Details for New Drug Application (NDA): 205060
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NDA 205060 describes EPANOVA, which is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug. Additional details are available on the EPANOVA profile page.
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.
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.
Summary for 205060
| Tradename: | EPANOVA |
| Applicant: | Astrazeneca |
| Ingredient: | omega-3-carboxylic acids |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205060
Generic Entry Date for 205060*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*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 | |||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Dec 20, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERTRIGLYCERIDEMIA | ||||||||
Expired US Patents for NDA 205060
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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