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EPIPEN Drug Profile

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Epipen is a drug marketed by Mylan Speclt and is included in one NDA. It is available from six suppliers. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-four patent family members in fifteen countries.

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

Summary for Tradename: EPIPEN

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speclt
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987RXYes8,870,827► subscribeY ► subscribe
Mylan Speclt
EPIPEN JR.
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987RXYes8,870,827► subscribeY ► subscribe
Mylan Speclt
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987RXYes8,048,035► 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
European Patent Office2311510► subscribe
Japan4362143► subscribe
South Korea20070083539► 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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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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