Last Updated: June 17, 2026

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 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

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:⤷  Start TrialPatent Expiration:Jun 2, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:⤷  Start TrialPatent Expiration:Jun 2, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUS, SUBCUTANEOUSStrengthEQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)
Approval Date:Mar 27, 2012TE:RLD:No
Patent:⤷  Start TrialPatent Expiration:Jun 2, 2026Product 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 peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-007 Mar 27, 2012 ⤷  Start Trial ⤷  Start Trial
Takeda Pharms Usa OMONTYS PRESERVATIVE FREE peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-004 Mar 27, 2012 ⤷  Start Trial ⤷  Start Trial
Takeda Pharms Usa OMONTYS peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-008 Mar 27, 2012 ⤷  Start Trial ⤷  Start Trial
Takeda Pharms Usa OMONTYS PRESERVATIVE FREE peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-002 Mar 27, 2012 ⤷  Start Trial ⤷  Start Trial
Takeda Pharms Usa OMONTYS PRESERVATIVE FREE peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-004 Mar 27, 2012 ⤷  Start Trial ⤷  Start Trial
Takeda Pharms Usa OMONTYS peginesatide acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799-007 Mar 27, 2012 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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