Ferric pyrophosphate citrate - Generic Drug Details
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What are the generic drug sources for ferric pyrophosphate citrate and what is the scope of patent protection?
Ferric pyrophosphate citrate
is the generic ingredient in two branded drugs marketed by Rockwell Medical Inc and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ferric pyrophosphate citrate has thirteen patent family members in eleven countries.
Summary for ferric pyrophosphate citrate
| International Patents: | 13 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 11 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ferric pyrophosphate citrate? | ferric pyrophosphate citrate excipients list |
| DailyMed Link: | ferric pyrophosphate citrate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ferric pyrophosphate citrate
Generic Entry Dates for ferric pyrophosphate citrate*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SOLUTION;INTRAVENOUS |
Generic Entry Dates for ferric pyrophosphate citrate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
Generic Entry Dates for ferric pyrophosphate citrate*:
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.
Recent Clinical Trials for ferric pyrophosphate citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rockwell Medical Technologies, Inc. | Phase 3 |
| Rockwell Medical Technologies, Inc. | Phase 2 |
| Rockwell Medical Technologies, Inc. | Phase 1/Phase 2 |
US Patents and Regulatory Information for ferric pyrophosphate citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rockwell Medical Inc | TRIFERIC AVNU | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 212860-001 | Mar 27, 2020 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | POWDER;INTRAVENOUS | 208551-001 | Apr 25, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-001 | Jan 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ferric pyrophosphate citrate
| 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 |
International Patents for ferric pyrophosphate citrate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 5489196 | ⤷ Try a Trial | |
| Denmark | 2016940 | ⤷ Try a Trial | |
| Poland | 2016940 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
