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Epinephrine; lidocaine hydrochloride - Generic Drug Details

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Epinephrine; lidocaine hydrochloride is the generic ingredient in nine branded drugs marketed by Intl Medication, Graham Chem, Vyteris, Eurohlth Intl Sarl, Astrazeneca, Carlisle, Bel Mar, Pharmaton, Iomed, Hospira, Septodont, Abbott, Eastman Kodak, Watson Labs, Dentsply Pharm, Empi, Fresenius Kabi Usa, and Dell Labs, 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.

This ingredient has eight patent family members in seven countries.

There are seventeen drug master file entries for epinephrine; lidocaine hydrochloride. Twelve suppliers are listed for this compound.

Summary for Generic Name: epinephrine; lidocaine hydrochloride

Tradenames:9
Patents:2
Applicants:18
NDAs:31
Drug Master File Entries: see list17
Suppliers / Packaging: see list12
Formulation / Manufacturing:see details

Pharmacology for Ingredient: epinephrine; lidocaine hydrochloride

Clinical Trials for: epinephrine; lidocaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Carlisle
ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION084720-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Watson Labs
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION085463-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Hospira
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION089646-001Jun 21, 1988RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: epinephrine; lidocaine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vyteris
LIDOSITE TOPICAL SYSTEM KIT
epinephrine; lidocaine hydrochloride
PATCH;IONTOPHORESIS, TOPICAL021504-001May 6, 20046,862,473<disabled>
Vyteris
LIDOSITE TOPICAL SYSTEM KIT
epinephrine; lidocaine hydrochloride
PATCH;IONTOPHORESIS, TOPICAL021504-001May 6, 20045,246,418<disabled>
Vyteris
LIDOSITE TOPICAL SYSTEM KIT
epinephrine; lidocaine hydrochloride
PATCH;IONTOPHORESIS, TOPICAL021504-001May 6, 20046,377,847<disabled>
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International Patent Family for Ingredient: epinephrine; lidocaine hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0202182<disabled in preview>
Germany60129965<disabled in preview>
Australia7310401<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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