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Epinephrine - Generic Drug Details

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Epinephrine is the generic ingredient in thirty-one branded drugs marketed by Par Sterile Products, Amedra Pharms, Sterling, Armstrong Pharms, Wyeth Cons, Mylan Speclt, Kaleo Inc, Forest Labs, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Belcher Pharms Llc, Intl Medication, Graham Chem, Vyteris, Eurohlth Intl Sarl, Carlisle, Bel Mar, Pharmaton, Iomed, Hospira, Septodont, Abbott, Eastman Kodak, Watson Labs, Empi, Fresenius Kabi Usa, and Dell Labs, and is included in fifty-one NDAs. There are thirty-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and sixty-one patent family members in twenty-three countries.

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

Summary for Generic Name: epinephrine

Tradenames:31
Patents:32
Applicants:30
NDAs:51
Drug Master File Entries: see list17
Suppliers / Packaging: see list12
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: epinephrine

Clinical Trials for: epinephrine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Empi
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
epinephrine; lidocaine hydrochloride
SOLUTION;IONTOPHORESIS, TOPICAL021486-001Oct 26, 2004DISCNNo<disabled><disabled>
Intl Medication
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION086402-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Deproco
LIGNOSPAN STANDARD
epinephrine bitartrate; lidocaine hydrochloride
INJECTABLE;INJECTION088390-001Jan 22, 1985RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: epinephrine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amedra Pharms
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-003Nov 25, 20095,665,071<disabled>
Amedra Pharms
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-004Nov 25, 20095,665,071<disabled>
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Non-Orange Book Patents for Generic Ingredient: epinephrine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,544,645Devices, systems and methods for medicament delivery<disabled in preview>
7,927,303Medicine injection devices and methods<disabled in preview>
9,327,077Medical injector with compliance tracking and monitoring<disabled in preview>
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International Patent Family for Ingredient: epinephrine

Country Document Number Estimated Expiration
Japan5599500<disabled in preview>
Canada2743303<disabled in preview>
World Intellectual Property Organization (WIPO)2007126851<disabled in preview>
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