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 three NDAs. There are two patents protecting this drug. Additional details are available on the TRIFERIC profile page.
The generic ingredient in TRIFERIC 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 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 206317
| Tradename: | TRIFERIC |
| Applicant: | Rockwell Medical Inc |
| Ingredient: | ferric pyrophosphate citrate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206317
Generic Entry Date for 206317*:
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 | 27.2MG IRON/5ML (5.44MG IRON/ML) | ||||
| Approval Date: | Jan 23, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 17, 2029 | Product Flag? | Y | Substance 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: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 272MG IRON/50ML (5.44MG IRON/ML) | ||||
| Approval Date: | Sep 4, 2015 | TE: | 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 Trial | ⤷ Try a Trial |
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-001 | Jan 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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