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. There is one drug master file entry for this compound. Additional details are available on the peginesatide acetate profile page.
The generic ingredient in OMONTYS PRESERVATIVE FREE is peginesatide acetate. There is one drug master file entry for this compound. 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: | 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: | ⤷ Start Trial | Patent Expiration: | Jun 2, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE | ||||||||
| Patent: | ⤷ Start Trial | 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: | ⤷ Start Trial | 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 | 202799-003 | Mar 27, 2012 | ⤷ Start Trial | ⤷ Start Trial |
| Takeda Pharms Usa | OMONTYS PRESERVATIVE FREE | peginesatide acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799-006 | 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 | 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 | 202799-005 | Mar 27, 2012 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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