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Last Updated: December 4, 2021

DrugPatentWatch Database Preview

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. It is available from one supplier. 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. Two suppliers are listed 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 Generic Entry Opportunity 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.

Pharmacology for NDA: 212860
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 212860
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIFERIC AVNU ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 212860 NDA Rockwell Medical Inc. 57278-318 57278-318-02 4 POUCH in 1 CARTON (57278-318-02) > 10 AMPULE in 1 POUCH (57278-318-01) > 4.5 mL in 1 AMPULE
TRIFERIC AVNU ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 212860 NDA Rockwell Medical Inc. 57278-318 57278-318-11 1 AMPULE in 1 POUCH (57278-318-11) > 4.5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength6.75MG IRON/4.5ML (1.5MG IRON/ML)
Approval Date:Mar 27, 2020TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Apr 17, 2029Product Flag?Substance Flag?YDelist Request?
Patented Use:METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT THERAPY

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Serving leading biopharmaceutical companies globally:

Moodys
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Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.