Viewing data from:

DURANEST

NDA

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE | N021384 | DENTSPLY PHARMACEUTICAL

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0527 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA Commissioner determine whether Duranest (Etidocaine Hydrochloride) Injections, 0.5% and 1%, approved under NDA 17-751 and owned by Astra Zeneca, were voluntarily withdrawn from sale for reasons relate	Other	2008-10-01	Open	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Products (1)

#001 — 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.