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TRIFERIC Drug Profile
» See Plans and Pricing
When do Triferic patents expire, and when can generic versions of Triferic launch?
Triferic is a drug marketed by Rockwell Medical Inc and is included in three NDAs. There are two patents protecting this drug.
This drug has thirteen patent family members in eleven countries.
The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are twenty 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.
US ANDA Litigation and Generic Entry Outlook for Triferic
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 8, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TRIFERIC
| International Patents: | 13 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 10 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRIFERIC |
| 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 3 |
| Rockwell Medical Technologies, Inc. | Phase 2 |
| Rockwell Medical Technologies, Inc. | Phase 1/Phase 2 |
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 | ||||
| >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 |
|---|---|---|
| Slovenia | 2016940 | Start Trial |
| Eurasian Patent Organization | 002479 | Start Trial |
| Austria | 311180 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
