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AstraZeneca
Chinese Patent Office
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US Department of Justice
Accenture
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Generated: July 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207648

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NDA 207648 describes SMOFLIPID 20%, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the SMOFLIPID 20% profile page.

The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.
Summary for 207648
Tradename:SMOFLIPID 20%
Applicant:Fresenius Kabi Usa
Ingredient:fish oil; medium chain triglycerides; olive oil; soybean oil
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 207648
Generic Entry Date for 207648*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage::
EMULSION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 207648
Ingredient-typeLipids
Suppliers and Packaging for NDA: 207648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820 N 63323-820-00
SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820 N 63323-820-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)
Approval Date:Jul 13, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)
Approval Date:Jul 13, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)
Approval Date:Jul 13, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
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Boehringer Ingelheim
McKinsey
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Julphar
Harvard Business School
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Queensland Health

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