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Last Updated: August 4, 2020

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EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for epinephrine; lidocaine hydrochloride and what is the scope of freedom to operate?

Epinephrine; lidocaine hydrochloride is the generic ingredient in nine branded drugs marketed by Carlisle, Belmora Llc, Eastman Kodak, Hospira, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Dentsply Pharm, Astrazeneca, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in thirty-one NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Epinephrine; lidocaine hydrochloride has eight patent family members in seven countries.

There are twenty-one drug master file entries for epinephrine; lidocaine hydrochloride. Eleven suppliers are listed for this compound.

Summary for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
International Patents:8
US Patents:2
Tradenames:9
Applicants:18
NDAs:31
Drug Master File Entries: 21
Suppliers / Packagers: 11
Clinical Trials: 160
DailyMed Link:EPINEPHRINE; LIDOCAINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St. Joseph's Healthcare HamiltonPhase 2
University of MinnesotaPhase 4
University of PennsylvaniaPhase 4

See all EPINEPHRINE; LIDOCAINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

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 W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 006488-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 080377-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmaton LIDOCATON epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 084728-001 Aug 17, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 078772-002 May 12, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Eastman Kodak LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 040057-001 Feb 26, 1993 DISCN No No   Start Trial   Start Trial   Start 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 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004   Start Trial   Start Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004   Start Trial   Start Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004   Start Trial   Start Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004   Start Trial   Start Trial
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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