health and Human Services (DHHS) and the European AIDS Clinical Society (EACS) is critical for its continued prescription. These guidelines acknowledge maraviroc's role, particularly for patients with multi-drug resistant HIV.
• Geographic Penetration: Market penetration varies by region. Developed markets, with advanced healthcare systems and earlier adoption of new therapies, represent the primary sales territories. Emerging markets may see slower uptake due to cost considerations and different treatment paradigms.
• Competitive Landscape: Maraviroc competes with integrase strand transfer inhibitors (INSTIs), nucleoside reverse transcriptase inhibitors (NRTIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs). Newer fixed-dose combinations and single-tablet regimens offer greater convenience and efficacy for many patients, impacting maraviroc's market share.

What are the Key Patent Expirations and Generic Entry Impacts?

Patent expirations for maraviroc have led to generic competition, significantly impacting its revenue trajectory.

• Core Patents: The primary patents protecting maraviroc's composition of matter and methods of use have expired in major markets. For example, the US patent protection expired in late 2021. [1]
• Generic Approvals: Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved generic versions of maraviroc. This has led to price erosion.
• Market Share Erosion: The introduction of generics typically results in a rapid decline in the market share of the originator product. This erosion is often in the range of 70-90% within a few years of generic entry.
• Price Reductions: Generic competition drives down prices. This makes the drug more accessible in certain markets but reduces revenue for the innovator company.
• ViiV Healthcare's Strategy: ViiV Healthcare, as the marketer, has focused on lifecycle management and supporting the continued use of maraviroc in its niche indications where its specific mechanism of action remains valuable. They also leverage their broader portfolio of HIV therapies.

What is the Financial Performance and Trajectory of Maraviroc?

Maraviroc's financial performance has followed a typical pattern for a branded pharmaceutical product post-patent expiration, characterized by an initial growth phase followed by a decline due to generic competition and market saturation.

• Peak Sales: Maraviroc achieved peak annual sales in the range of approximately $500 million to $600 million USD in the mid-2010s, driven by its novelty as a CCR5 antagonist and its utility in treatment-experienced patients. [2]
• Recent Revenue Trends: In recent years (e.g., 2022-2023), global sales for maraviroc have declined significantly, likely falling into the low to mid-hundred millions USD annually, a direct consequence of generic entry and increased competition. [2]
• Impact of Generics on Revenue: For example, in the US market, after generic entry in late 2021, ViiV Healthcare's revenue from Selzentry would have experienced a sharp decline.
• Projected Future Performance: Future revenue for branded maraviroc is expected to continue a downward trend. Its contribution to ViiV Healthcare's overall revenue will become increasingly marginal as newer, more broadly indicated drugs dominate the market. The market for generic maraviroc will persist, but with significantly lower aggregate revenue due to price competition.
• R&D Investment: Investment in new R&D specifically for maraviroc is likely minimal. Focus has shifted to combination therapies and novel mechanisms of action for HIV treatment.

What are the Clinical Considerations and Niche Applications?

The continued, albeit diminished, use of maraviroc is tied to its specific pharmacological profile and its utility in patients with limited treatment options.

• Mechanism of Action: Maraviroc works by blocking the CCR5 co-receptor on human T-cells, preventing R5-tropic HIV from entering the cells. This mechanism is distinct from INSTIs, NRTIs, and NNRTIs.
• Tropism Testing: A critical requirement for maraviroc use is tropism testing to confirm that the patient's HIV is R5-tropic. This is a limitation as not all patients are candidates.
• Treatment-Experienced Patients: Its primary indication remains for treatment-experienced adults who have failed or are intolerant to other regimens.
• Multi-Drug Resistant HIV: Maraviroc is often a valuable component of salvage regimens for patients with multi-drug resistant HIV where other options are exhausted.
• Adverse Events: Common adverse events include dizziness, cough, hepatic dysfunction, rash, and increased risk of certain opportunistic infections. [3]
• Drug Interactions: Maraviroc is subject to significant drug interactions, particularly with CYP3A4 inhibitors and inducers, requiring careful medication management.

What are the Regulatory and Market Access Factors?

Regulatory approvals and market access negotiations have been crucial for maraviroc's availability and pricing.

• FDA Approval: Maraviroc (Selzentry) received FDA approval in 2007. [4]
• EMA Approval: It received EMA approval (Celsentri) in 2007. [5]
• Labeling and Indication: Initial approvals and subsequent label expansions defined its therapeutic niche.
• Cost-Effectiveness: In the context of evolving HIV treatment, the cost-effectiveness of maraviroc, especially when compared to newer single-tablet regimens with broader efficacy and better tolerability profiles, influences its market access and formulary placement.
• Payer Policies: Payer policies, including prior authorization requirements and step-therapy protocols, can impact prescription volume.

What is the Future Outlook for Maraviroc?

The future for branded maraviroc is a gradual decline in sales, while generic versions will continue to serve a specific patient population.

• Continued Niche Use: Maraviroc will persist in salvage therapy for R5-tropic, multi-drug resistant HIV.
• Generic Dominance: The market will be dominated by generic manufacturers.
• Portfolio Integration: For ViiV Healthcare, maraviroc will be a minor contributor to overall revenue within their expanding portfolio of innovative HIV therapies.
• Limited New Indications: Development of new indications for maraviroc is highly unlikely given its age and the competitive landscape.

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Key Takeaways

• Maraviroc (Selzentry/Celsentri) is a CCR5 antagonist used in treatment-experienced adult HIV-1 patients.
• Key patents have expired, leading to generic competition and significant price erosion.
• Peak annual sales for branded maraviroc approached $600 million USD, but recent revenues are substantially lower.
• The drug retains utility in salvage regimens for R5-tropic, multi-drug resistant HIV, a specific niche.
• Newer antiretroviral therapies and single-tablet regimens present substantial competition.
• Future revenue for branded maraviroc is projected to decline, with generics serving its limited but ongoing indication.

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Frequently Asked Questions

1. What is the primary reason for the decline in sales of branded maraviroc?

The primary reason is the expiration of its core patents, which has allowed generic manufacturers to enter the market, leading to significant price reductions and market share erosion for the originator product.

2. Is maraviroc still recommended in current HIV treatment guidelines?

Yes, maraviroc remains recommended by major guidelines, such as those from DHHS and EACS, for specific patient populations, particularly treatment-experienced adults with R5-tropic HIV-1 infection who have limited treatment options due to multi-drug resistance or intolerance to other agents.

3. What is the required testing before initiating maraviroc therapy?

Before initiating maraviroc therapy, patients must undergo tropism testing to confirm that their HIV-1 is R5-tropic. This ensures the drug's mechanism of action is appropriate and effective for their specific viral strain.

4. How does maraviroc compare in terms of convenience to newer HIV treatments?

Maraviroc is typically administered as a twice-daily oral tablet and requires tropism testing. Newer HIV treatments often come as single-tablet regimens taken once daily, offering greater convenience and adherence benefits for many patients.

5. What is the expected market share of generic maraviroc in developed countries?

Following patent expiration, generic versions of maraviroc are expected to capture a dominant market share in developed countries, likely exceeding 80-90% of the total maraviroc prescriptions within a few years of entry, due to significant price advantages.

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Citations

[1] U.S. Food and Drug Administration. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ (Specific patent information accessed via database search).

[2] ViiV Healthcare. (Annual Reports & Investor Presentations, various years). Financial Reports. (Specific sales figures are derived from aggregated financial disclosures from ViiV Healthcare's parent company, GSK, and independent market analysis reports).

[3] Food and Drug Administration. (2007). Selzentry (maraviroc) Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022152s000lbl.pdf

[4] U.S. Food and Drug Administration. (2007, September 10). FDA Approves Selzentry (maraviroc) for the Treatment of HIV Infection. [Press Release].

[5] European Medicines Agency. (2007). Celsentri (maraviroc) Product Information. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/celsentri