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Last Updated: April 19, 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
Watson Labs	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083627-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	XYLOCAINE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	016801-005	Jan 19, 1988		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cosette	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211019-001	Dec 12, 2018	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	018461-003	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	091564-001	Aug 14, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	091058-001	Sep 30, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Wockhardt Bio Ag	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	SOLUTION;ORAL	087872-001	Nov 18, 1982	AT	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
Japan	5856153		⤷ Try a Trial
Brazil	122021017591	Uso de lidocaína para a preparação de um curativo adesivo não-aquoso para o tratamento de dor	⤷ Try a Trial
Portugal	2823815		⤷ Try a Trial
Canada	2835595	TIMBRE NON AQUEUX (NON-AQUEOUS PATCH)	⤷ Try a Trial
Poland	2823815		⤷ Try a Trial
Serbia	57451	NE-VODENA OBLOGA (NON-AQUEOUS PATCH)	⤷ Try a Trial
Mexico	368747	PARCHE NO ACUOSO DE LIDOCAÍNA Y UN AGENTE DE DISOLUCIÓN QUE COMPRENDE UN ÁCIDO ORGÁNICO Y UN POLIALCOHOL QUE ESTÁN CONTENIDOS EN UN EMPLASTE PARA USARSE EN EL TRATAMIENTO DE DOLOR MUSCULAR A TRAVÉS DE LA PIEL. (NON-AQUEOUS PATCH.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.