Viewing data from:

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies NCT07668505	Phase 4	Not Yet Recruiting	Chinese University of Hong Kong	10	2026-09-01 → 2029-08-31

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

Medicare Part D Spending

CMS annual spending data for Selzentry (2023)

Total Spending

$8.7M

Total Claims

4,173

Beneficiaries

947

Avg Cost/Unit

$29.82

Spending Trend

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

YoY Change:+4.8%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2023). 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