Viewing data from:

CARBOCAINE

NDA

MEPIVACAINE HYDROCHLORIDE | N012250 | HOSPIRA INC

3 strengths0 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hospira Inc. FDA-2006-P-0269 Hospira Inc. filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine the discontinued 1.8 mL cartridge formulation of Carbocaine Injection 3% (mepivacaine hydrochloride) was not withdrawn for safety or efficacy reasons and t	505(q)	2008-05-12	Withdrawn	Hospira Inc.

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MOEHS IBERICA SLMEPIVACAINE HYDROCHLORIDE

DMF 199912006

PCASMEPIVACAINE HYDROCHLORIDE

DMF 350132020

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1%

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 2%

RLD

0 patents0 exclusivities▾

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

#005 — 1.5%

RLD

0 patents0 exclusivities▾

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