NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as AM REGENT. It is marketed under 1 brand name, including INJECTAFER. Available in 4 different strengths, such as 750MG IRON/15ML (50MG IRON/ML), 500MG IRON/10ML (50MG IRON/ML), 1GM IRON/20ML (50MG IRON/ML) and others, and administered through 1 route including SOLUTION;INTRAVENOUS.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"1546","ingredient":"FERRIC CARBOXYMALTOSE","trade_name":"INJECTAFER","family_id":"70c2bf1998d7445bbd4c","publication_number":"US7612109B2","cleaned_patent_number":"7612109","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-02-05","publication_date":"2009-11-03","legal_status":"Expired"} | US7612109B2 Molecular Formulation | 03 Nov, 2009 | Expired | 05 Feb, 2026 | |
| {"application_id":"41008","ingredient":"FERRIC CARBOXYMALTOSE","trade_name":"INJECTAFER","family_id":"ec8f23a9c35745238d2a","publication_number":"US11364260B2","cleaned_patent_number":"11364260","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-08","publication_date":"2022-06-21","legal_status":"Patented case"} | US11364260B2 | 21 Jun, 2022 | Patented case | 08 Jan, 2027 | |
| {"application_id":"41010","ingredient":"FERRIC CARBOXYMALTOSE","trade_name":"INJECTAFER","family_id":"ec8f23a9c35745238d2a","publication_number":"US11433091B2","cleaned_patent_number":"11433091","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-08","publication_date":"2022-09-06","legal_status":"Patented case"} | US11433091B2 | 06 Sep, 2022 | Patented case | 08 Jan, 2027 | |
| {"application_id":"107326","ingredient":"FERRIC CARBOXYMALTOSE","trade_name":"INJECTAFER","family_id":"ec8f23a9c35745238d2a","publication_number":"US11478502B2","cleaned_patent_number":"11478502","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-08","publication_date":"2022-10-25","legal_status":"Granted"} | US11478502B2 | 25 Oct, 2022 | Granted | 08 Jan, 2027 | |
| {"application_id":"40984","ingredient":"FERRIC CARBOXYMALTOSE","trade_name":"INJECTAFER","family_id":"ec8f23a9c35745238d2a","publication_number":"US8895612B2","cleaned_patent_number":"8895612","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-08","publication_date":"2014-11-25","legal_status":"Patented case"} | US8895612B2 | 25 Nov, 2014 | Patented case | 08 Jan, 2027 | |
| {"application_id":"41004","ingredient":"FERRIC CARBOXYMALTOSE","trade_name":"INJECTAFER","family_id":"ec8f23a9c35745238d2a","publication_number":"US7754702B2","cleaned_patent_number":"7754702","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-15","publication_date":"2010-07-13","legal_status":"Patented case"} | US7754702B2 | 13 Jul, 2010 | Patented case | 15 Feb, 2028 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.