TRIFERIC Drug Patent Profile
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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.
DrugPatentWatch® 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 11 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TRIFERIC |
What excipients (inactive ingredients) are in TRIFERIC? | TRIFERIC excipients list |
DailyMed Link: | TRIFERIC at DailyMed |


DrugPatentWatch® Estimated 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 4 |
Rockwell Medical Technologies, Inc. | Phase 3 |
Rockwell Medical Technologies, Inc. | 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
TRIFERIC is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIFERIC is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TRIFERIC
Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Packaging of ferric pyrophosphate for dialysis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-002 | Sep 4, 2015 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | FOR SOLUTION;INTRAVENOUS | 208551-001 | Apr 25, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-001 | Jan 23, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-001 | Jan 23, 2015 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRIFERIC
When does loss-of-exclusivity occur for TRIFERIC?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Austria
Patent: 4754
Estimated Expiration: See Plans and Pricing
Canada
Patent: 50493
Estimated Expiration: See Plans and Pricing
Patent: 38081
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0120416
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 13903
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 16940
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 16940
Estimated Expiration: See Plans and Pricing
Japan
Patent: 89196
Estimated Expiration: See Plans and Pricing
Patent: 09108027
Estimated Expiration: See Plans and Pricing
Poland
Patent: 16940
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 16940
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 16940
Estimated Expiration: See Plans and Pricing
Spain
Patent: 83713
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TRIFERIC around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 5617298 | See Plans and Pricing | |
Slovenia | 2016940 | See Plans and Pricing | |
Slovenia | 20151 | Metode in farmacevtske zmesi za aplikacijo železa hemodializnim in peritonealno dializnim pacientom (METHOD AND PHARMACEUTICAL COMPOSITION FOR IRON DELIVERY IN HEMODIALYSIS AND PERITONEAL DIALYSIS PATIENTS) | See Plans and Pricing |
Denmark | 0951470 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |