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. 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 |
| 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 Loss of Exclusivity (LOE) 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 |
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Packaging of ferric pyrophosphate for dialysis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | SOLUTION;INTRAVENOUS | 206317-002 | Sep 4, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rockwell Medical Inc | TRIFERIC | ferric pyrophosphate citrate | FOR SOLUTION;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 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 | ⤷ 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 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: ⤷ Try a Trial
Canada
Patent: 50493
Estimated Expiration: ⤷ Try a Trial
Patent: 38081
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0120416
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 13903
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 16940
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 16940
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 89196
Estimated Expiration: ⤷ Try a Trial
Patent: 09108027
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 16940
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 16940
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 16940
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 83713
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Austria | 311180 | ⤷ Try a Trial | |
| Turkey | 9901518 | ⤷ Try a Trial | |
| Japan | 2009108027 | METHOD FOR PREPARATION AND USE OF FERRIC PYROPHOSPHATE CITRATE CHELATE COMPOSITION | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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