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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, Aleor Dermaceuticals, Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Cosette, Dr Reddys, Fougera Pharms Inc, Geneyork Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Quagen, Rising, Septodont Inc, Strides Pharma, Taro, Teligent, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Amneal, Mylan Technologies, Nal Pharm, Noven Pharms Inc, Rhodes Pharms, Teikoku Pharma Usa, Scilex Pharms Inc, Akorn, Abbott, Abraxis Pharm, Am Regent, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Dell Labs, Elkins Sinn, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma Inc, Sagent Pharms Inc, Watson Labs Inc, Wockhardt Bio Ag, Actavis Mid Atlantic, Lannett Co Inc, Hikma Pharms, Kendall Il, Paco, Powder Pharms, Pfizer, Teva Branded Pharm, Acrux Dds Pty, Fougera Pharms, Tolmar, Taro Pharms, and Galen Specialty, and is included in one hundred and forty-seven NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for lidocaine

International Patents:	36
US Patents:	12
Tradenames:	45
Applicants:	73
NDAs:	147
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	1,486
Patent Applications:	5,965
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for lidocaine
Drug Sales Revenues:	Drug sales revenues 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
VA Office of Research and Development	Phase 3
The Foundation for Barnes-Jewish Hospital	Phase 2
Fondation de l'Avenir	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	NDA	Submissiondate
LIDODERM	PATCH;TOPICAL	lidocaine	020612	2009-11-13

US Patents and Regulatory Information for lidocaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	019830-004	Apr 8, 1992	AP	RX	No	No
Macleods Pharms Ltd	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211697-001	Mar 16, 2020	AT	RX	No	No
West-ward Pharms Int	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	080407-002	Approved Prior to Jan 1, 1982	AP	RX	No	No
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005		RX	Yes	Yes
Teligent	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	SOLUTION;TOPICAL	204494-001	Mar 12, 2014	AT	RX	No	No
Hospira	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	018388-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for lidocaine

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

International Patents for lidocaine

Country	Patent Number	Estimated Expiration
Japan	6021269
Mexico	368747
Spain	2845524
Japan	WO2012153396
Brazil	112014006719
Cyprus	1120754