FISH OIL TRIGLYCERIDES - Generic Drug Details
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What are the generic drug sources for fish oil triglycerides and what is the scope of freedom to operate?
Fish oil triglycerides
is the generic ingredient in one branded drug marketed by Fresenius Kabi Usa and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fish oil triglycerides has five patent family members in four countries.
One supplier is listed for this compound.
Summary for FISH OIL TRIGLYCERIDES
| International Patents: | 5 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 676 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FISH OIL TRIGLYCERIDES |
| DailyMed Link: | FISH OIL TRIGLYCERIDES at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FISH OIL TRIGLYCERIDES
Generic Entry Date for FISH OIL TRIGLYCERIDES*:
Constraining patent/regulatory exclusivity:
INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC) 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 FISH OIL TRIGLYCERIDES
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Response Pharmaceuticals | Phase 1 |
| Collegium Medicum w Bydgoszczy | Phase 3 |
| Odense University Hospital, Department of Nephrology | Phase 4 |
US Patents and Regulatory Information for FISH OIL TRIGLYCERIDES
| 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 | 210589-002 | Jul 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-001 | Jul 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-002 | Jul 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-002 | Jul 27, 2018 | 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 |
International Patents for FISH OIL TRIGLYCERIDES
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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)) | ⤷ Try a Trial |
| 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)) | ⤷ Try a Trial |
| Australia | 2011201893 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2005046669 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
