Ferric carboxymaltose - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for ferric carboxymaltose and what is the scope of freedom to operate?
Ferric carboxymaltose
is the generic ingredient in one branded drug marketed by Am Regent and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ferric carboxymaltose has seventy-one patent family members in thirty-two countries.
There are two drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.
Summary for ferric carboxymaltose
International Patents: | 71 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 13 |
Clinical Trials: | 128 |
Patent Applications: | 105 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ferric carboxymaltose |
DailyMed Link: | ferric carboxymaltose at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ferric carboxymaltose
Generic Entry Date for ferric carboxymaltose*:
Constraining patent/regulatory exclusivity:
TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY 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 ferric carboxymaltose
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The First Hospital of Jilin University | Phase 1 |
Boji Data Technology (Beijing) Co., Ltd. | Phase 1 |
Suzhou Guochen Biotek Co., Ltd. | Phase 1 |
Pharmacology for ferric carboxymaltose
Drug Class | Parenteral Iron Replacement Phosphate Binder |
Mechanism of Action | Phosphate Chelating Activity |
Paragraph IV (Patent) Challenges for FERRIC CARBOXYMALTOSE
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 ferric carboxymaltose
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 | 203565-003 | Apr 28, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | 203565-003 | Apr 28, 2021 | 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 ferric carboxymaltose
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 ferric carboxymaltose
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 20052410 | ⤷ Sign Up | |
New Zealand | 539243 | Water-soluble iron-carbohydrate complexes, their production and medicaments containing them | ⤷ Sign Up |
European Patent Office | 3081219 | PROCÉDÉS ET COMPOSITIONS POUR L'ADMINISTRATION DE FER (METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ferric carboxymaltose
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 |
Make Better Decisions: Try a trial or see plans & pricing
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.