Details for New Drug Application (NDA): 212320
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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 | |||||
Regulatory Exclusivity Expiration: | Jul 25, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 6, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING IRON DEFICIENCY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 29, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING IRON DEFICIENCY |
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