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ZTLIDO

NDA

LIDOCAINE | N207962 | SCILEX PHARMACEUTICALS INC

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

2030

2031

Today

May. 10, 2031

May. 10, 2031

May. 10, 2031

May. 10, 2031

May. 10, 2031

May. 10, 2031

May. 10, 2031

May. 10, 2031

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
Scilex Pharmaceuticals, Inc. et al v. Aveva Drug Delivery Systems, Inc., et al 0:2022cv61192 3 patentsANDA 217221lidocaine	S.D. Fla.	2022-06-22	Terminated 2024-08-26	—

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 Ztlido (2023)

Total Spending

$50.7M

Total Claims

78,603

Beneficiaries

22,430

Avg Cost/Unit

$11.98

Spending Trend

$9.3M(2019)→$20.2M(2020)→$25.8M(2021)→$35.6M(2022)→$50.7M(2023)

YoY Change:+10.2%

5yr CAGR:+6.9%

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

3 letters from Drugs@FDA

Date	Submission	Document
Apr 9, 2021	SUPPL -5	View Letter (PDF)
Nov 9, 2018	SUPPL -1	View Letter (PDF)
Mar 15, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.8%

RLDAB

8 patents0 exclusivities▴

PATCH;TOPICAL | Approved: Feb 28, 2018

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9283174	May 10, 2031	—	—	Yes	—	—
9925264	May 10, 2031	—	—	Yes		—
9931403	May 10, 2031	—	—	Yes	—	—
10765640	May 10, 2031	—	—	Yes	—	—
10765749	May 10, 2031	—	—	Yes	—	—
11278623	May 10, 2031	—	—	Yes	—	—
11786455	May 10, 2031	—	—	Yes		—
11793766	May 10, 2031	—	—	—		—