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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, Belcher Pharms Llc, Mylan Speclt, Kaleo Inc, Forest Labs, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, 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. Fourteen 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 list14
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
Fresenius Kabi Usa
XYLOCAINE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION006488-019Nov 13, 1986RXYes<disabled><disabled>
Dell Labs
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION083390-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-002Aug 10, 2012RXYes7,731,686<disabled>Y <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
8,105,281Devices, systems and methods for medicament delivery<disabled in preview>
7,648,483Devices, systems and methods for medicament delivery<disabled in preview>
8,187,224Methods performed by medicine injection apparatuses<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: epinephrine

Country Document Number Estimated Expiration
European Patent Office2285360<disabled in preview>
World Intellectual Property Organization (WIPO)2006063015<disabled in preview>
European Patent Office2179759<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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