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 was eligible for patent challenges on July 27, 2022.
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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Summary for OMEGAVEN
| International Patents: | 5 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 52 |
| Drug Prices: | Drug price information for OMEGAVEN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OMEGAVEN |
| What excipients (inactive ingredients) are in OMEGAVEN? | OMEGAVEN excipients list |
| DailyMed Link: | OMEGAVEN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OMEGAVEN
*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
| Sponsor | Phase |
|---|---|
| Boston Children’s Hospital | Phase 2 |
| Boston Children's Hospital | Phase 2 |
| University of South Florida | Phase 3 |
US Patents and Regulatory Information for OMEGAVEN
OMEGAVEN is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OMEGAVEN is ⤷ Sign Up.
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
Patent Expiration: ⤷ Sign Up
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
Patent Expiration: ⤷ Sign Up
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
Patent Expiration: ⤷ Sign Up
Patented Use: USE FOR PATIENTS WITH PARENTERAL NUTRITION ASSOCIATED CHOLESTASIS OR PARENTERAL NUTRITION ASSOCIATED LIVER DISEASE
FDA Regulatory Exclusivity protecting OMEGAVEN
INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC)
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-002 | Jul 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-001 | Jul 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-002 | Jul 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-001 | Jul 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OMEGAVEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-001 | Jul 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-002 | Jul 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OMEGAVEN
See the table below for patents covering OMEGAVEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2004289353 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2005046669 | ⤷ Sign Up | |
| Australia | 2011201893 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) | ⤷ Sign Up |
| Canada | 2545752 | TRAITEMENT ET PREVENTION D'UNE MALADIE DU FOIE LIEE A LA NUTRITION PARENTERALE (PN) (TREATMENT AND PREVENTION OF LIVER DISEASE ASSOCIATED WITH PARENTERAL NUTRITION (PN)) | ⤷ Sign Up |
| European Patent Office | 1684739 | TRAITEMENT ET PREVENTION D'UNE MALADIE DU FOIE LIEE A LA NUTRITION PARENTERALE (PN) (TREATMENT AND PREVENTION OF LIVER DISEASE ASSOCIATED WITH PARENTERAL NUTRITION (PN)) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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