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Last Updated: November 25, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205060

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NDA 205060 describes EPANOVA, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are nine 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.
Summary for 205060
Tradename:EPANOVA
Applicant:Astrazeneca Pharms
Ingredient:omega-3-carboxylic acids
Patents:9
Formulation / Manufacturing:see details
Generic Entry Opportunity 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:DISCNDosage:CAPSULE;ORALStrength1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS
Approval Date:May 5, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 4, 2033Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:May 13, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:May 13, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 205060

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014   Start Trial   Start Trial
Astrazeneca Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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