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The generic ingredient in EPANOVA is omega-3-carboxylic acids. There is one drug master file entry for this compound. Additional details are available on the omega-3-carboxylic acids profile page.
Generic Entry Opportunity Date for 205060
*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.
Profile for product number 001
|Active Rx/OTC/Discontinued:||DISCN||Dosage:||CAPSULE;ORAL||Strength||1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS|
|Approval Date:||May 5, 2014||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||May 5, 2019|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||➤ Sign Up||Patent Expiration:||Jan 4, 2033||Product Flag?||Substance Flag?||Delist Request?|
|Patented Use:||TREATMENT OF SEVERE HYPERTRIGLYCERIDEMIA (500 MG/DL) IN ADULT PATIENTS AS AN ADJUNCT TO DIET|
|Patent:||➤ Sign Up||Patent Expiration:||May 13, 2019||Product Flag?||Y||Substance Flag?||Delist Request?|
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