Viewing data from:

BETHKIS

NDA

TOBRAMYCIN | N201820 | CHIESI USA INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Chiesi U.S.A., Inc. et al v. Teva Pharmaceuticals USA, Inc. et al 1:2017cv01772 3 patentsANDA 210915Tobramycin Inhalation Solution	D. Del.	2017-12-07	Terminated 2019-01-14	—

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

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 Bethkis (2023)

Total Spending

$75K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$19.86

Spending Trend

$238K(2019)→$288K(2020)→$157K(2021)→$93K(2022)→$75K(2023)

YoY Change:-30.9%

5yr CAGR:-8.8%

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 Bethkis (2023)

Total Spending

$15.1M

Total Claims

10,649

Beneficiaries

3,427

ASP Price

—

HCPCS: J7682 — Tobramycin, inhalation solution, fda-approved final product, non-compounded, unit dose form, administered through dme, per 300 milligrams

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

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
Feb 13, 2023	SUPPL -6	View Letter (PDF)
Dec 11, 2019	SUPPL -5	View Letter (PDF)
May 31, 2017	SUPPL -3	View Letter (PDF)
Oct 16, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/4ML

RLDAN

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Oct 12, 2012

No patent or exclusivity listings for this strength.