✉ Email this page to a colleague
« Back to Dashboard
▶ Start for $1
Remove trial restrictions
Eluxadolineis the generic ingredient in one branded drug marketed by Allergan Holdings and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Eluxadoline has one hundred and fifty-two patent family members in forty countries.
There are two drug master file entries for eluxadoline. One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for eluxadoline
|Drug Master File Entries:||2|
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||28|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for eluxadoline|
|What excipients (inactive ingredients) are in eluxadoline?||eluxadoline excipients list|
|DailyMed Link:||eluxadoline at DailyMed|
Recent Clinical Trials for eluxadoline
Identify potential brand extensions & 505(b)(2) entrants
|Temple University||Phase 2/Phase 3|
|University of North Carolina, Chapel Hill||Phase 2|
Generic filers with tentative approvals for ELUXADOLINE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for eluxadoline
|Drug Class|| mu-Opioid Receptor Agonist |
|Mechanism of Action||Opioid mu-Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for eluxadoline
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Allergan Holdings||VIBERZI||eluxadoline||TABLET;ORAL||206940-002||May 27, 2015||RX||Yes||Yes||See Plans and Pricing||See Plans and Pricing||Y||Y||See Plans and Pricing|
|Allergan Holdings||VIBERZI||eluxadoline||TABLET;ORAL||206940-001||May 27, 2015||RX||Yes||No||See Plans and Pricing||See Plans and Pricing||Y||Y||See Plans and Pricing|
|Allergan Holdings||VIBERZI||eluxadoline||TABLET;ORAL||206940-001||May 27, 2015||RX||Yes||No||See Plans and Pricing||See Plans and Pricing||Y||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|
|Company||Drugname||Inn||Product Number / Indication||Status||Generic||Biosimilar||Orphan||Marketing Authorisation||Marketing Refusal|
|Allergan Pharmaceuticals International Limited||Truberzi||eluxadoline||EMEA/H/C/004098
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|
|Country||Patent Number||Title||Estimated Expiration|
|Japan||4778954||See Plans and Pricing|
|Hong Kong||1099016||NOVEL COMPOUNDS AS OPIOID RECEPTOR MODULATORS||See Plans and Pricing|
|Cyprus||1114167||See Plans and Pricing|
|>Country||>Patent Number||>Title||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1725537||C 2017 006||Romania||See Plans and Pricing||PRODUCT NAME: ELUXADOLINA SAU UN ENANTIOMER, UN DIASTEREOMER, UN RACEMAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1126; DATE OF NATIONAL AUTHORISATION: 20160919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1126; DATE OF FIRST AUTHORISATION IN EEA: 20160919|
|1725537||2017/007||Ireland||See Plans and Pricing||PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1126 20160919|
|1725537||PA2017005,C1725537||Lithuania||See Plans and Pricing||PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.