Omegaven is a drug owned by Fresenius Kabi Usa Llc. It is protected by 3 US drug patents filed from 2018 to 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 27, 2025. Details of Omegaven's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10350186 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) |
Nov, 2024
(3 months from now) | Active |
| US9566260 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) |
Jul, 2025
(11 months from now) | Active |
| US9629821 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) |
Jul, 2025
(11 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Omegaven's patents.
Latest Legal Activities on Omegaven's Patents
Given below is the list of recent legal activities going on the following patents of Omegaven.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 01 Nov, 2023 | US9566260 |
| transaction for FDA Determination of Regulatory Review Period | 19 Oct, 2023 | US9566260 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Jan, 2023 | US10350186 |
| Second letter to regulating agency to determine regulatory review period | 11 May, 2021 | US9566260 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Oct, 2020 | US9629821 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Aug, 2020 | US9566260 |
| Letter from FDA or Dept of Agriculture re PTE application | 29 Nov, 2019 | US9566260 |
| Patent Issue Date Used in PTA Calculation | 16 Jul, 2019 | US10350186 |
| Recordation of Patent Grant Mailed | 16 Jul, 2019 | US10350186 |
| Email Notification | 27 Jun, 2019 | US10350186 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Omegaven and ongoing litigations to help you estimate the early arrival of Omegaven generic.
Omegaven's Litigations
Omegaven has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 31, 2014, against patent number US9566260. The petitioner , challenged the validity or infringement of this patent, with Mark Puder et al as the respondent. Click below to track the latest information on how companies are challenging Omegaven's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9566260 | March, 2014 | Decision | Mark Puder et al | |
FDA has granted some exclusivities to Omegaven. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Omegaven, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Omegaven.
Exclusivity Information
Omegaven holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Omegaven's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 27, 2023 |
| Orphan Drug Exclusivity(ODE-202) | Jul 27, 2025 |
US patents provide insights into the exclusivity only within the United States, but Omegaven is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Omegaven's family patents as well as insights into ongoing legal events on those patents.
Omegaven's family patents
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Generic Launch
Generic Release Date:
Omegaven's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 27, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Omegaven Generics:
There are no approved generic versions for Omegaven as of now.
About Omegaven
Omegaven is a drug owned by Fresenius Kabi Usa Llc. It is used for treating liver disease and cholestasis in pediatric patients through nutrition therapy. Omegaven uses Fish Oil Triglycerides as an active ingredient. Omegaven was launched by Fresenius Kabi Usa in 2018.
Market Authorisation Date:
Omegaven was approved by FDA for market use on 27 July, 2018.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Omegaven is 27 July, 2018, its NCE-1 date is estimated to be 27 July, 2022
Active Ingredient:
Omegaven uses Fish Oil Triglycerides as the active ingredient. Check out other Drugs and Companies using Fish Oil Triglycerides ingredient
Treatment:
Omegaven is used for treating liver disease and cholestasis in pediatric patients through nutrition therapy.
Dosage:
Omegaven is available in emulsion form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5GM/50ML (0.1GM/ML) | EMULSION | Prescription | INTRAVENOUS |
| 10GM/100ML (0.1GM/ML) | EMULSION | Prescription | INTRAVENOUS |