ZTLIDO Drug Patent Profile

When do Ztlido patents expire, and when can generic versions of Ztlido launch?

Ztlido is a drug marketed by Scilex Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in eighteen countries.

The generic ingredient in ZTLIDO is lidocaine. There are twenty-nine drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the lidocaine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ztlido

A generic version of ZTLIDO was approved as lidocaine by ACTAVIS LABS UT INC on August 23^rd, 2012.

Summary for ZTLIDO

International Patents:	37
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	8
Patent Applications:	5,829
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZTLIDO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZTLIDO
What excipients (inactive ingredients) are in ZTLIDO?	ZTLIDO excipients list
DailyMed Link:	ZTLIDO at DailyMed

See drug prices for ZTLIDO

Recent Clinical Trials for ZTLIDO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Scilex Pharmaceuticals, Inc.	Phase 1

See all ZTLIDO clinical trials

Pharmacology for ZTLIDO

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for ZTLIDO

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for ZTLIDO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZTLIDO	Topical Patch	lidocaine	1.80%	207962	1	2022-03-17

US Patents and Regulatory Information for ZTLIDO

ZTLIDO is protected by six US patents.

Patents protecting ZTLIDO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018		RX	Yes	Yes			Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018		RX	Yes	Yes			Y
Scilex Pharms	ZTLIDO	lidocaine	PATCH;TOPICAL	207962-001	Feb 28, 2018		RX	Yes	Yes			Y

International Patents for ZTLIDO

See the table below for patents covering ZTLIDO around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	122021017591	Uso de lidocaína para a preparação de um curativo adesivo não-aquoso para o tratamento de dor
Mexico	349572	PARCHE NO ACUOSO. (NON-AQUEOUS PATCH.)
Spain	2683006