INJECTAFER Drug Patent Profile
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When do Injectafer patents expire, and when can generic versions of Injectafer launch?
Injectafer is a drug marketed by Am Regent and is included in one NDA. There are five patents protecting this drug and two 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 November 19, 2024. This may change due to patent challenges or generic licensing.
There have been four 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
Summary for INJECTAFER
| International Patents: | 71 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 21 |
| 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 Generic Entry Opportunity Date for INJECTAFER
Generic Entry Date for INJECTAFER*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION NDA:
Dosage:
INJECTABLE;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 INJECTAFER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Baylor College of Medicine | Phase 3 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 |
| M.D. Anderson Cancer Center | Phase 2 |
Paragraph IV (Patent) Challenges for INJECTAFER
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| 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 US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of INJECTAFER is See Plans and Pricing.
This potential generic entry date is based on NEW PATIENT POPULATION.
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
Aqueous iron carbohydrate complexes, their production and medicaments containing them
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Aqueous iron carbohydrate complexes, their production and medicaments containing them
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Aqueous iron carbohydrate complexes, their production and medicaments containing them
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Aqueous iron carbohydrate complexes, their production and medicaments containing them
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods and compositions for administration of iron
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Aqueous iron carbohydrate complexes, their production and medicaments containing them
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting INJECTAFER
NEW STRENGTH
Exclusivity Expiration: See Plans and Pricing
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
International Patents for INJECTAFER
When does loss-of-exclusivity occur for INJECTAFER?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1472
Estimated Expiration: See Plans and Pricing
Australia
Patent: 03278111
Estimated Expiration: See Plans and Pricing
Austria
Patent: 7246
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 15452
Estimated Expiration: See Plans and Pricing
Patent: 0315452
Estimated Expiration: See Plans and Pricing
Patent: 0318840
Estimated Expiration: See Plans and Pricing
Canada
Patent: 93806
Estimated Expiration: See Plans and Pricing
China
Patent: 05682
Estimated Expiration: See Plans and Pricing
Patent: 0480275
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 12680
Estimated Expiration: See Plans and Pricing
Patent: 13387
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 54315
Estimated Expiration: See Plans and Pricing
Patent: 87204
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 54315
Estimated Expiration: See Plans and Pricing
Patent: 87204
Estimated Expiration: See Plans and Pricing
Germany
Patent: 249552
Estimated Expiration: See Plans and Pricing
Patent: 313653
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 81976
Estimated Expiration: See Plans and Pricing
Patent: 49574
Estimated Expiration: See Plans and Pricing
Israel
Patent: 6747
Estimated Expiration: See Plans and Pricing
Japan
Patent: 77653
Estimated Expiration: See Plans and Pricing
Patent: 89413
Estimated Expiration: See Plans and Pricing
Patent: 06505638
Estimated Expiration: See Plans and Pricing
Patent: 11052226
Estimated Expiration: See Plans and Pricing
Jordan
Patent: 0180046
Estimated Expiration: See Plans and Pricing
Patent: 86
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 4394
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 05004300
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 9243
Estimated Expiration: See Plans and Pricing
Norway
Patent: 3008
Estimated Expiration: See Plans and Pricing
Patent: 5770
Estimated Expiration: See Plans and Pricing
Patent: 052410
Estimated Expiration: See Plans and Pricing
Patent: 110654
Estimated Expiration: See Plans and Pricing
Peru
Patent: 040571
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 54315
Estimated Expiration: See Plans and Pricing
Patent: 87204
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 03039
Estimated Expiration: See Plans and Pricing
Patent: 05115455
Estimated Expiration: See Plans and Pricing
Saudi Arabia
Patent: 95
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 54315
Estimated Expiration: See Plans and Pricing
Patent: 87204
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0504174
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 0992178
Estimated Expiration: See Plans and Pricing
Patent: 050070014
Estimated Expiration: See Plans and Pricing
Spain
Patent: 64136
Estimated Expiration: See Plans and Pricing
Patent: 85788
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 65028
Estimated Expiration: See Plans and Pricing
Patent: 0420289
Estimated Expiration: See Plans and Pricing
Uruguay
Patent: 033
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 INJECTAFER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2626074 | Procédés et compositions pour l'administration de fer (Methods and compositions for administration of iron) | See Plans and Pricing |
| European Patent Office | 3081219 | PROCÉDÉS ET COMPOSITIONS POUR L'ADMINISTRATION DE FER (METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON) | See Plans and Pricing |
| Hong Kong | 1149574 | WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES | See Plans and Pricing |
| South Korea | 100992178 | See Plans and Pricing | |
| Norway | 20110654 | See Plans and Pricing | |
| Spain | 2602433 | See Plans and Pricing | |
| Hong Kong | 1081976 | WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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