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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Queensland Health
Medtronic
Cipla
QuintilesIMS
Express Scripts
Cerilliant
Argus Health
Federal Trade Commission

Generated: December 12, 2017

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EPIPEN Drug Profile

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When do Epipen patents expire, 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. Eighteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality LpEPIPENepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPEN JR.epinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPENepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPEN JR.epinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPENepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPENepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPEN E Z PENepinephrineINJECTABLE;INTRAMUSCULAR019430-003Aug 3, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Speciality LpEPIPENepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPEN JR.epinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpEPIPEN JR.epinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-002Dec 22, 1987BXRXYesYes► Subscribe► 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
Canada2576776► Subscribe
Spain2481366► Subscribe
Japan4806712► Subscribe
TaiwanI407981► Subscribe
Israel181118► Subscribe
Cyprus1115201► Subscribe
HungaryE028698► Subscribe
Australia2010201665► Subscribe
Japan2009090140► Subscribe
Taiwan200613027► 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:

Cerilliant
Chinese Patent Office
Medtronic
Citi
Cipla
Express Scripts
Queensland Health
McKinsey
Johnson and Johnson
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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