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, and I 3 Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for maraviroc

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	140
Patent Applications:	6,681
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
National Cancer Institute (NCI)	Phase 1/Phase 2
Orlando Immunology Center	Phase 4
Centro de Investigación en. Enfermedades Infecciosas, Mexico	Phase 2

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
Hetero Labs Ltd Iii	MARAVIROC	maraviroc	TABLET;ORAL	203347-002	Feb 7, 2022	AB	RX	No	No
I 3 Pharms	MARAVIROC	maraviroc	TABLET;ORAL	217114-001	Aug 17, 2023	AB	RX	No	No
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016		DISCN	Yes	No
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007	AB	RX	Yes	No
Hetero Labs Ltd Iii	MARAVIROC	maraviroc	TABLET;ORAL	203347-001	Feb 7, 2022	AB	RX	No	No
I 3 Pharms	MARAVIROC	maraviroc	TABLET;ORAL	217114-002	Aug 17, 2023	AB	RX	No	No

Expired US Patents for maraviroc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016	6,586,430
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016	6,586,430

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/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

Maraviroc Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Maraviroc

Introduction

Maraviroc, known by the trade names Celsentri in Europe and Selzentry in the United States, is a unique antiretroviral drug that belongs to the class of CCR5 inhibitors. It is the only licensed drug in this class and plays a crucial role in the treatment of HIV-1 infection by preventing the virus from entering uninfected cells through the CCR5 receptor.

Market Size and Growth

The global market for maraviroc is projected to experience significant growth over the coming years. According to market research, the global maraviroc market size is expected to grow from approximately USD 1.2 billion in 2023 to around USD 2.1 billion by 2032, exhibiting a compound annual growth rate (CAGR)[4].

Approval and Regulatory Landscape

Maraviroc was first approved in 2007 for use in combination with other antiretrovirals for treatment-experienced individuals with CCR5-tropic HIV in the United States. Subsequent approvals followed in Europe for treatment-experienced patients. In November 2009, maraviroc received licensing for use in antiretroviral-naive patients in the US, although it remains unlicensed for this group in Europe[1].

Clinical Effectiveness

The effectiveness of maraviroc has been demonstrated through several clinical trials, notably the MOTIVATE studies. These studies showed that maraviroc, when added to optimized background antiretroviral therapy (ART), significantly improved viral load outcomes compared to placebo. For instance, 56% of participants receiving twice-daily maraviroc achieved a viral load below 400 copies/ml, compared to 22% in the placebo group[1].

Treatment Guidelines

Current treatment guidelines recommend considering maraviroc as part of treatment regimens after the failure of first-line or second-line treatments, especially when resistance to other antiretroviral drugs is present. In the UK, 2016 treatment guidelines suggest its use after first-line treatment failure, while US guidelines from 2021 recommend it after the failure of a second-line regimen[1].

Resistance and Tropism

Maraviroc's efficacy is highly dependent on the tropism of the HIV virus. Treatment failures are more likely in patients who develop X4-tropic or dual/mixed tropic virus, as maraviroc specifically targets CCR5-tropic virus. However, even in cases of treatment failure, maraviroc has been shown to increase CD4 cell counts, and the virus population tends to shift back to R5 tropism if maraviroc treatment is ceased[1].

Side Effects and Safety

Maraviroc is generally well-tolerated, but common side effects include anaemia, loss of appetite, depression, difficulty sleeping, nausea, flatulence, weakness, rash, and abdominal pain. Rare but serious side effects include hypersensitivity reactions and acute hepatitis, necessitating careful monitoring and immediate cessation of the drug if these symptoms appear[1].

Dosage and Administration

Maraviroc is available in film-coated tablets of 150mg and 300mg strengths. The standard dosing is 300mg twice daily, but this can vary depending on the other antiretrovirals being used. For example, a 150mg dose is recommended when used with certain protease inhibitors or cobicistat, while a 300mg dose is used with other specific drugs[1].

Financial Performance of Related Companies

While the financial performance of maraviroc itself is not directly reported, companies involved in the broader antiretroviral and biotechnology sectors have shown significant growth. For instance, Maravai LifeSciences, a company involved in nucleic acid production and biologics safety testing, reported a 181% increase in revenue from 2020 to 2021, reaching $799.2 million. This growth indicates a robust market for antiretroviral and related therapies[2].

Market Drivers

The growth of the maraviroc market is driven by several factors, including the increasing prevalence of HIV-1 infection, the need for diverse treatment options due to drug resistance, and advancements in antiretroviral therapy. The expanding patient base and the continuous development of new antiretroviral agents also contribute to market growth[4].

Competitive Landscape

Maraviroc operates in a competitive landscape with other antiretroviral drugs, but its unique mechanism of action as a CCR5 inhibitor sets it apart. Other entry inhibitors like enfuvirtide are also approved, but maraviroc remains the only licensed CCR5 inhibitor, giving it a distinct market position[3].

Future Outlook

The future outlook for maraviroc is positive, with projected market growth and continued clinical relevance. As treatment guidelines evolve and more patients require alternative antiretroviral regimens, the demand for maraviroc is expected to increase. Additionally, ongoing research into new entry inhibitors and combination therapies may further enhance the market dynamics for maraviroc[4].

Key Takeaways

• Market Growth: The global maraviroc market is expected to grow significantly, reaching USD 2.1 billion by 2032.
• Clinical Effectiveness: Maraviroc has shown significant efficacy in clinical trials, especially for treatment-experienced patients.
• Treatment Guidelines: Recommended for use after first-line or second-line treatment failures due to its unique mechanism of action.
• Resistance and Tropism: Efficacy is dependent on HIV tropism, with treatment failures more likely in patients with X4-tropic or dual/mixed tropic virus.
• Side Effects and Safety: Generally well-tolerated but requires monitoring for rare serious side effects.
• Financial Performance: Part of a broader antiretroviral market showing robust growth.

FAQs

What is maraviroc, and how does it work?

Maraviroc is an antiretroviral drug that prevents HIV from entering uninfected cells by blocking the CCR5 receptor, a common entry point for the virus.

Who is eligible for maraviroc treatment?

Maraviroc is approved for treatment-experienced individuals with CCR5-tropic HIV and, in the US, for antiretroviral-naive patients. It is not licensed for antiretroviral-naive patients in Europe.

What are the common side effects of maraviroc?

Common side effects include anaemia, loss of appetite, depression, difficulty sleeping, nausea, flatulence, weakness, rash, and abdominal pain.

How is maraviroc dosed?

The standard dose is 300mg twice daily, but this can vary depending on the other antiretrovirals being used.

What is the market outlook for maraviroc?

The global maraviroc market is projected to grow from USD 1.2 billion in 2023 to approximately USD 2.1 billion by 2032.

Can maraviroc be used in combination with other antiretrovirals?

Yes, maraviroc is approved for use in combination with other antiretrovirals and is often part of optimized background therapy.

Sources

1. aidsmap: Maraviroc (Celsentri) | aidsmap
2. Maravai LifeSciences: Maravai LifeSciences Reports Fourth Quarter and Full Year 2021 Financial Results and Updates 2022 Financial Guidance
3. ScienceDirect: Entry inhibitors in the treatment of HIV-1 infection
4. Dataintelo: Maraviroc Market Research Report 2032 - Dataintelo