Details for New Drug Application (NDA): 210589
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NDA 210589 describes OMEGAVEN, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the OMEGAVEN profile page.
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.
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 210589
| Tradename: | OMEGAVEN |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | fish oil triglycerides |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210589
Generic Entry Date for 210589*:
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.
Suppliers and Packaging for NDA: 210589
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589 | NDA | Fresenius Kabi USA, LLC | 63323-205 | 63323-205-00 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31) |
| OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589 | NDA | Fresenius Kabi USA, LLC | 63323-205 | 63323-205-50 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;INTRAVENOUS | Strength | 5GM/50ML (0.1GM/ML) | ||||
| Approval Date: | Jul 27, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 5, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS IN PATIENTS UNDER THE AGE OF 12 | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 11, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF LIVER DISEASE THROUGH NUTRITION FOR PATIENTS UNDER THE AGE OF 12 | ||||||||
Expired US Patents for NDA 210589
| 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 |
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