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TOBREX

NDA

TOBRAMYCIN | N050541 | NOVARTIS PHARMACEUTICALS 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

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 Tobrex (2023)

Total Spending

$1.2M

Total Claims

4,574

Beneficiaries

3,603

Avg Cost/Unit

$73.73

Spending Trend

$2.0M(2019)→$1.4M(2020)→$1.1M(2021)→$1.0M(2022)→$1.2M(2023)

YoY Change:+13.5%

5yr CAGR:+3.7%

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

API Supply Chain5 active DMFs10 inactive

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

TAPI NL BVTOBRAMYCIN

DMF 137131998

CHONGQING DAXIN PHARMACEUTICAL CO LTDTOBRAMYCIN USP

DMF 137741998

XELLIA PHARMACEUTICALS APSTOBRAMYCIN SULPHATE, NON-STERILE BULK

DMF 150212000

XELLIA PHARMACEUTICALS APSTOBRAMYCIN SULPHATE, USP STERILE BULK

DMF 156292001

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDTOBRAMYCIN

DMF 350422020

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN BASE

DMF 75781988

GUANGDONG QINGYUAN NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN

DMF 121281996

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN

DMF 137401998

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN

DMF 137391998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN

DMF 137701998

XELLIA PHARMACEUTICALS APSInactiveTOBRAMYCIN SULFATE, USP STERILE

DMF 168102003

ALPHARMA APSInactiveTOBRAMYCIN BASE USP (NON-STERILE BULK)

DMF 190292005

ALPHARMA APSInactiveTOBRAMYCIN SULPHATE USP (NON-STERILE BULK)

DMF 190302005

CHONGQING DAXIN PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN FORM-1 USP

DMF 195062006

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN (NON-STERILE, BULK FORM)

DMF 207242007

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 17, 2021	SUPPL -31	View Letter (PDF)
Apr 28, 2020	SUPPL -30	View Letter (PDF)
Dec 19, 2012	SUPPL -24	View Letter (PDF)
Jul 28, 2003	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.