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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. Twenty 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 list20
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: epinephrine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012RXNo7,749,194► subscribeY ► subscribe
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-002Aug 10, 2012RXYes8,608,698► subscribeY ► subscribe
Hospira
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION089646-001Jun 21, 1988RXNo► subscribe► subscribe
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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► subscribe
Amedra Pharms
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-004Nov 25, 20095,665,071► subscribe
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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
8,123,719Devices, systems and methods for medicament delivery► subscribe
8,361,026Apparatus and methods for self-administration of vaccines and other medicaments► subscribe
8,187,224Methods performed by medicine injection apparatuses► subscribe
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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
Australia2013222015► subscribe
San MarinoAP200700024► subscribe
Japan5680852► subscribe
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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