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 fourteen patents protecting this drug.
This drug has one hundred and twenty-two patent family members in twenty-three 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 six 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: | 122 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 9 |
| Patent Applications: | 668 |
| 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 Loss of Exclusivity (LOE) 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 |
|---|---|
| Akebia Therapeutics | Phase 3 |
| USRC Kidney Research | Phase 3 |
| USRC Kidney Research | Phase 4 |
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
AURYXIA is protected by fourteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AURYXIA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting AURYXIA
Ferric citrate dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHORUS LEVELS
Ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Ferric citrate dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS
| 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 a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for AURYXIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AURYXIA
See the table below for patents covering AURYXIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 100464504 | ⤷ Try a Trial | |
| Taiwan | I754951 | ⤷ Try a Trial | |
| European Patent Office | 1978807 | MÉTHODE DE TRAITEMENT DE NÉPHROPATHIE CHRONIQUE (METHOD OF TREATING CHRONIC KIDNEY DISEASE) | ⤷ Try a Trial |
| Canada | 2272711 | PROCEDES DE TRAITEMENT DE L'INSUFFISANCE RENALE (METHOD FOR TREATING RENAL FAILURE) | ⤷ Try a Trial |
| Japan | 6154226 | ⤷ Try a Trial | |
| Hungary | E028029 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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