Details for New Drug Application (NDA): 202799

NDA 202799 describes OMONTYS PRESERVATIVE FREE, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two 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:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202799

Constraining patent/regulatory exclusivity:

7,550,433

Dosage:

SOLUTION;INTRAVENOUS, SUBCUTANEOUS

^*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:	SOLUTION;INTRAVENOUS, SUBCUTANEOUS			Strength	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
Approval Date:	Mar 27, 2012	TE:		RLD:	No
Patent:	7,550,433	Patent Expiration:	Jun 2, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:	7,919,461	Patent Expiration:	Jun 2, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS, SUBCUTANEOUS			Strength	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)
Approval Date:	Mar 27, 2012	TE:		RLD:	No
Patent:	7,550,433	Patent Expiration:	Jun 2, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

Expired US Patents for NDA 202799

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012	7,919,118
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-005	Mar 27, 2012	7,414,105
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012	7,414,105
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-001	Mar 27, 2012	7,084,245
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-003	Mar 27, 2012	7,084,245
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012	7,528,104

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