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Last Updated: April 20, 2024

Lidocaine - Generic Drug Details

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What are the generic sources for lidocaine and what is the scope of freedom to operate?

Lidocaine is the generic ingredient in forty-five branded drugs marketed by Astrazeneca, Noven, Carlisle, Ailex Pharms Llc, Alembic, Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Cosette, Dr Reddys, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Macleods Pharms Ltd, Quagen, Rising, Septodont Inc, Strides Pharma, Taro, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Amneal, Ibsa, Mylan Technologies, Nal Pharm, Noven Pharms Inc, Teikoku Pharma Usa, Scilex Pharms, Thea Pharma, Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical Inc, Bel Mar, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Sintetica Us, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Mylan Labs Ltd, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Sentiss, Watson Labs Inc, Hikma, Rubicon, Wockhardt Bio Ag, Actavis Mid Atlantic, Chartwell Molecular, Pai Holdings Pharm, Kendall Il, Lannett Co Inc, Novitium Pharma, Paco, Powder Pharms, Pfizer, Teva Branded Pharm, Fougera Pharms, Padagis Us, Rhodes Pharms, and Galen Specialty, and is included in one hundred and fifty-nine NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lidocaine has thirty-seven patent family members in eighteen countries.

There are twenty-nine drug master file entries for lidocaine. Forty-five suppliers are listed for this compound.

Summary for lidocaine

International Patents:	37
US Patents:	15
Tradenames:	45
Applicants:	82
NDAs:	159
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	1,780
Patent Applications:	5,720
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for lidocaine
Drug Sales Revenues:	Drug sales revenues for lidocaine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lidocaine
What excipients (inactive ingredients) are in lidocaine?	lidocaine excipients list
DailyMed Link:	lidocaine at DailyMed

See drug prices for lidocaine

See drug sales revenues for lidocaine

Recent Clinical Trials for lidocaine

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

Sponsor	Phase
Arkansas Children's Hospital Research Institute	Phase 4
Universitas Sebelas Maret	Phase 4
Indonesia Endowment Fund for Education	Phase 4

See all lidocaine clinical trials

Pharmacology for lidocaine

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for lidocaine

Anesthetics, Local
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Paragraph IV (Patent) Challenges for LIDOCAINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZTLIDO	Topical Patch	lidocaine	1.80%	207962	1	2022-03-17
LIDODERM	Topical Patch	lidocaine	5%	020612	1	2009-11-13

US Patents and Regulatory Information for lidocaine

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Mankind Pharma	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	217692-003	Nov 29, 2023	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gd Searle Llc	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083135-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	080377-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%	lidocaine hydrochloride	INJECTABLE;SPINAL	083914-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Wyeth Ayerst	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083083-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	213923-001	Apr 8, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for lidocaine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996	⤷ Try a Trial	⤷ Try a Trial
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	⤷ Try a Trial	⤷ Try a Trial
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	⤷ Try a Trial	⤷ Try a Trial
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996	⤷ Try a Trial	⤷ Try a Trial
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	⤷ Try a Trial	⤷ Try a Trial
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	⤷ Try a Trial	⤷ Try a Trial
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lidocaine

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2708229	TIMBRE NON AQUEUX (NON-AQUEOUS PATCH)	⤷ Try a Trial
Slovenia	2823815		⤷ Try a Trial
Japan	WO2012153396	非水性貼付剤	⤷ Try a Trial
Hungary	E039266		⤷ Try a Trial
Taiwan	I543761		⤷ Try a Trial
Japan	WO2013046335	非水性貼付剤	⤷ Try a Trial
Mexico	2013013121	PARCHE NO ACUOSO. (NON-AQUEOUS PATCH.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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