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Generated: November 23, 2017

DrugPatentWatch Database Preview

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 are three patents protecting this drug. Additional details are available on the TRIFERIC profile page.

The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are fourteen 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:
1
Applicant:
1
Ingredient:
1
Patents:3
Formulation / Manufacturing:see details

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;IV (INFUSION) 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;IV (INFUSION) 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength27.2MG IRON/5ML (5.44MG IRON/ML)
Approval Date:Jan 23, 2015TE:RLD:Yes
Patent:► SubscribePatent Expiration:Dec 31, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Patent:► SubscribePatent Expiration:Dec 31, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Patent:► SubscribePatent Expiration:Apr 17, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT

Expired Orange Book Patents for NDA: 206317

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rockwell Medical Inc
TRIFERIC
ferric pyrophosphate citrate
SOLUTION;IV (INFUSION)206317-001Jan 23, 2015► Subscribe► Subscribe
Rockwell Medical Inc
TRIFERIC
ferric pyrophosphate citrate
SOLUTION;IV (INFUSION)206317-001Jan 23, 2015► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Moodys
Citi
Harvard Business School
Baxter
McKinsey
Queensland Health
US Department of Justice
Dow
Farmers Insurance

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 verifification 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.

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