Viewing data from:

MOZOBIL

NDA

PLERIXAFOR | N022311 | GENZYME CORP

1 strength0 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Genzyme Corporation et al v. Fresenius Kabi USA, LLC 1:2018cv01934 2 patentsANDA 212395plerixafor	D. Del.	2018-12-06	Terminated 2019-04-01	—
Genzyme Corporation et al v. Gland Pharma Limited 1:2018cv01071 3 patentsANDA 206644plerixafor	D. Del.	2018-07-19	Terminated 2020-01-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma NCT01815749	Phase 1	Active	City of Hope Medical Center	30	2013-10-08 → 2027-05-31
CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors NCT07423728	N/A	Recruiting	First Affiliated Hospital of Zhejiang University	160	2026-03-01 → 2027-03-30
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS NCT00967785	Phase 1/2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	20	2010-01-06 → 2026-12-31
Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome NCT02231879	Phase 2/3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	20	2014-10-14 → 2021-02-24

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

Medicare Part D Spending

CMS annual spending data for Mozobil (2023)

Total Spending

$3.5M

Total Claims

122

Beneficiaries

111

Avg Cost/Unit

$8772.85

Spending Trend

$3.8M(2019)→$5.3M(2020)→$5.6M(2021)→$4.4M(2022)→$3.5M(2023)

YoY Change:+9.1%

5yr CAGR:+6.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Mozobil (2023)

Total Spending

$23.5M

Total Claims

2,355

Beneficiaries

1,522

ASP Price

—

HCPCS: J2562 — Injection, plerixafor, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain7 active DMFs1 inactive

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

DR REDDYS LABORATORIES LTDPLERIXAFOR

DMF 264442012

HETERO LABS LTDPLERIXAFOR

DMF 266032012

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPLERIXAFOR

DMF 295072015

MSN LABORATORIES PRIVATE LTDPLERIXAFOR

DMF 308772016

GLAND PHARMA LTDPLERIXAFOR

DMF 315722017

MATRIX PHARMACORP PRIVATE LTDPLERIXAFOR USP

DMF 323412018

ALEMBIC PHARMACEUTICALS LTDPLERIXAFOR

DMF 362782021

FRESENIUS KABI ONCOLOGY LTDInactivePLERIXAFOR

DMF 326152018

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Sep 22, 2023	SUPPL -23	View Letter (PDF)
Aug 20, 2020	SUPPL -22	View Letter (PDF)
Jun 4, 2019	SUPPL -20	View Letter (PDF)
Dec 4, 2017	SUPPL -18	View Letter (PDF)
Aug 6, 2015	SUPPL -16	View Letter (PDF)
Dec 5, 2014	SUPPL -15	View Letter (PDF)
Jun 6, 2013	SUPPL -13	View Letter (PDF)
Jun 16, 2010	SUPPL -1	View Letter (PDF)
Dec 19, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 24MG/1.2ML (20MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 15, 2008

No patent or exclusivity listings for this strength.