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ERAXIS Drug Profile
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See Plans and PricingWhen do Eraxis patents expire, and when can generic versions of Eraxis launch?
Eraxis is a drug marketed by Vicuron and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-seven patent family members in twenty-nine countries.
The generic ingredient in ERAXIS is anidulafungin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the anidulafungin profile page.
US ANDA Litigation and Generic Entry Outlook for Eraxis
Eraxis was eligible for patent challenges on February 17, 2010.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 12, 2021. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ERAXIS
| International Patents: | 67 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,461 |
| Drug Prices: | Drug price information for ERAXIS |
| DailyMed Link: | ERAXIS at DailyMed |
Generic Entry Opportunity Date for ERAXIS
Generic Entry Date for ERAXIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS |
*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 ERAXIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Center for Research Resources (NCRR) | Phase 4 |
| University of Texas Southwestern Medical Center | Phase 4 |
| Texas Tech University Health Sciences Center | Phase 4 |
Pharmacology for ERAXIS
| Drug Class | Echinocandin Antifungal |
Synonyms for ERAXIS
| 166663-25-8 |
| 663A258 |
| 9HLM53094I |
| AC1L4YAI |
| AKOS030526640 |
| AN-5571 |
| Anidulafungin |
| Anidulafungin (LY303366) |
| Anidulafungin [USAN:INN:BAN] |
| Anidulafungin [USAN:INN] |
| Anidulafungina |
| Anidulafungine |
| Anidulafunginum |
| AT-36943 |
| BDBM50417554 |
| C58H73N7O17 |
| CHEBI:55346 |
| CHEMBL264241 |
| DB00362 |
| Ecalta |
| Echinocandin B, 1-((4R,5R)-4,5-dihydroxy-N(sup 2)-((4'-(pentyloxy)(1,1':4',1'-terphenyl)-4-yl)carbonyl)-L-ornithine)- |
| Echinocandin B, 1-((4R,5R)-4,5-dihydroxy-N2-((4''-(pentyloxy)(1,1':4',1''-terphenyl)-4-yl)carbonyl)-L-ornithine) |
| Echinocandin B, 1-((4R,5R)-4,5-dihydroxy-N2-((4"-(pentyloxy)(1,1':4',1"-terphenyl)-4-yl)carbonyl)-L-ornithine) |
| J-010304 |
| LS-63738 |
| LY-303366 |
| LY303366 |
| MolPort-006-167-527 |
| N-((2R,6S,9S,11R,12R,14aS,15S,16S,20S,23S,25aS)-23-((1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl)-2,11,12,15-tetrahydroxy-6,20-bis((R)-1-hydroxyethyl)-16-methyl-5,8,14,19,22,25-hexaoxo |
| N-[[(1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-tetrahydroxy-bis[(1R)-1-hydroxyethyl]-methyl-hexaoxo-[?]yl]-4-[4-(4-pentoxyphenyl)phenyl]benzamide |
| NCGC00386349-01 |
| s4286 |
| SCHEMBL38292 |
| SW222238-1 |
| tetracosahydro-1H-dipyrrolo[2,1-c:2',1'-l][1,4,7,10,13,16]hexaazacyclohenicosin-9-yl)-4''-(pentyloxy)-[1,1':4',1''-terphenyl]-4-carboxamide |
| UNII-9HLM53094I |
| V-Echinocandin |
| VER-002 |
| Z-3192 |
US Patents and Regulatory Information for ERAXIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vicuron | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Vicuron | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Vicuron | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start 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 ERAXIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vicuron | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | Start Trial | Start Trial |
| Vicuron | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | Start Trial | Start Trial |
| Vicuron | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ERAXIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2004115540 | Start Trial |
| Norway | 930948 | Start Trial |
| Japan | 4936595 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ERAXIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0561639 | SPC002/2008 | Ireland | Start Trial | SPC002/2008: 20081105, EXPIRES: 20180317 |
| 0561639 | 91406 | Luxembourg | Start Trial | 91406, EXPIRES: 20180318 |
| 0561639 | C300334 | Netherlands | Start Trial | PRODUCT NAME: ANIDULAFUNGIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/416/001 20070920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
