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Last Updated: February 28, 2024

SMOFLIPID 20% Drug Patent Profile


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Summary for SMOFLIPID 20%
Drug patent expirations by year for SMOFLIPID 20%
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SMOFLIPID 20%
Generic Entry Date for SMOFLIPID 20%*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
NDA:
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.

Recent Clinical Trials for SMOFLIPID 20%

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityN/A
Assiut UniversityPhase 3
Giulia ManziniPhase 3

See all SMOFLIPID 20% clinical trials

Pharmacology for SMOFLIPID 20%
Drug ClassLipid Emulsion
Anatomical Therapeutic Chemical (ATC) Classes for SMOFLIPID 20%

US Patents and Regulatory Information for SMOFLIPID 20%

SMOFLIPID 20% is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SMOFLIPID 20% is ⤷  Try a Trial.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting SMOFLIPID 20%

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648-001 Jul 13, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648-004 Aug 10, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648-002 Jul 13, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648-003 Jul 13, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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 verification 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.