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Last Updated: March 28, 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202799
Generic Entry Date for 202799*:
Constraining patent/regulatory exclusivity:
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:DISCNDosage:SOLUTION;INTRAVENOUS, SUBCUTANEOUSStrengthEQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
Approval Date:Mar 27, 2012TE:RLD:No
Patent:⤷  Try a TrialPatent Expiration:May 12, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:⤷  Try a TrialPatent Expiration:May 12, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Patent:⤷  Try a TrialPatent Expiration:May 12, 2024Product Flag?YSubstance Flag?YDelist Request?

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