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TRIFERIC Drug Profile
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When do Triferic patents expire, and what generic alternatives are available?
Triferic is a drug marketed by Rockwell Medical Inc and is included in two NDAs. There are two patents protecting this drug.
This drug has twelve patent family members in ten countries.
The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric pyrophosphate citrate profile page.
US ANDA Litigation and Generic Entry Outlook for Triferic
Triferic was eligible for patent challenges on December 31st, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 8th, 2027. This may change due to patent challenges or generic licensing.
Summary for TRIFERIC
| International Patents: | 12 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 28 |
| Clinical Trials: | 8 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TRIFERIC at DailyMed |
Generic Entry Opportunity Date for TRIFERIC
Generic Entry Dates for TRIFERIC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SOLUTION;INTRAVENOUS |
Generic Entry Dates for TRIFERIC*:
Constraining patent/regulatory exclusivity:
NDA:
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 TRIFERIC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rockwell Medical Technologies, Inc. | Phase 2 |
| Rockwell Medical Technologies, Inc. | Phase 1/Phase 2 |
| Rockwell Medical Technologies, Inc. | Phase 1 |
Pharmacology for TRIFERIC
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
US Patents and Regulatory Information for TRIFERIC
| 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 | ferric pyrophosphate citrate | FOR SOLUTION;INTRAVENOUS | 208551-001 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-002 | Sep 4, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | FOR SOLUTION;INTRAVENOUS | 208551-001 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-001 | Jan 23, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 TRIFERIC
| 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 | Start Trial | Start Trial |
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-001 | Jan 23, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRIFERIC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2009108027 | Start Trial |
| Denmark | 2016940 | Start Trial |
| Canada | 2550493 | Start Trial |
| Croatia | P20120416 | Start Trial |
| Cyprus | 1113903 | Start Trial |
| Austria | 554754 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
