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Last Updated: October 14, 2019

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OMEGAVEN Drug Profile

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When do Omegaven patents expire, and what generic alternatives are available?

Omegaven is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are three patents protecting this drug.

This drug has five patent family members in four countries.

The generic ingredient in OMEGAVEN is fish oil triglycerides. 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 triglycerides profile page.

Summary for OMEGAVEN
Drug patent expirations by year for OMEGAVEN
Drug Prices for OMEGAVEN

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Generic Entry Opportunity Date for OMEGAVEN
Generic Entry Date for OMEGAVEN*:
Constraining patent/regulatory exclusivity:
INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC)
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 OMEGAVEN

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

SponsorPhase
University of South FloridaPhase 3
Boston Children’s HospitalPhase 2
Alexandra N. CareyPhase 1

See all OMEGAVEN clinical trials

US Patents and Regulatory Information for OMEGAVEN

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 OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes   See Pricing   See Pricing   See Pricing
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-002 Jul 27, 2018 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes   See Pricing   See Pricing   See Pricing
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-002 Jul 27, 2018 RX Yes Yes   See Pricing   See Pricing   See Pricing
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>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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