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 one supplier. 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. One supplier is 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. One supplier is 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203565
Generic Entry Date for 203565*:
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.
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 19, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| 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: | ⤷ Sign Up | 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 | ||||||||
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 | 203565-001 | 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 |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-002 | Oct 8, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-002 | Oct 8, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-002 | Oct 8, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-003 | Apr 28, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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