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Last Updated: June 21, 2024

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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUS, SUBCUTANEOUSStrengthEQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
Approval Date:Mar 27, 2012TE:RLD:No
Patent:⤷  Sign UpPatent Expiration:May 12, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:⤷  Sign UpPatent Expiration:May 12, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:⤷  Sign UpPatent Expiration:May 12, 2024Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 202799

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa OMONTYS peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-007 Mar 27, 2012 ⤷  Sign Up ⤷  Sign Up
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 202799-003 Mar 27, 2012 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa OMONTYS PRESERVATIVE FREE peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-004 Mar 27, 2012 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa OMONTYS peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-007 Mar 27, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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