INJECTAFER Drug Patent Profile
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Which patents cover Injectafer, and when can generic versions of Injectafer launch?
Injectafer is a drug marketed by Am Regent and is included in one NDA. There are six patents protecting this drug and four Paragraph IV challenges.
This drug has seventy-one patent family members in thirty-two countries.
The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
DrugPatentWatch® Generic Entry Outlook for Injectafer
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 31, 2026. This may change due to patent challenges or generic licensing.
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Summary for INJECTAFER
| International Patents: | 71 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 21 |
| Patent Applications: | 47 |
| Drug Prices: | Drug price information for INJECTAFER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INJECTAFER |
| What excipients (inactive ingredients) are in INJECTAFER? | INJECTAFER excipients list |
| DailyMed Link: | INJECTAFER at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INJECTAFER
*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 INJECTAFER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 |
| Baylor College of Medicine | Phase 3 |
| M.D. Anderson Cancer Center | Phase 2 |
Pharmacology for INJECTAFER
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Paragraph IV (Patent) Challenges for INJECTAFER
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| INJECTAFER | Injection | ferric carboxymaltose | 500 mg/10 mL | 203565 | 1 | 2024-02-22 |
| INJECTAFER | Injection | ferric carboxymaltose | 100 mg/2 mL | 203565 | 1 | 2022-09-23 |
| INJECTAFER | Injection | ferric carboxymaltose | 1 g/20 mL | 203565 | 1 | 2022-02-15 |
| INJECTAFER | Injection | ferric carboxymaltose | 750 mg/15 mL | 203565 | 1 | 2019-03-27 |
US Patents and Regulatory Information for INJECTAFER
INJECTAFER is protected by twenty-six US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of INJECTAFER is ⤷ Sign Up.
This potential generic entry date is based on TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY.
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 INJECTAFER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IRON DEFICIENCY IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN LESS THAN 15 MINUTES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.7 G OF IRON IN 15 MINUTES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 46.7 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN < 15 MINUTES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IDA IN ADULT PATIENTS WEIGHING AT LEAST 46.7 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULTS WHO HAVE INTOLERANCE TO OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR A GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER HAVING INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NON-IMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON IN ABOUT ≤ 15 MIN
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6 GRAMS OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
Methods and compositions for administration of iron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY ADMINISTERING IV AT LEAST ABOUT 0.6 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
FDA Regulatory Exclusivity protecting INJECTAFER
NEW STRENGTH
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-002 | Oct 8, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-004 | Feb 4, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 INJECTAFER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-001 | Jul 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-003 | Apr 28, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-001 | Jul 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INJECTAFER
See the table below for patents covering INJECTAFER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1118780 | ⤷ Sign Up | |
| South Korea | 20140117678 | METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON | ⤷ Sign Up |
| China | 100480275 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INJECTAFER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1554315 | C01554315/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EISEN ALS EISENCARBOXYMALTOSE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 57851 10.11.2022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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