Details for New Drug Application (NDA): 205874
✉ Email this page to a colleague
NDA 205874 describes AURYXIA, which is a drug marketed by Keryx Biopharms and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the AURYXIA profile page.
The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric citrate profile page.
The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric citrate profile page.
Summary for 205874
| Tradename: | AURYXIA |
| Applicant: | Keryx Biopharms |
| Ingredient: | ferric citrate |
| Patents: | 3 |
Pharmacology for NDA: 205874
| Mechanism of Action | Phosphate Chelating Activity |
Suppliers and Packaging for NDA: 205874
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AURYXIA | ferric citrate | TABLET;ORAL | 205874 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-2895 | 0378-2895-20 | 200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20) |
| AURYXIA | ferric citrate | TABLET;ORAL | 205874 | NDA | Akebia Therapeutics, Inc. | 59922-631 | 59922-631-01 | 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 210MG IRON | ||||
| Approval Date: | Sep 5, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 21, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | CONTROL OF SERUM PHOSPHORUS LEVELS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 21, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | CONTROL OF SERUM PHOSPHOROUS LEVELS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 21, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 205874
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
