ERAXIS Drug Patent Profile
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When do Eraxis patents expire, and when can generic versions of Eraxis launch?
Eraxis is a drug marketed by Vicuron Holdings and is included in one NDA.
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.
Summary for ERAXIS
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 45 |
| Clinical Trials: | 11 |
| Patent Applications: | 3,660 |
| Drug Prices: | Drug price information for ERAXIS |
| What excipients (inactive ingredients) are in ERAXIS? | ERAXIS excipients list |
| DailyMed Link: | ERAXIS at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ERAXIS
Generic Entry Date for ERAXIS*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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 |
|---|---|
| Texas Tech University Health Sciences Center | Phase 4 |
| University of Texas Southwestern Medical Center | Phase 4 |
| National Center for Research Resources (NCRR) | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ERAXIS
US Patents and Regulatory Information for ERAXIS
ERAXIS is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ERAXIS is See Plans and Pricing.
This potential generic entry date is based on NEW PATIENT POPULATION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting ERAXIS
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | See Plans and Pricing | See Plans and Pricing |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | See Plans and Pricing | See Plans and Pricing |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | See Plans and Pricing | See Plans and Pricing |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | See Plans and Pricing | See Plans and Pricing |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ERAXIS
See the table below for patents covering ERAXIS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 105048 | CYCLIC PEPTIDE ANTIFUNGAL AGENTS AND PROCESS FOR PREPARATION THEREOF | See Plans and Pricing |
| Japan | 4936595 | See Plans and Pricing | |
| European Patent Office | 0561639 | Dérivés cyclopeptidiques antifongiques et procédé de leur préparation (Cyclic peptide antifungal agents and process for preparation thereof) | See Plans and Pricing |
| Hungary | T63637 | See Plans and Pricing | |
| Australia | 689391 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ERAXIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0561639 | SPC002/2008 | Ireland | See Plans and Pricing | SPC002/2008: 20081105, EXPIRES: 20180317 |
| 0561639 | 08C0009 | France | See Plans and Pricing | PRODUCT NAME: ANIDULAFUNGINE; REGISTRATION NO/DATE: EU/1/07/416/001 20070920 |
| 0561639 | 91406 | Luxembourg | See Plans and Pricing | 91406, EXPIRES: 20180318 |
| 0561639 | SPC/GB08/016 | United Kingdom | See Plans and Pricing | PRODUCT NAME: ANIDULAFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/416/001 20070920 |
| 0561639 | 300334 | Netherlands | See Plans and Pricing | 300334, 20130318, EXPIRES: 20180317 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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