Details for New Drug Application (NDA): 203565
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NDA 203565 describes INJECTAFER, which is a drug marketed by Am Regent and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the INJECTAFER profile page.
The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
Summary for 203565
| Tradename: | INJECTAFER |
| Applicant: | Am Regent |
| Ingredient: | ferric carboxymaltose |
| Patents: | 6 |
Pharmacology for NDA: 203565
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 203565
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565 | NDA | American Regent, Inc. | 0517-0602 | 0517-0602-01 | 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
| INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565 | NDA | American Regent, Inc. | 0517-0620 | 0517-0620-01 | 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 750MG IRON/15ML (50MG IRON/ML) | ||||
| Approval Date: | Jul 25, 2013 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 31, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 8, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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: | ⤷ Start Trial | Patent Expiration: | Jan 8, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
Expired US Patents for NDA 203565
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-004 | Feb 4, 2022 | ⤷ Start Trial | ⤷ Start Trial |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-004 | Feb 4, 2022 | ⤷ Start Trial | ⤷ Start Trial |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-004 | Feb 4, 2022 | ⤷ Start Trial | ⤷ Start Trial |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-001 | Jul 25, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-003 | Apr 28, 2021 | ⤷ Start Trial | ⤷ Start Trial |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-002 | Oct 8, 2020 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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