Lidocaine hydrochloride - Generic Drug Details

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What are the generic drug sources for lidocaine hydrochloride and what is the scope of patent protection?

Lidocaine hydrochloride is the generic ingredient in thirty-five branded drugs marketed by Thea Pharma, Carlisle, Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical Inc, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Rising, Sintetica Us, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Hikma, Pharmaton, Meridian Medcl Techn, Astrazeneca, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Cosette, Sentiss, Watson Labs Inc, Rubicon, Wockhardt Bio Ag, Actavis Mid Atlantic, Chartwell Molecular, Pai Holdings Pharm, Kendall Il, Lannett Co Inc, Novitium Pharma, Paco, Taro, The J Molner, Powder Pharms, and Pfizer, and is included in one hundred and thirteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lidocaine hydrochloride has nineteen patent family members in ten countries.

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

Summary for lidocaine hydrochloride

International Patents:	19
US Patents:	4
Tradenames:	35
Applicants:	54
NDAs:	113
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	53
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	1,820
Patent Applications:	5
What excipients (inactive ingredients) are in lidocaine hydrochloride?	lidocaine hydrochloride excipients list
DailyMed Link:	lidocaine hydrochloride at DailyMed

Recent Clinical Trials for lidocaine hydrochloride

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 hydrochloride clinical trials

Pharmacology for lidocaine hydrochloride

Drug Class	Amide Local Anesthetic Antiarrhythmic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for lidocaine hydrochloride

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

US Patents and Regulatory Information for lidocaine hydrochloride

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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
Fresenius Kabi Usa	XYLOCAINE	lidocaine hydrochloride	INJECTABLE;INJECTION	006488-010	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LIDOCAINE VISCOUS	lidocaine hydrochloride	SOLUTION;ORAL	088802-001	Apr 26, 1985	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	086761-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	080377-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intl Medication	LIDOCAINE HYDROCHLORIDE VISCOUS	lidocaine hydrochloride	SOLUTION;ORAL	086389-001	Feb 2, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	XYLOCAINE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	016801-005	Jan 19, 1988		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083158-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ 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 hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	⤷ Sign Up	⤷ Sign Up
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	⤷ Sign Up	⤷ Sign Up
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	⤷ Sign Up	⤷ Sign Up
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lidocaine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2043601	FORMULATION DE GEL AQUEUX ET PROCÉDÉ POUR INDUIRE UNE ANESTHÉSIE TOPIQUE (AQUEOUS GEL FORMULATION AND METHOD FOR INDUCING TOPICAL ANESTHESIA)	⤷ Sign Up
United Kingdom	0708758		⤷ Sign Up
South Korea	101845648		⤷ Sign Up
Taiwan	200916139	Particle cassettes and processes therefor	⤷ Sign Up
Taiwan	201540331	Device for delivering particles	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2015130961		⤷ Sign Up
Japan	6369551		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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