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, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Belmora Llc, Cosette, Dr Reddys, Encube, Fougera Pharms Inc, Geneyork Pharms, 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, Hikma, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Sentiss, Watson Labs Inc, Rubicon, Wockhardt Bio Ag, Actavis Mid Atlantic, Chartwell Molecular, Pai Holdings Pharm, Kendall Il, Lannett Co Inc, Novitium Pharma, Paco, The J Molner, Powder Pharms, Pfizer, Teva Branded Pharm, Fougera Pharms, Padagis Us, Rhodes Pharms, Crescita Therap, and Galen Specialty, and is included in one hundred and sixty 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-four suppliers are listed for this compound.

Summary for LIDOCAINE

International Patents:	37
US Patents:	15
Tradenames:	45
Applicants:	84
NDAs:	160
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	1,820
Patent Applications:	7,044
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
Sichuan Cancer Hospital and Research Institute	N/A
Jessyka Lighthall	Phase 3
Sawanpracharak hospital	N/A

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

Anatomical Therapeutic Chemical (ATC) Classes for LIDOCAINE

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 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
Hospira	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	088330-001	May 17, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	088331-001	May 17, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	088586-003	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	217693-002	Jul 11, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intl Medication	LARYNG-O-JET KIT	lidocaine hydrochloride	SOLUTION;TOPICAL	086364-001	Approved Prior to Jan 1, 1982	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	084625-002	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	⤷ Sign Up	⤷ Sign Up
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	⤷ Sign Up	⤷ Sign Up
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996	⤷ Sign Up	⤷ Sign Up
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	⤷ Sign Up	⤷ Sign Up
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	⤷ Sign Up	⤷ Sign Up
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999	⤷ Sign Up	⤷ Sign Up
>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
World Intellectual Property Organization (WIPO)	2012153396		⤷ Sign Up
Spain	2743524		⤷ Sign Up
Brazil	112013028802	curativo adesivo não aquoso	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013046335		⤷ Sign Up
Taiwan	201318652	Non-aqueous patch	⤷ Sign Up
Japan	WO2013046335	非水性貼付剤	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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