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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 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

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ciprodex (2023)

Total Spending

$6.1M

Total Claims

22,355

Beneficiaries

17,816

Avg Cost/Unit

$35.98

Spending Trend

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

YoY Change:+3.8%

5yr CAGR:+1.5%

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

Approval Letters

4 letters from Drugs@FDA

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.