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TOBRAMYCIN SULFATE

NDA

TOBRAMYCIN SULFATE | N050789 | FRESENIUS KABI USA LLC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Tobramycin Sulfate (2023)

Total Spending

$2.0M

Total Claims

10,265

Beneficiaries

3,968

Avg Cost/Unit

$2.29

Spending Trend

$25.3M(2019)→$17.5M(2020)→$8.0M(2021)→$2.1M(2022)→$2.0M(2023)

YoY Change:+33.3%

5yr CAGR:-31.8%

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

API Supply Chain1 active DMF2 inactive

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

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDTOBRAMYCIN SULFATE

DMF 278412013

LILLY RESEARCH LABORATORIESInactiveTOBRAMYCIN SULFATE

DMF 135131998

FUJIAN FUKANG PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN SULFATE

DMF 171092004

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1.2GM BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 13, 2004

No patent or exclusivity listings for this strength.