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
PolyBio Research Foundation	PHASE2
Icahn School of Medicine at Mount Sinai	PHASE2
Yale University	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

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	022128-002	Aug 6, 2007
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007

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
Yugoslavia	40701
Brazil	PI9917007	azabicicloalcanos como moduladores de ccr5, composição farmacêutica contendo os mesmos, bem como seu uso
Australia	2001252482

Supplementary Protection Certificates for SELZENTRY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

Market Dynamics and Financial Trajectory for SELZENTRY

Last updated: July 27, 2025

Introduction

Selzentry (maraviroc), developed by Pfizer, is an antiretroviral drug primarily indicated for treating HIV-1 infection. Approved by the U.S. FDA in 2007, it operates as a CCR5 antagonist, targeting a specific co-receptor essential for viral entry into host cells. Over the past decade, its market dynamics and financial prospects have been influenced by evolving epidemiology, competitive landscape, regulatory shifts, and innovations in HIV therapies. This analysis examines factors impacting Selzentry’s current market standing and future financial trajectory within the rapidly changing HIV treatment landscape.

Market Overview and Epidemiological Trends

Global HIV Burden

HIV remains a significant global health burden, with approximately 38 million individuals living with the virus as per UNAIDS data in 2021.[1] Sub-Saharan Africa accounts for over 60% of the global cases, while infection rates in North America and Europe are relatively lower but stable. The increased availability of antiretroviral therapy (ART) and improved diagnostics have expanded treatment coverage; however, issues like drug resistance, access, and adherence challenge eradication efforts.

Selzentry’s Market Position

As a CCR5 antagonist, Selzentry is prescribed primarily for treatment-experienced patients harboring CCR5-tropic HIV-1 strains. Its niche positioning confines it to specific patient subsets, contrasting with the broader efficacy of integrase inhibitors like dolutegravir, which dominate current regimens.[2] Consequently, Selzentry’s market share remains constrained despite its unique mechanism.

Market Dynamics Influencing Selzentry

Treatment Guidelines and Scientific Advances

Global HIV treatment guidelines, including those from the WHO and NIH, emphasize the use of integrase strand transfer inhibitors (INSTIs) due to superior efficacy and tolerability.[3] CCR5 antagonists are recommended mainly when other options are unsuitable or in cases with confirmed CCR5-tropic virus. The requirement for tropism testing to confirm CCR5 presence adds complexity and cost, limiting widespread adoption.

Competitor Landscape

The HIV therapeutic landscape is highly competitive, featuring multiple blockbuster drugs:

• Integrase inhibitors (e.g., Dolutegravir, Bictegravir): Market leaders, offering simplified, effective, and well-tolerated regimens.
• Protease inhibitors and NNRTIs: Still used but declining due to resistance and side-effect profiles.
• Novel agents and long-acting therapies: Emerging therapies such as Cabotegravir and Lenacapavir are on the horizon, offering long-acting injectable options, which appeal to adherence challenges.

Selzentry faces stiff competition from these classes, pushing its sales trajectory downward or limiting growth potential unless used in specific niches.

Regulatory and Patent Considerations

Pfizer holds patent exclusivity for maraviroc until 2024-2025, after which generic versions could emerge, significantly impacting price and market share. Additionally, regulatory environments differ globally, with some countries requiring confirmatory tropism testing, limiting broader use.

Pricing and Reimbursement

Selzentry’s pricing has been relatively high due to its specialized use, with costs around $3,000–$4,000 per month in the US.[4] Reimbursement policies and insurance coverage influence patient access, affecting its market penetration. With the entry of generics, pricing pressure is anticipated to intensify.

Market Penetration Barriers

• Tropism Test Requirement: Adds cost and delays initiation.
• Limited Indication: Prescribed primarily as salvage therapy for CCR5-tropic HIV.
• Physician Preference: Clinicians favor potent, well-tolerated, and simple regimens, which marginalize Selzentry's role.

Financial Trajectory

Historical Sales Performance

Pfizer reported modest sales for Selzentry, with estimates around $200–$300 million annually in the U.S. and select global markets.[5] Sales plateaued post-2015, reflecting constrained usage and market saturation.

Future Revenue Outlook

The upcoming patent expiry is likely to depress prices and sales. Unless Pfizer innovates or expands indications, revenue from Selzentry may decline steadily over the next five years. Conversely, potential niche uses—such as in patients with CCR5-tropic only HIV, or in combination with emerging therapeutics—could mitigate declines.

Potential Growth Drivers

• Expanded Use in CCR5-tropic Disease: If tropism testing becomes more accessible or validated in broader indications, Selzentry’s use could expand.
• Combination Regimens: Incorporation into novel combination therapies might improve utility.
• Long-acting Formulations: While not currently available, development of long-acting maraviroc could rejuvenate interest.

Risks to Financial Stability

• Generic Competition: Patent expiration could significantly reduce margins.
• Market Trends: Favoring of INSTI-based regimens continues to erode market share.
• Regulatory Hurdles: Changing guidelines or tarnished efficacy perception could hamper sales.

Conclusion

Selzentry faces a complex market environment characterized by potent competition, evolving treatment guidelines favoring integrase inhibitors, and impending patent expiration. Its niche positioning as a CCR5 antagonist limits its broader market penetration, constraining revenue growth. Nevertheless, targeted utilization in specific patient populations and pipeline innovations could sustain its relevance.

Key Takeaways

• Selzentry's current market share remains limited, with revenues plateauing due to stiff competition and niche indication constraints.
• The global shift toward simpler, highly effective ART regimens favors drugs with broader activity, reducing Selzentry's relative importance.
• Patent expiration post-2024 could accelerate generic entry, exerting downward pressure on pricing and sales.
• Future growth hinges on expanding indications, improving tropism testing accessibility, and developing long-acting formulations.
• Companies must monitor evolving clinical guidelines and competitive innovations to protect and maximize Selzentry's financial potential.

FAQs

1. What are the primary factors limiting Selzentry's market growth?
   Its niche focus on CCR5-tropic HIV, requirement for tropism testing, competition from more potent integrase inhibitors, and impending patent expiration are key limiting factors.

2. How does the patent expiry affect Selzentry’s future sales?
   Patent expiry likely will open the market to generic formulations, drastically reducing drug prices and overall sales volume.

3. Are there new developments that could revive Selzentry’s market position?
   Yes, innovations like long-acting formulations, broader indications for CCR5-tropic HIV, or combination therapies could positively influence its trajectory.

4. How does the competitive landscape impact Selzentry?
   The dominance of integrase inhibitors and emerging long-acting therapies overshadow Selzentry, confining it to niche indications and limiting revenue growth.

5. What strategies can Pfizer adopt to sustain Selzentry’s revenue?
   Strategies include expanding indications, improving tropism testing, developing long-acting formulations, and positioning the drug for specialized patient subsets.

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Sources

[1] UNAIDS. (2021). Global HIV & AIDS statistics — 2021 fact sheet.
[2] NIH Guidelines for the Use of Antiretroviral agents in Adults and Adolescents.
[3] WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring.
[4] GoodRx. (2022). Cost of Selzentry (maraviroc).
[5] Pfizer Annual Reports and Market Data.