Lovaza is a drug owned by Woodward Pharma Services Llc. It is protected by 3 US drug patents filed in 2013. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 30, 2025. Details of Lovaza'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7732488 | Pharmaceutical composition comprising low concentrations of environmental pollutants |
Jan, 2025
(2 months from now) | Active |
| US5656667 | Fatty acid composition |
Apr, 2017
(7 years ago) |
Expired
|
| US5502077 | Fatty acid composition |
Mar, 2013
(11 years ago) |
Expired
|
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 Lovaza's patents.
Latest Legal Activities on Lovaza's Patents
Given below is the list of recent legal activities going on the following patents of Lovaza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Nov, 2021 | US7732488 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Dec, 2017 | US7732488 |
| Recordation of Patent Grant Mailed Critical | 08 Jun, 2010 | US7732488 |
| Patent Issue Date Used in PTA Calculation Critical | 08 Jun, 2010 | US7732488 |
| Issue Notification Mailed Critical | 19 May, 2010 | US7732488 |
| Dispatch to FDC | 27 Apr, 2010 | US7732488 |
| Application Is Considered Ready for Issue Critical | 26 Apr, 2010 | US7732488 |
| Issue Fee Payment Verified Critical | 22 Apr, 2010 | US7732488 |
| Issue Fee Payment Received Critical | 22 Apr, 2010 | US7732488 |
| Printer Rush- No mailing | 13 Apr, 2010 | US7732488 |
FDA has granted several exclusivities to Lovaza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lovaza, 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 Lovaza.
Exclusivity Information
Lovaza holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Lovaza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-87) | Sep 16, 2012 |
US patents provide insights into the exclusivity only within the United States, but Lovaza 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 Lovaza's family patents as well as insights into ongoing legal events on those patents.
Lovaza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lovaza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 30, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lovaza Generic API suppliers:
Omega-3-acid Ethyl Esters is the generic name for the brand Lovaza. 13 different companies have already filed for the generic of Lovaza, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lovaza's generic
How can I launch a generic of Lovaza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lovaza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lovaza's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Lovaza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 g | 10 Nov, 2008 | 3 | 07 Apr, 2014 | 10 Apr, 2017 | Deferred |
About Lovaza
Lovaza is a drug owned by Woodward Pharma Services Llc. It is used for managing lipid levels. Lovaza uses Omega-3-Acid Ethyl Esters as an active ingredient. Lovaza was launched by Woodward in 2004.
Approval Date:
Lovaza was approved by FDA for market use on 10 November, 2004.
Active Ingredient:
Lovaza uses Omega-3-acid Ethyl Esters as the active ingredient. Check out other Drugs and Companies using Omega-3-acid Ethyl Esters ingredient
Treatment:
Lovaza is used for managing lipid levels.
Dosage:
Lovaza is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE | Prescription | ORAL |