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Last Updated: January 28, 2022

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OMEGAVEN Drug Patent Profile


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Which patents cover Omegaven, and when can generic versions of Omegaven launch?

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.

DrugPatentWatch® Generic Entry Outlook for Omegaven

Omegaven will be eligible for patent challenges on July 27, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 27, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for OMEGAVEN
Drug Prices for OMEGAVEN

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DrugPatentWatch® Estimated 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
Boston Children's HospitalPhase 2
Boston Children’s HospitalPhase 2
University of South FloridaPhase 3

See all OMEGAVEN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OMEGAVEN

US Patents and Regulatory Information for OMEGAVEN

OMEGAVEN is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OMEGAVEN is ⤷  Sign up for a Free Trial.

This potential generic entry date is based on INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC).

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

Patents protecting OMEGAVEN

Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: TREATMENT OF PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS IN PATIENTS UNDER THE AGE OF 12

Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: TREATMENT OF LIVER DISEASE THROUGH NUTRITION FOR PATIENTS UNDER THE AGE OF 12

Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: USE FOR PATIENTS WITH PARENTERAL NUTRITION ASSOCIATED CHOLESTASIS OR PARENTERAL NUTRITION ASSOCIATED LIVER DISEASE

FDA Regulatory Exclusivity protecting OMEGAVEN

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign up for a Free Trial

INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC)
Exclusivity Expiration: ⤷  Sign up for a Free 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 OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-002 Jul 27, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-002 Jul 27, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-001 Jul 27, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Fresenius Kabi Usa OMEGAVEN fish oil triglycerides EMULSION;INTRAVENOUS 210589-002 Jul 27, 2018 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free 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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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Johnson and Johnson
Colorcon
Mallinckrodt
AstraZeneca

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.