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Serving 500+ biopharmaceutical companies globally:

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Federal Trade Commission
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Generated: September 21, 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 Impax Labs Inc, Par Sterile Products, 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-six 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-seven 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:36
Applicants:31
NDAs:52
Drug Master File Entries: see list19
Suppliers / Packagers: see list15
Bulk Api Vendors: see list54
Clinical Trials: see list378
Patent Applications: see list9,305
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
Carlisle
ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION084720-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012BXRXYesNo► Subscribe► SubscribeY ► Subscribe
Dentsply Pharm
XYLOCAINE DENTAL WITH EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION021381-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Vyteris
LIDOSITE TOPICAL SYSTEM KIT
epinephrine; lidocaine hydrochloride
PATCH;IONTOPHORESIS, TOPICAL021504-001May 6, 2004DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012BXRXYesNo► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN E Z PEN
epinephrine
INJECTABLE;INTRAMUSCULAR019430-003Aug 3, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-002Aug 10, 2012BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012BXRXYesNo► Subscribe► SubscribeY ► Subscribe
Hospira
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION078772-002May 12, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Deproco
LIGNOSPAN FORTE
epinephrine bitartrate; lidocaine hydrochloride
INJECTABLE;INJECTION088389-001Jan 22, 1985RXNoYes► Subscribe► 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, 2009► Subscribe► Subscribe
Impax Labs Inc
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-004Nov 25, 2009► Subscribe► 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
8,920,367Devices, systems and methods for medicament delivery► Subscribe
8,932,252Medical injector simulation device► Subscribe
7,927,303Medicine injection devices and methods► Subscribe
8,123,719Devices, systems and methods for medicament delivery► Subscribe
7,416,540Devices systems and methods for medicament delivery► Subscribe
7,648,483Devices, systems and methods for medicament delivery► Subscribe
9,555,191Apparatus and methods for self-administration of vaccines and other medicaments► Subscribe
8,690,827Devices, systems, and methods for medicament delivery► Subscribe
9,022,980Medical injector simulation device► Subscribe
8,105,281Devices, 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
Japan2011519712► Subscribe
European Patent Office2179759► Subscribe
SloveniaEP1786491► Subscribe
United Kingdom2440039► Subscribe
European Patent Office1848490► Subscribe
Taiwan200724182► Subscribe
Mexico2007005946► Subscribe
Denmark1786491► Subscribe
Japan2009531143► Subscribe
Israel203925► 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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Serving 500+ biopharmaceutical companies globally:

Moodys
Accenture
QuintilesIMS
McKinsey
Dow
Harvard Business School
Mallinckrodt
McKesson
Boehringer Ingelheim
Citi

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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