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.

Summary for 205060

Tradename:	EPANOVA
Applicant:	Astrazeneca
Ingredient:	omega-3-carboxylic acids
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205060

Generic Entry Date for 205060^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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:	⤷ 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:	Dec 20, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Feb 7, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HYPERTRIGLYCERIDEMIA

Expired US Patents for NDA 205060

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

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Summary for 205060

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205060

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205060