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Serving leading biopharmaceutical companies globally:

McKinsey
Novartis
Argus Health
Fish and Richardson
Covington
McKesson
QuintilesIMS
Mallinckrodt
Julphar
Chinese Patent Office

Generated: December 17, 2017

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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 Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax Labs Inc, Kaleo Inc, Par Sterile Products, Adamis Pharms Corp, Belcher Pharms Llc, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, Belmora Llc, Eastman Kodak, Hospira, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, 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 eighty-seven patent family members in twenty-six countries.

There are nineteen drug master file entries for epinephrine. Eighteen suppliers are listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
AbbottLIDOCAINE HYDROCHLORIDE W/ EPINEPHRINEepinephrine; lidocaine hydrochlorideINJECTABLE;INJECTION083154-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Kaleo IncAUVI-QepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012BXRXYesNo► Subscribe► SubscribeY► Subscribe
Kaleo IncAUVI-QepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012BXRXYesNo► Subscribe► Subscribe► Subscribe
AstrazenecaDURANESTepinephrine; etidocaine hydrochlorideINJECTABLE;INJECTION017751-004Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
HospiraLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEepinephrine; lidocaine hydrochlorideINJECTABLE;INJECTION089650-001Jun 21, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Kaleo IncAUVI-QepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012BXRXYesNo► Subscribe► SubscribeY► Subscribe
CarlisleALPHACAINE HYDROCHLORIDE W/ EPINEPHRINEepinephrine; lidocaine hydrochlorideINJECTABLE;INJECTION084732-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
DeprocoLIGNOSPAN FORTEepinephrine bitartrate; lidocaine hydrochlorideINJECTABLE;INJECTION088389-001Jan 22, 1985RXNoYes► Subscribe► Subscribe► Subscribe
Dentsply PharmCITANEST FORTE DENTALepinephrine bitartrate; prilocaine hydrochlorideINJECTABLE;INJECTION021383-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Kaleo IncAUVI-QepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-001Aug 10, 2012BXRXYesNo► Subscribe► SubscribeY► 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 IncADRENACLICKepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-003Nov 25, 2009► Subscribe► Subscribe
Impax Labs IncADRENACLICKepinephrineINJECTABLE;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
8,932,252Medical injector simulation device► Subscribe
8,899,987Simulated medicament delivery device having an electronic circuit system► Subscribe
7,416,540Devices systems and methods for medicament delivery► Subscribe
9,278,177Medical injector with compliance tracking and monitoring► Subscribe
8,622,973Simulated medicament delivery device configured to produce an audible output► Subscribe
8,172,082Devices, systems and methods for medicament delivery► Subscribe
7,927,303Medicine injection devices and methods► Subscribe
9,352,091Devices, systems and methods for medicament delivery► Subscribe
9,805,620Medical injector simulation device► Subscribe
7,648,482Devices, 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
Australia2016233682► Subscribe
United Kingdom2480407► Subscribe
South Africa200704515► Subscribe
Canada2905774► Subscribe
South Korea20070083539► Subscribe
Portugal2179759► Subscribe
Israel203925► Subscribe
Japan4362143► Subscribe
United Kingdom2458586► Subscribe
Taiwan200724182► 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:

Dow
Argus Health
Covington
Baxter
Merck
Colorcon
Cerilliant
Fish and Richardson
Moodys
Fuji

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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