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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKinsey
Fuji
Accenture
Moodys
AstraZeneca
Teva
Healthtrust
Dow
Medtronic

Generated: October 20, 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 ninety patent family members in twenty-six countries.

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

Summary for Generic Name: epinephrine

US Patents:36
Tradenames:32
Applicants:31
NDAs:52
Drug Master File Entries: see list19
Suppliers / Packagers: see list17
Bulk Api Vendors: see list54
Clinical Trials: see list379
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
Hospira
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION078772-002May 12, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
EPI E Z PEN JR
epinephrine
INJECTABLE;INTRAMUSCULAR019430-004Aug 3, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION089635-001Jun 21, 1988APRXNoNo► Subscribe► Subscribe► Subscribe
Abbott
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION083154-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Kaleo Inc
AUVI-Q
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-002Aug 10, 2012BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca
XYLOCAINE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION010418-006Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca
XYLOCAINE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION010418-008Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION080377-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION089651-001Jun 21, 1988APRXNoNo► Subscribe► Subscribe► Subscribe
Intl Medication
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION086402-001Approved Prior to Jan 1, 1982DISCNNoNo► 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
8,690,827Devices, systems, and methods for medicament delivery► Subscribe
8,932,252Medical injector simulation device► Subscribe
7,416,540Devices systems and methods for medicament delivery► Subscribe
7,927,303Medicine injection devices and methods► Subscribe
8,123,719Devices, systems and methods for medicament delivery► Subscribe
8,622,973Simulated medicament delivery device configured to produce an audible output► Subscribe
7,648,482Devices, systems, and methods for medicament delivery► Subscribe
9,352,091Devices, systems and methods for medicament delivery► Subscribe
8,544,645Devices, systems and methods for medicament delivery► Subscribe
8,172,082Devices, 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 Kingdom2491283► Subscribe
European Patent Office2285360► Subscribe
Canada2905774► Subscribe
Canada2978464► Subscribe
World Intellectual Property Organization (WIPO)2010056712► Subscribe
United Kingdom201105021► Subscribe
Taiwan200613027► Subscribe
Spain2396745► Subscribe
European Patent Office2058020► Subscribe
World Intellectual Property Organization (WIPO)2006017732► 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 leading biopharmaceutical companies globally:

Harvard Business School
QuintilesIMS
Citi
Dow
Mallinckrodt
Colorcon
Daiichi Sankyo
Farmers Insurance
Fuji
AstraZeneca

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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