Details for New Drug Application (NDA): 212860
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NDA 212860 describes TRIFERIC AVNU, which is a drug marketed by Rockwell Medical Inc and is included in one NDA. There is one patent protecting this drug. Additional details are available on the TRIFERIC AVNU profile page.
The generic ingredient in TRIFERIC AVNU is ferric pyrophosphate citrate. There are twenty drug master file entries for this compound. Additional details are available on the ferric pyrophosphate citrate profile page.
The generic ingredient in TRIFERIC AVNU is ferric pyrophosphate citrate. There are twenty drug master file entries for this compound. Additional details are available on the ferric pyrophosphate citrate profile page.
Summary for 212860
| Tradename: | TRIFERIC AVNU |
| Applicant: | Rockwell Medical Inc |
| Ingredient: | ferric pyrophosphate citrate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212860
Generic Entry Date for 212860*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*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 | Strength | 6.75MG IRON/4.5ML (1.5MG IRON/ML) | ||||
| Approval Date: | Mar 27, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 17, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT THERAPY | ||||||||
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