Viewing data from:

IXEMPRA KIT

NDA

IXABEPILONE | N022065 | R-PHARM US LLC

2 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ixempra (2023)

Total Spending

$275K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$3268.73

Spending Trend

$274K(2019)→$566K(2020)→$494K(2021)→$275K(2023)

5yr CAGR:+9.8%

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 IXempra (2023)

Total Spending

$2.6M

Total Claims

400

Beneficiaries

ASP Price

—

HCPCS: J9207 — Injection, ixabepilone, 1 mg

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

FORMOSA LABORATORIES INCIXABEPILONE

DMF 258942012

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 12, 2023	SUPPL -13	View Letter (PDF)
Jan 25, 2022	SUPPL -11	View Letter (PDF)
Oct 20, 2011	SUPPL -6	View Letter (PDF)
May 17, 2010	SUPPL -5	View Letter (PDF)
May 17, 2010	SUPPL -4	View Letter (PDF)
Oct 13, 2009	SUPPL -3	View Letter (PDF)
Oct 13, 2009	SUPPL -2	View Letter (PDF)
Mar 17, 2009	SUPPL -1	View Letter (PDF)
Oct 22, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Oct 16, 2007

No patent or exclusivity listings for this strength.

#002 — 45MG/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Oct 16, 2007