Viewing data from:

LIDODERM

NDA

LIDOCAINE | N020612 | TEIKOKU PHARMA USA 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
Endo Pharmaceuticals Inc. et al v. TWi Pharmaceuticals Inc. et al 1:2012cv00848 3 patentsANDA 203128lidocaine 5%	D. Del.	2012-07-05	Terminated 2014-04-23	—

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

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 Lidoderm (2023)

Total Spending

$2.6M

Total Claims

2,215

Beneficiaries

1,313

Avg Cost/Unit

$24.12

Spending Trend

$12.6M(2019)→$12.6M(2020)→$12.0M(2021)→$12.3M(2022)→$2.6M(2023)

YoY Change:+6.5%

5yr CAGR:+7.5%

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

API Supply Chain14 active DMFs8 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLLIDOCAINE BASE CRYSTALLIZED & LIDOCAINE HcL

DMF 41391981

W R GRACE AND CO -CONNLIDOCAINE HCL, USP, BP & PH EUR

DMF 43231981

DELTA SYNTHETIC CO LTDLIDOCAINE

DMF 113391995

W R GRACE AND CO -CONNLIDOCAINE USP

DMF 115641995

MOEHS IBERICA SLLIDOCAINE

DMF 132351998

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLLIDOCAINE BASE

DMF 183182005

CAMBREX KARLSKOGA ABLIDOCAINE

DMF 195322006

MAHENDRA CHEMICALSLIDOCAINE USP

DMF 240502010

SWATI SPENTOSE PRIVATE LTDLIDOCAINE USP

DMF 258302012

HARMAN FINOCHEM LTDLIDOCAINE USP

DMF 271802013

HARMAN FINOCHEM LTDLIDOCAINE HCL USP

DMF 287842014

APEX HEALTHCARE LTDLIDOCAINE USP

DMF 341092019

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDLIDOCAINE

DMF 408002024

THE MOLECULEZLIDOCAINE IP/BP/EP/USP

DMF 433162025

SANOFI PHARMACEUTICALS INCInactiveLIDOCAINE HCL

DMF 28011976

WARD BLENKINSOP AND CO LTDInactiveLIDOCAINE (LIGNOCAINE)

DMF 31371978

PROFARMACO SRLInactiveLIDOCAINE HCL & BASE---2-(diethylamino)-2-6 acetoxylidide hcl

DMF 41401981

NAPP CHEMICALS INCInactiveLIDOCAINE HCL

DMF 41821981

ORGAMOL SAInactiveLIDOCAINE BASE / LIDOCAINE HCL

DMF 43301981

MEDICHEM SAInactiveLIDOCAINE BASE & LIDOCAINE HYDROCHLORIDE

DMF 56641985

SYN-TECH CHEM AND PHARM CO LTDInactiveLIDOCAINE USP

DMF 180052005

GUFIC BIOSCIENCES LTDInactiveLIDOCAINE USP

DMF 207892007

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2018	SUPPL -14	View Letter (PDF)
Jan 8, 2015	SUPPL -12	View Letter (PDF)
Apr 19, 2010	SUPPL -11	View Letter (PDF)
May 1, 2006	SUPPL -8	View Letter (PDF)
May 17, 2005	SUPPL -7	View Letter (PDF)
Mar 19, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

RLDAB

0 patents0 exclusivities▴

PATCH;TOPICAL | Approved: Mar 19, 1999

No patent or exclusivity listings for this strength.