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, Mylan Labs Ltd, Pharmaton, Meridian Medcl Techn, Astrazeneca, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Cosette, 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, 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 suppliers are listed for this compound.

Summary for lidocaine hydrochloride

International Patents:	19
US Patents:	4
Tradenames:	35
Applicants:	55
NDAs:	113
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	1,788
Patent Applications:	5
Formulation / Manufacturing:	see details
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
Arkansas Children's Hospital Research Institute	Phase 4
Indonesia Endowment Fund for Education	Phase 4
Universitas Sebelas Maret	Phase 4

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
Hospira	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	040302-002	Sep 28, 1998	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intl Medication	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083173-002	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Carlisle	ALPHACAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	084721-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Mid Atlantic	LIDOCAINE HYDROCHLORIDE VISCOUS	lidocaine hydrochloride	SOLUTION;ORAL	086578-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	088586-002	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	XYLOCAINE	lidocaine hydrochloride	INJECTABLE;INJECTION	006488-008	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
United Kingdom	0708758		⤷ Sign Up
European Patent Office	3110404	DISPOSITIF DE DISTRIBUTION DE PARTICULES (DEVICE FOR DELIVERING PARTICLES)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008014036		⤷ Sign Up
Singapore	11201606034W	DEVICE FOR DELIVERING PARTICLES	⤷ Sign Up
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
Argentina	066425	CASETE PARA PARTICULAS Y PROCESOS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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