Omega-3-carboxylic acids
Omega-3-carboxylic acids: 1 brand, 0 generics; first approved May 05, 2014; on patent until Dec 20, 2026.
Protected until Dec 20, 2026 (earliest listed patent expiry).
Brand (NDA) products
- EPANOVARLDASTRAZENECANDA 2050602014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS CAPSULE ORAL Discontinued -
Patent & exclusivity timeline
Listed patents
| Patent | Expires | In | Type |
|---|---|---|---|
| 7960370 | in 1 mo | Product | |
| 10117844 | in 6 yr 3 mo | U-2447 | |
| 9050308 | in 6 yr 3 mo | U-1511 | |
| 9050309 | in 6 yr 3 mo | Substance |
Approval history
All 1 application were approved in 2014.
Omega-3-carboxylic acids: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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