Viewing data from:

CIPRODEX

NDA

CIPROFLOXACIN; DEXAMETHASONE | N021537 | SANDOZ 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
SUN PHARMACEUTICAL INDUSTRIES, LTD. et al v. NOVARTIS PHARMACEUTICALS CORP. et al 2:2019cv21733 6 patentsANDA 210470ciprofloxacin and dexamethasone	D.N.J.	2019-12-20	Terminated 2020-05-14	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Alcon Pharmaceuticals, Ltd. (Novartis Pharmaceuticals C... FDA-2016-P-2782 · 31 docket documents Alcon Pharmaceuticals, Ltd. and Novartis Pharmaceuticals Corporation submitted this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act on September 14, 2016, requesting that the FDA require abbreviated new drug application (ANDA) applicants citing Ciprodex (ciprofloxac	505(q)	2016-09-19	Partially Denied	Alcon Pharmaceuticals, Ltd. (Novartis Pharmaceuticals Corporation)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

8 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa NCT02216071	Phase 3	Completed	Exela Pharma Sciences, LLC.	499	2014-07-20 → 2015-08-11
Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa NCT01359098	Phase 2	Completed	Otic Pharma	100	2011-07 → 2011-11
Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes NCT01994642	Phase 3	Terminated	Par Pharmaceutical, Inc.	203	2013-11 → 2015-03
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes NCT01908803	Phase 2	Terminated	Alcon Research	84	2013-12 → 2014-08
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa NCT01910155	Phase 3	Terminated	Par Pharmaceutical, Inc.	455	2013-07 → 2015-03
FST-201 In The Treatment of Acute Otitis Externa NCT00945802	Phase 3	Terminated	Shire	5	2009-07-31 → 2010-07-31
Otiprio Versus Ciprodex Tympanostomy Tube Outcomes NCT03347461	Phase 4	Withdrawn	Boston Medical Center	—	2018-10 → 2019-06
N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media NCT00956748	Phase 4	Withdrawn	St. Paul's Hospital, Canada	—	2019-11-29 → 2019-11-29

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.34

per ml

Lowest NADAC/Unit

$7.34

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00781618667CIPROFLOX-DEXAMETH OTIC SUSP	$7.34	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$45.68

Highest Price

$45.68

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-6186-67CIPROFLOXACIN HCL 0.3%/DEXAMETHASONE 0.1% SUS	$45.68	FSS	Sandoz, Inc.	08/14/2028

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

Medicare Part D Spending

CMS annual spending data for Ciprodex (2024)

Total Spending

$62K

Total Claims

279

Beneficiaries

264

Avg Cost/Unit

$29.60

Spending Trend

$12K(2020)→$4.3M(2021)→$6.2M(2022)→$6.1M(2023)→$62K(2024)

YoY Change:-17.7%

5yr CAGR:-3.7%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 4, 2020	SUPPL -18	View Letter (PDF)
Feb 22, 2019	SUPPL -17	View Letter (PDF)
Dec 14, 2015	SUPPL -12	View Letter (PDF)
Jul 28, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3%;0.1%

RLDAB

0 patents0 exclusivities▴

SUSPENSION/DROPS;OTIC | Approved: Jul 18, 2003

No patent or exclusivity listings for this strength.