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Generated: November 15, 2018

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Details for New Drug Application (NDA): 206317

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NDA 206317 describes TRIFERIC, which is a drug marketed by Rockwell Medical Inc and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the TRIFERIC profile page.

The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are eighteen 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 206317
Tradename:TRIFERIC
Applicant:Rockwell Medical Inc
Ingredient:ferric pyrophosphate citrate
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 206317
Generic Entry Date for 206317*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;IV (INFUSION)

*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: 206317
Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 206317
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIFERIC ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 206317 NDA Rockwell Medical, Inc 57278-314 57278-314-01 8 POUCH in 1 CARTON (57278-314-01) > 5 AMPULE in 1 POUCH > 5 mL in 1 AMPULE
TRIFERIC ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 206317 NDA Rockwell Medical, Inc 57278-316 57278-316-03 6 POUCH in 1 CARTON (57278-316-03) > 4 AMPULE in 1 POUCH (57278-316-02) > 50 mL in 1 AMPULE (57278-316-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength27.2MG IRON/5ML (5.44MG IRON/ML)
Approval Date:Jan 23, 2015TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 17, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength272MG IRON/50ML (5.44MG IRON/ML)
Approval Date:Sep 4, 2015TE:RLD:Yes

Expired US Patents for NDA 206317

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rockwell Medical Inc TRIFERIC ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 206317-001 Jan 23, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Rockwell Medical Inc TRIFERIC ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 206317-001 Jan 23, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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QuintilesIMS
Daiichi Sankyo

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