FDA Orange Book · active-ingredient family
Omega-3-carboxylic acids
Omega-3-carboxylic acids is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:EPANOVA · NDA 205060
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPANOVARLD | ASTRAZENECA | NDA 205060 | — | May 05, 2014 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7960370 | Dec 20, 2026 | in 6 mo | Product |
| 10117844 | Jan 04, 2033 | in 6 yr 8 mo | U-2447 |
| 9050308 | Jan 04, 2033 | in 6 yr 8 mo | U-1511 |
| 9050309 | Jan 04, 2033 | in 6 yr 8 mo | Substance |
Omega-3-carboxylic acids — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
