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:	7,544
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
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	022128-004	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	022128-003	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
African Regional IP Organization (ARIPO)	1697	Azabicycloalkanes as CCR5 modulators.
Argentina	023345	COMPUESTOS MODULADORES DE CCR5, COMPOSICIONES, USO, METODO DE EVALUACION DE UN SUPUESTO MUTANTE DEL RETROVIRUS VIH, VIRUS MUTANTE, AGENTE DE DIAGNOSTICO Y PROCEDIMIENTO PARA DESCUBRIR LA PRESENCIA Y/O CONFIRMAR LA ACTIVIDAD DE UN MODULADOR DE QUIMIOCINAS
Argentina	023363	COMPUESTOS DERIVADOS DE 3,3-BIARILPIPERIDINA Y 2,2-BIARILMORFOLINA, COMPOSICION Y USO DE LOS MISMOS
Argentina	024233	COMPUESTOS MODULADORES DE CCR5, COMPOSICIONES FARMACEUTICAS, SU USO EN MEDICINA.
Austria	266637
Austria	505190

Supplementary Protection Certificates for SELZENTRY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1284974	CA 2008 00018	Denmark		PRODUCT NAME: MARAVIROC, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT
1284974	91417	Luxembourg		91417, EXPIRES: 20220918
1284974	PA2008004	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010 20070918
1284974	300338	Netherlands
1284974	PA2008004,C1284974	Lithuania		PRODUCT NAME: MARAVIROCUM; REGISTRATION NO/DATE: EU/1/07/418/001 - EU/1/07/418/010, 0070918
1284974	SPC008/2008	Ireland		SPC008/2008: 20081105, EXPIRES: 20220917

Last updated: July 28, 2026

SELZENTRY (maraviroc) market dynamics and financial trajectory

Executive summary: SELZENTRY (maraviroc) is a Janssen (Johnson & Johnson) brand in HIV. Its market trajectory is shaped by (1) competitive pressure from integrase strand transfer inhibitor (INSTI)-based regimens that reduced reliance on CCR5 antagonists, (2) sensitivity to guideline positioning for treatment-experienced patients with CCR5-tropic virus, and (3) patent/regulatory barriers affecting generic and biosimilar competition. The result is a long-term volume decline pattern after peak years, followed by a more stable but lower revenue base anchored to specific patient segments and line-of-therapy niches.

Why does SELZENTRY (maraviroc) have limited growth versus INSTI-based HIV regimens?

SELZENTRY targets CCR5 using maraviroc. In practice, its addressable use depends on viral tropism (CCR5 vs CXCR4) and line of therapy. The drug’s competitive set is dominated by INSTI-containing combination antiretroviral therapy (cART), which expanded first-line uptake globally and displaced older non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor-heavy patterns, with CCR5 antagonists playing a narrower role.

Key market dynamic: CCR5 antagonism is regimen- and tropism-dependent. Many HIV-treated patients across major markets moved earlier to regimens with higher barriers to resistance and broader activity profiles, which reduced the incremental demand for maraviroc.

Which patient segments drive SELZENTRY demand?

• Treatment-experienced patients where CCR5 tropism supports maraviroc inclusion.
• Patients with limited options due to resistance or intolerance affecting alternatives.
• Regimen substitution cases where clinicians preserve CCR5 activity while adjusting other agents.

What dosing, formulation, and monitoring constraints influence uptake?

• Maraviroc selection depends on tropism testing. That testing requirement limits automatic prescribing.
• Drug-drug interactions via CYP pathways can restrict use depending on background therapy, lowering clinician willingness to start or switch unless a stable interaction plan exists.

How have competitive pressures affected SELZENTRY pricing power and share?

Competitive pressure comes from two angles: therapeutic substitution and channel leverage.

Therapeutic substitution

• INSTI-based cART reduced the relative attractiveness of CCR5 antagonists as a general-purpose backbone.
• In markets where guideline changes supported earlier INSTI initiation, maraviroc’s addressable population narrowed to specific tropism and treatment history situations.

Channel leverage and procurement

• Large payers prefer preferred regimens with lower administrative friction and predictable outcomes.
• Formularies tend to concentrate spend on preferred classes, leaving older or more conditional mechanisms such as CCR5 antagonism with narrower reimbursement coverage.

What is the revenue trajectory for SELZENTRY by major geography?

SELZENTRY’s financial profile follows typical brand dynamics: peak during adoption for its indicated niche, then gradual decline as competitive options expanded and formulary preferences shifted toward INSTI-based combinations and newer agents.

Business pattern seen across mature antiretroviral brands: once INSTI penetration rises and patents near expiry (or generics enter for adjacent options), brand revenues soften.

United States (commercial and policy forces)

• Use is concentrated in the subset with CCR5-tropic virus and treatment history matching guideline logic.
• US pricing pressure typically increases as competitive formularies and generic competition for other antiretrovirals compress net pricing.

EU5 and other developed markets

• Similar guideline and purchasing pressures apply, with additional weight on HTA and national procurement structures that favor lower cost and simplified regimens.

Emerging markets

• In many emerging markets, pricing is shaped by tenders and local manufacturing availability for multiple antiretrovirals.
• A conditional-use drug like maraviroc can face lower uptake even when globally recommended, because tender frameworks and fixed regimen kits tend to favor broader-activity backbones.

When do patent and exclusivity changes impact SELZENTRY generic entry risk?

Market dynamics hinge on whether generic entry is feasible in the specific dosage forms and strengths on the relevant label, and on whether exclusivity extends beyond the primary compound.

Patent estate and exclusivity pathways (risk drivers)

Generic entry risk depends on:

• Whether ANDA filers can establish bioequivalence without running into formulation, method, or use patents.
• Whether any pediatric, marketing, or data exclusivities remain applicable.
• Whether Orange Book listings create a clean path for paragraph IV certification versus carve-outs or litigation stays.

Practical implication: Even after core patent expiry, a brand can remain commercially relevant longer when remaining listed patents delay “at-risk” generic approvals or limit entry timing to specific strengths/dosage forms.

How does Orange Book status drive SELZENTRY market access for generics?

Orange Book listings generally control the mechanics of generic access in the US. The higher the number of listed patents that match the NDA/approved indications, the longer a brand can constrain entry, either by:

• Litigation that results in 30-month stays following paragraph IV filings, and/or
• Settlement agreements that push launch dates.

Market consequence: SELZENTRY’s pace of generic erosion depends on the number and type of remaining listed patents (compound, polymorph/formulation, method-of-use).

What Paragraph IV litigation patterns have mattered for SELZENTRY?

In HIV antiretrovirals, the most commercially relevant litigation patterns are:

• Paragraph IV ANDA filings against listed patents.
• 30-month stays.
• Settlements that define launch dates and design-around requirements.

Business impact: Litigation does not just affect FDA approval timing. It also affects payer contracting, inventory positioning, and the credibility of generic supply timelines.

How do formulation and method-of-use patents affect SELZENTRY competitive substitution?

Maraviroc’s CCR5 antagonist mechanism is clinically established, but IP can also cover:

• Specific formulations (tablet composition, film-coating, excipients, dissolution profile).
• Method-of-use claims tied to tropism testing or regimen combination patterns.

Commercial impact: Even if an ANDA filer can replicate active ingredients, formulation or use patent barriers can delay FDA launch even after a compound is no longer patent protected.

What regulatory milestones matter for SELZENTRY financials?

For HIV drugs, FDA milestones drive entry/competition timelines more than label expansions.

Key drivers

• ANDA submission timing and acceptance (administrative and scientific review).
• Patent litigation outcomes that trigger automatic stays or settlement launch windows.
• Label updates that narrow or clarify indications can affect demand, while expansions or refined positioning can shift physician adoption.

How does SELZENTRY dosing and interaction profile influence physician prescribing and persistence?

CCR5 antagonists require clinicians to:

• Confirm CCR5 tropism.
• Manage drug-drug interactions with background antiretroviral therapy.
• Monitor for adverse events that can lead to discontinuation.

Market consequence: persistence and switching rates influence net sales more than penetration metrics alone. If real-world persistence is lower due to interaction burden or clinical complexity, net revenue declines faster than volume-only metrics would predict.

How does SELZENTRY compare with other HIV CCR5 antagonists and INSTIs?

Versus INSTI-based regimens

• INSTIs generally have simpler positioning across broader patient groups.
• INSTI regimens are often the default first-line choice, leaving maraviroc as a niche switch option when CCR5 tropism and resistance patterns support it.

Versus other CCR5-relevant agents

• CCR5 antagonism is a narrow class. Competition within it tends to be limited.
• When alternatives broaden beyond CCR5-specific drugs into multi-class regimens, CCR5 antagonists face reduced incremental demand.

What commercial outcomes should investors and licensors infer from SELZENTRY’s dynamics?

Inference 1: Expected revenue is range-bound. Mature HIV markets increasingly favor regimens with broader activity and simplified selection. That caps SELZENTRY upside.

Inference 2: Financial trajectory is more sensitive to competitive entry timing than to R&D pipeline. In a mature therapeutic area, the main variable is when generics arrive and whether settlements and remaining patents delay launches.

Inference 3: Net sales track with treated patient cohort size and regimen persistence. Tropism testing and interaction constraints reduce the feasible “addressable” population versus broader-class therapies.

Key Takeaways

• SELZENTRY’s growth ceiling is structural: CCR5-tropism and line-of-therapy dependence limit expansion versus INSTI-based cART.
• Market share and net pricing power are pressured by guideline and formulary shifts toward INSTIs and by payer preference for simpler regimens.
• Patent and Orange Book dynamics, including remaining listed patents and litigation/settlement outcomes, are the main determinants of generic erosion timing.
• Revenue trajectory is likely characterized by long-run decline followed by stability at a lower niche base, driven by persistent demand in CCR5-tropic, treatment-experienced segments.

FAQs

1) What is SELZENTRY’s main competitive set in HIV?
INSTI-based combination regimens are the primary substitutes, with maraviroc used more narrowly for CCR5-tropic, treatment-experienced scenarios.

2) Does SELZENTRY compete primarily on efficacy, tolerability, or treatment positioning?
Positioning and patient selection are central. Efficacy must align with CCR5-tropic virus and suitable background therapy due to interaction constraints.

3) What factor most controls SELZENTRY generic launch timing in the US?
Orange Book-listed patents and any associated paragraph IV litigation and settlement timelines that delay or restrict launch.

4) Why is tropism testing relevant to SELZENTRY sales?
CCR5 antagonism requires CCR5-tropic virus selection, which narrows the eligible treated cohort and adds clinical friction.

5) How do settlements typically affect branded antiretroviral revenue trajectories?
Settlements can extend market exclusivity by setting launch dates for generics or by limiting entry configurations, extending the brand revenue window.

References

1. Johnson & Johnson. SELZENTRY (maraviroc) prescribing information.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (SELZENTRY/maraviroc listings).

DrugChatter Q&A for SELZENTRY

Is Selzentry effective for CCR5-tropic HIV?