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AURYXIA Drug Patent Profile
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Which patents cover Auryxia, and when can generic versions of Auryxia launch?
Auryxia is a drug marketed by Keryx Biopharms and is included in one NDA. There are fifteen patents protecting this drug.
This drug has one hundred and thirty-four patent family members in twenty-six countries.
The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric citrate profile page.
DrugPatentWatch® Generic Entry Outlook for Auryxia
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 18, 2024. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for AURYXIA
| International Patents: | 134 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 69 |
| Clinical Trials: | 8 |
| Patent Applications: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AURYXIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AURYXIA |
| What excipients (inactive ingredients) are in AURYXIA? | AURYXIA excipients list |
| DailyMed Link: | AURYXIA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for AURYXIA
Generic Entry Date for AURYXIA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for AURYXIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| USRC Kidney Research | Phase 4 |
| Akebia Therapeutics Inc. | Phase 4 |
| Akebia Therapeutics | Phase 1 |
Pharmacology for AURYXIA
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for AURYXIA
US Patents and Regulatory Information for AURYXIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for AURYXIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 192545 | ⤷ Try it Free |
| Australia | 2007210090 | ⤷ Try it Free |
| China | 101374416 | ⤷ Try it Free |
| European Patent Office | 2360139 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
