Details for New Drug Application (NDA): 212320
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NDA 212320 describes ACCRUFER, which is a drug marketed by Shield Tx and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ACCRUFER profile page.
The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric maltol profile page.
The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric maltol profile page.
Summary for 212320
| Tradename: | ACCRUFER |
| Applicant: | Shield Tx |
| Ingredient: | ferric maltol |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212320
Generic Entry Date for 212320*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*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: 212320
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 212320
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320 | NDA | Shield TX (UK) Ltd | 73059-001 | 73059-001-10 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC |
| ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320 | NDA | Shield TX (UK) Ltd | 73059-001 | 73059-001-60 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG IRON | ||||
| Approval Date: | Jul 25, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 10,179,120 | Patent Expiration: | Jan 6, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING IRON DEFICIENCY | ||||||||
| Patent: | 9,248,148 | Patent Expiration: | Mar 29, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING IRON DEFICIENCY | ||||||||
| Patent: | 9,802,973 | Patent Expiration: | Oct 23, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING IRON DEFICIENCY | ||||||||
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