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SELZENTRY

NDA

MARAVIROC | N022128 | VIIV HEALTHCARE CO

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

115 trials from ClinicalTrials.gov, 84 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects NCT00098722	Phase 2/3	Completed	ViiV Healthcare	474	2004-12 → 2011-04
Expanded Access Program for Maraviroc At Multiple Centers NCT00426660	Phase 3	Completed	ViiV Healthcare	1,047	2007-02 → 2010-06
Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers NCT00771823	Phase 1	Completed	St Stephens Aids Trust	16	2008-05 → 2008-11
Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers NCT00821535	Phase 1	Completed	ViiV Healthcare	12	2009-02 → 2009-05
A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Maraviroc Therapy NCT00870363	Phase 4	Completed	University of California, Davis	44	2009-04 → 2013-04
Combined PD-1 and CCR5 Inhibition for the Treatment of Refractory Microsatellite Stable mCRC NCT03274804	Phase 1	Completed	University Hospital Heidelberg	20	2018-04-01 → 2020-03-01
A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants NCT02039323	Phase 1	Completed	University of North Carolina, Chapel Hill	6	2014-02 → 2014-04
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects NCT00098748	Phase 2/3	Completed	ViiV Healthcare	190	2004-11 → 2009-04
Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration NCT00944541	Phase 2	Completed	French National Agency for Research on AIDS and Viral Hepatitis	60	2009-09 → 2011-01
Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)NCT02208037	Phase 2	Completed	National Heart, Lung, and Blood Institute (NHLBI)	279	2014-08 → 2017-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$28.13

per ea

Lowest NADAC/Unit

$28.02

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49702022418SELZENTRY 300 MG TABLET	$28.13	EA	Brand	$7.06	2026-06-17
49702022318SELZENTRY 150 MG TABLET	$28.02	EA	Brand	$9.15	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1246.09

Highest Price

$1614.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
49702-0223-18SELZENTRY 150MG TAB	$1614.89	FSS	ViiV HealthCare Company	08/14/2026
49702-0223-18SELZENTRY 150MG TAB	$1246.83	Big4	ViiV HealthCare Company	08/14/2026
49702-0224-18SELZENTRY 300MG TAB	$1614.89	FSS	ViiV HealthCare Company	08/14/2026
49702-0224-18SELZENTRY 300MG TAB	$1246.09	Big4	ViiV HealthCare Company	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Selzentry (2024)

Total Spending

$4.1M

Total Claims

2,034

Beneficiaries

346

Avg Cost/Unit

$27.28

Spending Trend

$47.5M(2019)→$43.5M(2020)→$40.1M(2021)→$27.1M(2022)→$8.7M(2023)→$4.1M(2024)

YoY Change:-8.5%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

HETERO LABS LTDMARAVIROC (FORM-B)

DMF 251152011

HETERO LABS LTDMARAVIROC AMORPHOUS

DMF 251212011

CAMBREX PROFARMACO MILANO SRLMARAVIROC

DMF 341822020

COHANCE LIFESCIENCES LTDMARAVIROC

DMF 357892021

NAVINTA LLCMARAVIROC

DMF 369172022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Nov 3, 2020	SUPPL -19	View Letter (PDF)
Jul 20, 2018	SUPPL -18	View Letter (PDF)
Apr 22, 2015	SUPPL -15	View Letter (PDF)
Mar 28, 2014	SUPPL -12	View Letter (PDF)
Feb 19, 2013	SUPPL -11	View Letter (PDF)
Feb 4, 2013	SUPPL -10	View Letter (PDF)
Aug 15, 2012	SUPPL -9	View Letter (PDF)
Oct 25, 2011	SUPPL -7	View Letter (PDF)
Jun 3, 2010	SUPPL -4	View Letter (PDF)
Nov 27, 2009	SUPPL -2	View Letter (PDF)
Nov 28, 2008	SUPPL -1	View Letter (PDF)
Aug 7, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 150MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 6, 2007

No patent or exclusivity listings for this strength.

#002 — 300MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 6, 2007

#003 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 4, 2016

#004 — 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 4, 2016