Details for New Drug Application (NDA): 205874
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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. Two 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. Two 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205874
Generic Entry Date for 205874*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 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: | RLD: | Yes | |||||
| Patent: | 10,300,039 | Patent Expiration: | Jul 21, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | CONTROL OF SERUM PHOSPHORUS LEVELS | ||||||||
| Patent: | 8,093,423 | Patent Expiration: | Apr 21, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | CONTROL OF SERUM PHOSPHOROUS LEVELS | ||||||||
| Patent: | 9,387,191 | 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 | 9,050,316 | ⤷ Get Started Free |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | 8,609,896 | ⤷ Get Started Free |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | 8,901,349 | ⤷ Get Started Free |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | 5,753,706 | ⤷ Get Started Free |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | 8,754,258 | ⤷ Get Started Free |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | 9,328,133 | ⤷ Get Started Free |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | 8,754,257 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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