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Serving 500+ biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Queensland Health
Dow
Medtronic
AstraZeneca
Deloitte
Julphar
Boehringer Ingelheim
Mallinckrodt

Generated: August 23, 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 thirty patent family members in seventeen countries.

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

Summary for Tradename: EPIPEN

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list54
Clinical Trials: see list5
Patent Applications: see list7,980
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
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Paragraph IV activity 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
Portugal2311510► Subscribe
Cyprus1115201► Subscribe
Portugal2179759► Subscribe
HungaryE028698► Subscribe
Mexico2007001298► 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:

McKinsey
Chinese Patent Office
Argus Health
Healthtrust
Cerilliant
Harvard Business School
Dow
Moodys
Farmers Insurance
Express Scripts

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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