Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Medtronic
Colorcon

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210589

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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.
Summary for 210589
Tradename:OMEGAVEN
Applicant:Fresenius Kabi Usa
Ingredient:fish oil triglycerides
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity 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:RXDosage:EMULSION;INTRAVENOUSStrength5GM/50ML (0.1GM/ML)
Approval Date:Jul 27, 2018TE: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)
Regulatory Exclusivity Expiration:Jul 27, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Nov 5, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS IN PATIENTS UNDER THE AGE OF 12

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Express Scripts
McKesson
McKinsey
Mallinckrodt

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 verifification 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.