Viewing data from:

TOBI PODHALER

NDA

TOBRAMYCIN | N201688 | VIATRIS SPECIALTY LLC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

Today

8869794

Sep. 12, 2028

10207066

Nov. 4, 2030

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

86 trials from ClinicalTrials.gov, 68 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis NCT00705159	Phase 4	Completed	Bausch & Lomb Incorporated	137	2008-06 → 2010-05
Early Changes Among FLEx, LASIK and FS-LASIK NCT02551796	N/A	Completed	Sun Yat-sen University	75	2015-09 → 2016-04
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis NCT00006280	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	98	2000-02 → 2002-02
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.NCT01155999	Phase 3	Completed	Laboratoires Thea	286	2008-12 → 2011-02
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis NCT03464435	Phase 4	Completed	Zhongshan Ophthalmic Center, Sun Yat-sen University	20	2016-11-01 → 2018-02-01
Intraarticular Antibiotic in TKA NCT04297631	Phase 4	Completed	Washington University School of Medicine	20	2020-02-14 → 2020-11-01
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery NCT03739528	Phase 3	Completed	NTC srl	808	2018-09-03 → 2018-12-19
Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis NCT00004829	Phase 3	Completed	FDA Office of Orphan Products Development	200	1995-06 → 1998-05
Topical Antibiotics in Chronic Rhinosinusitis NCT03673956	Phase 1/2	Completed	Mayo Clinic	19	2018-09-26 → 2021-02-01
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)NCT00105469	Phase 3	Completed	Merck Sharp & Dohme LLC	743	2004-07 → 2005-10

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$8469.77

Highest Price

$8469.77

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
49502-0401-24TOBI PODHALER 28MG	$8469.77	FSS	Mylan Specialty L.P.	01/14/2027
49502-0401-24TOBI PODHALER 28MG	$8469.77	Big4	Mylan Specialty L.P.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Tobi Podhaler (2024)

Total Spending

$11.6M

Total Claims

1,054

Beneficiaries

332

Avg Cost/Unit

$49.14

Spending Trend

$1.3M(2020)→$2.0M(2021)→$10.2M(2022)→$11.1M(2023)→$11.6M(2024)

YoY Change:-8.1%

5yr CAGR:+1.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs9 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 137391998

PHARMACHIM ECONOMIC CORPInactiveTOBRAMYCIN

DMF 137401998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTOBRAMYCIN

DMF 137701998

ALPHARMA APSInactiveTOBRAMYCIN SULPHATE USP (NON-STERILE BULK)

DMF 190302005

ALPHARMA APSInactiveTOBRAMYCIN BASE USP (NON-STERILE BULK)

DMF 190292005

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

7 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2023	SUPPL -19	View Letter (PDF)
Jul 17, 2020	SUPPL -10	View Letter (PDF)
Jan 18, 2017	SUPPL -8	View Letter (PDF)
Oct 6, 2015	SUPPL -6	View Letter (PDF)
Nov 20, 2014	SUPPL -4	View Letter (PDF)
Apr 28, 2014	SUPPL -2	View Letter (PDF)
Mar 26, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 28MG

RLD

2 patents0 exclusivities▴

POWDER;INHALATION | Approved: Mar 22, 2013

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8869794	Sep 12, 2028	—	—	Yes		—
10207066	Nov 4, 2030	—	—	Yes		—