Viewing data from:

OTOVEL

NDA

CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE | N208251 | LABORATORIOS SALVAT SA

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

Today

Mar. 24, 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Otovel (2023)

Total Spending

$4K

Total Claims

Beneficiaries

Avg Cost/Unit

$19.31

Spending Trend

$19K(2022)→$4K(2023)

YoY Change:+1.7%

5yr CAGR:+1.7%

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 2, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.3% BASE;0.025%

RLD

1 patent0 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Apr 29, 2016

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8932610	Mar 24, 2030	—	—	Yes		—