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Last Updated: May 25, 2022

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

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Summary for INJECTAFER
Drug patent expirations by year for INJECTAFER
Drug Prices for INJECTAFER

See drug prices for INJECTAFER

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

SponsorPhase
Baylor College of MedicinePhase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
M.D. Anderson Cancer CenterPhase 2

See all INJECTAFER clinical trials

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

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Boehringer Ingelheim
McKinsey
Mallinckrodt
Colorcon

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.