Viewing data from:

ZETONNA

NDA

CICLESONIDE | N202129 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

8371292

Feb. 1, 2028

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 Zetonna (2023)

Total Spending

$323K

Total Claims

968

Beneficiaries

225

Avg Cost/Unit

$36.58

Spending Trend

$501K(2019)→$435K(2020)→$378K(2021)→$335K(2022)→$323K(2023)

YoY Change:+1.9%

5yr CAGR:+1.3%

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

API Supply Chain5 active DMFs1 inactive

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

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIKCICLESONIDE

DMF 166062003

STERLING SPACICLESONIDE

DMF 225872009

AARTI PHARMALABS LTDCICLESONIDE

DMF 236502010

CORAL DRUGS PVT LTDCICLESONIDE

DMF 382832023

NEWCHEM SPACICLESONIDE

DMF 422892025

ALP PHARM BEIJING CO LTDInactiveCICLESONIDE

DMF 242552010

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 17, 2023	SUPPL -9	View Letter (PDF)
Oct 27, 2014	SUPPL -4	View Letter (PDF)
Oct 27, 2014	SUPPL -6	View Letter (PDF)
Oct 27, 2014	SUPPL -5	View Letter (PDF)
Jan 25, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.037MG/INH

RLD

1 patent0 exclusivities▴

AEROSOL, METERED;NASAL | Approved: Jan 20, 2012

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8371292	Feb 1, 2028	—	—	—		—