Details for New Drug Application (NDA): 202799

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NDA 202799 describes OMONTYS PRESERVATIVE FREE, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are six patents protecting this drug. Additional details are available on the OMONTYS PRESERVATIVE FREE profile page.

The generic ingredient in OMONTYS PRESERVATIVE FREE is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

Summary for 202799

Tradename:	OMONTYS PRESERVATIVE FREE
Applicant:	Takeda Pharms Usa
Ingredient:	peginesatide acetate
Patents:	6

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS, SUBCUTANEOUS			Strength	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
Approval Date:	Mar 27, 2012	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	May 12, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:	⤷ Sign Up	Patent Expiration:	May 12, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:	⤷ Sign Up	Patent Expiration:	May 12, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 202799

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-001	Mar 27, 2012	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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