At this time, Lovaza (omega-3-acid ethyl esters) is available as a brand-name drug only, despite the fact that its first patent has expired. It's possible that a generic version could be introduced as soon as April 2017 (when the next patent is set to expire), barring any lawsuits or other patents for specific uses of the drug.
Lovaza® (omega-3-acid ethyl esters) is a prescription omega-3 fish oil medication. It is approved for the treatment of very high triglycerides (defined as 500 mg/dL or higher).
Lovaza is manufactured by GlaxoSmithKline. Currently, no generic versions are available in the United States.
Although the first patent for Lovaza expired in March 2013, no generic versions are available. This suggests that another, later-expiring patent may still be providing protection for the drug. The next patent is set to expire in April 2017. This is the earliest predictable date that a generic version could become available.
However, there are other circumstances that could come up to extend or shorten the exclusivity period of Lovaza. This could include such things as lawsuits or other patents for specific Lovaza uses.
It is important to point out that non-prescription fish oil supplements are not equivalent to Lovaza. Lovaza is an FDA-approved prescription fish oil medication.
Some people wonder why they should take Lovaza, when there are inexpensive non-prescription fish oil dietary supplements that seem to be just as good. There are several advantages of Lovaza over such supplements.
For example, it's important to note that the cheaper supplements almost always have a low concentration of EPA and DHA, regardless of the strength on the label. This can be misleading; it may take numerous 1000 mg supplement capsules to have the same amount of EPA and DHA as a single Lovaza 1000 mg capsule.
When this is taken into consideration, much of the cost advantage of the inexpensive supplements is lost.
Perhaps more importantly, dietary supplements are not regulated as strictly as prescription drugs (like Lovaza). In fact, they are regulated as foods. This means that some supplements could potentially be contaminated or could have less (or more) of the active ingredients than stated on the label.
Lovaza is made using a 5-step refinement process that removes impurities, ensuring a safe and pure product. Also, this refinement process removes some of the fish oil components that cause the "fish burp," and it is thought that Lovaza is probably less likely to cause the fish burp, compared to the supplements.
Additionally, many prescription insurance plans cover Lovaza; virtually none cover non-prescription dietary supplements.