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Serving 500+ biopharmaceutical companies globally:

Express Scripts
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US Army
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Covington
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Generated: July 23, 2017

DrugPatentWatch Database Preview

Epinephrine - Generic Drug Details

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

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

Epinephrine has one hundred and seventy-two patent family members in twenty-six countries.

There are nineteen drug master file entries for epinephrine. Fifteen suppliers are listed for this compound.

Summary for Generic Name: epinephrine

Tradenames:32
Patents:35
Applicants:31
NDAs:52
Drug Master File Entries: see list19
Suppliers / Packagers: see list15
Bulk Api Vendors: see list54
Clinical Trials: see list367
Patent Applications: see list7,862
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:epinephrine at DailyMed

Pharmacology for Ingredient: epinephrine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dell Labs
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION083389-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-002Aug 10, 2012BXRXYesYes9,278,182► SubscribeY ► Subscribe
Fresenius Kabi Usa
XYLOCAINE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION006488-004Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe
Astrazeneca
XYLOCAINE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION010418-006Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Astrazeneca
DURANEST
epinephrine; etidocaine hydrochloride
INJECTABLE;INJECTION017751-004Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: epinephrine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax Labs Inc
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-003Nov 25, 20095,665,071► Subscribe
Impax Labs Inc
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
9,555,191Apparatus and methods for self-administration of vaccines and other medicaments► Subscribe
7,648,482Devices, systems, and methods for medicament delivery► Subscribe
8,920,367Devices, systems and methods for medicament delivery► Subscribe
8,123,719Devices, systems and methods for medicament delivery► Subscribe
9,352,091Devices, systems and methods for medicament delivery► 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
United Kingdom2449027► Subscribe
United Kingdom201105021► Subscribe
United Kingdom0818178► Subscribe
United Kingdom0910105► Subscribe
Mexico2007005946► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Army
Fish and Richardson
Teva
Baxter
Dow
Daiichi Sankyo
Moodys
Merck
Covington
Farmers Insurance

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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