Viewing data from:

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

500 trials from ClinicalTrials.gov — 5 recruiting, 2 active, 472 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Perioperative Lidocaine and Ketamine in Abdominal Surgery NCT04084548	Phase 3	Active	The Cleveland Clinic	420	2019-10-15 → 2025-12
Intralipid® 20% for Reversal of Local Anesthetics NCT03968822	Phase 4	Active	Hospital for Special Surgery, New York	18	2019-07-26 → 2026-10
Exparel Injection Effect on Postoperative Opioid Usage NCT04085913	Early Phase 1	By Invitation	University of Missouri-Columbia	100	2019-09-30 → 2025-07
Transforaminal Epidural Injection in Acute Sciatica NCT03924791	N/A	Recruiting	C.L.A.Vleggeert-Lankamp	142	2019-06-01 → 2026-07
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery NCT03756961	N/A	Recruiting	Göteborg University	220	2019-05-01 → 2029-12-31
Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.NCT03984656	Phase 3	Recruiting	Centre Hospitalier Universitaire, Amiens	70	2019-06-04 → 2026-09-06
Lidocaine Infusion in Pancreatic Cancer NCT04048278	Early Phase 1	Recruiting	University of Illinois at Chicago	46	2018-11-08 → 2028-01-01
SPI-directed Analgesia for Vitreoretinal Surgeries NCT02973581	N/A	Completed	Medical University of Silesia	176	2016-02 → 2017-05
Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA NCT02920905	Phase 3	Completed	Assiut University	75	2015-11 → 2017-04
Intravenous Lidocaine and Ketorolac for Pain Management NCT02902770	Phase 4	Completed	Antonios Likourezos	150	2016-10 → 2019-09-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$12.31

per ea

Lowest NADAC/Unit

$12.31

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69557011130ZTLIDO 1.8% TOPICAL SYSTEM	$12.31	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$241.95

Highest Price

$241.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69557-0111-30ZTLIDO 1.8% PATCH	$241.95	FSS	Scilex Pharmaceuticals, Inc.	08/01/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Ztlido (2024)

Total Spending

$50.5M

Total Claims

81,208

Beneficiaries

21,360

Avg Cost/Unit

$11.64

Spending Trend

$9.3M(2019)→$20.2M(2020)→$25.8M(2021)→$35.6M(2022)→$50.7M(2023)→$50.5M(2024)

YoY Change:-2.8%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs9 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

NAPP CHEMICALS INCInactiveLIDOCAINE, USP

DMF 27081976

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) · 3 use codes

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	—	—	—		—