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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
Baxter
Argus Health
Queensland Health
McKinsey
Merck
Fuji
Mallinckrodt
Citi

Generated: October 17, 2017

DrugPatentWatch Database Preview

EPIPEN Drug Profile

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What is the patent landscape for Epipen, and when can generic versions of Epipen launch?

Epipen is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has forty-one patent family members in seventeen countries.

The generic ingredient in EPIPEN is epinephrine. There are nineteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

Summary for Tradename: EPIPEN

US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Bulk Api Vendors: see list54
Clinical Trials: see list5
Patent Applications: see list8,324
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EPIPEN at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN JR.
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN JR.
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN E Z PEN
epinephrine
INJECTABLE;INTRAMUSCULAR019430-003Aug 3, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN JR.
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EPIPEN JR.
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for EPIPEN

Drugname Dosage Strength RLD Submissiondate
epinephrineInjection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mLEpipen11/21/2008
epinephrineInjection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mLEpipen Jr.11/21/2008

International Patent Family for Tradename: EPIPEN

Country Document Number Estimated Expiration
Denmark2179759► Subscribe
Australia2010201665► Subscribe
Taiwan200613027► Subscribe
SloveniaEP2179759► Subscribe
Slovenia2179759► Subscribe
Spain2559866► Subscribe
Spain2481366► Subscribe
Canada2683253► Subscribe
Spain2564236► Subscribe
Canada2576776► 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 leading biopharmaceutical companies globally:

Cerilliant
Healthtrust
Teva
Queensland Health
Daiichi Sankyo
Cipla
US Department of Justice
Dow
Accenture
Baxter

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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